Guided self-determination in treatment of chronic pain – a randomized, controlled trial

Anne Paarup Pickering; Nina Jeanette Bache; Stine Estrup

doi:10.1515/sjpain-2021-0007

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Guided self-determination in treatment of chronic pain – a randomized, controlled trial

Anne Paarup Pickering , Nina Jeanette Bache und Stine Estrup

Veröffentlicht/Copyright: 31. Juli 2021

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Aus der Zeitschrift Scandinavian Journal of Pain Band 22 Heft 2

Abstract

Objectives

To test whether Guided Self-Determination (GSD) used in chronic pain management could improve the health-related quality of life, patient activation and sense of coherence (SoC) as a measurement of life skills in patients with chronic pain. The method has been shown to be effective in other chronic conditions, but has not been tested in chronic pain.

Methods

A three-site randomised, controlled trial at three major multidisciplinary pain centres in Denmark. 200 patients were included and randomised. In the intervention period, both groups had regular visits to the pain centre with both doctors and nurses. The intervention group additionally received the GSD intervention with weekly sessions for eight weeks. Data were collected from February 2013 to July 2016 and consisted of three questionnaires answered before and after the 8-week intervention period, and after six months. The primary outcome was self-reported health related quality of life. Secondary outcomes included self-reported activation and SoC.

Results

We found no clinically relevant difference between the groups for health-related quality of life, patient activation or SoC at either baseline, at three months or at six months. We also analysed data for trends over time using mixed model analysis, and this did not show any significant differences between groups.

Conclusions

GSD did not improve health-related quality of life, patient activation or SoC when administered to patients with chronic pain treated in a multidisciplinary pain centre. New research is recommended using a combination of self-reported and objective measures and longer follow-up.

IRB approval number: H-4-2012-FSP

Clinicaltrials.gov identifier: NCT02084459

Keywords: chronic pain care; empowerment; guided self-determination; nursing intervention; patient activation; sense of coherence

Introduction

In Denmark, every fifth adult suffers daily from chronic pain, leading to high socio-economic costs related to treatment, sick leave and early retirement, exceeding DKK 10 billion annually for back pain alone [1], [2], [3]. This is similar to other studies across Europe, finding 19% of people to experience chronic pain, and furthermore, back pain is the leading cause of disability in a global perspective [4], [5], [6], [7], [8]. Hereto may be added the human cost of reduced physical ability, anxiety, depression, disaster thinking, fatigue and often inappropriate attempts to adjust to the condition [5]. The International Association of the Study of Pain defines chronic pain as: ‘pain that persists beyond normal tissue healing time, which is assumed to be 3 months’ [9].

Fear of pain can be a significant part of chronic pain, and a better prophylactic effort must be made including the education of the pain patients in taking responsibility for their condition. High participation in decision making is the basis of meaningfulness, which is the key motivating factor in Antonovsky’s theory of SoC [10]. Comprehensibility, manageability and meaningfulness are the three main components of SoC. When others act on our behalf as human beings and decide for us, we are reduced to objects [7]. The patients find themselves in a health system where they experience increased responsibility and involvement, but the responsibility is expected to be taken within the framework of the health system which is still bio-medically based, and thereby a more passive patient role model is assumed [9]. Hence, chronic pain patients and health professionals tend to have opposing attitudes and goals in that health professionals tend to focus on the disease and see the challenges from a more general-centred, theoretical angle, and patients focus more on their life situation from a person-centred angle with individual norms and values. They want to be understood as the individual human beings that they are, and struggle to legitimise their pain problems. By focusing on diagnoses and treatment rather than life quality and everyday life, the professionals may lose insight into the patients’ decisions according to their personal convictions and inner core values [3, 11, 12]. Communication training and altered attitudes towards ‘shared decision making’ may contribute to an improved interaction [12, 13]. Shared decision making has been defined as: ‘An approach where clinicians and patients share the best available evidence when faced with the task of making decisions, and where patients are supported to consider options, to achieve informed preferences’ [14].

The aim of the chronic pain treatment at multidisciplinary pain centres is for the individual patients to develop coping strategies leading to best possible life quality with the chronic pain condition. This includes acceptance of the fact that pain is a part of their daily life [15]. The multidisciplinary treatment is considered most effective and therefore as best practice at the pain centres [16, 17]. Current treatment options have, however, yielded less than satisfactory results, and new methods are needed.

In 2004, Zoffmann developed and tested the method GSD to facilitate a meaningful and effective way of problem solving for the diabetic patient and the health professional [18]. Both staff and patients are guided through 32 reflection sheets to use their potential – separately and together – in a process to improve the life skills of the patient [18, 19]. GSD has subsequently been used for other chronic diseases [19].

It is the aim of GSD for the patients to gain ownership of the disease, enabling the patients to be the actual problem solvers and the health professionals to support the patients in gaining control of their own situation, strength to make decisions and to carry through changes adhering to the concept of empowerment – a process whereby people gain greater control over decisions and actions affecting their health. This is achieved through a social, cultural, psychological or political process in which they are able to express their needs, present their concerns, devise strategies for involvement in decision making, and achieve political, social and cultural action to meet those needs [11, 13].

It is in this light that GSD is now being tested. GSD is a method which in a structured set-up for a limited time period invites the patients to reflect on their thoughts and actions. It is believed that by the patients pointing out themselves how and when to make life changes, rather than having the possibilities presented to them, they will actually carry out the changes and maintain them over time.

The aim of this study was to assess effect of a GSD intervention on health-related quality of life, patient activation and SoC as a measurement of life skills. We hypothesised that life skills would improve. Life skills are abilities for adaptive and positive behaviour that enable individuals to deal effectively with the demands and challenges of everyday life. Life skills consist of personal, interpersonal, cognitive and physical skills which enable people to control and direct their lives, and to develop the capacity to live with and produce change in their environment.

Methods

The study design was a randomised, controlled intervention study using the method of GSD with a group of chronic pain patients compared with a control group. The intervention was carried out at three multidisciplinary hospital pain centres with comparable set-ups: University Hospital of Copenhagen, Herlev; Naestved Hospital in the Region of Zealand; and University Hospital of Zealand, Koege. The study was registered at clinicaltrials.gov with identifier NCT02084459.

Participants

Patients were recruited at the three above-mentioned centres as these centres cover both urban and rural areas, giving a more diverse sample.

In order to show a defined minimal clinically important difference (MCID) of 5 points in the mental score of SF-36 between the intervention and the control group, 80% power and a 5% significance level, data from a minimum of 63 participants would be needed in each group, i.e. a total of 126 participants. To allow for loss to follow-up, 200 patients were planned to be recruited.

Between February 2013 and December 2015, 200 patients were recruited for the study, having met the following eligibility criteria: (a) age 18 years old or more; (b) diagnosed with chronic pain; (c) had not been diagnosed with any psychiatric disease [determined from referral and history taken at first visit – all patients having answered an HAD (Hospital Anxiety and Depression) questionnaire prior to the visit]; (d) were not engaged in psychological treatment at the time of recruitment; (e) did not have a known medical abuse problem and (f) had the ability to speak, write and understand Danish. All patients were consecutively recruited at their first visit at the three centres. There was no a priori allocation distribution between the participating centres.

GSD intervention

Two pain management nurses (NJB and APP) provided the GSD intervention in addition to their conventional outpatient clinical care. The same two nurses provided the intervention at all three centres. Both nurses were trained and certified in the method of GSD for groups by Steno Diabetes Center and professor V. Zoffmann, and received subsequent supervision by a senior GSD instructor at the pain centres. Targeted communication training of the pain management nurses was an obligatory part of the method [13, 18]. The training covered 4 × 6 h of common introduction to the theoretical background of the method as well as communication training and subsequent supervision.

The original GSD method was adapted to chronic pain patients with the full prior approval of professor Zoffmann and her team. The intervention was divided into eight weekly sessions over an 8-week period with a standard duration of 2 ½ hours per session in a group setting with four patients and one pain management nurse per group. The groups were set consecutively at recruitment. The intervention consisted of 32 reflection sheets developed as a specific working tool to support the process of GSD, see Table S1. The reflection sheets are semi-structured, inviting the patients to reflect on their individual situations and to be actively co-operating with the nurses [18]. GSD can be a tool to promote shared decision making in patients with chronic conditions.

The 32 reflection sheets are divided into sheets on (1) working relationship, (2) your life with pain, (3) between ideal and reality and (4) working with change, where the patients explore important areas and personal challenges in relation to living with pain, based on their own experiences, through words and drawings (Table S1 in supplementary material).

Standard care

At all three centres, patients are treated using a multidisciplinary approach. Patients are seen by both nurses and doctors in all cases. If needed, patients can receive treatment and advice from physiotherapists, psychologists and social workers. For the first ten weeks of the trial, both groups were seen only by doctors and nurses for pharmacological treatment and advice on coping strategies. It is normal pain centre practice to rationalise medicine before other multidisciplinary interventions.

After ten weeks, both groups could then receive treatment from the full multidisciplinary team for as long as they attended the pain centre.

Blinding

The nature of the intervention did not permit the nurses providing the intervention or the participants receiving the intervention to be unaware of group allocation. As far as possible, other nurses would attend to the patients in the control group having the project nurses concentrate on the intervention group. This was, however, not always possible. Secretaries and analysts were blind to participants’ group allocation at each data collection time-point.

Data collection and allocation

At the initial visit at the pain centre, the eligible patients were invited to participate in the study and informed verbally hereof. This information was given by one of the research nurses (APP and NJB) or by one of the other staff members at the pain centre. The patient was given oral and written information of the project plus a written consent form. A new appointment to see the nurse a week later was made. On recruitment, the patient received three questionnaires and a demographic data form for completion.

At the second visit, the verbal information was repeated. If the patient wanted to participate, it was checked if questionnaires were returned and the written consent form duly signed. If questionnaires were not filled, patients were reminded of this. An envelope was then drawn by a secretary from the pile of consecutively numbered, randomly stacked, opaque sealed envelopes containing information of whether the patient was recruited to the intervention group or to the control group. The participants were randomised in blocks of 16 envelopes. This was for practical reasons to ensure a flow in the study, as each intervention period covered 8 weeks, and it was needed to have an equal number of participants in the two groups, i.e. 4 participants in each of the two groups before an intervention period of 8 weeks could begin.

The participants of both groups were informed that they could receive further multidisciplinary treatment two weeks after the end of the intervention period if indicated. Visitation to further treatment followed the usual criteria in the centre and was based on individual needs.

Outcome measures

Primary outcome was health-related quality of life at three months.

Secondary outcomes were patient activation and self-reported SoC measured by the questionnaires, both at baseline, at three and at six months, and health-related quality of life at baseline and at six months.

Health-related quality of life was measured by the Medical Outcomes Study 36-item short-form health survey (SF-36) [20] which is a 36-item self-evaluated life quality questionnaire where higher scores are better. Examples of items are ‘During the past 4 weeks, how much did pain interfere with your normal work (including both work outside the home and housework)?’ ‘How much of the time during the last 4 weeks have you been a very nervous person?’ Questions are answered on a Likert scale of 3–6 points.

SF-36 represents eight of the most important health concepts used in health questionnaires in general. SF-36 gives a profile of 8 multi-item scales (2–10 items each), and each scale goes from 0 (bad health) to 100 (good health), plus there is an additional question regarding change in self-evaluated health. Two general health components (physical and mental component score) are calculated. Norm values for the mental component score (MCS) is 51.2 (9.1) with little variation between sexes and age groups [21]. For the physical component score, the norm is 49.5 (10.2) for the general population with lower values for females and in older adults. SF-36 is widely used in pain research, and the Danish version of SF-36 has been valicdated [22], [23], [24].

For measurement of patient activation, we used Patient Activation Measure (PAM) [25, 26]. The PAM questionnaire is a 13-item scoring instrument, assessing a patient’s knowledge, skills and confidence for self-management, a high score meaning a high level of activation. Examples of items are: ‘I am confident I can help prevent or reduce problems associated with my health,’ ‘I have been able to maintain lifestyle changes, like healthy eating or exercising.’ Questions are answered on a Likert scale of 4 points.

PAM segments patients into one of four progressively higher levels of activation, Level 1: May not yet believe that the patient role is important (score of 47), Level 2: Lacks confidence and knowledge to take action (score of 47.1–55.1), Level 3: Beginning to take action (score of 55.2–67.0), Level 4: Has difficulty maintaining behaviours over time (score of 67.1 or above). PAM is used in chronic pain, and the Danish version of PAM has been validated [27, 28].

Competence for coping was measured with SoC [29]. The SoC questionnaire is a 29-item questionnaire scoring a patient’s SoC, a high score meaning a strong SoC. Antonovsky developed a 29-item Orientation to Life questionnaire to measure the SoC, covering comprehensibility (11 items), manageability (10 items) and meaningfulness (8 items) [10]. Examples of items are: “Doing the things you do every day is: (from ‘a source of deep pleasure and satisfaction’ to ‘a source of pain and boredom’)”, “Do you have a feeling that you are in an unfamiliar situation and do not know what to do? (from ‘very often’ to ‘very seldom or never’)”. The response alternatives are a semantic scale of 1–7 points. The questionnaire yields a summed score with a range from 29 to 203. SoC is closely related to quality of life [30]. SoC has been used in the chronic pain population [31, 32]. There is no Danish validation study, but the scale is widely used and is deemed valid in both healthy populations and patients with a wide range of diseases from dialysis to coronary heart disease [33].

Ethical considerations

The project was set up according to the Helsinki II declaration and was approved by the Scientific Ethical Committees of the Capital Region of Copenhagen as well as the Danish Data Protection Agency and was registered with clinicaltrials.gov (NCT02084459).

Participants were fully informed of the study, including their right to withdraw from the project at any time without the need to explain their decision. They were informed that any subsequent care would not be compromised by this decision and signed a consent form to this effect.

Data analysis

Data were described with mean and standard deviation (SD), median and interquartile range (IQR) or percentages as relevant. Continuous variables were tested for normal distribution graphically with histograms and Q–Q plots. Comparison between groups were made by Student’s t-test, Mann–Whitney test and chi-square/Fisher’s exact test depending on the nature and distribution of data. Paired analyses were done only for patients with data at both time points. We applied mixed model analysis for repeated measurements to evaluate change over time. We used a constrained linear mixed model to account for possible baseline differences. We ran four models, one with each of the outcomes (PCS, MCS, PAM and SoC) as outcome measure. Analyses were adjusted for age and sex. Visit was the repeated measure. Group allocation was also a covariate in the model. We assumed an unstructured covariance pattern.

Statistical significance was set at p≤0.05 (two-tailed) and 95% confidence intervals were calculated for all estimates.

SAS 9.4 (SAS Institute, Cary, USA) software was used for all analyses.

Results

During the study period, we screened 848 patients and included the planned number of 200 patients. Reasons for exclusion and drop-out are given in Figure 1.

Figure 1:

Consort diagram.

Most patients were female (77%), and median age was 50 (IQR 42–60). Education was equally distributed between elementary school, short and medium higher education. Most patients were married (59% in GSD group and 52% in control). There were more people in the control group receiving welfare support from the government (12% in GSD group and 21% in control group) (Table 1).

Table 1:

Baseline demographic characteristics for intervention and control group.

	Baseline		Two months		Six months
	GSD intervention (n=100)	Control (n=100)	GSD intervention (n=73)	Control (n=86)	GSD intervention (n=77)	Control (n=89)
Sex, male, %	23(23)	23(23)	21(27)	918(22)	21(27)	18(21)
Age (years, median, IQR)	51(42–61)	50(41–58)	51(44–60)	50(41–58)	52(45–61)	51(42–58)

Marital status, n, %

Married	59(59)	52(52)	44(61)	45(52)	46(60)	47(52)
Single	32(32)	37(37)	23(32)	34(39)	25(32)	33(38)
Other	7(7)	10(10)	6(7)	7(8)	6(8)	9(9)

Education

Elementary school	21(21)	25(25)	19(25)	19(23)	19(25)	21(24)
Short higher education	29(29)	33(33)	26(36)	30(36)	24(31)	32(37)
Medium higher education	28(28)	25(25)	18(25)	21(25)	20(26)	21(24)
Long higher education	5(5)	3(3)	2(3)	3(4)	4(5)	4(4)
Other	15(15)	11(11)	80(11)	10(12)	10(13)	11(12)

Employment

Employed	15(15)	10(10)	13(18)	9(10)	13(17)	8(9)
Retired, including early	44(44)	43(43)	33(45)	37(43)	34(44)	39(44)
Job with disability adjustment	11(11)	9(9)	8(11)	6(7)	8(10)	7(8)
Sick leave	9(9)	5(5)	5(7)	5(6)	7(9)	4(4)
Unemployment benefits	12(12)	21(21)	8(11)	19(22)	10(13)	19(21)
Other	7(7)	6(6)	5(7)	10(12)	5(7)	12(13)

GSD=guided self-determination, IQR=interquartile range.

For the primary outcome (health-related quality of life at three months measured by SF-36), 186 participants gave data at baseline. At three months, 156 gave data, and at six months, 158 gave data.

For PAM, 144 gave data at baseline, 131 at three months and 139 at six months.

For SoC, we have data for 194 participants at baseline, 163 at three months and 165 at six months.

Health-related quality of life

At baseline, mean mental component score (MCS) was less than an SD below the reference population with 44.71 (SD 11.22) for the GSD group and 41.99 (SD 10.80) for the control group (Table 2). Baseline mean values were not different between the groups (p=0.087). The GSD group had a mean MCS of 44.86 (SD 10.46) at three months and the control group 41.44 (SD 12.04) with a p-value of 0.054; there was no difference at this time. At six months, the GSD group had a mean MCS of 43.57 (SD 10.86) and the control group 43.45 (SD 10.36). There was no difference at this time point (p=0.93).

Table 2:

Results for primary and secondary outcomes.

	GSD intervention	Control	Estimate with 95% CI and p-value
SF-36, mean (SD)
MCS
Baseline	44.71(11.22)	41.99(10.80)	2.78(−0.41–5.98) p=0.087
Three months	44.86(10.46)	41.44(12.04)	3.53(−0.070–7.14) p=0.054
Six months	43.57(10.86)	43.45(10.36)	0.15(−3.20–3.50) p=0.93
PCS
Baseline	26.02(6.80)	26.81(7.25)	−0.56(−2.55–1.43) p=0.58
Three months	29.21(7.30)	28.66(7.10)	0.70(−1.56–2.97) p=0.54
Six months	30.27(7.45)	28.25(8.16)	2.28(−0.14–4.69) p=0.064

PAM, mean (SD)

Baseline	55.38(14.60)	51.59(12.17)	3.78(−0.67–8.23) p=0.10
Three months	57.21(13.52)	52.72(11.56)	4.37(0.02–8.72) p=0.049
Six months	57.68(15.09)	56.15(13.09)	1.43(−3.1-6.17) p=0.56

SoC, mean (SD)

Baseline	119.27(26.42)	111.93(27.85)	7.80(0.14–15.46) p=0.04
Three months	115.10(23.66)	111.88(26.83)	3.82(−3.96–11.60) p=0.33
Six months	113.94(34.69)	112.81(29.38)	1.47(−8.38–11.31) p=0.77

Means and standard deviations, GSD=guided self-determination, SF-36=medical outcomes study 36-item short-form health survey, MCS=mental component score, PCS=physical component score, PAM=patient activation measure, SoC=sense of coherence. Normal scores for MCS and PCS are 50. Max scores for PAM is 100. Max score for SoC is 203.

When using mixed model analysis adjusted for age and sex, we found no difference between the groups at neither three nor six months (Table 3). The overall test for difference between groups showed no difference.

Table 3:

Results from mixed model analysis of primary and secondary outcomes.

	Estimate between group at three months with 95% CI and p-value	Estimate between groups at six months with 95% CI and p-value	Test for overall difference between groups, p-value
SF-36
MCS	1.59(−1.51-4-78) p=0.31	−0.74(−3.75–2.28) p=0.63	0.32
PCS	0.96(−0.91–2.87) p=0.31	1.05(0.31–4.44) p=0.02	0.080
PAM	3.45(−0.56–7.47) p=0.012	0.40(−4.10–4.89) p=0.86	0.15
SoC	−1.68(−7.32–3.96) p=0.56	−3.12(−11.78–5.55) p=0.48	0.75

Adjusted for age and sex. Control group was reference. SF-36=medical outcomes study 36-item short-form health survey, MCS=mental component score, PCS=physical component score, PAM=patient activation measure, SoC=sense of coherence.

For physical component score (PCS), the mean score at baseline was 26.02 (SD 6.80) for the intervention group and 26.81 (SD 7.25) for the control group (Table 2). This is half of the normal value. There was no difference in baseline value between the groups (p=0.58). At three months, the GSD group scored a mean of 29.21 (SD 7.30) and the control group 28.66 (SD 7.10). This was not a significant difference (p=0.54). At six months, the GSD group had a mean score of 30.27 (SD 7.45) and the control group 28.25 (SD 8.16) with no significant difference (p=0.064).

When analysed with mixed model, we found a difference between groups of 0.96 (CI −0.91–2.87, p=0.31) at three months and 1.05 (CI 0.31–4.44, p=0.02) at six months. Although statistically significant, this difference is not clinically relevant. The overall test of difference between groups yielded a p-value of 0.080.

We also evaluated SF-36 individual domain scores. As a score of 100 indicates no impairment, we saw severe impairment in every domain, with bodily pain and role physical showing very poor scores, and no score being above 65 (Table 4). This is illustrated in Figures S1 and S2 in the supplementary material.

Table 4:

SF-36 domain scores for intervention and control group.

	GSD intervention	Control group
Role emotional
Baseline	33.33(0–100)	33.33(0–66.67)
Three months	33.33(0–100)	33.33(0–66.67)
Six months	33.33(0–100)	33.33(0–100)

Mental health

Baseline	64(48–80)	60(44–75)
Three months	64(52–80)	60(44–76)
Six months	60(48–76)	60(52–72)

Vitality

Baseline	30(10–50)	25(10–45)
Three months	35(20–50)	25(10–40)
Six months	35(15–45)	35(15–50)

Social functioning

Baseline	50(25–75)	50(25–62.5)
Three months	50(37.5–75)	50(25–62.5)
Six months	50(37.5–75)	50(25–62.5)

Bodily pain

Baseline	25(0–25)	25(0–25)
Three months	25(0–25)	0(0–25)
Six months	25(0–25)	0(0–25)

Physical function

Baseline	40(25–60)	40(20–60)
Three months	45(30–65)	40(27.5–60)
Six months	45(25–65)	45(20–65)

General health

Baseline	35(25–50)	30(25–45)
Three months	35(25–50)	30(20–50)
Six months	35(25–45)	30(20–45)

Role physical

Baseline	0(0–25)	0(0–25)
Three months	23.75(33.5–45)	22.5(10–35)
Six months	32.5(22.5–45)	22.5(20–35)

Medians and interquartile range, SF-36=medical outcomes study 36-item short-form health survey.

Patient activation measure

For PAM, mean scores were 55.38 (SD 14.60) at baseline for the intervention group and 51.59 (SD 12.17) for the control group (Table 2). We did not find any difference at baseline (p=0.10). At three months, the GSD group scored a mean of 57.21 (SD 13.52), while the control group scored 52.72 (SD 11.56). The difference was statistically different at this time (p=0.049). At six months, the GSD group had mean scores of 57.68 (SD 15.09) and the control group 56.15 (13.09). This was not a significant difference (p=0.56).

When using mixed model, we found a difference of 3.45 (CI −0.56–7.47, p=0.012) at three months and 0.40 (CI −4.10–4.89, p=0.86) at six months (Table 3). Test for overall difference found no difference.

A graphical description of the distribution of PAM levels is found in Figure S3 in the supplementary material.

Sense of coherence

When evaluating SoC, we found a mean of 119.27 (SD 26.42) at baseline in the intervention group and 111.93 (SD 27.85) in the control group with a statistically significant difference (p=0.04) (Table 2). The GSD group had a mean score of 115.10 (SD 23.66) at three months and the control group 111.88 (SD 26.83) with no difference (p=0.33). At six months, the GSD group scored a mean of 113.94 (SD 34.69) and the control group 112.81 (SD 29.38). This was not a significant difference (p=0.77).

When performing mixed model analysis accounting for baseline difference, we found no statistically significant differences between groups at three or six months. We did not find any overall difference between the intervention and control group either (Table 3).

Discussion

In this randomised trial, we evaluated the effect of an eight-week intervention with GSD on patients with chronic pain. We found no difference in health-related quality of life, patient activation or SoC between the groups during six-month follow-up.

Our patients were comparable to the population of patients with chronic non-cancer pain in Denmark in terms of age, sex and educational level. These findings are in line with other studies, both in Denmark and internationally [34], [35], [36], [37], [38], [39].

GSD is a method for patient empowerment which has proven effective in the treatment of chronic conditions [18], but has not yet been examined in patients with chronic pain.

This study is the first made with chronic pain patients. It was the aim of this study to evaluate if GSD would have an effect on the self-reported parameters of SF-36, PAM and SoC in this patient group. For nearly all outcomes, differences between the groups were small and non-significant and did not favour the study intervention.

For the main outcome, we found no difference between control and intervention groups at either time point, neither for mental nor physical component score. Using mixed model analysis, we could not demonstrate an effect of the intervention. The small, significant difference at six months for PCS was not clinically relevant.

The nurses carrying out the intervention were part of the staff at the pain centre, thereby also treating many patients from the control group. Being trained in GSD may have had an impact on the communication with the patients of the control group, so despite not using the GSD work sheets and having group sessions, it may have had an influence.

SF-36 was chosen to measure the self-reported physical and mental function of the patient as it includes 8 mental and physical parameters and thereby aims to cover the complexity of a person’s health condition. It is the most frequently used questionnaire in pain management nationally and internationally and can therefore be used for comparison by the pain centres [2, 36, 40], [41], [42], [43], [44]. However, as pain is subjective, it can be difficult to give an answer that reflects the actual present situation. A combination of a subjective questionnaire and a more objective questionnaire of facts, such as physical function (test of walk distance, actual participation in specific physical functions) and mental function (actual social interaction, estimate of level of tiredness, interest in others, smiling, etc. given by relatives) may be a better measurement of the effect of GSD.

We found a statistically significant difference in PAM at three months, but not at six. Mixed model analysis confirmed the difference at three months. At six-month follow-up, the groups had similar distributions of activation levels (see Figure S3 in the supplementary material). This could point to the general support in the pain centre activating patients to take more interest in their health. Another possibility is a spillover effect from the intervention group, as the nurses providing the intervention also took part in treating the control group, as mentioned above. At the six month mark, both groups had received multidisciplinary treatment at the pain centre including medicine adjustments, psychological support and access to physiotherapy. This may also contribute to the groups becoming more similar.

Other studies of psychosocial interventions have found a similar pattern in patients with chronic pain, but as reflection and change in perspective take time, the follow-up time may not have been long enough to detect a positive effect of the intervention [27].

For SoC, we found a difference at baseline, but not at follow-up. Using a constrained mixed model analysis, we accounted for this baseline difference, and the groups did not have different scores at follow-up. SoC is in other studies related to health-related quality of life, meaning that a strong SoC is associated with a better health-related quality of life. In the light of this, it was not surprising to see that we did not find a difference [45]. Time may be a deciding factor, as perspective, acceptance and changes in SoC (and thus quality of life) may take months to develop. It may take longer than six months and may depend on the starting point of SoC and the impact of the chronic disease, and of the intervention [46].

Strengths and limitations

A strength of this study is the randomised, controlled design and the structured reporting following the CONSORT statement [47]. The sample was large and included patients from three different centres. Also, a low proportion of patients was lost to follow-up.

The follow-up time is a potential weakness as it takes time to incorporate skills in self-management into daily routine [48].

A weakness of the study is the lack of blinding which is very hard in psychosocial interventions. The nurses providing the GSD intervention also to some extent cared for the control group. This could lead to the control group getting more support than usual, inspired by the GSD intervention. However, this is not supported by the results only showing small differences over time. The GSD intervention is grounded in reflection sheets which the participants have to use to gain insight into their own situation, and since these were only given to the intervention group, the control group could only achieve a smaller effect of the GSD intervention. It is also a potential bias that the staff treating patients were to some extent also the ones asking for participation in the study. This limitation could have been overcome by having separate nurses treating the patients and performing the intervention or by using a cluster randomised design.

This study is the first study of GSD with chronic pain patients. If comparing to studies with GSD and diabetes, objective measurements are used, e.g. HBA1C blood tests, which is not possible for pain. VAS and NRS pain scores are not objective parameters to be used to measure chronic pain intensity. The chosen questionnaires are widely used and well validated, but may still not cover the potential benefits of the intervention. We could have chosen to include more open and subjective measures or even interviews with patients to uncover more subtle benefits.

A method may or may not have an isolated effect, but set in a context of various methods in a multi-disciplinary set-up, the interventions seen together may have an effect. Where to place a method in the chronological order of interventions is an issue for debate. GSD was offered to the intervention group at the beginning of the multidisciplinary treatment at the pain centre, in order to best isolate the method for the purpose of measuring the effect. At the same time, the patient was given medical and advisory treatment by doctors and nurses – the same for the intervention group and for the control group. The result might have been different if GSD were given to the intervention group in advance of other treatment, or even at the very end.

Perspective

GSD did not increase health-related quality of life in the present study. The method could, however, be meaningful for patients and staff in a multidisciplinary setting in that it invites both the patients and the nurses involved to communicate in a structured way about the pain condition and thereby enhances pain patients’ pain vocabulary and nurses’ skills to invite the patient’s perspective into the communication [19, 49].

Conclusion

In this first, randomised study of GSD in patients with chronic pain following patients for six months, the method offers no additional benefit over treatment-as-usual in the multidisciplinary set-up. No significant difference was found between the intervention group and the control group in health-related quality of life, PAM and SoC. New research is recommended using a combination of self-reported and objective measures, and a longer follow-up period.

Corresponding author: Stine Estrup, Department of Anaesthesia and Intensive Care, Zealand University Hospital, Lykkebækvej 1, 4600 Køge, Denmark, E-mail: sed@regionsjaelland.dk

Acknowledgments

The authors would like to thank Niels–Henrik Jensen and Torsten Jonsson for help and support in planning and executing the trial, and Sonia Maria Pickering for proofreading.

Research funding: Authors state no funding involved.
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
Competing interests: Authors state no conflict of interest.
Informed consent: Informed consent has been obtained from all individuals included in this study.
Ethical approval: The research related to human use complies with all the relevant national regulations, institutional policies and was performed in accordance with the tenets of the Helsinki Declaration (as amended in 2013), and has been approved by the regional ethics committee (reference number 36553 protocol H-4-2012-FSP) and the Danish Data Protection Agency (reference number 2007-58-0015, ID HEH-2013-007).

References

1. Hansson, KS, Fridlund, B, Brunt, D, Hansson, B, Rask, M. The meaning of the experiences of persons with chronic pain in their encounters with the health service. Scand J Caring Sci 2011;25:444–50.10.1111/j.1471-6712.2010.00847.xSuche in Google Scholar PubMed

2. Sjøgren, P, Ekholm, O, Peuckmann, V, Grønbæk, M. Epidemiology of chronic pain in Denmark: an update. Eur J Pain 2009;13:287–92. https://doi.org/10.1016/j.ejpain.2008.04.007.Suche in Google Scholar PubMed

3. Frantsve, LME, Kerns, RD. Patient-provider interactions in the management of chronic pain: current findings within the context of shared medical decision making. Pain Med 2007;8:25–35.10.1111/j.1526-4637.2007.00250.xSuche in Google Scholar PubMed

4. Breivik, H, Collett, B, Ventafridda, V, Cohen, R, Gallacher, D. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain 2006;10:287. https://doi.org/10.1016/j.ejpain.2005.06.009.Suche in Google Scholar PubMed

5. Vos, T, Abajobir, AA, Abbafati, C, Abbas, KM, Abate, KH, Abd-Allah, F, et al.. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: a systematic analysis for the global burden of disease study 2016. Lancet 2017;390:1211–59. https://doi.org/10.1016/S0140-6736(17)32154-2.Suche in Google Scholar PubMed PubMed Central

6. Steingrímsdóttir, ÓA, Landmark, T, Macfarlane, GJ, Nielsen, CS. Defining chronic pain in epidemiological studies: a systematic review and meta-analysis. Pain 2017;158:2092–107. https://doi.org/10.1097/j.pain.0000000000001009.Suche in Google Scholar PubMed

7. Mansfield, KE, Sim, J, Jordan, JL, Jordan, KP. A systematic review and meta-analysis of the prevalence of chronic widespread pain in the general population. Pain 2016;157:55–64. https://doi.org/10.1097/j.pain.0000000000000314.Suche in Google Scholar PubMed PubMed Central

8. Andrews, P, Steultjens, M, Riskowski, J. Chronic widespread pain prevalence in the general population: a systematic review. Eur J Pain 2018;22:5–18. https://doi.org/10.1002/ejp.1090.Suche in Google Scholar PubMed

9. Merskey, H, Bogduk, N, editors. Classification of chronic pain, 2nd ed. Seattle: IASP Press; 1994.Suche in Google Scholar

10. Antonovsky, A. Unraveling the mystery of health: how people manage stress and stay well. Jossey Bass social and behavioral science series; 1987.Suche in Google Scholar

11. Zoffmann, V, Kirkevold, M. Life versus disease in difficult diabetes care: conflicting perspectives disempower patients and professionals in problem solving. Qual Health Res 2005;15:750–65. https://doi.org/10.1177/1049732304273888.Suche in Google Scholar PubMed

12. Vranceanu, AM, Cooper, C, Ring, D. Integrating patient values into evidence-based practice: effective communication for shared decision-making. Hand Clin 2009;25:83–96. https://doi.org/10.1016/j.hcl.2008.09.003.Suche in Google Scholar PubMed

13. Zoffmann, V, Harder, I, Kirkevold, M. A person-centered communication and reflection model: sharing decision-making in chronic care. Qual Health Res 2008;18:670–85. https://doi.org/10.1177/1049732307311008.Suche in Google Scholar PubMed

14. Elwyn, G, Laitner, S, Coulter, A, Walker, E, Watson, P, Thomson, R. Implementing shared decision making in the NHS. BMJ 2010;341:971–2. https://doi.org/10.1136/bmj.c5146.Suche in Google Scholar PubMed

15. Vartiainen, P, Heiskanen, T, Sintonen, H, Roine, RP, Kalso, E. Health-related quality of life change in patients treated at a multidisciplinary pain clinic. Eur J Pain 2019;23:1318–28. https://doi.org/10.1002/ejp.1398.Suche in Google Scholar PubMed

16. Kamper, SJ, Apeldoorn, AT, Chiarotto, A, Smeets, RJEM, Ostelo, RWJG, Guzman, J, et al.. Multidisciplinary biopsychosocial rehabilitation for chronic low back pain: cochrane systematic review and meta-analysis. BMJ 2015;350:h444. https://doi.org/10.1136/bmj.h444.Suche in Google Scholar PubMed PubMed Central

17. Guzmán, J, Esmail, R, Karjalainen, K, Malmivaara, A, Irvin, E, Bombardier, C. Multidisciplinary rehabilitation for chronic low back pain: systematic review. BMJ 2001;322:1511–6. https://doi.org/10.1136/bmj.322.7301.1511.Suche in Google Scholar PubMed PubMed Central

18. Zoffmann, V, Lauritzen, T. Guided self-determination improves life skills with Type 1 diabetes and A1C in randomized controlled trial. Patient Educ Counsel 2006;64:78–86. https://doi.org/10.1016/j.pec.2005.11.017.Suche in Google Scholar PubMed

19. Simonsen, SM, Strømberg, C, Zoffmann, V, Hartwell, D, Olesen, ML. About me as a person not only the disease – piloting guided self-determination in an outpatient endometriosis setting. Scand J Caring Sci 2019;34:1017–27. https://doi.org/10.1111/scs.12810.Suche in Google Scholar PubMed

20. Ware, JE, Sherbourne, CD. The MOS 36-item short-form health survey (Sf-36): I. Conceptual framework and item selection. Med Care 1992;30:473–83.10.1097/00005650-199206000-00002Suche in Google Scholar

21. Garratt, AM, Stavem, K. Measurement properties and normative data for the Norwegian SF-36: results from a general population survey. Health Qual Life Outcome 2017;15:51. https://doi.org/10.1186/s12955-017-0625-9.Suche in Google Scholar PubMed PubMed Central

22. Hawker, GA, Mian, S, Kendzerska, T, French, M. Measures of adult pain: visual analog scale for pain (VAS pain), numeric rating scale for pain (NRS pain), McGill pain questionnaire (MPQ), short-form McGill pain questionnaire (SF-MPQ), chronic pain grade scale (CPGS), short form-36 bodily pain scale (SF-36 BPS), and measure of intermittent and constant osteoarthritis pain (ICOAP). Arthritis Care Res 2011;63:S240–52. https://doi.org/10.1002/acr.20543.Suche in Google Scholar PubMed

23. Chapman, JR, Norvell, DC, Hermsmeyer, JT, Bransford, RJ, Devine, J, McGirt, MJ, et al.. Evaluating common outcomes for measuring treatment success for chronic low back pain. Spine (Phila Pa 1976) 2011;36:S54–68. https://doi.org/10.1097/BRS.0b013e31822ef74d.Suche in Google Scholar PubMed

24. Bjorner, JB, Thunedborg, K, Kristensen, TS, Modvig, J, Bech, P. The Danish SF-36 health survey: translation and preliminary validity studies. J Clin Epidemiol 1998;51:991–9. https://doi.org/10.1016/S0895-4356(98)00091-2.Suche in Google Scholar

25. Hibbard, JH, Mahoney, ER, Stock, R, Tusler, M. Do increases in patient activation result in improved self-management behaviors? Health Serv Res 2007;42:1443–63. https://doi.org/10.1111/j.1475-6773.2006.00669.x.Suche in Google Scholar PubMed PubMed Central

26. Mosen, DM, Schmittdiel, J, Hibbard, J, Sobel, D, Remmers, C, Bellows, J. Is patient activation associated with outcomes of care for adults with chronic conditions? J Ambul Care Manag 2007;30:21–9. https://doi.org/10.1097/00004479-200701000-00005.Suche in Google Scholar PubMed

27. Nøst, TH, Steinsbekk, A, Bratås, O, Grønning, K. Twelve-month effect of chronic pain self-management intervention delivered in an easily accessible primary healthcare service – a randomised controlled trial. BMC Health Serv Res 2018;18:1012. https://doi.org/10.1186/s12913-018-3843-x.Suche in Google Scholar PubMed PubMed Central

28. Maindal, HT, Sokolowski, I, Vedsted, P. Translation, adaptation and validation of the American short form patient activation measure (PAM13) in a Danish version. BMC Publ Health 2009;9:209. https://doi.org/10.1186/1471-2458-9-209.Suche in Google Scholar PubMed PubMed Central

29. Lillefjell, M, Jakobsen, K. Sense of coherence as a predictor of work reentry following multidisciplinary rehabilitation for individuals with chronic musculoskeletal pain. J Occup Health Psychol 2007;12:222–31. https://doi.org/10.1037/1076-8998.12.3.222.Suche in Google Scholar PubMed

30. Eriksson, M, Lindström, B. Antonovsky’s sense of coherence scale and its relation with quality of life: a systematic review. J Epidemiol Community Health 2007;61:938–44. https://doi.org/10.1136/jech.2006.056028.Suche in Google Scholar PubMed PubMed Central

31. Lillefjell, M, Jakobsen, K, Ernstsen, L. The impact of a sense of coherence in employees with chronic pain. Work 2015;50:313–22. https://doi.org/10.3233/WOR-141838.Suche in Google Scholar PubMed

32. Schult, ML, Soderback, I, Jacobs, K. The sense-of-coherence and the capability of performing daily occupations in persons with chronic pain. Work 2000;15:189–201.Suche in Google Scholar

33. Eriksson, M, Lindström, B. Validity of Antonovsky’s sense of coherence scale: a systematic review. J Epidemiol Community Health 2005;59:460–6. https://doi.org/10.1136/jech.2003.018085.Suche in Google Scholar PubMed PubMed Central

34. Kurita, GP, Sjogren, P, Juel, K, Hojsted, J, Ekholm, O. The burden of chronic pain: a cross-sectional survey focussing on diseases, immigration, and opioid use. Pain 2012;153:2332–8. https://doi.org/10.1016/j.pain.2012.07.023.Suche in Google Scholar PubMed

35. Kurita, GP, Højsted, J, Sjøgren, P. Tapering off long-term opioid therapy in chronic non-cancer pain patients: a randomized clinical trial. Eur J Pain 2018;22:1528–43. https://doi.org/10.1002/ejp.1241.Suche in Google Scholar PubMed

36. Diasso, PDK, Sjøgren, P, Højsted, J, Nielsen, SD, Main, KM, Kurita, GP. Patient reported outcomes and neuropsychological testing in patients with chronic non-cancer pain in long-term opioid therapy: a pilot study. Scand J Pain 2019;19:533–43. https://doi.org/10.1515/sjpain-2019-0007.Suche in Google Scholar PubMed

37. Richards, GC, Lluka, LJ, Smith, MT, Haslam, C, Moore, B, O’Callaghan, J, et al.. Effects of long-term opioid analgesics on cognitive performance and plasma cytokine concentrations in patients with chronic low back pain: a cross-sectional pilot study. Pain Reports 2018;3:e669. https://doi.org/10.1097/PR9.0000000000000669.Suche in Google Scholar PubMed PubMed Central

38. Campbell, G, Nielsen, S, Bruno, R, Lintzeris, N, Cohen, M, Hall, W, et al.. The pain and opioids in treatment study: characteristics of a cohort using opioids to manage chronic non-cancer pain. Pain 2015;156:231–42. https://doi.org/10.1097/01.j.pain.0000460303.63948.8e.Suche in Google Scholar PubMed

39. Schiltenwolf, M, Akbar, M, Hug, A, Pfüller, U, Gantz, S, Neubauer, E, et al.. Evidence of specific cognitive deficits in patients with chronic low back pain under long-term substitution treatment of opioids. Pain Physician 2014;17:9–20. https://doi.org/10.1016/j.spinee.2011.08.290.Suche in Google Scholar

40. Els, C, Jackson, TD, Kunyk, D, Lappi, VG, Sonnenberg, B, Hagtvedt, R, et al.. Adverse events associated with medium- and long-term use of opioids for chronic non-cancer pain: an overview of Cochrane reviews. Cochrane Database Syst Rev 2017;10:1–44. https://doi.org/10.1002/14651858.CD012509.pub2.Suche in Google Scholar PubMed PubMed Central

41. Devulder, J, Richarz, U, Nataraja, SH. Impact of long-term use of opioids on quality of life in patients with chronic, non-malignant pain. Curr Med Res Opin 2005;21:1555–68. https://doi.org/10.1185/030079905X65321.Suche in Google Scholar PubMed

42. Moulin, DE, Iezzi, A, Amireh, R, Sharpe, WKJ, Boyd, D, Merskey, H. Randomised trial of oral morphine for chronic non-cancer pain. Lancet 1996;347:143–7. https://doi.org/10.1016/S0140-6736(96)90339-6.Suche in Google Scholar

43. Chou, R, Turner, JA, Devine, EB, Hansen, RN, Sullivan, SD, Blazina, I, et al.. The effectiveness and risks of long-term opioid therapy for chronic pain: a systematic review for a national institutes of health pathways to prevention workshop. Ann Intern Med 2015;162:276–86. https://doi.org/10.7326/M14-2559.Suche in Google Scholar PubMed

44. Frank, JW, Lovejoy, TI, Becker, WC, Morasco, BJ, Koenig, CJ, Hoffecker, L, et al.. Patient outcomes in dose reduction or discontinuation of long-term opioid therapy: a systematic review. Ann Intern Med 2017;167:181–91. https://doi.org/10.7326/M17-0598.Suche in Google Scholar PubMed

45. Chumbler, NR, Kroenke, K, Outcalt, S, Bair, MJ, Krebs, E, Wu, J, et al.. Association between sense of coherence and health-related quality of life among primary care patients with chronic musculoskeletal pain. Health Qual Life Outcome 2013;11:216. https://doi.org/10.1186/1477-7525-11-216.Suche in Google Scholar PubMed PubMed Central

46. Heggdal, K, Lovaas, BJ. Health promotion in specialist and community care: how a broadly applicable health promotion intervention influences patient’s sense of coherence. Scand J Caring Sci 2018;32:690–7. https://doi.org/10.1111/scs.12498.Suche in Google Scholar PubMed

47. Schulz, KF, Altman, DG, Moher, D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:698–702. https://doi.org/10.1136/bmj.c332.Suche in Google Scholar PubMed PubMed Central

48. Du, S, Yuan, C, Xiao, X, Chu, J, Qiu, Y, Qian, H. Self-management programs for chronic musculoskeletal pain conditions: a systematic review and meta-analysis. Patient Educ Counsel 2011;85:e299–310. https://doi.org/10.1016/j.pec.2011.02.021.Suche in Google Scholar PubMed

49. Thisted, LB, Zoffmann, V, Olesen, ML. Labeled as lucky: contradictions between what women and healthcare professionals experience regarding the need for help after the early stages of gynecological cancer. Support Care Canc 2020;28:907–16. https://doi.org/10.1007/s00520-019-04882-2.Suche in Google Scholar PubMed

Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/sjpain-2021-0007).

Received: 2021-01-13

Revised: 2021-07-07

Accepted: 2021-07-10

Published Online: 2021-07-31

Published in Print: 2022-04-26

Supplementary Material

Artikel in diesem Heft

https://doi.org/10.1515/sjpain-2021-0007

Schlagwörter für diesen Artikel

chronic pain care; empowerment; guided self-determination; nursing intervention; patient activation; sense of coherence

Guided self-determination in treatment of chronic pain – a randomized, controlled trial

Artikel

Abstract

Objectives

Methods

Results

Conclusions

Introduction

Methods

Participants

GSD intervention

Standard care

Blinding

Data collection and allocation

Outcome measures

Ethical considerations

Data analysis

Results

Health-related quality of life

Patient activation measure

Sense of coherence

Discussion

Strengths and limitations

Perspective

Conclusion

Acknowledgments

References

Supplementary Material

Zusatzmaterial

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