The Manual Intervention Trial (MINT)—The effect of various combinations of naprapathic manual therapy. The study protocol of a randomized controlled trial
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Eva Skillgate
Objective
Naprapathy is defined as a specific system for examining, diagnostics, manual treatment and rehabilitation of pain/dysfunction in the neuromusculoskeletal system. The therapy aims to reduce pain and dysfunction through treatment of the connective tissue, muscle- and neural tissue in/around the spine and other joints, by a combination of manual techniques. Earlier trials show that Naprapathy is effective for patients with unspecific back/neck pain. The current trial aims to compare the effect of three combinations of Naprapathic manual therapy (NMT) on such pain, to examine prevalence, severity and duration of adverse reactions after NMT, and to identify subgroups of patients who have greater benefit from the treatments.
Methods
A randomized controlled trial with three arms (target number: 1050 patients). Inclusion criteria: Patients 18–65 years at the student clinic at The Scandinavian College of Naprapathic Manuel Medicine with a new episode of non-specific neck and/or back pain (duration one week). Exclusion criteria: Pain < 2 on a 10 point NRS, pregnancy, contraindication for spinal manipulation, recent trauma, specific diagnosis, red flags, recent treatment.
Treatment arms (all given by students in year 4): NMT (a combination of soft tissue techniques, stretching, and spinal manipulation/mobilization), NMT but not spinal manipulation and NMT but not stretching (treatment or advice).
Patients will get up to 6 treatments within 6 weeks. They will get questionnaires about adverse reactions at new appointments and web based or postal questionnaires regarding the outcomes four times within a year.
Primary outcomes: Pain/disability and prevalence; duration and intensity of possible adverse reactions. Secondary outcomes: Quality of life and perceived recovery.
Results
A pilot trial of 75 patients is finished. The main trial will take place in March 2010 to December 2012. We will report on the process and on the characteristics of the 75 included patients in the pilot trial.
© 2010 Scandinavian Association for the Study of Pain
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