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02 September 2010
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| [ Print-friendly version ] |
| The effect of various combinations of naprapathic manual therapy for patients with neck pain and/or back pain |
| ISRCTN | ISRCTN92249294 |
| ClinicalTrials.gov identifier | |
| Public title | The effect of various combinations of naprapathic manual therapy for patients with neck pain and/or back pain |
| Scientific title | The effect of various combinations of naprapathic manual therapy. A randomised controlled trial |
| Acronym | The MInT Trial |
| Serial number at source | N/A |
| Study hypothesis |
The main purpose of this study is to:
Examine the difference in treatment effect between different combinations of Naprapathic manual therapy including massage techniques, stretching (both as a treatment technique and a home exercise), spinal mobilisation and spinal manipulation, for patients with neck pain and/or back pain. Secondary objectives are to provide answers to the following questions. 1. What is the prevalence of adverse reactions to treatment in the different combinations of naprapathic manual therapy, and what is the severity and duration of such symptoms post treatment? 2. Are there specific subgroups of patients who have greater benefit from the respectively treatment? |
| Ethics approval | The regional Ethic Board in Stockholm (Regionala etikprövningsnämnden i Stockholm) approved on the 11th of January 2010 (Ref: 2009/1848-31/2) |
| Study design | Single centre 3 arm open label randomized controlled trial |
| Countries of recruitment | Sweden |
| Disease/condition/study domain | Non-Specific neck and/or back pain |
| Participants - inclusion criteria | Patients 18-65 years of age who seek naprapathic therapy for a new episode of non-specific episode of neck and/or back pain with a duration of at least one week, at the student clinic at The Scandinavian College of Naprapathic Manual Medicine |
| Participants - exclusion criteria |
1. Pain level < 2 on a 10 point numerical rating scale
2. Pregnancy 3. Not fluent in the Swedish language 4. Contraindication for spinal manipulation according to SOSFS 1996:16 (The regulations and general recommendations from the Swedish National Board of Health and Welfare), such as pain caused by trauma. 5. Treatment by a naprapath, chiropractor, osteopath or a physiotherapist in the past month. 6. Specific diagnoses such as 6.1. Spondylitis 6.2. Ankylosing spondylitis (Morbus Bechterew's disease) 6.3. Disc herniation 6.4. Red flags not included in the SOSFS, above 7. Other primary pain diagnosis according to the judgment made by the therapist at the time of inclusion |
| Anticipated start date | 15/03/2010 |
| Anticipated end date | 31/12/2012 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | 1,050 |
| Interventions |
The treatment arms being evaluated are:
1. Naprapathic manual therapy (which includes a combination of various massage techniques, stretching (both as a treatment technique and a home exercise), spinal mobilisation and spinal manipulation. 2. Naprapathic manual therapy, except spinal manipulation. 3. Naprapathic manual therapy, except stretching (both as a treatment technique and as a advice for home exercise) All patients in each arm will receive up to 6 treatment sessions within 6 weeks from inclusion in the trial. The total duration of follow up will be 12 months. |
| Primary outcome measure(s) |
1. Self rated pain and function with the use of Chronic Pain Questionnaire (CPQ) will be assessed at baseline, 7 weeks, 3, 6 and 12 months.
2. Prevalence, duration and intensity of adverse treatment reactions. This is measured with the use of a questionnaire including eight numerical rating scales (NRS 0-10) seven of which concern symptoms that has been reported in other studies after naprapathic treatment sessions or other manual therapy. The last question is “other” in case of other symptoms experienced by the patient. Patients will answer this questionnaire when coming back to the clinic for a new treatment session. |
| Secondary outcome measure(s) |
1. Health related quality of life (Short-Form [SF-12])
2. Perceived recovery (A 6-point Likert scale including ”Complete pain free and have no complaints from neck/back” to ”Is much worse”) Outcomes will be measured at baseline, 7 weeks, 3, 6 and 12 months. |
| Sources of funding |
1. The Scandinavian College of Naprapathic Manual Medicine (Sweden)
2. Swedish Association of Naprapaths (Sweden) |
| Trial website | |
| Publications | |
| Contact name | Dr Eva Skillgate |
| Address |
Karolinska Institutet
Institute of Environmental Medicine Box 210 |
| City/town | Stockholm |
| Zip/Postcode | 17177 |
| Country | Sweden |
| eva.skillgate@ki.se | |
| Sponsor | The Scandinavian College of Naprapathic Manual Medicine (Sweden) |
| Address | Kräftriket 23A |
| City/town | Stockholm |
| Zip/Postcode | 11419 |
| Country | Sweden |
| Tel | +46 (0)8 160120 |
| info@nph.se | |
| Sponsor website: | http://www.nph.se |
| Date applied | 04/02/2010 |
| Last edited | 09/02/2010 |
| Date ISRCTN assigned | 09/02/2010 |
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