The effect of various combinations of naprapathic manual therapy for patients with neck pain and/or back pain
| ISRCTN | ISRCTN92249294 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92249294 |
| Secondary identifying numbers | N/A |
- Submission date
- 04/02/2010
- Registration date
- 09/02/2010
- Last edited
- 11/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Eva Skillgate
Scientific
Scientific
Karolinska Institutet
Institute of Environmental Medicine
Box 210
Stockholm
17177
Sweden
| eva.skillgate@ki.se |
Study information
| Study design | Single-centre three-arm open-label randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The effect of various combinations of naprapathic manual therapy: a randomised controlled trial |
| Study acronym | The MInT Trial |
| Study objectives | 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(s) | The regional Ethic Board in Stockholm (Regionala etikprövningsnämnden i Stockholm), 11/01/2010, Ref: 2009/1848-31/2 |
| Health condition(s) or problem(s) studied | Non-specific neck and/or back pain |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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. |
| Overall study start date | 15/03/2010 |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 1,050 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/03/2010 |
| Date of final enrolment | 31/12/2012 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Karolinska Institutet
Stockholm
17177
Sweden
17177
Sweden
Sponsor information
The Scandinavian College of Naprapathic Manual Medicine (Sweden)
Hospital/treatment centre
Hospital/treatment centre
Kräftriket 23A
Stockholm
11419
Sweden
| Phone | +46 (0)8 160120 |
|---|---|
| info@nph.se | |
| Website | http://www.nph.se |
Funders
Funder type
University/education
The Scandinavian College of Naprapathic Manual Medicine (Sweden)
No information available
Swedish Association of Naprapaths (Sweden)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 12/03/2014 | Yes | No | |
| Results article | results | 23/04/2016 | Yes | No | |
| Results article | results | 12/06/2019 | 23/01/2020 | Yes | No |
| Results article | 08/10/2021 | 11/10/2021 | Yes | No |
Editorial Notes
11/10/2021: Publication reference added.
23/01/2020: Publication reference added.
04/05/2016: Publication reference added.
