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

Karolinska Institutet
Institute of Environmental Medicine
Box 210
Stockholm
17177
Sweden

Email eva.skillgate@ki.se

Study information

Study designSingle-centre three-arm open-label randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe effect of various combinations of naprapathic manual therapy: a randomised controlled trial
Study acronymThe MInT Trial
Study objectivesThe 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) studiedNon-specific neck and/or back pain
InterventionThe 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 typeOther
Primary outcome measure1. 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 measures1. 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 date15/03/2010
Completion date31/12/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants1,050
Key inclusion criteriaPatients 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 criteria1. 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 enrolment15/03/2010
Date of final enrolment31/12/2012

Locations

Countries of recruitment

  • Sweden

Study participating centre

Karolinska Institutet
Stockholm
17177
Sweden

Sponsor information

The Scandinavian College of Naprapathic Manual Medicine (Sweden)
Hospital/treatment centre

Kräftriket 23A
Stockholm
11419
Sweden

Phone +46 (0)8 160120
Email 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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.