Condition category
Musculoskeletal Diseases
Date applied
04/02/2010
Date assigned
09/02/2010
Last edited
04/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Eva Skillgate

ORCID ID

Contact details

Karolinska Institutet
Institute of Environmental Medicine
Box 210
Stockholm
17177
Sweden
-
eva.skillgate@ki.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effect of various combinations of naprapathic manual therapy: a randomised controlled trial

Acronym

The MInT Trial

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), 11/01/2010, Ref: 2009/1848-31/2

Study design

Single-centre three-arm open-label randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

15/03/2010

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1,050

Participant 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

Recruitment start date

15/03/2010

Recruitment end date

31/12/2012

Locations

Countries of recruitment

Sweden

Trial participating centre

Karolinska Institutet
Stockholm
17177
Sweden

Sponsor information

Organisation

The Scandinavian College of Naprapathic Manual Medicine (Sweden)

Sponsor details

Kräftriket 23A
Stockholm
11419
Sweden
+46 (0)8 160120
info@nph.se

Sponsor type

Hospital/treatment centre

Website

http://www.nph.se

Funders

Funder type

University/education

Funder name

The Scandinavian College of Naprapathic Manual Medicine (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Swedish Association of Naprapaths (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24618345
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27107960

Publication citations

  1. Results

    Paanalahti K, Holm LW, Nordin M, Asker M, Lyander J, Skillgate E, Adverse events after manual therapy among patients seeking care for neck and/or back pain: a randomized controlled trial., BMC Musculoskelet Disord, 2014, 15, 77, doi: 10.1186/1471-2474-15-77.

  2. Results

    Paanalahti K, Holm LW, Nordin M, Höijer J, Lyander J, Asker M, Skillgate E, Three combinations of manual therapy techniques within naprapathy in the treatment of neck and/or back pain: a randomized controlled trial, BMC Musculoskelet Disord, 2016, 17, 1, 176, doi: 10.1186/s12891-016-1030-y.

Additional files

Editorial Notes

04/05/2016: Publication reference added.