Contact information
Type
Scientific
Primary contact
Dr Eva Skillgate
ORCID ID
Contact details
Karolinska Institutet
Institute of Environmental Medicine
Box 210
Stockholm
17177
Sweden
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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
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
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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.
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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.