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
Protocol serial number	N/A
Sponsor	The Scandinavian College of Naprapathic Manual Medicine (Sweden)
Funders	The Scandinavian College of Naprapathic Manual Medicine (Sweden), Swedish Association of Naprapaths (Sweden)

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

Primary study design	Interventional
Study design	Single-centre three-arm open-label randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(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.
Key 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.
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	1050
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

11/10/2021: Publication reference added.
23/01/2020: Publication reference added.
04/05/2016: Publication reference added.