- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02313480
Does the Addition of Massage to Manual Therapy and Exercise Improve Outcome in Chronic Neck Pain?
Study Overview
Detailed Description
39 patients with neck pain of greater than three months duration were randomised to either a massage or non-massage group in a primary care setting in the Dublin region. One therapist administered all treatments. Randomisation was carried out by the use of sequential sampling, utilising permuted blocks. Patients were excluded from the study if they had severe co-existing disease, had neck pain due to fracture, tumour, infection or other non-mechanical causes, or if the patient had a diagnosis of osteoporosis anywhere in the body.
Both groups underwent up to eight weekly physiotherapy sessions. The non-massage group received exercise, manual therapy and advice over the 30 minute intervention period, in conjunction with an exercise program to perform at home. The massage group received all of the above as well as Swedish massage. Follow up was for the duration of treatment only.
A number of T-tests and non-parametric tests were conducted to establish if the two groups were comparable at baseline.
A mixed ANOVA was then used to analyse between-group and within-group data simultaneously. No blinding was possible, although the questionnaires were self-administered which may have limited bias.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- neck pain for greater than three months
- over 18 years of age
- had not received treatment for their neck pain in the previous month
- could speak conversational English
- were not involved in any current compensation case and
- had provided written, informed consent.
Exclusion Criteria:
- severe co-existing disease,
- neck pain due to fracture, tumour, infection or other non-mechanical causes,
- if the patient had a diagnosis of osteoporosis anywhere in the body.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: non-massage group
received exercise, manual therapy and advice over the 30 minute intervention period, in conjunction with an exercise program to perform at home.
|
Swedish massage was included in one arm of the study and not the other.
Administered by a trained therapist as part of the usual 30 minute treatment time.
Amount of massage administered dependant on Therapist's clinical reasoning
|
|
Experimental: massage group
Received massage, exercise, manual therapy and advice over the 30 minute intervention period, in conjunction with an exercise program to perform at home.
|
Swedish massage was included in one arm of the study and not the other.
Administered by a trained therapist as part of the usual 30 minute treatment time.
Amount of massage administered dependant on Therapist's clinical reasoning
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numerical Pain Rating Scale
Time Frame: Compared baseline to score after 8 weeks of treatment
|
Used to accurately measure pain.
On this, patients verbally rated their usual and worst (in the last week) pain from 0 ("no pain") to 10 ("worst possible pain").
Its test-retest reliability in the chronic neck pain population was established as fair to moderate (intraclass correlation coefficient (ICC) =.76; 95% CI, .51-.87) by Cleland et al (2008).
Farrar et al (2010) found a difference of two points to be a clinically meaningful change in the chronic pain population.
|
Compared baseline to score after 8 weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neck Disability Index
Time Frame: Compared baseline to score after 8 weeks of treatment
|
The NDI (Appendix 3) is the most widely used and most strongly validated instrument for assessing self-rated disability in patients with neck pain (Vernon, 2008).It includes ten self-report items covering activities of daily living, concentration and pain.
Responses are on a 0-5 point scale, with a total score ranging from 0 (no pain or disability) to 50 (severe pain and disability; Gay et al, 2007).
|
Compared baseline to score after 8 weeks of treatment
|
Collaborators and Investigators
Investigators
- Study Chair: Elaine Atkins, Physio, Society of Musculoskeletal Medicine
Publications and helpful links
General Publications
- Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.
- Cleland JA, Childs JD, Whitman JM. Psychometric properties of the Neck Disability Index and Numeric Pain Rating Scale in patients with mechanical neck pain. Arch Phys Med Rehabil. 2008 Jan;89(1):69-74. doi: 10.1016/j.apmr.2007.08.126.
- Vernon H. The Neck Disability Index: state-of-the-art, 1991-2008. J Manipulative Physiol Ther. 2008 Sep;31(7):491-502. doi: 10.1016/j.jmpt.2008.08.006.
- Ezzo J, Haraldsson BG, Gross AR, Myers CD, Morien A, Goldsmith CH, Bronfort G, Peloso PM; Cervical Overview Group. Massage for mechanical neck disorders: a systematic review. Spine (Phila Pa 1976). 2007 Feb 1;32(3):353-62. doi: 10.1097/01.brs.0000254099.07294.21.
- Haraldsson BG, Gross AR, Myers CD, Ezzo JM, Morien A, Goldsmith C, Peloso PM, Bronfort G; Cervical Overview Group. Massage for mechanical neck disorders. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD004871. doi: 10.1002/14651858.CD004871.pub3.
- Gay RE, Madson TJ, Cieslak KR. Comparison of the Neck Disability Index and the Neck Bournemouth Questionnaire in a sample of patients with chronic uncomplicated neck pain. J Manipulative Physiol Ther. 2007 May;30(4):259-62. doi: 10.1016/j.jmpt.2007.03.009.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RM01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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