Does the Addition of Massage to Manual Therapy and Exercise Improve Outcome in Chronic Neck Pain?
Primary Purpose
Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
massage
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
non-massage group
massage group
Arm Description
received exercise, manual therapy and advice over the 30 minute intervention period, in conjunction with an exercise program to perform at home.
Received massage, exercise, manual therapy and advice over the 30 minute intervention period, in conjunction with an exercise program to perform at home.
Outcomes
Primary Outcome Measures
Numerical Pain Rating Scale
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.
Secondary Outcome Measures
Neck Disability Index
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).
Full Information
NCT ID
NCT02313480
First Posted
December 8, 2014
Last Updated
December 8, 2014
Sponsor
Society of Musculoskeletal Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02313480
Brief Title
Does the Addition of Massage to Manual Therapy and Exercise Improve Outcome in Chronic Neck Pain?
Official Title
Does the Addition of Massage to Manual Therapy and Exercise Improve Outcome in Chronic Neck Pain?
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Society of Musculoskeletal Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To date, the benefits of massage in chronic neck pain patients has only been investigated as a singular treatment, rather than as part of a treatment package. The need for this research has been highlighted in the literature (Ezzo et al, 2007; Haraldsson et al, 2006) This research aimed to establish whether the addition of massage to a program of exercise and manual therapy offers any additional benefits over exercise and manual therapy alone in the treatment of patients with chronic neck pain.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
non-massage group
Arm Type
Active Comparator
Arm Description
received exercise, manual therapy and advice over the 30 minute intervention period, in conjunction with an exercise program to perform at home.
Arm Title
massage group
Arm Type
Experimental
Arm Description
Received massage, exercise, manual therapy and advice over the 30 minute intervention period, in conjunction with an exercise program to perform at home.
Intervention Type
Other
Intervention Name(s)
massage
Intervention Description
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
Primary Outcome Measure Information:
Title
Numerical Pain Rating Scale
Description
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.
Time Frame
Compared baseline to score after 8 weeks of treatment
Secondary Outcome Measure Information:
Title
Neck Disability Index
Description
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).
Time Frame
Compared baseline to score after 8 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elaine Atkins, Physio
Organizational Affiliation
Society of Musculoskeletal Medicine
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
17268268
Citation
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.
Results Reference
background
PubMed Identifier
16856066
Citation
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.
Results Reference
background
PubMed Identifier
18164333
Citation
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.
Results Reference
background
PubMed Identifier
11690728
Citation
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.
Results Reference
background
PubMed Identifier
18803999
Citation
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.
Results Reference
background
PubMed Identifier
17509434
Citation
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.
Results Reference
background
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Does the Addition of Massage to Manual Therapy and Exercise Improve Outcome in Chronic Neck Pain?
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