Does the Addition of Massage to Manual Therapy and Exercise Improve Outcome in Chronic Neck Pain?
1 other identifier
interventional
39
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2013
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 8, 2014
CompletedFirst Posted
Study publicly available on registry
December 10, 2014
CompletedDecember 10, 2014
December 1, 2014
5 months
December 8, 2014
December 8, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Compared baseline to score after 8 weeks of treatment
Secondary Outcomes (1)
Neck Disability Index
Compared baseline to score after 8 weeks of treatment
Study Arms (2)
non-massage group
ACTIVE COMPARATORreceived exercise, manual therapy and advice over the 30 minute intervention period, in conjunction with an exercise program to perform at home.
massage group
EXPERIMENTALReceived massage, exercise, manual therapy and advice over the 30 minute intervention period, in conjunction with an exercise program to perform at home.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (6)
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.
PMID: 17268268BACKGROUNDHaraldsson 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.
PMID: 16856066BACKGROUNDCleland 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.
PMID: 18164333BACKGROUNDFarrar 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.
PMID: 11690728BACKGROUNDVernon 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.
PMID: 18803999BACKGROUNDGay 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.
PMID: 17509434BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Elaine Atkins, Physio
Society of Musculoskeletal Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2014
First Posted
December 10, 2014
Study Start
April 1, 2013
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
December 10, 2014
Record last verified: 2014-12