Clinical trial NCT02313480: 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
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Lead sponsor: Society of Musculoskeletal Medicine
Sponsor class: OTHER
First posted: 2014-12-10
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Numerical Pain Rating Scale
timeFrame: Compared baseline to score after 8 weeks of treatment
Secondary outcomes:
measure: Neck Disability Index
timeFrame: Compared baseline to score after 8 weeks of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Society of Musculoskeletal Medicine
name: Elaine Atkins, Physio
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.