Does the Addition of Massage to Manual Therapy and Exercise Improve Outcome in Chronic Neck Pain?

December 8, 2014 updated by: Society of Musculoskeletal Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Elaine Atkins, Physio, Society of Musculoskeletal Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

December 8, 2014

First Submitted That Met QC Criteria

December 8, 2014

First Posted (Estimate)

December 10, 2014

Study Record Updates

Last Update Posted (Estimate)

December 10, 2014

Last Update Submitted That Met QC Criteria

December 8, 2014

Last Verified

December 1, 2014

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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