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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
Society of Musculoskeletal Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 8, 2014
    Last Updated
    December 8, 2014
    Sponsor
    Society of Musculoskeletal Medicine
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    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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