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Effect of Massage Therapy on Muscle Fatigue

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Massage
Sponsored by
Université du Québec à Trois-Rivières
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring massage

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Non specific low back pain

Exclusion Criteria:

  • Low back pain of specific origin including but not limited to:

herniated disk fractures spondylolisthesis

  • inflammatory rheumatic disease
  • infectious disease
  • neuromuscular disease
  • vascular disease
  • connective tissue disease
  • severe disabling pain
  • neurologic signs and symptoms
  • pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Massage

    Control

    Arm Description

    Massage therapy of the lumbar muscles in a prone position during 30 minutes

    Rest during 5 minutes in a prone position

    Outcomes

    Primary Outcome Measures

    Median frequency slope of the lumbar muscles (Hz/s)
    Fatigue will be assess during a extensor muscle endurance task throught surface electromyography electrodes (the more the slope value is negative and high, the more the muscle presents an important fatigue)
    Maximal isometric force of the lumbar muscles (Newtons)
    Back extensor isometric force is assess throught surface electromyography electrodes during a five seconds maximal volontary contraction

    Secondary Outcome Measures

    Full Information

    First Posted
    April 11, 2017
    Last Updated
    April 21, 2017
    Sponsor
    Université du Québec à Trois-Rivières
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03124238
    Brief Title
    Effect of Massage Therapy on Muscle Fatigue
    Official Title
    Effect of Massage Therapy on Muscle Fatigue in Individuals With Low Back Pain: Physiological or Clinical Changes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1, 2016 (Actual)
    Primary Completion Date
    November 1, 2016 (Actual)
    Study Completion Date
    November 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Université du Québec à Trois-Rivières

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The main objective of the current proposal is to investigate the clinical and physiological changes triggered by massage therapy in a group of individuals with chronic low back pain experiencing muscular fatigue. The investigators believe these objectives are in line with the "2014 Massage Therapy Research Fund research priorities", since the results produced by these investigations will generate knowledge with regard to the short term clinical efficacy of massage therapy and will provide critical information related to the physiological mechanisms underlying massage therapy clinical effects. Most importantly, the combined assessment of clinical and physiological outcomes will also yield key information to identify specific biological components of the massage therapy intervention. Determining the presence of a biological mechanism is, as for any treatment, considered one of the necessary criteria to declare a causal relationship between a specific intervention and its associated clinical effects. The investigators strongly believe that the proposed research will contribute to the identification of specific mechanisms that will complement the emerging clinical evidence supporting massage therapy in the treatment of chronic low back pain. The proposed research project will involve researchers and future practitioners of massage therapy. In conjunction with a high quality research environment, it is the goal of the investigators to create an educational environment for undergraduate and graduate students that will foster interdisciplinary collaboration in order to ensure a diversified; high quality training of young researchers and clinician scientists working in the field of manual therapies.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain
    Keywords
    massage

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    repeated measures crossover
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Massage
    Arm Type
    Experimental
    Arm Description
    Massage therapy of the lumbar muscles in a prone position during 30 minutes
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Rest during 5 minutes in a prone position
    Intervention Type
    Other
    Intervention Name(s)
    Massage
    Intervention Description
    Massage therapy localized to the back of the individuals for a duration of 30 minutes
    Primary Outcome Measure Information:
    Title
    Median frequency slope of the lumbar muscles (Hz/s)
    Description
    Fatigue will be assess during a extensor muscle endurance task throught surface electromyography electrodes (the more the slope value is negative and high, the more the muscle presents an important fatigue)
    Time Frame
    assessed immediatly after massage or rest
    Title
    Maximal isometric force of the lumbar muscles (Newtons)
    Description
    Back extensor isometric force is assess throught surface electromyography electrodes during a five seconds maximal volontary contraction
    Time Frame
    assessed immediatly after massage or rest

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Non specific low back pain Exclusion Criteria: Low back pain of specific origin including but not limited to: herniated disk fractures spondylolisthesis inflammatory rheumatic disease infectious disease neuromuscular disease vascular disease connective tissue disease severe disabling pain neurologic signs and symptoms pregnancy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Martin Descarreaux, DC PhD
    Organizational Affiliation
    Université du Québec à Trois-Rivières
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    No data sharing will be done

    Learn more about this trial

    Effect of Massage Therapy on Muscle Fatigue

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