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
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring massage
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
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
NCT ID
NCT03124238
First Posted
April 11, 2017
Last Updated
April 21, 2017
Sponsor
Université du Québec à Trois-Rivières
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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