Effect of Massage Therapy on Muscle Fatigue | NCT03124238

Studies
Effect of Massage Therapy on Muscle Fatigue

NCT03124238

Sponsor

Université du Québec à Trois-Rivières

Status

Completed

Last Update Posted

Apr 24, 2017Actual

Enrollment

36Actual

Phase

Not Applicable

Conditions

Low Back Pain

Interventions

Massage

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2016Actual

Primary Completion Date

Nov 1, 2016Actual

Completion Date

Nov 1, 2016Actual

First Submitted Date

Apr 11, 2017

First Submission Date that Met QC Criteria

Apr 20, 2017

First Posted Date

Apr 21, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2017

Last Update Posted Date

Apr 24, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Martin Descarreaux, Professor, Université du Québec à Trois-RivièresPrincipal Investigator

Lead Sponsor

Université du Québec à Trois-RivièresOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Massage	Experimental	Massage therapy of the lumbar muscles in a prone position during 30 minutes	Other: Massage
Control	No Intervention	Rest during 5 minutes in a prone position

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Massage	Other	Massage therapy localized to the back of the individuals for a duration of 30 minutes	Massage

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)	assessed immediatly after massage or rest
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	assessed immediatly after massage or rest

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Martin Descarreaux, DC PhD	Université du Québec à Trois-Rivières	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

No data sharing will be done

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017116	Low Back Pain

Ancestor Terms

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008405	Massage

Ancestor Terms

ID	Term
D064746	Therapy, Soft Tissue
D026201	Musculoskeletal Manipulations
D000529	Complementary Therapies
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided