NCT03124238

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable low-back-pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 21, 2017

Completed
Last Updated

April 24, 2017

Status Verified

April 1, 2017

Enrollment Period

6 months

First QC Date

April 11, 2017

Last Update Submit

April 21, 2017

Conditions

Keywords

massage

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

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

MassageOTHER

Massage therapy localized to the back of the individuals for a duration of 30 minutes

Massage

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non specific low back pain

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back Pain

Interventions

Massage

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Martin Descarreaux, DC PhD

    Université du Québec à Trois-Rivières

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: repeated measures crossover
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 11, 2017

First Posted

April 21, 2017

Study Start

May 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

April 24, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

No data sharing will be done