NCT02660801

Brief Summary

The objective of the present study is to compare the neuromechanical responses to spinal manipulation and spinal mobilization in participants with chronic nonspecific middle back pain.

Trial Health

57
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Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

January 18, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 21, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

June 21, 2019

Completed
Last Updated

June 26, 2019

Status Verified

June 1, 2019

Enrollment Period

1.1 years

First QC Date

January 18, 2016

Results QC Date

November 23, 2017

Last Update Submit

June 20, 2019

Conditions

Keywords

spinal manipulationspinal mobilizationspinal stiffness

Outcome Measures

Primary Outcomes (5)

  • Global Spinal Stiffness

    Global stiffness was defined as the slope of the straight-line best fitting the force-displacement data between 10 and 45 N

    two-minutes before spinal manipulation delivery up to two-minutes after

  • Terminal Spinal Stiffness

    Terminal stiffness was defined as the ratio of the variation of force and displacement between 10 and 45 N

    two-minutes before spinal mobilization delivery up to two-minutes after

  • Pressure Provoked Pain

    Pressure provoked pain intensity was assessed immediately after each spinal stiffness assessment using a 0 to 100 visual analog pain scale minimum value=0, maximum value=100. 0 is no pain while 100 is the worse outcome

    immediately after the therapeutic modality application

  • Muscular Response, Superior Level Ratio

    To assess the muscular response during therapeutic modalities, the resulting bipolar sEMG signals were first digitally band-pass filtered using a frequency bandwidth of 20-450 Hz (2nd order Butterworth filter). For SMa, the peak root mean square (RMS) value was computed for each electrode using a 250 ms window (125 ms before and 125 ms after the peak force). The RMS values obtained for each electrode were then normalized (nRMS) to the respective RMS value calculated during the sEMG normalization trial.

    During the spinal manipulation and mobilization

  • Muscular Response, Inferior Level Ratio, Normalized RMS

    To assess the muscular response during therapeutic modalities, the resulting bipolar sEMG signals were first digitally band-pass filtered using a frequency bandwidth of 20-450 Hz (2nd order Butterworth filter). For SMa, the peak root mean square (RMS) value was computed for each electrode using a 250 ms window (125 ms before and 125 ms after the peak force). The RMS values obtained for each electrode were then normalized (nRMS) to the respective RMS value calculated during the sEMG normalization trial.

    During the spinal manipulation and mobilization

Study Arms (2)

Spinal manipulation

EXPERIMENTAL

Twenty-six participants with chronic nonspecific back pain will participate in two experimental sessions. During the first session, each participant will received either a spinal manipulation of a spinal mobilization of their thoracic spine preceded and followed by the assessment of their thoracic spine stiffness. The second session (24 to 48h after) will be identical but with the other experimental condition (spinal manipulation or spinal mobilization).

Procedure: Spinal manipulation

Spinal mobilization

EXPERIMENTAL

Twenty-six participants with chronic nonspecific back pain will participate in two experimental sessions. During the first session, each participant will received either a spinal manipulation of a spinal mobilization of their thoracic spine preceded and followed by the assessment of their thoracic spine stiffness. The second session (24 to 48h after) will be identical but with the other experimental condition (spinal manipulation or spinal mobilization).

Procedure: Spinal mobilization

Interventions

A high-velocity and low-amplitude thrust delivered posteroanteriorly to a thoracic vertebra

Also known as: SMa
Spinal manipulation

Three repetitions of a low-velocity and low-amplitude nonthrust movement delivered posteroanteriorly to a thoracic vertebra

Also known as: SMo
Spinal mobilization

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • presenting or not a history of chronic nonspecific back pain

You may not qualify if:

  • History of back trauma or surgery
  • Severe osteoarthritis
  • Inflammatory arthritis
  • Vascular conditions
  • Contraindication to the use of spinal manipulation or spinal mobilization
  • Pregnancy
  • Scoliosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, G9A 5H7, Canada

Location

MeSH Terms

Conditions

Back Pain

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsPhysical Therapy ModalitiesTherapeuticsRehabilitation

Results Point of Contact

Title
Pr Martin Descarreaux
Organization
UQTR

Study Officials

  • Martin Descarreaux, DC, PhD

    Université du Québec à Trois-Rivières

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Martin Descarreaux DC, PhD

Study Record Dates

First Submitted

January 18, 2016

First Posted

January 21, 2016

Study Start

March 1, 2016

Primary Completion

April 1, 2017

Study Completion

November 1, 2017

Last Updated

June 26, 2019

Results First Posted

June 21, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations