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Spinal Manipulation and Spinal Mobilization Effects in Participants With and Without Back Pain

Primary Purpose

Back Pain

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Spinal manipulation
Spinal mobilization
Sponsored by
Université du Québec à Trois-Rivières
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Back Pain focused on measuring spinal manipulation, spinal mobilization, spinal stiffness

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • presenting or not a history of chronic nonspecific back pain

Exclusion Criteria:

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

Sites / Locations

  • Université du Québec à Trois-Rivières

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Spinal manipulation

Spinal mobilization

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 18, 2016
Last Updated
June 20, 2019
Sponsor
Université du Québec à Trois-Rivières
Collaborators
Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec, Unité de recherche en santé musculosqulettique
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1. Study Identification

Unique Protocol Identification Number
NCT02660801
Brief Title
Spinal Manipulation and Spinal Mobilization Effects in Participants With and Without Back Pain
Official Title
Spinal Manipulation and Spinal Mobilization Effects in Participants With and Without Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Study Start Date
March 2016 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université du Québec à Trois-Rivières
Collaborators
Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec, Unité de recherche en santé musculosqulettique

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Although evidences suggest a similar effectiveness of spinal manipulation and spinal mobilization, there is no study that compares the neuromechanical effects of these manual therapies in a experimental context and with the standardization of both interventions. Therefore, the objective of the present study is to compare the neuromechanical responses to spinal manipulation (low-amplitude and high-velocity dynamic thrust) and spinal mobilization (repetitions of a low-amplitude and low-velocity nonthrust movement) in participants with and without chronic nonspecific back pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain
Keywords
spinal manipulation, spinal mobilization, spinal stiffness

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spinal manipulation
Arm Type
Experimental
Arm Description
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).
Arm Title
Spinal mobilization
Arm Type
Experimental
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Spinal manipulation
Other Intervention Name(s)
SMa
Intervention Description
A high-velocity and low-amplitude thrust delivered posteroanteriorly to a thoracic vertebra
Intervention Type
Procedure
Intervention Name(s)
Spinal mobilization
Other Intervention Name(s)
SMo
Intervention Description
Three repetitions of a low-velocity and low-amplitude nonthrust movement delivered posteroanteriorly to a thoracic vertebra
Primary Outcome Measure Information:
Title
Global Spinal Stiffness
Description
Global stiffness was defined as the slope of the straight-line best fitting the force-displacement data between 10 and 45 N
Time Frame
two-minutes before spinal manipulation delivery up to two-minutes after
Title
Terminal Spinal Stiffness
Description
Terminal stiffness was defined as the ratio of the variation of force and displacement between 10 and 45 N
Time Frame
two-minutes before spinal mobilization delivery up to two-minutes after
Title
Pressure Provoked Pain
Description
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
Time Frame
immediately after the therapeutic modality application
Title
Muscular Response, Superior Level Ratio
Description
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.
Time Frame
During the spinal manipulation and mobilization
Title
Muscular Response, Inferior Level Ratio, Normalized RMS
Description
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.
Time Frame
During the spinal manipulation and mobilization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: presenting or not a history of chronic nonspecific back pain Exclusion Criteria: History of back trauma or surgery Severe osteoarthritis Inflammatory arthritis Vascular conditions Contraindication to the use of spinal manipulation or spinal mobilization Pregnancy Scoliosis
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
Facility Information:
Facility Name
Université du Québec à Trois-Rivières
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G9A 5H7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Spinal Manipulation and Spinal Mobilization Effects in Participants With and Without Back Pain

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