- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02660801
Spinal Manipulation and Spinal Mobilization Effects in Participants With and Without Back Pain
June 20, 2019 updated by: Martin Descarreaux, Université du Québec à Trois-Rivières
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Quebec
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Trois-Rivieres, Quebec, Canada, G9A 5H7
- Université du Québec à Trois-Rivières
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Spinal manipulation
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).
|
A high-velocity and low-amplitude thrust delivered posteroanteriorly to a thoracic vertebra
Other Names:
|
Experimental: 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).
|
Three repetitions of a low-velocity and low-amplitude nonthrust movement delivered posteroanteriorly to a thoracic vertebra
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Global Spinal Stiffness
Time Frame: two-minutes before spinal manipulation delivery up to two-minutes after
|
Global stiffness was defined as the slope of the straight-line best fitting the force-displacement data between 10 and 45 N
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two-minutes before spinal manipulation delivery up to two-minutes after
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Terminal Spinal Stiffness
Time Frame: two-minutes before spinal mobilization delivery up to two-minutes after
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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
Time Frame: immediately after the therapeutic modality application
|
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
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Muscular Response, Superior Level Ratio
Time Frame: During the spinal manipulation and mobilization
|
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.
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During the spinal manipulation and mobilization
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Muscular Response, Inferior Level Ratio, Normalized RMS
Time Frame: During the spinal manipulation and mobilization
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Martin Descarreaux, DC, PhD, Université du Québec à Trois-Rivières
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2016
Primary Completion (Actual)
April 1, 2017
Study Completion (Actual)
November 1, 2017
Study Registration Dates
First Submitted
January 18, 2016
First Submitted That Met QC Criteria
January 18, 2016
First Posted (Estimate)
January 21, 2016
Study Record Updates
Last Update Posted (Actual)
June 26, 2019
Last Update Submitted That Met QC Criteria
June 20, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UQTR-2016-STIF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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