Back PainNCT02660801

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

A study testing Spinal manipulation and Spinal mobilization in people with Back Pain, run by Université du Québec à Trois-Rivières at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Back Pain
What is being tested?: Spinal manipulation and Spinal mobilization
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteCanada
Study dates: Mar 2016to Nov 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

presenting or not a history of chronic nonspecific back pain

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

Université du Québec à Trois-Rivières
Trois-Rivières, Quebec, G9A 5H7

Other trials in Canada

About this study

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.

Read the 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.

Conditions: Back Pain
Being tested: Spinal manipulation, Spinal mobilization
Keywords: spinal manipulation, spinal mobilization, spinal stiffness
Medical subject headings: Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Spinal manipulationProcedure or surgery
Also called SMa
A high-velocity and low-amplitude thrust delivered posteroanteriorly to a thoracic vertebra
Spinal mobilizationProcedure or surgery
Also called SMo
Three repetitions of a low-velocity and low-amplitude nonthrust movement delivered posteroanteriorly to a thoracic vertebra

Study groups in NCT02660801
Study group	Role	What they receive
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). Receives: 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). Receives: Procedure: Spinal mobilization

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: During the spinal manipulation and mobilization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2016Nov 2017

First posted21 Jan 2016 (estimated)
Study startMar 2016
Primary completionApr 2017
Study completionNov 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02660801
Sponsor's protocol ID: UQTR-2016-STIF
Status last verified: Jun 2019
First submitted: 18 Jan 2016
Last updated: 26 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain

All Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Spinal Manipulation and Spinal Mobilization Effects in Participants With and Without Back Pain
ClinicalTrials.gov ID: NCT02660801
Acronym / sponsor ID: UQTR-2016-STIF
Conditions: Back Pain
Keywords: spinal manipulation, spinal mobilization, spinal stiffness
Study type: Interventional
Recruitment status: Terminated
Enrolment: 26 participants (actual)
Lead sponsor: Université du Québec à Trois-RivièresUniversity, hospital or other
Collaborators: Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec, Unité de recherche en santé musculosqulettique
Study start: Mar 2016 (actual)
Primary completion: Apr 2017 (actual)
Study completion: Nov 2017 (actual)
First posted: 21 Jan 2016 (estimated)
Results: Posted 21 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Spinal manipulation	Experimental	Procedure: Spinal manipulationTwenty-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).
Spinal mobilization	Experimental	Procedure: Spinal mobilizationTwenty-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).

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

presenting or not a history of chronic nonspecific back pain

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Spinal manipulationAlso: SMaA high-velocity and low-amplitude thrust delivered posteroanteriorly to a thoracic vertebra	Procedure or surgery	Spinal manipulation
Spinal mobilizationAlso: SMoThree repetitions of a low-velocity and low-amplitude nonthrust movement delivered posteroanteriorly to a thoracic vertebra	Procedure or surgery	Spinal mobilization

Primary outcome

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
Terminal Spinal Stiffness
Time frame: two-minutes before spinal mobilization delivery up to two-minutes after
Terminal stiffness was defined as the ratio of the variation of force and displacement between 10 and 45 N
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
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.
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.

Results and safety

Results posted to the registry on 21 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Spinal Manipulation Then Spinal Mobilization	11	11
Spinal Mobilization Then Spinal Manipulation	15	15

Primary outcome: Global Spinal Stiffness

Time frame: two-minutes before spinal manipulation delivery up to two-minutes after. Mean (Standard Deviation). Unit: N/mm

Measure	Spinal Manipulation n = 26	Spinal Mobilization n = 26
Value	7.6 (1.8)	7.8 (1.7)

Primary outcome: Terminal Spinal Stiffness

Time frame: two-minutes before spinal mobilization delivery up to two-minutes after. Mean (Standard Deviation). Unit: N/mm

Measure	Spinal Manipulation n = 26	Spinal Mobilization n = 26
Value	7.9 (1.5)	7.8 (1.9)

Primary outcome: Pressure Provoked Pain

Time frame: immediately after the therapeutic modality application. Mean (Standard Deviation). Unit: score on a scale

Measure	Spinal Manipulation n = 26	Spinal Mobilization n = 26
Value	36.6 (23.7)	45.4 (24.3)

Primary outcome: Muscular Response, Superior Level Ratio

Time frame: During the spinal manipulation and mobilization. Mean (Standard Deviation). Unit: ratio

Measure	Spinal Manipulation n = 26	Spinal Mobilization n = 26
Value	0.78 (0.56)	0.16 (0.09)

Adverse events

Time frame: 48 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Spinal Manipulation Then Spinal Mobilization	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Spinal Mobilization Then Spinal Manipulation	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Back Pain

RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
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Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
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Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Martin Descarreaux, DC, PhD principal investigator

Université du Québec à Trois-Rivières

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Spinal manipulation and Spinal mobilization in people with Back Pain, run by Université du Québec à Trois-Rivières at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global Spinal Stiffness (time frame: two-minutes before spinal manipulation delivery up to two-minutes after). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02660801.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2019.