Back PainNCT03063177
Evaluation of How Different Dosages of Spinal Manipulation Modulate Spinal Stiffness in Participants With Back Pain
A study testing Spinal manipulative therapy in people with Back Pain, run by Université du Québec à Trois-Rivières at 1 site in Canada.
Trial summary
This study evaluate the relationships between spinal manipulative therapy dosage (speed and peak force), the resulting modulation of thoracic spinal stiffness and changes in the clinical status in participants with chronic thoracic pain. Participants will attend four sessions of one hour over 2 weeks. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Back Pain
- What is being tested?
- Spinal manipulative therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2017to 22 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged between 18 and 60 years hold and presenting a constant or recurrent pain in the thoracic area for at least 12 weeks. Thoracic are is defined as the region boarded superiorly by T1 spinous process, inferiorly by T12 spinous process and laterally by the lateral border of the thoracic erector spinae muscles. The pain has to be of non organic origin.
Who cannot join
- Spinal arthritis, aortic aneurysm, collagenosis, advanced osteoporosis, spine surgery, neuromuscular disease, current cancer, uncontrolled hypertension, thoracic radiculopathy, thoracic herniated disc, current infection, thoracic scoliosis, current pregnancy, any contraindication to spinal manipulative therapy of the thoracic spine.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Université du Québec à Trois-Rivières
Trois-Rivières, Quebec, G9A 5H7
About this study
Official title: Evaluation of the Associations Between Spinal Manipulative Therapy Dosage and the Related Spinal Stiffness Modulation in Participants With Chronic Thoracic Pain
This study evaluate the relationships between spinal manipulative therapy dosage (speed and peak force), the resulting modulation of thoracic spinal stiffness and changes in the clinical status in participants with chronic thoracic pain. Participants will attend four sessions of one hour over 2 weeks. During session 1 to 3, participants will receive one of three different spinal manipulative therapy dosages based on their group assignment and preceded and followed by the measurement of their thoracic spinal stiffness. Session 4 will include spinal stiffness measurement and clinical status evaluation through questionnaires.
Read the detailed description
Spinal manipulative therapy (SMT) is based on the premise that clinicians can identify spine mechanical changes and accordingly determine the dosage of its biomechanical parameters: preload force, rate of force application and peak force. In recent years, our research team showed, using an apparatus to deliver specific dosage SMTs, that SMT-related neurophysiological responses depend on the dosage of these parameters. Beside determining the SMT dosage, clinicians have to select the spinal level to be treated which is partly done by applying a light pressure to each spinous process (spinal stiffness assessment). This study consist of a randomized controlled trial including 75 participants with chronic thoracic pain who will be randomized in one of three groups. Based on their group assignment, participants will receive a specific dosage SMT delivered at T7 three times over 2 weeks. These SMT dosages are distinct regarding their speed and/or their peak force in order to generate either a high vertebral displacement or a high muscle reflex response. T6, T7 and T8 spinal stiffness will be measured just before and after treatment and clinical status will be assessed at each session beginning through questionnaires. Session four will include the questionnaires and the spinal stiffness measurement procedure. Both SMT and spinal stiffness measurement will be performed using an apparatus aiming at simulating force-time profiles. Surface electromyography electrodes and accelerometers will be positioned over the upper back skin in order to measure the muscle response and vertebral displacement during SMT and spinal stiffness measurement procedures.
- Conditions
- Back Pain
- Being tested
- Spinal manipulative therapy
- Keywords
- chronic thoracic pain, spine stiffness, spinal manipulation, spinal manipulative therapy
- 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 manipulative therapyProcedure or surgery
A SMT will be delivered by contacting the transverse processes of T7 through our apparatus. Each participant will receive one SMT per session for 3 sessions.
| Study group | Role | What they receive |
|---|---|---|
| 1840Newtons/s(N/s);125ms;250 Newtons(N) | Experimental | Participants will receive a spinal manipulative therapy of 20 Newtons (N) preload leading to a peak force of 250N over 125ms (rate of force application of 1840N/s). Receives: Procedure: Spinal manipulative therapy |
| 920N/s;125ms;135N | Experimental | Participants will receive a spinal manipulative therapy of 20N preload leading to a peak force of 135N over 125ms (rate of force application of 920N/s). Receives: Procedure: Spinal manipulative therapy |
| 920N/s;250ms;250N | Experimental | Participants will receive a spinal manipulative therapy of 20N preload leading to a peak force of 250N over 250ms (rate of force application of 920N/s). Receives: Procedure: Spinal manipulative therapy |
| control | No intervention | Spinal stiffness will be assessed at each sesssion, however, participants won't receive any spinal manipulative therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in spinal stiffness
Changes in spinal stiffness between session four and the first session will be assessed at T6, T7 and T8. Spinal stiffness is measured by applying a gradual load of 45 Newtons (N) (5 kg) through our apparatus and by recording the associated indenter displacement. The resulting force-displacement data are used to calculate a spinal stiffness coefficient (N/mm) with lower value indicating more mobility at the spinal level. The change in spinal stiffness will be calculated for each participant by subtracting the value obtained during the fourth session to the one during the first session. A positive value will indicate a decrease in spinal stiffness (increase mobility) while a negative value will indicate an increase in spinal stiffness (decrease mobility) with higher value indicating more important changes.
Measured: 2 weeks
Secondary outcomes (1)
Change in pain intensity
Changes in pain intensity between session four and the first session will be evaluated by subtracting the pain value (over a 0-100 point visual analogue rating scale) obtained at session four by the one at the first session. Positive value indicates a decrease in pain with higher value indicating a more important decrease.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start1 May 2017
- Primary completion22 Dec 2017
- Study completion22 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université du Québec à Trois-Rivières
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Descarreaux, Université du Québec à Trois-Rivières
- Investigators
- Martin Descarreaux, Dc, Principal investigator, Université du Québec à Trois-Rivières
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063177
- Sponsor's protocol ID
- UQTR_2017_dose_stiffness
- Status last verified
- Sep 2018
- First submitted
- 20 Feb 2017
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Descarreaux M, Nougarou F, Dugas C. Standardization of spinal manipulation therapy in humans: development of a novel device designed to measure dose-response. J Manipulative Physiol Ther. 2013 Feb;36(2):78-83. doi: 10.1016/j.jmpt.2012.12.007.
PubMed 23499142Page I, Descarreaux M. Effects of spinal manipulative therapy biomechanical parameters on clinical and biomechanical outcomes of participants with chronic thoracic pain: a randomized controlled experimental trial. BMC Musculoskelet Disord. 2019 Jan 18;20(1):29. doi: 10.1186/s12891-019-2408-4.
PubMed 30658622
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Associations Between Spinal Manipulative Therapy Dosage and the Related Spinal Stiffness Modulation in Participants With Chronic Thoracic Pain
- ClinicalTrials.gov ID
- NCT03063177
- Acronym / sponsor ID
- UQTR_2017_dose_stiffness
- Conditions
- Back Pain
- Keywords
- chronic thoracic pain, spine stiffness, spinal manipulation, spinal manipulative therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Université du Québec à Trois-RivièresUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- 22 Dec 2017 (actual)
- First posted
- 24 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluate the relationships between spinal manipulative therapy dosage (speed and peak force), the resulting modulation of thoracic spinal stiffness and changes in the clinical status in participants with chronic thoracic pain. Participants will attend four sessions of one hour over 2 weeks. During session 1 to 3, participants will receive one of three different spinal manipulative therapy dosages based on their group assignment and preceded and followed by the measurement of their thoracic spinal stiffness. Session 4 will include spinal stiffness measurement and clinical status evaluation through questionnaires.
Detailed description
Spinal manipulative therapy (SMT) is based on the premise that clinicians can identify spine mechanical changes and accordingly determine the dosage of its biomechanical parameters: preload force, rate of force application and peak force. In recent years, our research team showed, using an apparatus to deliver specific dosage SMTs, that SMT-related neurophysiological responses depend on the dosage of these parameters. Beside determining the SMT dosage, clinicians have to select the spinal level to be treated which is partly done by applying a light pressure to each spinous process (spinal stiffness assessment). This study consist of a randomized controlled trial including 75 participants with chronic thoracic pain who will be randomized in one of three groups. Based on their group assignment, participants will receive a specific dosage SMT delivered at T7 three times over 2 weeks. These SMT dosages are distinct regarding their speed and/or their peak force in order to generate either a high vertebral displacement or a high muscle reflex response. T6, T7 and T8 spinal stiffness will be measured just before and after treatment and clinical status will be assessed at each session beginning through questionnaires. Session four will include the questionnaires and the spinal stiffness measurement procedure. Both SMT and spinal stiffness measurement will be performed using an apparatus aiming at simulating force-time profiles. Surface electromyography electrodes and accelerometers will be positioned over the upper back skin in order to measure the muscle response and vertebral displacement during SMT and spinal stiffness measurement procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1840Newtons/s(N/s);125ms;250 Newtons(N) | Experimental | Procedure: Spinal manipulative therapyParticipants will receive a spinal manipulative therapy of 20 Newtons (N) preload leading to a peak force of 250N over 125ms (rate of force application of 1840N/s). |
| 920N/s;125ms;135N | Experimental | Procedure: Spinal manipulative therapyParticipants will receive a spinal manipulative therapy of 20N preload leading to a peak force of 135N over 125ms (rate of force application of 920N/s). |
| 920N/s;250ms;250N | Experimental | Procedure: Spinal manipulative therapyParticipants will receive a spinal manipulative therapy of 20N preload leading to a peak force of 250N over 250ms (rate of force application of 920N/s). |
| control | No intervention | –Spinal stiffness will be assessed at each sesssion, however, participants won't receive any spinal manipulative therapy. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adults aged between 18 and 60 years hold and presenting a constant or recurrent pain in the thoracic area for at least 12 weeks. Thoracic are is defined as the region boarded superiorly by T1 spinous process, inferiorly by T12 spinous process and laterally by the lateral border of the thoracic erector spinae muscles. The pain has to be of non organic origin.
Key exclusion criteria (1 listed)
- Spinal arthritis, aortic aneurysm, collagenosis, advanced osteoporosis, spine surgery, neuromuscular disease, current cancer, uncontrolled hypertension, thoracic radiculopathy, thoracic herniated disc, current infection, thoracic scoliosis, current pregnancy, any contraindication to spinal manipulative therapy of the thoracic spine.
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 manipulative therapyA SMT will be delivered by contacting the transverse processes of T7 through our apparatus. Each participant will receive one SMT per session for 3 sessions. | Procedure or surgery | 1840Newtons/s(N/s);125ms;250 Newtons(N), 920N/s;125ms;135N, 920N/s;250ms;250N |
Primary outcome
Change in spinal stiffness
Time frame: 2 weeks
Changes in spinal stiffness between session four and the first session will be assessed at T6, T7 and T8. Spinal stiffness is measured by applying a gradual load of 45 Newtons (N) (5 kg) through our apparatus and by recording the associated indenter displacement. The resulting force-displacement data are used to calculate a spinal stiffness coefficient (N/mm) with lower value indicating more mobility at the spinal level. The change in spinal stiffness will be calculated for each participant by subtracting the value obtained during the fourth session to the one during the first session. A positive value will indicate a decrease in spinal stiffness (increase mobility) while a negative value will indicate an increase in spinal stiffness (decrease mobility) with higher value indicating more important changes.
1 secondary outcome
Change in pain intensity
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Background: PubMed 23499142Descarreaux M, Nougarou F, Dugas C. Standardization of spinal manipulation therapy in humans: development of a novel device designed to measure dose-response. J Manipulative Physiol Ther. 2013 Feb;36(2):78-83. doi: 10.1016/j.jmpt.2012.12.007.
- Derived from this study: PubMed 30658622Page I, Descarreaux M. Effects of spinal manipulative therapy biomechanical parameters on clinical and biomechanical outcomes of participants with chronic thoracic pain: a randomized controlled experimental trial. BMC Musculoskelet Disord. 2019 Jan 18;20(1):29. doi: 10.1186/s12891-019-2408-4.
- Individual participant dataSharing planned: No
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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 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 manipulative therapy 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 1 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: finished, as of the sponsor's last update on 10 Sep 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in spinal stiffness (time frame: 2 weeks). 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 NCT03063177, which also lists 2 linked publications.
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 10 Sep 2018.