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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Fonds de la Recherche en Santé du Québec | OTHER_GOV |
| Unité de recherche en santé musculosqulettique | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal manipulation | Procedure | A high-velocity and low-amplitude thrust delivered posteroanteriorly to a thoracic vertebra |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Descarreaux, DC, PhD | Université du Québec à Trois-Rivières | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Université du Québec à Trois-Rivières | Trois-Rivières | Quebec | G9A 5H7 | Canada |
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the participants were recruited among the local community
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| ID | Title | Description |
|---|---|---|
| FG000 | Spinal Manipulation Then Spinal Mobilization | Participants first received spinal manipulation*. After a washout period of 48h, they then received a spinal mobilization* at the same spinal level. *Spinal manipulation is characterized by a preload force of 70 N for 500 ms leading to a peak force of 260 N in 125 ms (rate of force application: 1520 N/s) and spinal mobilization use 3 oscillatory cycles of 85 N in 800 ms (rate of force application: 106 N/s) |
| FG001 | Spinal Mobilization Then Spinal Manipulation | Participants first received spinal mobilization*. After a washout period of 48h, they then received a spinal manipulation* at the same spinal level. *Spinal manipulation is characterized by a preload force of 70 N for 500 ms leading to a peak force of 260 N in 125 ms (rate of force application: 1520 N/s) and spinal mobilization use 3 oscillatory cycles of 85 N in 800 ms (rate of force application: 106 N/s) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Experimental group 1: spinal manipulation, spinal mobilization Participants first received spinal manipulation. After a washout period of 48h, they then received a spinal mobilization at the same spinal level. Experimental group 2: spinal mobilization, spinal manipulation Participants first received spinal mobilization. After a washout period of 48h, they then received a spinal manipulation at the same spinal level. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | N/mm | two-minutes before spinal manipulation delivery up to two-minutes after |
|
48 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Spinal Manipulation Then Spinal Mobilization | 11 participants with chronic nonspecific middle back pain will participate in two experimental sessions. During the first session, each participant received either a spinal manipulation 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 spinal mobilization. Spinal manipulation: A high-velocity and low-amplitude thrust delivered posteroanteriorly to a thoracic vertebra Spinal mobilization: Three repetitions of a low-velocity and low-amplitude nonthrust movement delivered posteroanteriorly to a thoracic vertebra |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pr Martin Descarreaux | UQTR | 819-376-5011 | 3791 | martin.descarreaux@uqtr.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 1, 2016 | Mar 25, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020393 | Manipulation, Spinal |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Spinal mobilization | Procedure | Three repetitions of a low-velocity and low-amplitude nonthrust movement delivered posteroanteriorly to a thoracic vertebra |
|
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| During the spinal manipulation and mobilization |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Global spinal stiffness | Spinal stiffness is the relationship between spinal displacement and the resistive force to that movement Global stiffness was defined as the slope of the straight-line best fitting the force-displacement data between 10 and 45 N | Mean | Standard Deviation | N/mm |
|
| Terminal spinal stiffness | terminal stiffness was defined as the ratio of the variation of force and displacement between 10 and 45 N | Mean | Standard Deviation | N/mm |
|
| Pressure provoked pain | Pressure provoked pain intensity was assessed immediately after each spinal stiffness assessment using a 0 to 100 visual analog pain scale. 0 is no pain and 100 represents the maximum | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Terminal Spinal Stiffness | Terminal stiffness was defined as the ratio of the variation of force and displacement between 10 and 45 N | Posted | Mean | Standard Deviation | N/mm | two-minutes before spinal mobilization delivery up to two-minutes after |
|
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | score on a scale | immediately after the therapeutic modality application |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | ratio | During the spinal manipulation and mobilization |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | ratio | During the spinal manipulation and mobilization |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Spinal Mobilization Then Spinal Manipulation | 11 participants with chronic nonspecific middle back pain will participate in two experimental sessions. During the first session, each participant received 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 spinal manipulation . Spinal manipulation: A high-velocity and low-amplitude thrust delivered posteroanteriorly to a thoracic vertebra Spinal mobilization: Three repetitions of a low-velocity and low-amplitude nonthrust movement delivered posteroanteriorly to a thoracic vertebra | 0 | 15 | 0 | 15 | 0 | 15 |
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