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| Name | Class |
|---|---|
| Scottish Hospital Endowments Research Trust | OTHER |
| Pacla Medical Limited | INDUSTRY |
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The objective of the study is to measure and analyse the effect of a spinal mobilisation intervention on muscle tissue quality in people with lower back pain. The mobilisation intervention will be compared to a control with participants taking part in both conditions for a factorial, within-subject repeated measures study. The study will analyse lumbar muscle response to the manual intervention and analyse the potential influence of anthropometric measures of participants. The study hypothesises a decrease in lumbar stiffness post the intervention, compared to the control session.
Various types of spinal manual therapies have been common practice for many years, particularly for treatment of lower back pain. Spinal mobilisation is a specific technique within spinal physiotherapy, often used as a treatment for lower back pain. This is despite limited objective evidence of the effect on muscle tissue quality.
The objective of this study is to measure and analyse the acute effect of a spinal mobilisation intervention on muscle tissue quality in people with lower back pain. The intervention consists of the mobilisation of the lumbar spine for 30 minutes, at a specific rate and pressure. This will be performed by a chartered physiotherapist. This will be tested with 40 participants with lower back pain. This was the recommended sample size given by G Power for a medium effect size, a power of 0.95 and alpha level of 0.05.
Participants will take part in an intervention and a control condition. Lumbar muscle response will be measured for stiffness, tone and elasticity immediately before and after the intervention and the control. The control session consists of lying still for the 30 minutes. Results for both sessions will then be compared. A myometer (MyotonPRO) will be used to assess the change in lumbar muscle objectively. This is a non-invasive, handheld device with many reliability studies on its functionality. Analysis will consider the degree of muscle response with individual covariates involved. This includes gender, height, weight, waist circumference, BMI and level of back pain (discerned by score on Oswestry Disability Index).
The results will compared in 2-way repeated measures, within participant ANOVA for significant differences between conditions and time. Anthropometric measures will be analysed in separate ANOCOVAs to determine any significant factors contributing to level of change.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A - Intervention then control | Experimental | Intervention (30 minutes spinal mobilisations) received in first session, then control (30 minutes lying still) received in second session. |
|
| B - Control then intervention | Experimental | Control (30 minutes lying still) received in first session, then intervention (30 minutes spinal mobilisations) received in second session. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual spinal mobilisations | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Erector Spinae Stiffness Change | Stiffness values measured before and after 30 minute spinal mobilisation intervention. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. Recorded 3 times and mean value used for analysis. | Change in muscle stiffness immediately after the 30 minute spinal mobilisation intervention. |
| Control Erector Spinae Stiffness Change. | Stiffness values measured before and after 30 minute control lying still. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. Recorded 3 times and mean value used for analysis. | Change in muscle stiffness immediately after the 30 minute control session (lying still). |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Erector Spinae Tone Change | Tone values measured before and after 30 minute spinal mobilisation intervention. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. Recorded 3 times and mean value used for analysis. | Change in muscle tone immediately after the 30 minute spinal mobilisation intervention. |
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Inclusion Criteria:
Exclusion Criteria:
Respond positively to any absolute contraindications for spinal therapy, including:
Respond positively to relative contra-indications, excluded based on severity, including:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Brown | Director of PhD Studies | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edinburgh Napier University | Edinburgh | EH11 4BN | United Kingdom |
Participant data sets that underlie the results for publication will be shared on a raw data set. This includes the muscle quality data, back pain result, and anthropometric data.
The data will be entered when the study is completed and remain until 1 year post publication of summary data.
The anonymised participant data underlying the summary data published, will be shared on the Edinburgh Napier University Repository with submission of PhD thesis.
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| ID | Title | Description |
|---|---|---|
| FG000 | A - Intervention Then Control | Intervention (30 minutes spinal mobilisations) received in first session, control (30 minutes lying still) received in second session. |
| FG001 | B - Control Then Intervention | Control (30 minutes lying still) received in first session, then intervention (30 minutes spinal mobilisations) received in second session. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention Session, 30 Minutes |
| |||||||||||||
| Control Session, 30 Minutes |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A - Intervention Then Control | Intervention (30 minutes spinal mobilisations) received in first session, then control (30 minutes lying still) received in second session. |
| BG001 | B - Control Then Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Intervention Erector Spinae Stiffness Change | Stiffness values measured before and after 30 minute spinal mobilisation intervention. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. Recorded 3 times and mean value used for analysis. | Posted | Mean | Standard Error | Newton metres (Nm) | Change in muscle stiffness immediately after the 30 minute spinal mobilisation intervention. |
|
|
1 hour testing time from baseline to post intervention, and 1 hour testing time on separate occasion 1 week apart from baseline to post control.
The intervention consisted of a gentle grade manual therapy, with no serious side effect risk.
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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 | Group A - Intervention | Group A received the 30 minutes spinal mobilisations intervention in the first session. |
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Variation in level of lower back pain participants was low. Physical activity was not controlled and could be a factor in baseline muscle measurements.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Hamilton, PhD student | Edinburgh Napier Univerisity | 0131 455 | 2350 | rebeccaisabel.hamilton@napier.ac.uk |
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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 | Jun 27, 2016 | Oct 11, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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Cross-over study design, within-subject repeated measures (intervention versus no intervention).
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| Control Erector Spinae Tone Change | Tone values measured before and after 30 minute control lying still. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. Recorded 3 times and mean value used for analysis. | Change in muscle tone immediately after the 30 minute control session (lying still). |
| Intervention Erector Spinae Elasticity Change | Elasticity values measured before and after 30 minute spinal mobilisation intervention. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. The device records the logarithmic decrement of the tissue by recording the dissipation of the mechanical energy of the tissue when it recovers shape after deformation. Elasticity is then inversely proportional to the decrement, so a higher decrement value equates to a higher dissipation of mechanical energy and a lower elasticity value. Recorded 3 times and mean value used for analysis. | Change in muscle elasticity immediately after the 30 minute spinal mobilisation intervention. |
| Control Erector Spinae Elasticity Change | Elasticity values measured before and after 30 minute control lying still. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. The device records the logarithmic decrement of the tissue by recording the dissipation of the mechanical energy of the tissue when it recovers shape after deformation. Elasticity is then inversely proportional to the decrement, so a higher decrement value equates to a higher dissipation of mechanical energy and a lower elasticity value. Recorded 3 times and mean value used for analysis. | Change in muscle elasticity immediately after the 30 minute control session (lying still). |
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|
Control (30 minutes lying still) received in first session, then intervention (30 minutes spinal mobilisations) received in second session.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
|
| Primary | Control Erector Spinae Stiffness Change. | Stiffness values measured before and after 30 minute control lying still. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. Recorded 3 times and mean value used for analysis. | Posted | Mean | Standard Error | Newton metres (Nm) | Change in muscle stiffness immediately after the 30 minute control session (lying still). |
|
|
|
|
| Secondary | Intervention Erector Spinae Tone Change | Tone values measured before and after 30 minute spinal mobilisation intervention. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. Recorded 3 times and mean value used for analysis. | Posted | Mean | Standard Error | Hertz (Hz) | Change in muscle tone immediately after the 30 minute spinal mobilisation intervention. |
|
|
|
|
| Secondary | Control Erector Spinae Tone Change | Tone values measured before and after 30 minute control lying still. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. Recorded 3 times and mean value used for analysis. | Posted | Mean | Standard Error | Hertz (Hz) | Change in muscle tone immediately after the 30 minute control session (lying still). |
|
|
|
|
| Secondary | Intervention Erector Spinae Elasticity Change | Elasticity values measured before and after 30 minute spinal mobilisation intervention. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. The device records the logarithmic decrement of the tissue by recording the dissipation of the mechanical energy of the tissue when it recovers shape after deformation. Elasticity is then inversely proportional to the decrement, so a higher decrement value equates to a higher dissipation of mechanical energy and a lower elasticity value. Recorded 3 times and mean value used for analysis. | Posted | Mean | Standard Error | Logarithmic decrement | Change in muscle elasticity immediately after the 30 minute spinal mobilisation intervention. |
|
|
|
|
| Secondary | Control Erector Spinae Elasticity Change | Elasticity values measured before and after 30 minute control lying still. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. The device records the logarithmic decrement of the tissue by recording the dissipation of the mechanical energy of the tissue when it recovers shape after deformation. Elasticity is then inversely proportional to the decrement, so a higher decrement value equates to a higher dissipation of mechanical energy and a lower elasticity value. Recorded 3 times and mean value used for analysis. | Posted | Mean | Standard Error | Logarithmic decrement | Change in muscle elasticity immediately after the 30 minute control session (lying still). |
|
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Group A - Control | Group A received the control (30 minutes lying still) in the second session. | 0 | 26 | 0 | 26 | 0 | 26 |
| EG002 | Group B - Intervention | Group B received the control (30 minutes lying still) in the second session. . | 0 | 14 | 0 | 14 | 0 | 14 |
| EG003 | Group B - Control | Group B received the 30 minutes spinal mobilisations intervention in the first session. | 0 | 14 | 0 | 14 | 0 | 14 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| <0.01 |
| Superiority |
| <0.05 |
| Superiority |
| <0.05 |
| Superiority |