Condition or disease | Intervention/treatment | Phase |
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Lower Back Pain | Other: Manual spinal mobilisations | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | Cross-over study design, within-subject repeated measures (intervention versus no intervention). |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Investigation of Muscle Stiffness, Tone and Elasticity After a Spinal Mobilisation Intervention in People With Lower Back Pain |
Actual Study Start Date : | July 1, 2016 |
Actual Primary Completion Date : | September 30, 2016 |
Actual Study Completion Date : | September 30, 2016 |
Arm | Intervention/treatment |
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Experimental: A - Intervention then control
Intervention (30 minutes spinal mobilisations) received in first session, then control (30 minutes lying still) received in second session.
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Other: Manual spinal mobilisations |
Experimental: B - Control then intervention
Control (30 minutes lying still) received in first session, then intervention (30 minutes spinal mobilisations) received in second session.
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Other: Manual spinal mobilisations |
Ages Eligible for Study: | 16 Years to 80 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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:
United Kingdom | |
Edinburgh Napier University | |
Edinburgh, United Kingdom, EH11 4BN |
Study Director: | Susan Brown | Director of PhD Studies |
Tracking Information | |||||||||||||
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First Submitted Date ICMJE | July 3, 2019 | ||||||||||||
First Posted Date ICMJE | July 9, 2019 | ||||||||||||
Results First Submitted Date ICMJE | July 12, 2019 | ||||||||||||
Results First Posted Date ICMJE | November 29, 2019 | ||||||||||||
Last Update Posted Date | November 29, 2019 | ||||||||||||
Actual Study Start Date ICMJE | July 1, 2016 | ||||||||||||
Actual Primary Completion Date | September 30, 2016 (Final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
Descriptive Information | |||||||||||||
Brief Title ICMJE | Investigating the Effects of a Spinal Mobilisation Intervention in People With Lower Back Pain | ||||||||||||
Official Title ICMJE | The Investigation of Muscle Stiffness, Tone and Elasticity After a Spinal Mobilisation Intervention in People With Lower Back Pain | ||||||||||||
Brief Summary | 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. | ||||||||||||
Detailed Description |
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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Study Type ICMJE | Interventional | ||||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Intervention Model Description: Cross-over study design, within-subject repeated measures (intervention versus no intervention). Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Lower Back Pain | ||||||||||||
Intervention ICMJE | Other: Manual spinal mobilisations | ||||||||||||
Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||
Actual Enrollment ICMJE |
40 | ||||||||||||
Original Actual Enrollment ICMJE | Same as current | ||||||||||||
Actual Study Completion Date ICMJE | September 30, 2016 | ||||||||||||
Actual Primary Completion Date | September 30, 2016 (Final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria ICMJE |
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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Sex/Gender ICMJE |
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Ages ICMJE | 16 Years to 80 Years (Child, Adult, Older Adult) | ||||||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
Listed Location Countries ICMJE | United Kingdom | ||||||||||||
Removed Location Countries | |||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT04012970 | ||||||||||||
Other Study ID Numbers ICMJE | PILOT_LBP_1 | ||||||||||||
Has Data Monitoring Committee | No | ||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Rebecca Hamilton, Edinburgh Napier University | ||||||||||||
Study Sponsor ICMJE | Edinburgh Napier University | ||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Edinburgh Napier University | ||||||||||||
Verification Date | November 2019 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |