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出境医 / 临床实验 / Investigating the Effects of a Spinal Mobilisation Intervention in People With Lower Back Pain

Investigating the Effects of a Spinal Mobilisation Intervention in People With Lower Back Pain

Study Description
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.

Condition or disease Intervention/treatment Phase
Lower Back Pain Other: Manual spinal mobilisations Not Applicable

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.

Study Design
Layout table for study information
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
Arms and Interventions
Arm Intervention/treatment
Experimental: A - Intervention then control
Intervention (30 minutes spinal mobilisations) received in first session, then control (30 minutes lying still) received in second session.
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.
Other: Manual spinal mobilisations
Outcome Measures
Primary Outcome Measures :
  1. Intervention Erector Spinae Stiffness Change [ Time Frame: Change in muscle stiffness immediately after the 30 minute spinal mobilisation intervention. ]
    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.

  2. Control Erector Spinae Stiffness Change. [ Time Frame: Change in muscle stiffness immediately after the 30 minute control session (lying still). ]
    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.


Secondary Outcome Measures :
  1. Intervention Erector Spinae Tone Change [ Time Frame: Change in muscle tone immediately after the 30 minute spinal mobilisation intervention. ]
    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.

  2. Control Erector Spinae Tone Change [ Time Frame: Change in muscle tone immediately after the 30 minute control session (lying still). ]
    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.

  3. Intervention Erector Spinae Elasticity Change [ Time Frame: Change in muscle elasticity immediately after the 30 minute spinal mobilisation intervention. ]
    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.

  4. Control Erector Spinae Elasticity Change [ Time Frame: Change in muscle elasticity immediately after the 30 minute control session (lying still). ]
    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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Suffering from lower back pain (region between 12th rib and gluteal folds), acute or chronic.

Exclusion Criteria:

Respond positively to any absolute contraindications for spinal therapy, including:

  • segment instability
  • infectious disease
  • osteomyelitis
  • bone tumours
  • neurological deficit
  • upper motor neuron lesion
  • spinal cord damage
  • cervical arterial dysfunction

Respond positively to relative contra-indications, excluded based on severity, including:

  • osteoporosis
  • spinal instability
  • rheumatoid arthritis
  • inflammatory disease
  • active history of cancer
  • hypermobile syndrome
  • segment hypermobility
  • cardiovascular disease
  • cervical anomalies
  • nerve root disorder
  • spinal surgery
  • respiratory problems
  • thrombosis
  • open wounds
  • local infection
  • fractures or dislocations
Contacts and Locations

Locations
Layout table for location information
United Kingdom
Edinburgh Napier University
Edinburgh, United Kingdom, EH11 4BN
Sponsors and Collaborators
Edinburgh Napier University
Scottish Hospital Endowments Research Trust
Pacla Medical Ltd
Investigators
Layout table for investigator information
Study Director: Susan Brown Director of PhD Studies
Tracking Information
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
 (submitted: November 11, 2019)
  • Intervention Erector Spinae Stiffness Change [ Time Frame: Change in muscle stiffness immediately after the 30 minute spinal mobilisation intervention. ]
    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.
  • Control Erector Spinae Stiffness Change. [ Time Frame: Change in muscle stiffness immediately after the 30 minute control session (lying still). ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • Erector spinae stiffness change, intervention [ Time Frame: Change in muscle stiffness immediately after the 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.
  • Erector spinae stiffness change, control [ Time Frame: Change in muscle stiffness immediately after the 30 minute control session (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 History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2019)
  • Intervention Erector Spinae Tone Change [ Time Frame: Change in muscle tone immediately after the 30 minute spinal mobilisation intervention. ]
    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.
  • Control Erector Spinae Tone Change [ Time Frame: Change in muscle tone immediately after the 30 minute control session (lying still). ]
    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.
  • Intervention Erector Spinae Elasticity Change [ Time Frame: Change in muscle elasticity immediately after the 30 minute spinal mobilisation intervention. ]
    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.
  • Control Erector Spinae Elasticity Change [ Time Frame: Change in muscle elasticity immediately after the 30 minute control session (lying still). ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • Erector spinae tone change, intervention [ Time Frame: Change in muscle tone immediately after the 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.
  • Erector spinae tone change, control [ Time Frame: Change in muscle tone immediately after the 30 minute control session (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.
  • Erector spinae elasticity change, intervention [ Time Frame: Change in muscle elasticity immediately after the 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.
  • Erector spinae elasticity change, control [ Time Frame: Change in muscle elasticity immediately after the 30 minute control session (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.
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.

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
Condition  ICMJE Lower Back Pain
Intervention  ICMJE Other: Manual spinal mobilisations
Study Arms  ICMJE
  • Experimental: A - Intervention then control
    Intervention (30 minutes spinal mobilisations) received in first session, then control (30 minutes lying still) received in second session.
    Intervention: 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.
    Intervention: Other: Manual spinal mobilisations
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 8, 2019)
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:

  • Suffering from lower back pain (region between 12th rib and gluteal folds), acute or chronic.

Exclusion Criteria:

Respond positively to any absolute contraindications for spinal therapy, including:

  • segment instability
  • infectious disease
  • osteomyelitis
  • bone tumours
  • neurological deficit
  • upper motor neuron lesion
  • spinal cord damage
  • cervical arterial dysfunction

Respond positively to relative contra-indications, excluded based on severity, including:

  • osteoporosis
  • spinal instability
  • rheumatoid arthritis
  • inflammatory disease
  • active history of cancer
  • hypermobile syndrome
  • segment hypermobility
  • cardiovascular disease
  • cervical anomalies
  • nerve root disorder
  • spinal surgery
  • respiratory problems
  • thrombosis
  • open wounds
  • local infection
  • fractures or dislocations
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: The data will be entered when the study is completed and remain until 1 year post publication of summary data.
Access Criteria: The anonymised participant data underlying the summary data published, will be shared on the Edinburgh Napier University Repository with submission of PhD thesis.
Responsible Party Rebecca Hamilton, Edinburgh Napier University
Study Sponsor  ICMJE Edinburgh Napier University
Collaborators  ICMJE
  • Scottish Hospital Endowments Research Trust
  • Pacla Medical Ltd
Investigators  ICMJE
Study Director: Susan Brown Director of PhD Studies
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