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

Primary Purpose

Lower Back Pain

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Manual spinal mobilisations
Sponsored by
Edinburgh Napier University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Back Pain focused on measuring lower back pain, myometer, muscle stiffness, spinal mobilisations

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Edinburgh Napier University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A - Intervention then control

B - Control then intervention

Arm Description

Intervention (30 minutes spinal mobilisations) received in first session, then control (30 minutes lying still) received in second session.

Control (30 minutes lying still) received in first session, then intervention (30 minutes spinal mobilisations) received in second session.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
July 3, 2019
Last Updated
November 11, 2019
Sponsor
Edinburgh Napier University
Collaborators
Scottish Hospital Endowments Research Trust, Pacla Medical Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04012970
Brief Title
Investigating the Effects of a Spinal Mobilisation Intervention in People With Lower Back Pain
Official Title
The Investigation of Muscle Stiffness, Tone and Elasticity After a Spinal Mobilisation Intervention in People With Lower Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
September 30, 2016 (Actual)
Study Completion Date
September 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Edinburgh Napier University
Collaborators
Scottish Hospital Endowments Research Trust, Pacla Medical Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Back Pain
Keywords
lower back pain, myometer, muscle stiffness, spinal mobilisations

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Cross-over study design, within-subject repeated measures (intervention versus no intervention).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A - Intervention then control
Arm Type
Experimental
Arm Description
Intervention (30 minutes spinal mobilisations) received in first session, then control (30 minutes lying still) received in second session.
Arm Title
B - Control then intervention
Arm Type
Experimental
Arm Description
Control (30 minutes lying still) received in first session, then intervention (30 minutes spinal mobilisations) received in second session.
Intervention Type
Other
Intervention Name(s)
Manual spinal mobilisations
Primary Outcome Measure Information:
Title
Intervention Erector Spinae Stiffness Change
Description
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.
Time Frame
Change in muscle stiffness immediately after the 30 minute spinal mobilisation intervention.
Title
Control Erector Spinae Stiffness Change.
Description
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.
Time Frame
Change in muscle stiffness immediately after the 30 minute control session (lying still).
Secondary Outcome Measure Information:
Title
Intervention Erector Spinae Tone Change
Description
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.
Time Frame
Change in muscle tone immediately after the 30 minute spinal mobilisation intervention.
Title
Control Erector Spinae Tone Change
Description
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.
Time Frame
Change in muscle tone immediately after the 30 minute control session (lying still).
Title
Intervention Erector Spinae Elasticity Change
Description
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.
Time Frame
Change in muscle elasticity immediately after the 30 minute spinal mobilisation intervention.
Title
Control Erector Spinae Elasticity Change
Description
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.
Time Frame
Change in muscle elasticity immediately after the 30 minute control session (lying still).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Brown
Organizational Affiliation
Director of PhD Studies
Official's Role
Study Director
Facility Information:
Facility Name
Edinburgh Napier University
City
Edinburgh
ZIP/Postal Code
EH11 4BN
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
The data will be entered when the study is completed and remain until 1 year post publication of summary data.
IPD Sharing 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.

Learn more about this trial

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

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