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

November 11, 2019 updated by: Rebecca Hamilton, Edinburgh Napier University

The Investigation of Muscle Stiffness, Tone and Elasticity After a Spinal Mobilisation Intervention in People With Lower Back Pain

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Edinburgh, United Kingdom, EH11 4BN
        • Edinburgh Napier University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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.
EXPERIMENTAL: B - Control then intervention
Control (30 minutes lying still) received in first session, then intervention (30 minutes spinal mobilisations) received in second session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change in muscle stiffness immediately after the 30 minute spinal mobilisation intervention.
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.
Change in muscle stiffness immediately after the 30 minute control session (lying still).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change in muscle tone immediately after the 30 minute spinal mobilisation intervention.
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.
Change in muscle tone immediately after the 30 minute control session (lying still).
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.
Change in muscle elasticity immediately after the 30 minute spinal mobilisation intervention.
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.
Change in muscle elasticity immediately after the 30 minute control session (lying still).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Susan Brown, Director of PhD Studies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2016

Primary Completion (ACTUAL)

September 30, 2016

Study Completion (ACTUAL)

September 30, 2016

Study Registration Dates

First Submitted

July 3, 2019

First Submitted That Met QC Criteria

July 8, 2019

First Posted (ACTUAL)

July 9, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 29, 2019

Last Update Submitted That Met QC Criteria

November 11, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PILOT_LBP_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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