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

NCT ID: NCT04012970

Last Updated: 2019-11-29

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lower Back Pain

Keywords

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lower back pain myometer muscle stiffness spinal mobilisations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Cross-over study design, within-subject repeated measures (intervention versus no intervention).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A - Intervention then control

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

Group Type EXPERIMENTAL

Manual spinal mobilisations

Intervention Type OTHER

B - Control then intervention

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

Group Type EXPERIMENTAL

Manual spinal mobilisations

Intervention Type OTHER

Interventions

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Manual spinal mobilisations

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Scottish Hospital Endowments Research Trust

OTHER

Sponsor Role collaborator

Pacla Medical Ltd

INDUSTRY

Sponsor Role collaborator

Edinburgh Napier University

OTHER

Sponsor Role lead

Responsible Party

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Rebecca Hamilton

Principal Investigator, PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susan Brown

Role: STUDY_DIRECTOR

Director of PhD Studies

Locations

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Edinburgh Napier University

Edinburgh, , United Kingdom

Site Status

Countries

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United Kingdom

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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PILOT_LBP_1

Identifier Type: -

Identifier Source: org_study_id