Completed

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

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What is being tested

Manual spinal mobilisations

Other
Who is being recruted

Back Pain+3

+ Neurologic Manifestations

+ Pain

From 16 to 80 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: July 2016
See protocol details

Summary

Principal SponsorEdinburgh Napier University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2016

Actual date on which the first participant was enrolled.

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.

Official TitleThe Investigation of Muscle Stiffness, Tone and Elasticity After a Spinal Mobilisation Intervention in People With Lower Back Pain
NCT04012970
Principal SponsorEdinburgh Napier University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 16 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Back PainNeurologic ManifestationsPainSigns and SymptomsPathological Conditions, Signs and SymptomsLow Back Pain

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Edinburgh Napier University

Edinburgh, United KingdomOpen Edinburgh Napier University in Google Maps
CompletedOne Study Center
The Investigation of Muscle Stiffness, Tone and Elasticity After a Spinal Mobilisation Intervention in People With Lower Back Pain | PatLynk