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

Not Applicable

Completed

Conditions: Lower Back Pain

Interventions: Other: Manual spinal mobilisations

Registration Number: NCT04012970

Lead Sponsor: Edinburgh Napier University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

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 & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A - Intervention then control	Manual spinal mobilisations	Intervention (30 minutes spinal mobilisations) received in first session, then control (30 minutes lying still) received in second session.
B - Control then intervention	Manual spinal mobilisations	Control (30 minutes lying still) received in first session, then intervention (30 minutes spinal mobilisations) received in second session.

Primary Outcome Measures

Name	Time	Method
Intervention Erector Spinae Stiffness Change	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.	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

Name	Time	Method
Control Erector Spinae Tone Change	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	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.
Intervention Erector Spinae Tone Change	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 Elasticity Change	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.