Clinical trial NCT04012970: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lower Back Pain
Keywords: lower back pain
myometer
muscle stiffness
spinal mobilisations
Lead sponsor: Edinburgh Napier University
Sponsor class: OTHER
Collaborators: name: Scottish Hospital Endowments Research Trust
name: Pacla Medical Ltd
First posted: 2019-07-09
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Cross-over study design, within-subject repeated measures (intervention versus no intervention).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Intervention Erector Spinae Stiffness Change
timeFrame: Change in muscle stiffness immediately after the 30 minute spinal mobilisation intervention.
measure: Control Erector Spinae Stiffness Change.
timeFrame: Change in muscle stiffness immediately after the 30 minute control session (lying still).
Secondary outcomes:
measure: Intervention Erector Spinae Tone Change
timeFrame: Change in muscle tone immediately after the 30 minute spinal mobilisation intervention.
measure: Control Erector Spinae Tone Change
timeFrame: Change in muscle tone immediately after the 30 minute control session (lying still).
measure: Intervention Erector Spinae Elasticity Change
timeFrame: Change in muscle elasticity immediately after the 30 minute spinal mobilisation intervention.
measure: Control Erector Spinae Elasticity Change
timeFrame: Change in muscle elasticity immediately after the 30 minute control session (lying still).
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Edinburgh Napier University
Study officials:
affiliation: Director of PhD Studies
name: Susan Brown
role: STUDY_DIRECTOR
References: