N/A N=40 Randomized Treatment

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

Lower Back Pain

Bottom Line

View on ClinicalTrials.gov: NCT04012970 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2019

Primary outcome: Primary: Intervention Erector Spinae Stiffness Change — -10.959 Newton metres (Nm) — p=<0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Manual spinal mobilisations (Other)
Age: Pediatric, Adult, Older Adult · 16+ yrs
Sex: All
Sponsor: Edinburgh Napier University
Primary completion: Sep 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Intervention Erector Spinae Stiffness Change	-10.959	<0.05 sig
PRIMARY Control Erector Spinae Stiffness Change.	12.192	<0.01 sig
SECONDARY Intervention Erector Spinae Tone Change	-0.317	<0.01 sig
SECONDARY Control Erector Spinae Tone Change	0.29	<0.01 sig
SECONDARY Intervention Erector Spinae Elasticity Change	0.068	<0.01 sig
SECONDARY Control Erector Spinae Elasticity Change	0.05	<0.001 sig

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04012970). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.