Clinical trial NCT02065531: Myofascial Release and Mobilization With Impulse Technique Torsion in Low Back Pain
Official title: Effects of Myofascial Soft Tissue Release and Mobilization With Impulse Technique Torsion in Subjects With Chronic Non-specific Low Back Pain: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Low Back Pain
Chronic Disease
Keywords: Low Back Pain
Chronic Pain
Manipulation
Manual Therapy
Randomized Controlled Trial
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
First posted: 2014-02-19
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the current randomized clinical trial was to compare the effectiveness of myofascial soft tissue release versus mobilization with impulse technique torsion (anterior) on pain, disability, and kinesiophobia in individuals with chronic non-specific low back pain.

Detailed description: Design: Randomized Clinical Trial. Objective: to determine the effects of myofascial soft tissue release versus mobilization with impulse technique torsion (anterior) on pain, disability and kinesiophobia in individuals with chronic non-specific low back pain.

Methods and Measures: sixty-four individuals will be randomly assigned to one of two groups.

Intervention: For 12-week, the group 1 will undergo treatment comprising a myofascial soft tissue release protocol (1/week) and the group 2 will receive a mobilization with impulse technique torsion (anterior) (1/week).

Main Outcome Measures: Intensity of pain, disability, fear of movement, isometric endurance of trunk flexor muscles and lumbar mobility in flexion data will be collected at baseline, and 24hr after the last manual therapy application. Mixed-model analyses of variance will be used to examine the effects of the treatment on each outcome measure.

Eligibility criteria: Inclusion Criteria:

* Score ≥4 on the Roland Morris Disability Questionnaire
* Inability to achieve lumbar muscle flexion-relaxation in trunk flexion
* Low back pain for ≥3 months
* Not undergoing another physical therapy treatment

Exclusion Criteria:

* Disease of the central or peripheral nervous system
* Having previously undergone spinal manipulative therapy
* Contraindication to low back thrust manipulation
* A history of spinal surgery
* Treatment with corticosteroid in the past two weeks
* Clinical signs of radiculopathy
* Presence of lumbar stenosis
* Diagnosis of spondylolisthesis

Primary outcomes:
measure: Change from baseline in Roland Morris Disability Questionnaire (RMDQ)
timeFrame: At baseline, 12 weeks and 16 weeks
Secondary outcomes:
measure: Change from baseline in Oswestry Low Back Pain Disability Index (ODI)
timeFrame: At baseline, 12 weeks and 16 weeks
measure: Change from baseline in Numerical Pain Rating Scale
timeFrame: At baseline, 12 weeks and 16 weeks
measure: Change from baseline in Tampa Scale of Kinesiophobia
timeFrame: At baseline, 12 weeks and 16 weeks
measure: Change from baseline in Isometric endurance of trunk flexor muscles
timeFrame: At baseline, 12 weeks and 16 weeks
measure: Change from baseline in Lumbar mobility in flexion
timeFrame: At baseline, 12 weeks and 16 weeks
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Universidad de Almeria
Study officials:
affiliation: Universidad de Almeria
name: Adelaida Castro-Sánchez, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
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