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Clinical Trials/NCT02065531
NCT02065531
Completed
Phase 1

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

Universidad de Almeria1 site in 1 country64 target enrollmentJanuary 2014

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
Universidad de Almeria
Enrollment
64
Locations
1
Primary Endpoint
Change from baseline in Roland Morris Disability Questionnaire (RMDQ)
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
November 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Adelaida María Castro-Sánchez

Lecturer

Universidad de Almeria

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

Outcomes

Primary Outcomes

Change from baseline in Roland Morris Disability Questionnaire (RMDQ)

Time Frame: At baseline, 12 weeks and 16 weeks

This is a self-reported questionnaire consisting of 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, bending over, sitting, lying down, dressing, sleeping, self-care and daily activities.

Secondary Outcomes

  • Change from baseline in Numerical Pain Rating Scale(At baseline, 12 weeks and 16 weeks)
  • Change from baseline in Tampa Scale of Kinesiophobia(At baseline, 12 weeks and 16 weeks)
  • Change from baseline in Isometric endurance of trunk flexor muscles(At baseline, 12 weeks and 16 weeks)
  • Change from baseline in Lumbar mobility in flexion(At baseline, 12 weeks and 16 weeks)
  • Change from baseline in Oswestry Low Back Pain Disability Index (ODI)(At baseline, 12 weeks and 16 weeks)

Study Sites (1)

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