Myofascial Release and Mobilization With Impulse Technique Torsion in Low Back Pain

November 23, 2014 updated by: Adelaida María Castro-Sánchez, Universidad de Almeria

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Almería, Spain, 04120
        • Universidad de Almeria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Myofascial Soft Tissue Release
Protocol: Transverse Plane-Level Clavicular Release. Diaphragmatic Transverse Plane Release. Square the Lumbar Fascia Release. Gluteal Fascia Release. Hint Of Pubic Region Release. Fascia Psoas Release. Lumbo-sacral Decompression. Pelvic Floor Release.
Other: Myofascial Soft Tissue Release
Protocol: Transverse Plane-Level Clavicular Release. Diaphragmatic Transverse Plane Release. Square the Lumbar Fascia Release. Gluteal Fascia Release. Hint Of Pubic Region Release. Fascia Psoas Release. Lumbo-sacral Decompression. Pelvic Floor Release.
ACTIVE_COMPARATOR: Mobilization with impulse technique
Subject in lateral decubitus with extension and lower limb traction contact the couch with contralateral lower limb was performed triple flexion and left trunk rotation. This technique reduces the slack (tension joints) of the ventral pelvis, head and into the contralateral side of the sacrum support (base) with the forearm.
Other: Mobilization with impulse technique.
Subject in lateral decubitus with extension and lower limb traction contact the couch with contralateral lower limb was performed triple flexion and left trunk rotation. This technique reduces the slack (tension joints) of the ventral pelvis, head and into the contralateral side of the sacrum support (base) with the forearm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline, 12 weeks and 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Oswestry Low Back Pain Disability Index (ODI)
Time Frame: At baseline, 12 weeks and 16 weeks
The ODI has 10 items referring to activities of daily living that might be disrupted by low back pain. Each item is answered on a 6-point Likert scale ranging from "no problem at all" [0] to "not possible" [5]. The total score ranges from 0 to 50.
At baseline, 12 weeks and 16 weeks
Change from baseline in Numerical Pain Rating Scale
Time Frame: At baseline, 12 weeks and 16 weeks
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) assesses the patients' current level of pain, and the worst and lowest level of pain experienced in the preceding 24 hours.
At baseline, 12 weeks and 16 weeks
Change from baseline in Tampa Scale of Kinesiophobia
Time Frame: At baseline, 12 weeks and 16 weeks
The Tampa Scale of Kinesiophobia (TSK) is a 17-item questionnaire developed to measure the fear of movement and (re)injury. Each item is scored on a four-point Likert scale ranging from "strongly disagree" [1] to "strongly agree" [4].
At baseline, 12 weeks and 16 weeks
Change from baseline in Isometric endurance of trunk flexor muscles
Time Frame: At baseline, 12 weeks and 16 weeks
The McQuade test measures the isometric resistance of abdominal muscles in seconds.
At baseline, 12 weeks and 16 weeks
Change from baseline in Lumbar mobility in flexion
Time Frame: At baseline, 12 weeks and 16 weeks
Lumbar mobility in flexion is determined by measuring the finger-to-floor distance with a tape.
At baseline, 12 weeks and 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Almeria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (ACTUAL)

October 1, 2014

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

January 10, 2014

First Submitted That Met QC Criteria

February 16, 2014

First Posted (ESTIMATE)

February 19, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

November 25, 2014

Last Update Submitted That Met QC Criteria

November 23, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UAL-021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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