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

Primary Purpose

Low Back Pain, Chronic Disease

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Myofascial Soft Tissue Release
Mobilization with impulse technique.
Sponsored by
Universidad de Almeria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low Back Pain, Chronic Pain, Manipulation, Manual Therapy, Randomized Controlled Trial

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universidad de Almeria

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Myofascial Soft Tissue Release

Mobilization with impulse technique

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline in Roland Morris Disability Questionnaire (RMDQ)
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 Outcome Measures

Change from baseline in Oswestry Low Back Pain Disability Index (ODI)
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.
Change from baseline in Numerical Pain Rating Scale
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.
Change from baseline in Tampa Scale of Kinesiophobia
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].
Change from baseline in Isometric endurance of trunk flexor muscles
The McQuade test measures the isometric resistance of abdominal muscles in seconds.
Change from baseline in Lumbar mobility in flexion
Lumbar mobility in flexion is determined by measuring the finger-to-floor distance with a tape.

Full Information

First Posted
January 10, 2014
Last Updated
November 23, 2014
Sponsor
Universidad de Almeria
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1. Study Identification

Unique Protocol Identification Number
NCT02065531
Brief Title
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

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Almeria

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Chronic Disease
Keywords
Low Back Pain, Chronic Pain, Manipulation, Manual Therapy, Randomized Controlled Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Myofascial Soft Tissue Release
Arm Type
Experimental
Arm Description
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.
Arm Title
Mobilization with impulse technique
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Myofascial Soft Tissue Release
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Mobilization with impulse technique.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in Roland Morris Disability Questionnaire (RMDQ)
Description
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.
Time Frame
At baseline, 12 weeks and 16 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in Oswestry Low Back Pain Disability Index (ODI)
Description
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.
Time Frame
At baseline, 12 weeks and 16 weeks
Title
Change from baseline in Numerical Pain Rating Scale
Description
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.
Time Frame
At baseline, 12 weeks and 16 weeks
Title
Change from baseline in Tampa Scale of Kinesiophobia
Description
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].
Time Frame
At baseline, 12 weeks and 16 weeks
Title
Change from baseline in Isometric endurance of trunk flexor muscles
Description
The McQuade test measures the isometric resistance of abdominal muscles in seconds.
Time Frame
At baseline, 12 weeks and 16 weeks
Title
Change from baseline in Lumbar mobility in flexion
Description
Lumbar mobility in flexion is determined by measuring the finger-to-floor distance with a tape.
Time Frame
At baseline, 12 weeks and 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adelaida Castro-Sánchez, Lecturer
Organizational Affiliation
Universidad de Almeria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad de Almeria
City
Almería
ZIP/Postal Code
04120
Country
Spain

12. IPD Sharing Statement

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

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