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Completed

NCT Number: NCT02065531

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

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.

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Key information

Conditions

Low Back Pain Back Pain Chronic Disease Chronic Pain Disease Attributes Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Universidad de Almeria

Almería, 04120, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Myofascial Soft Tissue Release

Other

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.

Mobilization with impulse technique.

Other

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 outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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].

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Universidad de Almeria

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 19, 2014
Registry last updated
Nov 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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