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Completed

NCT Number: NCT03434990

Effects of the Spinal Manipulative Therapy and Myofascial Release in Individuals With Non-specific Chronic Low Back Pain

The aim will be to compare a experimental group submitted to a protocol of spinal manipulation and myofascial release; and a control group composed by spinal manipulation only, in individuals with chronic non-specific low back pain. This is a randomized controlled trial, characterized by the application of manual therapy, in two modalities: spinal manipulation plus myofascial release and spinal manipulation alone. Participants will be enrolled and randomly allocated into two groups: 1) spinal manipulation plus myofascial release, totaling 6 sessions, 2x/week, for 3 weeks; 2) spinal manipulation: 6 sessions, 2x/week, for 3 weeks. Participants will be evaluated in two different moments: 1) Baseline (pre-intervention); 2) at the end of intervention period (3 weeks); and 3) after 3 months follow-up. The primary outcomes will be pain intensity (measured in centimeters with the visual analogue scale - VAS) and disability (measured by the Quebec questionnaire - QDS). The secondary outcomes will be muscle fatigue (measured by the Biering-Sorensen test), postural balance (measured by the Y Balance test), pain threshold (algometry, in kgf) and perception of recovery (Likert scale of 6-points) and health status (measured by the Eq5d3L questionnaire). Data analysis will be performed with the SPSS (Statistical Package for the Social Sciences) software version 24.0. Data normality assumptions will be confirmed by the Shapiro Wilk test. If the assumptions were met, a mixed ANOVA with repeated measures will be adopted, based on the outcomes and the independent variables (groups), for the comparison between pre-intervention and post-intervention. Spinal manipulation plus myofascial release is expected to have better effects than spinal manipulation alone, associated with the outcomes of interest.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Complexo da Academia do Bombeiro Militar DF

Brasília, Federal District, 70602-900, Brazil

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • presence of non-specific chronic low back pain for more than 12 consecutive weeks;
  • have not performed Physical Therapy, Osteopathic and/or chiropractic sessions for at least 3 months prior to the research.

Exclusion criteria

  • history of trauma or fractures in the trunk and lumbar spine;
  • presence of neural root symptoms;
  • infection and inflammation on spine and upper and lower limbs for at least 3 months prior to research;
  • have undergone surgery on spine, chest and abdomen;
  • rheumatologic and myopathic diseases;
  • renal, digestion and neurological diseases;
  • use of anti-inflammatories drugs and analgesic drugs for at least 2 weeks prior the research.

Treatment and study plan

Spinal manipulation/myofascial release

Other

The protocol will be composed by myofascial release followed by spinal manipulation. Paravertebral muscles and gluteus maximus and piriform muscles will be manually checked for tension, stiffness, spasm and painful points. The intervention will be composed by: trigger points release, release of muscle fascia and active release technique. The myofacial release will be done with a constant pressure during 30 seconds, 3x in each point. After this procedure, the spinal manipulation will be performed in high velocity and low amplitude thrust technique, on the lumbar spine and sacroiliac joint.

Other names: Manual therapy

Spinal Manipulation

Other

The sacroiliac joint will be test and manually verified for any dysfunction, and the lumbar spine will be also assessed to verify any hypomobility and vertebral rotation. The segments with alterations will be manipulated with a high velocity and low amplitude thrust technique.

Other names: Manual therapy

Primary outcomes

  1. Pain intensity

    Time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)

    Pain intensity measured by a Visual Analog Scale (in centimeters)

  2. Disability

    Time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)

    Quebec Back Pain Disability Scale (scores ranging from 0 to 100)

Secondary outcomes

  1. Muscle fatigue

    Time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)

    Muscle fatigue measured by the Biering-Sorensen test (in seconds)

  2. Health Status

    Time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)

    Health Status measured by the EQ-5D-3L questionnaire, consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The responses record three levels of severity

  3. Balance

    Time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)

    Y-Balance test (in cm)

  4. Perception of Recovery

    Time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)

    Perception of Recovery measured by a Likert scale (6-points)

  5. Pain threshold

    Time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)

    Pain threshold measured by Algometry (in kgf)

Sponsors and collaborators

Lead sponsor

University of Brasilia

Other

Registry information

Official study title

Effects of the Spinal Manipulative Therapy and Myofascial Release on Pain Threshold, Muscle Function and Balance of Individuals With Non-specific Chronic Low Back Pain: Randomized Controlled Trial

Acronym: ChiroRCT

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 15, 2018
Registry last updated
Nov 27, 2018

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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