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

Chronic Low Back Pain Clinical Trial

— ChiroRCT  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03434990
• Other study ID #: ChiroRCT
• Status: Completed
• Phase: N/A
• Start date: February 8, 2018
• Est. completion date: September 17, 2018

Study information

• Verified date: November 2018
• Source: University of Brasilia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 17, 2018
• Est. primary completion date: September 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Other:
• Spinal manipulation/myofascial release
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.
• Spinal manipulation
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.

Locations

Country	Name	City	State
Brazil	Complexo da Academia do Bombeiro Militar DF	Brasília	DF

Sponsors (1)

Lead Sponsor	Collaborator
University of Brasilia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Pain intensity measured by a Visual Analog Scale (in centimeters)	Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
Primary	Disability	Quebec Back Pain Disability Scale (scores ranging from 0 to 100)	Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
Secondary	Muscle fatigue	Muscle fatigue measured by the Biering-Sorensen test (in seconds)	Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
Secondary	Health Status	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	Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
Secondary	Balance	Y-Balance test (in cm)	Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
Secondary	Perception of Recovery	Perception of Recovery measured by a Likert scale (6-points)	Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)
Secondary	Pain threshold	Pain threshold measured by Algometry (in kgf)	Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)