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Clinical Trials/NCT02646280
NCT02646280
Completed
Not Applicable

The Myofascial Massage in the Treatment of Chronic Non-specific Low Back Pain: the Experience of Contact

University of Roma La Sapienza1 site in 1 country51 target enrollmentJuly 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Low Back Pain
Sponsor
University of Roma La Sapienza
Enrollment
51
Locations
1
Primary Endpoint
Change of Visual Analogue Scale (VAS) from baseline to 12 weeks
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The purpose of the study is to determine the effectiveness of an approach that combines massage therapy with elements of neurocognitive rehabilitation such as motor imagery and the words of the physiotherapist compared to a traditional massage therapy in reducing pain in patients with chronic low back pain (CLBP) and to evaluate if and how the pain reduction is linked to the interoceptive awareness and which is the patient's ability to relax through the measurement of the hearth rate variability (HRV).

Registry
clinicaltrials.gov
Start Date
July 2015
End Date
January 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Roma La Sapienza
Responsible Party
Principal Investigator
Principal Investigator

Teresa Paolucci

Medical Director

University of Roma La Sapienza

Eligibility Criteria

Inclusion Criteria

  • Presence of chronic nonspecific low back pain for at least three months
  • Subjects aged between 18 and 50 years

Exclusion Criteria

  • Presence of acute low back pain
  • Low back pain due to other causes (vertebral fractures, spondylolisthesis, herniated discs, lumbar canal stenosis)
  • Disorders of central and/or peripheral nervous system
  • Systemic inflammatory disease (eg rheumatoid arthritis)
  • Systemic infectious disease
  • Neoplastic disease
  • Previous Surgery
  • Cognitive impairment
  • Pregnancy

Outcomes

Primary Outcomes

Change of Visual Analogue Scale (VAS) from baseline to 12 weeks

Time Frame: baseline, 4 weeks, 12 weeks

It is a scale for the assessment of pain and it's based on a ten point scale, where 0 means no pain and 10 the greatest pain ever both at rest and during movements.

Secondary Outcomes

  • Change of Multidimensional Assessment of Interoceptive Awareness (MAIA) from baseline to 12 weeks(baseline, 4 weeks, 12 weeks)
  • Change of SF-12 Health Survey Questionnaire from baseline to 12 weeks(baseline, 4 weeks, 12 weeks)
  • Change of hearth rate variability (HRV) expressed as coherent ratio from baseline to 4 weeks(baseline, 4 weeks)
  • Change of McGill Pain Questionnaire from baseline to 12 weeks(baseline, 4 weeks, 12 weeks)
  • Change of Waddell Disability Index from baseline to 12 weeks(baseline, 4 weeks, 12 weeks)

Study Sites (1)

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