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Clinical Trials/NCT01269983
NCT01269983
Unknown
N/A

Effectiveness of Fascial Manipulation for Chronic Low Back Pain. A Randomized Controlled Trial

University of Bologna1 site in 1 country50 target enrollmentApril 2009
ConditionsLow Back Pain

Overview

Phase
N/A
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
University of Bologna
Enrollment
50
Locations
1
Primary Endpoint
disabilty level, evaluated with the Roland and Morris Disability Questionnaire
Last Updated
15 years ago

Overview

Brief Summary

The purpose is to evaluate the effectiveness of a physiotherapy program for chronic low back pain. We'll randomize more about 35 patients in two groups. Both groups will receive an 8 physioterapy intervention in 4 weeks, in particular the first group (study) will receive 4 Fascial Manipulation treatment combined with 4 session of a standard approach (mobilization and stretching exercises); whereas the second (control) will receive only the standard approach.

Detailed Description

All patients were assessed and randomised by a physician. The control group intervention concerned of: relaxation of lumbar and respiration muscles, stretching for posterior muscular chain and hip flexors, assisted/active mobilization of lumbar region in sagittal plane and rotation, exercises to improve proprioception of lumbar spine, active and progressive movement of lumbar spine in anterior flexion, extension, lateroflexion and rotation, active exercise for lumbar stabilizers muscles, occupational training for activity of daily living, indications and recommendations for correct postures. The study group intervention received 4 manual intervention on deep fascial tissues, according to fascial manipulation tecnique, providing a specific motor and manual assessment, and a deep manual intervention over specific fascial alteration.

Registry
clinicaltrials.gov
Start Date
April 2009
End Date
December 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Bologna

Eligibility Criteria

Inclusion Criteria

  • patients with a chronic low back pain (more than 7 weeks)
  • age between 20 to 60 years old

Exclusion Criteria

  • presence of neurological red flags
  • continuative assumption of drugs for low back pain
  • no positive imaging for spine lesions (fractures, spondilolistesi,
  • vascular desease (aneurism abdominal aorta)
  • secondary lesions (oncological desease)
  • rheumatic systemic desease
  • any other neurological desease which could compromise the partecipation to the program exercise

Outcomes

Primary Outcomes

disabilty level, evaluated with the Roland and Morris Disability Questionnaire

Time Frame: from the first evaluation, at the end of the treatment

we'll compare the baseline data (the first evaluation), with data at the end of the treatment, and with at every fullow up (30 and 90 days from the end of the treatment)

Secondary Outcomes

  • pain and social activity level evaluated with Brief Pain Inventory.(from the first evaluation, at the end of the treatment)
  • quality of life, evaluated with SF-36(from the first evaluation, at the end of the treatment)
  • pain, assessed with visual analogical scale(at the first evaluation, at the end of the treatment)

Study Sites (1)

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