Effectiveness of Fascial Manipulation for Chronic Low Back Pain

Not Applicable

• Conditions: Low Back Pain
• Interventions: Other: Fascial Manipulation

• Registration Number: NCT01269983
• Lead Sponsor: University of Bologna

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.

Study Timeline

• Status Verified: 2009-04
• Study Start: 2009-04
• Primary Completion: 2009-12
• Study Completion: 2010-12
• Study First Submitted: 2011-01-03
• Study First Submitted QC: 2011-01-04
• Last Update Submitted: 2011-01-04
• Study First Posted: 2011-01-05
• Last Update Posted: 2011-01-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fascial manipolation	Fascial Manipulation	8 treatment sessions: 4 of fascial manipulation treatment, and 4 of standard physiotherapy (rexing exercise, stretching, abdominal and paravertebral isometric muscular recruiting)
physiotherapy	Fascial Manipulation	8 treatment sessions of standard physiotherapy (rexing exercise, stretching, abdominal and paravertebral isometric muscular recruiting)

Primary Outcome Measures

Name	Time	Method
disabilty level, evaluated with the Roland and Morris Disability Questionnaire	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 Outcome Measures

Name	Time	Method
pain and social activity level evaluated with Brief Pain Inventory.	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)
quality of life, evaluated with SF-36	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)
pain, assessed with visual analogical scale	at 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)

Trial Locations

Locations (1)

Universitary Hospital of Bologna - S.Orsola Malpighi; 🇮🇹 Bologna, Italy