Clinical trial NCT01269983: Effectiveness of Fascial Manipulation for Chronic Low Back Pain
Official title: Effectiveness of Fascial Manipulation for Chronic Low Back Pain. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain
fascial manipulation
physioterapy
physical activity
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2011-01-05
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: disabilty level, evaluated with the Roland and Morris Disability Questionnaire
timeFrame: from the first evaluation, at the end of the treatment
Secondary outcomes:
measure: pain and social activity level evaluated with Brief Pain Inventory.
timeFrame: from the first evaluation, at the end of the treatment
measure: quality of life, evaluated with SF-36
timeFrame: from the first evaluation, at the end of the treatment
measure: pain, assessed with visual analogical scale
timeFrame: at the first evaluation, at the end of the treatment
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Universitary Hospital of Bologna - S.Orsola Malpighi
Study officials:
affiliation: University of Bologna - Degree course in Physioterapy
name: Mirco Branchini, Ph.
role: STUDY_DIRECTOR
References:
citation: Langevin HM, Stevens-Tuttle D, Fox JR, Badger GJ, Bouffard NA, Krag MH, Wu J, Henry SM. Ultrasound evidence of altered lumbar connective tissue structure in human subjects with chronic low back pain. BMC Musculoskelet Disord. 2009 Dec 3;10:151. doi: 10.1186/1471-2474-10-151.
citation: Chou R, Qaseem A, Snow V, Casey D, Cross JT Jr, Shekelle P, Owens DK; Clinical Efficacy Assessment Subcommittee of the American College of Physicians; American College of Physicians; American Pain Society Low Back Pain Guidelines Panel. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007 Oct 2;147(7):478-91. doi: 10.7326/0003-4819-147-7-200710020-00006.
citation: Bednar DA, Orr FW, Simon GT. Observations on the pathomorphology of the thoracolumbar fascia in chronic mechanical back pain. A microscopic study. Spine (Phila Pa 1976). 1995 May 15;20(10):1161-4. doi: 10.1097/00007632-199505150-00010.