Effectiveness of Fascial Manipulation for Chronic Low Back Pain
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable low-back-pain
Started Apr 2009
Typical duration for not_applicable low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 3, 2011
CompletedFirst Posted
Study publicly available on registry
January 5, 2011
CompletedJanuary 5, 2011
April 1, 2009
8 months
January 3, 2011
January 4, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
disabilty level, evaluated with the Roland and Morris Disability Questionnaire
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)
from the first evaluation, at the end of the treatment
Secondary Outcomes (3)
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 Arms (2)
fascial manipolation
EXPERIMENTAL8 treatment sessions: 4 of fascial manipulation treatment, and 4 of standard physiotherapy (rexing exercise, stretching, abdominal and paravertebral isometric muscular recruiting)
physiotherapy
ACTIVE COMPARATOR8 treatment sessions of standard physiotherapy (rexing exercise, stretching, abdominal and paravertebral isometric muscular recruiting)
Interventions
8 treatment session in 4 weeks: every week both fascial manipulation and standard physiotherapy
Eligibility Criteria
You may qualify if:
- patients with a chronic low back pain (more than 7 weeks)
- age between 20 to 60 years old
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitary Hospital of Bologna - S.Orsola Malpighi
Bologna, 40138, Italy
Related Publications (3)
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.
PMID: 19958536BACKGROUNDChou 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.
PMID: 17909209BACKGROUNDBednar 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.
PMID: 7638659BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mirco Branchini, Ph.
University of Bologna - Degree course in Physioterapy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 3, 2011
First Posted
January 5, 2011
Study Start
April 1, 2009
Primary Completion
December 1, 2009
Study Completion
December 1, 2010
Last Updated
January 5, 2011
Record last verified: 2009-04