Effectiveness of Fascial Manipulation for Chronic Low Back Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by University of Bologna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Bologna
ClinicalTrials.gov Identifier:
NCT01269983
First received: January 3, 2011
Last updated: January 4, 2011
Last verified: April 2009
  Purpose

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.


Condition Intervention
Low Back Pain
Other: Fascial Manipulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Fascial Manipulation for Chronic Low Back Pain. A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Bologna:

Primary Outcome Measures:
  • disabilty level, evaluated with the Roland and Morris Disability Questionnaire [ Time Frame: from the first evaluation, at the end of the treatment ] [ Designated as safety issue: No ]
    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:
  • pain and social activity level evaluated with Brief Pain Inventory. [ Time Frame: from the first evaluation, at the end of the treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: from the first evaluation, at the end of the treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: at the first evaluation, at the end of the treatment ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 50
Study Start Date: April 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fascial manipolation
8 treatment sessions: 4 of fascial manipulation treatment, and 4 of standard physiotherapy (rexing exercise, stretching, abdominal and paravertebral isometric muscular recruiting)
Other: Fascial Manipulation
8 treatment session in 4 weeks: every week both fascial manipulation and standard physiotherapy
Other Names:
  • fascial manipulation
  • manipolazione fasciale
  • manipolazione della fascia
  • manipulacion de la fascia
Active Comparator: physiotherapy
8 treatment sessions of standard physiotherapy (rexing exercise, stretching, abdominal and paravertebral isometric muscular recruiting)
Other: Fascial Manipulation
8 treatment session in 4 weeks: every week both fascial manipulation and standard physiotherapy
Other Names:
  • fascial manipulation
  • manipolazione fasciale
  • manipolazione della fascia
  • manipulacion de la fascia

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

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01269983

Contacts
Contact: Mirco Branchini +393394458374 mirco.branchini@gmail.com
Contact: Francesca Lopopolo +393494373497 francesca.lopopolo@gmail.com

Locations
Italy
Universitary Hospital of Bologna - S.Orsola Malpighi Recruiting
Bologna, Italy, 40138
Contact: mirco branchini, Ph.    +393394458374    mirco.branchini@gmail.com   
Contact: francesca lopopolo, ph.       francesca.lopopolo@gmail.com   
Principal Investigator: Mirco Branchini, Ph.         
Sponsors and Collaborators
University of Bologna
Investigators
Study Director: Mirco Branchini, Ph. University of Bologna - Degree course in Physioterapy
  More Information

Additional Information:
Publications:
Responsible Party: Mirco Branchini - Dr. Physioterapist, Degree Course in Physiotherapy - University of Bologna
ClinicalTrials.gov Identifier: NCT01269983     History of Changes
Other Study ID Numbers: CdL_Ft_lombalgia_09
Study First Received: January 3, 2011
Last Updated: January 4, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by University of Bologna:
low back pain
fascial manipulation
physioterapy
physical activity

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014