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

January 3, 2011
January 4, 2011
April 2009
December 2009   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01269983 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Effectiveness of Fascial Manipulation for Chronic Low Back Pain
Effectiveness of Fascial Manipulation for Chronic Low Back Pain. A Randomized Controlled Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Low Back Pain
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
  • 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)
    Intervention: Other: Fascial Manipulation
  • Active Comparator: physiotherapy
    8 treatment sessions of standard physiotherapy (rexing exercise, stretching, abdominal and paravertebral isometric muscular recruiting)
    Intervention: Other: Fascial Manipulation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2010
December 2009   (final data collection date for primary outcome measure)

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
Both
20 Years to 60 Years
No
Contact: Mirco Branchini +393394458374 mirco.branchini@gmail.com
Contact: Francesca Lopopolo +393494373497 francesca.lopopolo@gmail.com
Italy
 
NCT01269983
CdL_Ft_lombalgia_09
No
Mirco Branchini - Dr. Physioterapist, Degree Course in Physiotherapy - University of Bologna
University of Bologna
Not Provided
Study Director: Mirco Branchini, Ph. University of Bologna - Degree course in Physioterapy
University of Bologna
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP