Effectiveness of Fascial Manipulation for Chronic Low Back Pain

Sponsor
University of Bologna (Other)
Overall Status
Unknown status
CT.gov ID
NCT01269983
Collaborator
(none)
50
1
2
20
2.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Fascial Manipulation
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effectiveness of Fascial Manipulation for Chronic Low Back Pain. A Randomized Controlled Trial
Study Start Date :
Apr 1, 2009
Anticipated Primary Completion Date :
Dec 1, 2009
Anticipated Study Completion Date :
Dec 1, 2010

Arms and Interventions

Arm Intervention/Treatment
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:
  • 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:
  • manipolazione fasciale
  • manipolazione della fascia
  • manipulacion de la fascia
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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)

    2. 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)

    3. 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Universitary Hospital of Bologna - S.Orsola Malpighi Bologna Italy 40138

    Sponsors and Collaborators

    • University of Bologna

    Investigators

    • Study Director: Mirco Branchini, Ph., University of Bologna - Degree course in Physioterapy

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01269983
    Other Study ID Numbers:
    • CdL_Ft_lombalgia_09
    First Posted:
    Jan 5, 2011
    Last Update Posted:
    Jan 5, 2011
    Last Verified:
    Apr 1, 2009
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 5, 2011