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Effectiveness of Fascial Manipulation for Chronic Low Back Pain

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Fascial Manipulation
Sponsored by
University of Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, fascial manipulation, physioterapy, physical activity

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitary Hospital of Bologna - S.Orsola MalpighiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

fascial manipolation

physiotherapy

Arm Description

8 treatment sessions: 4 of fascial manipulation treatment, and 4 of standard physiotherapy (rexing exercise, stretching, abdominal and paravertebral isometric muscular recruiting)

8 treatment sessions of standard physiotherapy (rexing exercise, stretching, abdominal and paravertebral isometric muscular recruiting)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

pain and social activity level evaluated with Brief Pain Inventory.
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
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
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)

Full Information

First Posted
January 3, 2011
Last Updated
January 4, 2011
Sponsor
University of Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT01269983
Brief Title
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

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Bologna

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
low back pain, fascial manipulation, physioterapy, physical activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
fascial manipolation
Arm Type
Experimental
Arm Description
8 treatment sessions: 4 of fascial manipulation treatment, and 4 of standard physiotherapy (rexing exercise, stretching, abdominal and paravertebral isometric muscular recruiting)
Arm Title
physiotherapy
Arm Type
Active Comparator
Arm Description
8 treatment sessions of standard physiotherapy (rexing exercise, stretching, abdominal and paravertebral isometric muscular recruiting)
Intervention Type
Other
Intervention Name(s)
Fascial Manipulation
Other Intervention Name(s)
manipolazione fasciale, manipolazione della fascia, manipulacion de la fascia
Intervention Description
8 treatment session in 4 weeks: every week both fascial manipulation and standard physiotherapy
Primary Outcome Measure Information:
Title
disabilty level, evaluated with the Roland and Morris Disability Questionnaire
Description
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)
Time Frame
from the first evaluation, at the end of the treatment
Secondary Outcome Measure Information:
Title
pain and social activity level evaluated with Brief Pain Inventory.
Description
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)
Time Frame
from the first evaluation, at the end of the treatment
Title
quality of life, evaluated with SF-36
Description
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)
Time Frame
from the first evaluation, at the end of the treatment
Title
pain, assessed with visual analogical scale
Description
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)
Time Frame
at the first evaluation, at the end of the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mirco Branchini
Phone
+393394458374
Email
mirco.branchini@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Francesca Lopopolo
Phone
+393494373497
Email
francesca.lopopolo@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mirco Branchini, Ph.
Organizational Affiliation
University of Bologna - Degree course in Physioterapy
Official's Role
Study Director
Facility Information:
Facility Name
Universitary Hospital of Bologna - S.Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mirco branchini, Ph.
Phone
+393394458374
Email
mirco.branchini@gmail.com
First Name & Middle Initial & Last Name & Degree
francesca lopopolo, ph.
Email
francesca.lopopolo@gmail.com
First Name & Middle Initial & Last Name & Degree
Mirco Branchini, Ph.

12. IPD Sharing Statement

Citations:
PubMed Identifier
19958536
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.
Results Reference
background
PubMed Identifier
17909209
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. Erratum In: Ann Intern Med. 2008 Feb 5;148(3):247-8.
Results Reference
background
PubMed Identifier
7638659
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.
Results Reference
background
Links:
URL
http://fascialmanipulation.com
Description
This is the official link of Fascial Manipulation tecnique

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Effectiveness of Fascial Manipulation for Chronic Low Back Pain

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