Effectiveness of Fascial Manipulation for Chronic Low Back Pain

NCT ID: NCT01269983

Last Updated: 2011-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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fascial manipolation

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

Group Type EXPERIMENTAL

Fascial Manipulation

Intervention Type OTHER

8 treatment session in 4 weeks: every week both fascial manipulation and standard physiotherapy

physiotherapy

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

Group Type ACTIVE_COMPARATOR

Fascial Manipulation

Intervention Type OTHER

8 treatment session in 4 weeks: every week both fascial manipulation and standard physiotherapy

Interventions

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Fascial Manipulation

8 treatment session in 4 weeks: every week both fascial manipulation and standard physiotherapy

Intervention Type OTHER

Other Intervention Names

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manipolazione fasciale manipolazione della fascia manipulacion de la fascia

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bologna

OTHER

Sponsor Role lead

Responsible Party

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Degree Course in Physiotherapy - University of Bologna

Principal Investigators

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Mirco Branchini, Ph.

Role: STUDY_DIRECTOR

University of Bologna - Degree course in Physioterapy

Locations

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Universitary Hospital of Bologna - S.Orsola Malpighi

Bologna, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Mirco Branchini

Role: CONTACT

+393394458374

Francesca Lopopolo

Role: CONTACT

+393494373497

Facility Contacts

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mirco branchini, Ph.

Role: primary

+393394458374

francesca lopopolo, ph.

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 19958536 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17909209 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7638659 (View on PubMed)

Related Links

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http://fascialmanipulation.com

This is the official link of Fascial Manipulation tecnique

Other Identifiers

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CdL_Ft_lombalgia_09

Identifier Type: -

Identifier Source: org_study_id

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