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.

Study Overview

• Status: Unknown
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Fascial Manipulation

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • Universitary Hospital of Bologna - S.Orsola Malpighi
    • Contact: mirco branchini, Ph.; Phone Number: +393394458374; Email: mirco.branchini@gmail.com
    • Contact: francesca lopopolo, ph.; Email: francesca.lopopolo@gmail.com
    • Principal Investigator: Mirco Branchini, Ph.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	from the first evaluation, at the end of the treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	from the first evaluation, at 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)	from the first evaluation, at 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)	at the first evaluation, at the end of the treatment

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• This is the official link of Fascial Manipulation tecnique

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Anticipated): December 1, 2009
• Study Completion (Anticipated): December 1, 2010

Study Registration Dates

• First Submitted: January 3, 2011
• First Submitted That Met QC Criteria: January 4, 2011
• First Posted (Estimate): January 5, 2011

Study Record Updates

• Last Update Posted (Estimate): January 5, 2011
• Last Update Submitted That Met QC Criteria: January 4, 2011
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Keywords: physical activity; low back pain; fascial manipulation; physioterapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: CdL_Ft_lombalgia_09