Feldenkrais vs Back School for Treating Chronic Low Back Pain: a Randomized Controlled Trial

NCT02231554 | Completed DMC

• 1 other identifier: 3297/2014
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study study is to determine whether the Feldenkrais method is effective on pain control, functional recovery and quality of life in patients with chronic low back pain by comparing it with a Back School program.

Conditions

Chronic Low Back Pain

Keywords

low back pain; quality of life; rehabilitation; exercise

Outcome Measures

Primary Outcomes (1)

• Change of Visual analogue scale (VAS) from baseline to 12 weeks

  It is based on a ten point scale, where 0 means no pain and 10 the greatest pain ever. It enables the patients to express their pain intensity as numerical values.

  baseline, 4 weeks, 12 weeks

Secondary Outcomes (4)

• Change of SF-36 Health Survey Questionnaire from baseline to 12 weeks

  baseline, 4 weeks, 12 weeks

• Change of McGill Pain Questionnaire from baseline to 12 weeks

  baseline, 4 weeks, 12 weeks

• Change of Waddell Disability Index from baseline to 12 weeks

  baseline, 4 weeks, 12 weeks

• Change of Multidimensional Assessment of Interoceptive Awarness (MAIA) from baseline to 12 weeks

  baseline, 4 weeks, 12 weeks

Study Arms (2)

Feldenkrais

EXPERIMENTAL

The Feldenkrais method is a self education method that uses the somatic sensory-motor learning to enhance the functions of people in daily life activities through the awareness of their motor habits and the experience of more efficient alternatives.

Other: Feldenkrais Method

Back School

ACTIVE COMPARATOR

The Back School teaches the patient, with theoretical and practical knowledge, how to defend his own back from the pain and how to prevent their disease, considering awareness and education as important parts of the therapeutic process .

Other: Back School

Interventions

Feldenkrais Method OTHER

The program of Awareness Through Movement ® chosen for this study, teaches the basic movements of the column. The aim is to stimulate changes in the chronic pathological patterns and in the distorted kinesthetic perceptions that so often hinder the rehabilitation of chronic non-specific low back pain. The patients will be treated in outpatient with the Feldenkrais method. Each group will consist of four or five patients who carry out the rehabilitation treatment with a frequency of twice a week for five consecutive weeks for a total of 10 sessions, each lasting about one hour.

Also known as: Awarness through movement program

Feldenkrais

Back School OTHER

The rehabilitation program of Back School is divided into two parts: one theoretical and one practical. To obtain an effective action not only in reducing pain but also in preventing relapse, the Back School acts on the typical risk factors of chronic non-specific low back pain, such as incorrect postures and movements, psychological stress, poor physical fitness, overweight, obesity, smoking, and insufficient knowledge of the spine. The patients will be treated in outpatient with a Back School program. Each group will consist of four or five patients who carry out the rehabilitation treatment with a frequency of twice a week for five consecutive weeks for a total of 10 sessions, each lasting about one hour.

Back School

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of chronic nonspecific low back pain for at least three months;
• Subjects aged between 18 and 80 years.

You may not qualify if:

• Presence of acute low back pain;
• Low back pain due to other causes (vertebral fractures, spondylolisthesis, herniated discs, lumbar canal stenosis);
• CNS and/or PNS disorders;
• Systemic inflammatory disease (eg rheumatoid arthritis);
• Systemic infectious disease;
• Neoplastic disease;
• Previous Surgery;
• Cognitive impairment;
• Pregnancy.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Umberto I Hospital

Rome, 00165, Italy

Location

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Vincenzo Maria Saraceni

  Umberto I Hospital, Sapienza University of Rome

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical director

Study Record Dates

• First Submitted: August 8, 2014
• First Posted: September 4, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: May 1, 2015

Record last verified: 2014-09

Locations

IT (1)