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

Effectiveness of Feldenkrais Method Versus a Back School Program in Patients With Chronic Low Back Pain: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Other: Feldenkrais Method; Other: Back School

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00165
    • Umberto I Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

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: Feldenkrais; 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; 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.; Other Names: Awarness through movement program
Active Comparator: Back School; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of SF-36 Health Survey Questionnaire from baseline to 12 weeks	The questionnaire is divided into eight sub-categories that measure the physical activity, role limitations due to physical health and emotional state, physical pain, the perception of general health, vitality, social activities, mental health and changes in health status and two indices that summarize the overall assessment of the subject with respect to his physical health (ISF) and mental (ISM).	baseline, 4 weeks, 12 weeks
Change of McGill Pain Questionnaire from baseline to 12 weeks	This scales evaluates the degree of functional impairment in activities of daily life caused by pain. It consist of ten sections including pain intensity, personal care, lifting, walking, sitting standing, sleeping, sex, social life and travelling. Each section includes six sentences relating to different level of limitation in the same activity (0: no limitation, 5: maximal limitation).	baseline, 4 weeks, 12 weeks
Change of Waddell Disability Index from baseline to 12 weeks	It includes nine parameters: pain experienced in a sitting position, travelling, standing,walking and lifting weights and the need to put on or remove footwear, sleep disturbance, life restriction and sex life restriction to measure. The maximum score is 9 points. A score > 5 indicates significant disability.	baseline, 4 weeks, 12 weeks
Change of Multidimensional Assessment of Interoceptive Awarness (MAIA) from baseline to 12 weeks	The questionnaire is divided into 32 items organized into eight subcategories consisting of three to seven items each. The subcategories measure: the awareness of unpleasant, pleasant or neutral body sensations, the tendency not to ignore the feelings of pain or discomfort, not to worry about painful sensations or discomfort, the ability not to draw attention away from body sensations, awareness of the existence of connections between body sensations and emotional status, the ability to control the psychological stress by focusing on body sensations, the ability to listen to your body and the belief that the experiences coming from your body are safe and reliable. It 'a multidimensional assessment questionnaire and self-administered. For each subcategory, the patient may express a score from 0 (never) to 5 (always), the highest score corresponds to a higher level of awareness.	baseline, 4 weeks, 12 weeks

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza
• Investigators: Study Director: Vincenzo Maria Saraceni, Umberto I Hospital, Sapienza University of Rome

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: August 8, 2014
• First Submitted That Met QC Criteria: September 1, 2014
• First Posted (Estimate): September 4, 2014

Study Record Updates

• Last Update Posted (Estimate): May 1, 2015
• Last Update Submitted That Met QC Criteria: April 30, 2015
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: exercise; rehabilitation; quality of life; low back pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 3297/2014