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

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Feldenkrais Method
Back School
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring low back pain, quality of life, rehabilitation, exercise

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Umberto I Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Feldenkrais

Back School

Arm Description

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.

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 .

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).
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.
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.

Full Information

First Posted
August 8, 2014
Last Updated
April 30, 2015
Sponsor
University of Roma La Sapienza
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1. Study Identification

Unique Protocol Identification Number
NCT02231554
Brief Title
Feldenkrais vs Back School for Treating Chronic Low Back Pain: a Randomized Controlled Trial
Official Title
Effectiveness of Feldenkrais Method Versus a Back School Program in Patients With Chronic Low Back Pain: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
low back pain, quality of life, rehabilitation, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Feldenkrais
Arm Type
Experimental
Arm Description
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.
Arm Title
Back School
Arm Type
Active Comparator
Arm Description
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 .
Intervention Type
Other
Intervention Name(s)
Feldenkrais Method
Other Intervention Name(s)
Awarness through movement program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Back School
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Visual analogue scale (VAS) from baseline to 12 weeks
Description
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.
Time Frame
baseline, 4 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
Change of SF-36 Health Survey Questionnaire from baseline to 12 weeks
Description
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).
Time Frame
baseline, 4 weeks, 12 weeks
Title
Change of McGill Pain Questionnaire from baseline to 12 weeks
Description
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).
Time Frame
baseline, 4 weeks, 12 weeks
Title
Change of Waddell Disability Index from baseline to 12 weeks
Description
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.
Time Frame
baseline, 4 weeks, 12 weeks
Title
Change of Multidimensional Assessment of Interoceptive Awarness (MAIA) from baseline to 12 weeks
Description
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.
Time Frame
baseline, 4 weeks, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincenzo Maria Saraceni
Organizational Affiliation
Umberto I Hospital, Sapienza University of Rome
Official's Role
Study Director
Facility Information:
Facility Name
Umberto I Hospital
City
Rome
ZIP/Postal Code
00165
Country
Italy

12. IPD Sharing Statement

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

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