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Completed

NCT Number: NCT02231554

Feldenkrais vs Back School for Treating 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.

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Key information

Conditions

Chronic Low Back Pain Back Pain Behavior Low Back Pain Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Umberto I Hospital

Rome, 00165, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Awarness through movement program

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.

Primary outcomes

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

    Time frame: baseline, 4 weeks, 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 outcomes

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

    Time frame: baseline, 4 weeks, 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).

  2. Change of McGill Pain Questionnaire from baseline to 12 weeks

    Time frame: baseline, 4 weeks, 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).

  3. Change of Waddell Disability Index from baseline to 12 weeks

    Time frame: baseline, 4 weeks, 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.

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

    Time frame: baseline, 4 weeks, 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.

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Sep 4, 2014
Registry last updated
May 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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