The Effect of Grinberg Method (GM) Intervention on Low-back Pain (LBP) and Improving the Quality of Life

Low Back Pain (LBP) Clinical Trial

Official title:

The Research Protocol: The Effect of Grinberg Method (GM) Intervention on Low-back Pain (LBP) and Improving the Quality of Life

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01474447
• Other study ID #: TASMC-11-SB-541-CTIL
• Status: Recruiting
• Phase: N/A
• First received: November 2, 2011
• Last updated: February 28, 2013
• Start date: December 2011
• Est. completion date: December 2013

Study information

• Verified date: February 2013
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Silviu Brill, M.D
• Phone: 972-3-6974477
• Email: silviub[@]tasmc.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of the research is to check the efficiency of practicing the tools of the Grinberg method (GM) in reducing Low-back Pain (LBP), reducing limitations in movement as a result of the pain, and improving the general quality of life.

The hypothesis suggests that by learning to perceive pain differently, the level of pain will reduce and general well-being improved.

Description:

The research will include 140 patients, who attended the pain clinic due to chronic LBP. Any change in the pharmacological regimen will be done with consult of the tending doctor and the change will be reported.

Tools and Methods A patient, whom volunteers to take part in the research, will be invited to the Ichilov Pain clinic in order to fill-in questionnaires and sign an informed consent form.

Each participant in the experiment group will participate in a series of 6 sessions lasting 1 hour each, extending between 6 to 8 consecutive weeks, with one of the qualified GM practitioners partaking in the experiment. Each participant will have all their sessions with the same GM practitioner throughout the experiment. Immediately after the last session, the participants will fill-in the same questionnaires given at the beginning of the experiment. The non-GM intervention group will answer the questionnaires after 6-8 weeks of pharmacological treatment only.

Questionnaires:

• General Details and Pain Questionnaire

• SF-MPQ Short Form McGill Pain Questionnaire, Ronald Melzack

• RMDQ - Roland Morris Disability Questionnaire

• SF 36 - The Short Form Health Survey

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Women and men, age range 18-65; patients of the Ichilov Pain clinic, who suffer from chronic LBP that lasts over 3 months and that appears several times a week.

• LBP which is localized between the 12th rib and the inferior gluteal folds, with or without leg pain. The LBP may be non-specific, mechanical or radicular.

Exclusion Criteria:

• Patients with malignancy and/or other life threatening conditions

• Diabetic patients

• Patients with fibromyalgia

• Pregnancy

• Paralysis

• Patients with obesity

• Patients that underwent organ transplantation

• Severe osteoporosis

• Patients that are scheduled to receive spinal cord injections during the research

• Patients that received less than 4 weeks before the research, other pain interventions than the standard of care treatment such as: alternative medicine (acupuncture, shiatsu, massage, reflexology, homeopathy etc'); physiotherapy, chiropractic, hydrotherapy, bio-feedback, osteopathy and others.

• Patients with severe mental disorders (such as schizophrenia, bipolar disorder, suicidal tendencies etc')

• Pain lasting less than 3 months

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Low Back Pain (LBP)

Intervention

Behavioral:
• Grinberg Method
The GM is a methodology of attention that teaches through expanding and focusing body attention to create a change and an improvement in pain and in quality of life. The method focuses on the way in which we experience pain, and offers an approach that trains people to use their attention and will in order to turn an unwanted experience that causes suffering, into a controlled experience in which they can take responsibility on the way they react to an existing pain. The method uses attention in order to learn the fixed ways in which we respond to pain in our body: where we focus our attention, what is the level of tension in our muscles, how we breathe and relax and more. It gives simple and effective tools to control all these, in order to create optimal conditions in the body to utilize its natural potential to recover and recuperate

Locations

Country	Name	City	State
Israel	Pain Medicine Unit	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain questionnaires that will assess the improvement on back pain in patients treated with the Grinberg method		change of pain from baseline and after 8 weeks	No