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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01474447
Recruitment Status : Unknown
Verified February 2013 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
First Posted : November 18, 2011
Last Update Posted : March 1, 2013
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Low Back Pain (LBP) Behavioral: Grinberg Method Not Applicable

Detailed 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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Research Protocol: The Effect of Grinberg Method (GM) Intervention on Low-back Pain (LBP) and Improving the Quality of Life
Study Start Date : December 2011
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: Grinberg Method 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


Outcome Measures
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Primary Outcome Measures :
  1. pain questionnaires that will assess the improvement on back pain in patients treated with the Grinberg method [ Time Frame: change of pain from baseline and after 8 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01474447


Contacts
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Contact: Silviu Brill, M.D 972-3-6974477 silviub@tasmc.health.gov.il

Locations
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Israel
Pain Medicine Unit Recruiting
Tel Aviv, Israel
Contact: silviu Brill, M.D    972-3-6974477    silviub@tasmc.health.gov.il   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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Principal Investigator: Silviu Brill, MD Tel-Aviv Sourasky Medical Center
More Information
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Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01474447    
Other Study ID Numbers: TASMC-11-SB-541-CTIL
First Posted: November 18, 2011    Key Record Dates
Last Update Posted: March 1, 2013
Last Verified: February 2013
Keywords provided by Tel-Aviv Sourasky Medical Center:
low back pain
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations