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

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

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.

Study Overview

• Status: Unknown
• Conditions: Low Back Pain (LBP)
• Intervention / Treatment: Behavioral: Grinberg Method

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 Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel
    • Recruiting
    • Pain Medicine Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (ANTICIPATED): December 1, 2013
• Study Completion (ANTICIPATED): December 1, 2013

Study Registration Dates

• First Submitted: November 2, 2011
• First Submitted That Met QC Criteria: November 17, 2011
• First Posted (ESTIMATE): November 18, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): March 1, 2013
• Last Update Submitted That Met QC Criteria: February 28, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: low back pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: TASMC-11-SB-541-CTIL