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

Primary Purpose

Low Back Pain (LBP)

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Grinberg Method

About this trial

This is an interventional treatment trial for Low Back Pain (LBP) focused on measuring low back pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Pain Medicine UnitRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Grinberg Method

Arm Description

Outcomes

Primary Outcome Measures

pain questionnaires that will assess the improvement on back pain in patients treated with the Grinberg method

Secondary Outcome Measures

Full Information

NCT ID

NCT01474447

First Posted

November 2, 2011

Last Updated

February 28, 2013

Sponsor

Tel-Aviv Sourasky Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01474447

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Unknown status

Study Start Date

December 2011 (undefined)

Primary Completion Date

December 2013 (Anticipated)

Study Completion Date

December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tel-Aviv Sourasky Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain (LBP)

Keywords

low back pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Grinberg Method

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Grinberg Method

Intervention Description

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

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Silviu Brill, M.D

Phone

972-3-6974477

silviub@tasmc.health.gov.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Silviu Brill, MD

Organizational Affiliation

Tel-Aviv Sourasky Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pain Medicine Unit

City

Tel Aviv

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

silviu Brill, M.D

Phone

972-3-6974477

silviub@tasmc.health.gov.il

12. IPD Sharing Statement

Learn more about this trial

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

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