NCT01474447

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2011

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 18, 2011

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 1, 2013

Status Verified

February 1, 2013

Enrollment Period

2 years

First QC Date

November 2, 2011

Last Update Submit

February 28, 2013

Conditions

Keywords

low back pain

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Grinberg Method

EXPERIMENTAL
Behavioral: Grinberg Method

Interventions

Grinberg MethodBEHAVIORAL

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

Grinberg Method

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pain Medicine Unit

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Silviu Brill, MD

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2011

First Posted

November 18, 2011

Study Start

December 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 1, 2013

Record last verified: 2013-02

Locations