Clinical trial NCT01474447: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain (LBP)
Keywords: low back pain
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-11-18
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: pain questionnaires that will assess the improvement on back pain in patients treated with the Grinberg method
timeFrame: change of pain from baseline and after 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Pain Medicine Unit
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Silviu Brill, MD
role: PRINCIPAL_INVESTIGATOR
References: