Low Back Pain (LBP)NCT01474447
The Effect of Grinberg Method (GM) Intervention on Low-back Pain (LBP) and Improving the Quality of Life
A study testing Grinberg Method in people with Low Back Pain (LBP), run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain (LBP)
- What is being tested?
- Grinberg Method
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with malignancy and/or other life threatening conditions
- Diabetic patients
- Patients with fibromyalgia
- Pregnancy
- Paralysis
- Patients with obesity
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Pain Medicine Unit
Tel Aviv
silviu Brill, M.D, 972-3-6974477, silviub@tasmc.health.gov.il
About this study
Official title: 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.
Read the 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
- Conditions
- Low Back Pain (LBP)
- Being tested
- Grinberg Method
- Keywords
- low back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grinberg MethodBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Grinberg Method | Experimental | Not described Receives: Behavioral: Grinberg Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain questionnaires that will assess the improvement on back pain in patients treated with the Grinberg method
Measured: change of pain from baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain (LBP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Silviu Brill, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474447
- Sponsor's protocol ID
- TASMC-11-SB-541-CTIL
- Status last verified
- Feb 2013
- First submitted
- 2 Nov 2011
- Last updated
- 1 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Research Protocol: The Effect of Grinberg Method (GM) Intervention on Low-back Pain (LBP) and Improving the Quality of Life
- ClinicalTrials.gov ID
- NCT01474447
- Acronym / sponsor ID
- TASMC-11-SB-541-CTIL
- Conditions
- Low Back Pain (LBP)
- Keywords
- low back pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Dec 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 18 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Grinberg Method | Experimental | Behavioral: Grinberg Method |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (12 listed)
- Patients with malignancy and/or other life threatening conditions
- Diabetic patients
- Patients with fibromyalgia
- Pregnancy
- Paralysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grinberg MethodThe 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 | Behavioural | Grinberg Method |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silviu Brill, MD principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grinberg Method in people with Low Back Pain (LBP), run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silviu Brill, M.D (972-3-6974477, silviub@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2013.