Low Back PainNCT03138460
Analysis of Orthopedic Patients Response to New Pain Modulating Substances and Drugs
An observational study of Low Back Pain, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Data of patient reported outcomes (PRO) are collected during treatment with various pain alleviation methods (drugs or substances) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- standard medications crossed over to cannabis
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2015to 1 Aug 2018
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: chronic pain sufferers mostly low back pain but also fibromyalgia and arthritis
Who may be able to join
- Chronic pain of orthopedic origin treated for at least one year unsuccessfully
Who cannot join
- contra-indication for cannabis treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of New Pain Modulating Substances in Orthopedics
Data of patient reported outcomes (PRO) are collected during treatment with various pain alleviation methods (drugs or substances)
Read the detailed description
The study aims at collecting BPI (brief pain inventory) and other PRO of patients in need of pain relief due to chronic orthopedic pain conditions
- Conditions
- Low Back Pain
- Being tested
- standard medications crossed over to cannabis
- 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.
standard medications crossed over to cannabisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief pain inventory score (BPI)
score of PRO
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start1 Jan 2015
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DROR ROBINSON, Rabin Medical Center
- Investigators
- dror robinson, md, Principal investigator, head orthopedic research unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138460
- Sponsor's protocol ID
- 0612-16
- Status last verified
- Aug 2018
- First submitted
- 1 May 2017
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of New Pain Modulating Substances in Orthopedics
- ClinicalTrials.gov ID
- NCT03138460
- Acronym / sponsor ID
- 0612-16
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 3 May 2017 (actual)
- 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.
Data of patient reported outcomes (PRO) are collected during treatment with various pain alleviation methods (drugs or substances)
Detailed description
The study aims at collecting BPI (brief pain inventory) and other PRO of patients in need of pain relief due to chronic orthopedic pain conditions
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- chronic pain sufferers mostly low back pain but also fibromyalgia and arthritis
Key inclusion criteria (1 listed)
- Chronic pain of orthopedic origin treated for at least one year unsuccessfully
Key exclusion criteria (1 listed)
- contra-indication for cannabis treatment
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 |
|---|---|---|
| standard medications crossed over to cannabis | Other | – |
Primary outcome
Brief pain inventory score (BPI)
Time frame: 2 years
score of PRO
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Individual participant dataSharing planned: No
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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.
dror robinson, md principal investigator
head orthopedic research unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Rabin 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 31 Aug 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief pain inventory score (BPI) (time frame: 2 years). 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 31 Aug 2018.