- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03138460
Analysis of Orthopedic Patients Response to New Pain Modulating Substances and Drugs
August 30, 2018 updated by: DROR ROBINSON, Rabin Medical Center
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)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Petaẖ Tiqwa, Israel
- Hasharon Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
chronic pain sufferers mostly low back pain but also fibromyalgia and arthritis
Description
Inclusion Criteria:
Chronic pain of orthopedic origin treated for at least one year unsuccessfully
Exclusion Criteria:
contra-indication for cannabis treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief pain inventory score (BPI)
Time Frame: 2 years
|
score of PRO
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: dror robinson, md, head orthopedic research unit
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2015
Primary Completion (Actual)
August 1, 2018
Study Completion (Actual)
August 1, 2018
Study Registration Dates
First Submitted
May 1, 2017
First Submitted That Met QC Criteria
May 2, 2017
First Posted (Actual)
May 3, 2017
Study Record Updates
Last Update Posted (Actual)
August 31, 2018
Last Update Submitted That Met QC Criteria
August 30, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0612-16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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