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Analysis of Orthopedic Patients Response to New Pain Modulating Substances and Drugs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03138460
Recruitment Status : Completed
First Posted : May 3, 2017
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
DROR ROBINSON, Rabin Medical Center

Tracking Information
First Submitted Date May 1, 2017
First Posted Date May 3, 2017
Last Update Posted Date August 31, 2018
Actual Study Start Date January 1, 2015
Actual Primary Completion Date August 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 2, 2017)
Brief pain inventory score (BPI) [ Time Frame: 2 years ]
score of PRO
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03138460 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Analysis of Orthopedic Patients Response to New Pain Modulating Substances and Drugs
Official Title Effect of New Pain Modulating Substances in Orthopedics
Brief Summary 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 Type Observational
Study Design Observational Model: Case-Crossover
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population chronic pain sufferers mostly low back pain but also fibromyalgia and arthritis
Condition Low Back Pain
Intervention Other: standard medications crossed over to cannabis
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 2, 2017)
100
Original Estimated Enrollment Same as current
Actual Study Completion Date August 1, 2018
Actual Primary Completion Date August 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Chronic pain of orthopedic origin treated for at least one year unsuccessfully

Exclusion Criteria:

contra-indication for cannabis treatment

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT03138460
Other Study ID Numbers 0612-16
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party DROR ROBINSON, Rabin Medical Center
Study Sponsor Rabin Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: dror robinson, md head orthopedic research unit
PRS Account Rabin Medical Center
Verification Date August 2018