The Effect of Cannabis on Pain and Related Quality Of Life Outcomes In Chronic Pain: A Prospective Open-Label Study
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|ClinicalTrials.gov Identifier: NCT02388217|
Recruitment Status : Active, not recruiting
First Posted : March 13, 2015
Last Update Posted : March 8, 2016
|Condition or disease|
This is a prospective, observational, open-label study carried out at the ambulatory pain clinic of Hadassah-Hebrew University Medical Center Pain Relief Unit.
Study population: Patients suffering from chronic pain that has not been relieved with other analgesic medications, who are eligible for treatment with medical cannabis (cigarettes, oil or cookies) following approval of Israeli Ministry of health.The patients will receive a prescription to be dispensed at pre-approved cannabis distribution points by a certified provider.
In this study, the efficacy of the cannabis treatment on pain and related quality of life (QoL) outcomes will be assessed by administering the S-TOPS questionnaire (Haroutiunian, Pain 2012), and the Brief Pain Inventory (BPI) before the treatment (baseline), and on expected follow-up visits at approximately 6 and 12 months.
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||The Effect of Cannabis on Pain and Related Quality Of Life Outcomes In Chronic Pain: A Prospective Open-Label Study|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||November 2020|
- Change from baseline on the S-TOPS pain symptom scale [ Time Frame: 1 year ]The primary outcome is pain reduction (change from baseline) assessed by the Pain Symptom scale of the S-TOPS instrument
- Change from baseline on S-TOPS physical disability scales [ Time Frame: 6 and 12 months ]
- Change from baseline on S-TOPS emotional/social disability scales [ Time Frame: 6 and 12 months ]
- Change from baseline on S-TOPS satisfaction scales [ Time Frame: 6 and 12 months ]
- Change from baseline on SLP9 sleep disability scale [ Time Frame: 6 and 12 months ]
- Change from baseline on BPI severity/interference scales [ Time Frame: 6 and 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02388217
|Hadassah Medical Center|