NCT03138460

Brief Summary

Data of patient reported outcomes (PRO) are collected during treatment with various pain alleviation methods (drugs or substances)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

3.6 years

First QC Date

May 1, 2017

Last Update Submit

August 30, 2018

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Brief pain inventory score (BPI)

    score of PRO

    2 years

Interventions

standard medications crossed over to cannabisOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

chronic pain sufferers mostly low back pain but also fibromyalgia and arthritis

You may qualify if:

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

You may not qualify if:

  • contra-indication for cannabis treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasharon Hospital

Petah Tikva, Israel

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • dror robinson, md

    head orthopedic research unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Orthopedic Research Unit

Study Record Dates

First Submitted

May 1, 2017

First Posted

May 3, 2017

Study Start

January 1, 2015

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

August 31, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)