A Single Centre Observational Study to Assess whether a Topically Applied Cannabidiol Gel can Reduce Symptoms of Painful Osteoarthritis of the Hand

Phase 1

Completed

• Conditions: Osteoarthritis of the hand; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12621001512819
• Lead Sponsor: Avecho Biotechnology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-05
• Study Completion: 2022-03-19
• Last Update Posted: 23 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Males and females with symptomatic hand OA affecting the fingers and thumb.
- At least 3 joints affected by distal interphalangeal (DIP) nodal hand OA, defined by Heberden's Nodes on physical exam.
- At least one DIP nodal hand OA with:
-Sufficiently severe frequent pain, as categorized by a minimum NPRS pain severity of 3 on a 0 - 10 scale.
-Frequent pain: pain on most days of the month for at least one month in the last year.
- Access to the internet and a smart phone, and the ability to use an app.
- Able to understand and sign the Informed Consent Form.
- Willing to follow the protocol requirements and comply with protocol restrictions.

Exclusion Criteria

- History or current inflammatory arthritis (examples: gout, psoriatic arthritis, and rheumatoid arthritis).
- Medications and/or medical conditions that are likely to change over the 6-week trial period.
- Prior surgery on the DIP joints.
- Pregnancy or lactation.
- Dermatology conditions of the hand.
- Regular self-reported use of cannabis, or cannabis-based products during the past three months.
- Known allergies or hypersensitivity to cannabis-based products or any of the excipients in the study drug.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in hand pain as assessed by the Numeric Pain Rating Scale (NPRS)<br> [Pain scores will be recorded on a daily basis during week 1 to calculate baseline pain scores. Pain scores will be recorded on a daily basis from weeks 2-5 to accompany the 4 week dosing period. The primary outcome will compare pain scores 4 weeks post commencement with those obtained at baseline to determine whether the treatment has had any effect..]

Secondary Outcome Measures

Name	Time	Method
Changes in grip strength as assessed by a squeeze ball dynamometer connected via Bluetooth to a recording app<br><br>[Grip strength will be recorded on a daily basis during week 1 to calculate baseline scores. Grip strength will be recorded on a daily basis from weeks 2-5 to accompany the 4 week dosing period. The secondary outcome will compare grip strength scores 4 weeks post commencement with those obtained at baseline to determine whether the treatment has had any effect..];Changes in hand functionality as measured by the Functional Index for Hand OsteoArthritis (FIHOA) score.<br>[FIHOA scores will be recorded on a weekly basis. FIHOA scores at 4 weeks will be compared with those recorded at Baseline..]