Health TrialsbyHealthPanel

Cannabidiol (CBD) in Pain Reduction for Knee Osteoarthritis

ConditionKnee Arthritis
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age40-75
SponsorNYU Langone Health

About this trial

The purpose of this study is to see if cannabidiol (CBD) orally dissolving tablets (ODTs) can lessen pain, improve function, and improve patient satisfaction in cases of knee osteoarthritis. CBD comes from the cannabis plant and is non-psychoactive (i.e. does not produce a 'high' or altered mental state) as compared to tetrahydrocannabinol (THC), another compound found in cannabis. Researchers are studying different forms of CBD for potential use in treating pain, inflammation, and illnesses.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients presenting with knee osteoarthritis (KL Grade II-III)

Knee pain for at least three months, occurring in at least half of the days in that period

VAS ≥ 4

Patients ages 40-75, inclusive

Disqualifiers

Knee Injections within the last 3 months (cortisone, PRP, hyaluronic acid)

Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.)

Younger than 40 years of age

Older than 75 years of age

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cannabidiol (CBD)

    Drug

    Patients will be dispensed enough 25mg cannabidiol (CBD) Orally Disintegrating Tablets (ODT) to take a standard dose of 50mg three times daily for 84 days.

  • Placebo

    Drug

    25mg Placebo ODT looks like the cannabidiol (CBD) Orally Disintegrating Tablets (ODT), but contains no active ingredients.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: CBD GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

VAS Pain Severity Score

A Visual Analogue Scale (VAS) will be used to measure differences in pain between patients receiving CBD with knee OA undergoing physiotherapy compared to patients who do not receive CBD. Patients rate their pain on a scale ranging from 0 (no pain) to 10 (worst pain imaginable). Total scores range from 0-10; higher scores indicates greater pain intensity.

Time frame
Day 1
2

VAS Pain Severity Score

A Visual Analogue Scale (VAS) will be used to measure differences in pain between patients receiving CBD with knee OA undergoing physiotherapy compared to patients who do not receive CBD. Patients rate their pain on a scale ranging from 0 (no pain) to 10 (worst pain imaginable). Total scores range from 0-10; higher scores indicates greater pain intensity.

Time frame
Day 2
3

VAS Pain Severity Score

A Visual Analogue Scale (VAS) will be used to measure differences in pain between patients receiving CBD with knee OA undergoing physiotherapy compared to patients who do not receive CBD. Patients rate their pain on a scale ranging from 0 (no pain) to 10 (worst pain imaginable). Total scores range from 0-10; higher scores indicates greater pain intensity.

Time frame
Day 7
4

VAS Pain Severity Score

A Visual Analogue Scale (VAS) will be used to measure differences in pain between patients receiving CBD with knee OA undergoing physiotherapy compared to patients who do not receive CBD. Patients rate their pain on a scale ranging from 0 (no pain) to 10 (worst pain imaginable). Total scores range from 0-10; higher scores indicates greater pain intensity.

Time frame
Day 14

Secondary outcomes

1

Knee Injury and Osteoarthritis Outcome Score (KOOS)

KOOS is a knee-specific instrument, developed to assess patients' opinion about their knee and associated problems. The five patient-relevant subscales of KOOS are scored separately: Pain (9 items); Symptoms (7 items); ADL Function (17 items); Sport and Recreation Function (5 items); Quality of Life (4 items). Patients rank each item using a 5-piont Likert scale ranging from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores are calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.

Time frame
Baseline
2

Knee Injury and Osteoarthritis Outcome Score (KOOS)

KOOS is a knee-specific instrument, developed to assess patients' opinion about their knee and associated problems. The five patient-relevant subscales of KOOS are scored separately: Pain (9 items); Symptoms (7 items); ADL Function (17 items); Sport and Recreation Function (5 items); Quality of Life (4 items). Patients rank each item using a 5-piont Likert scale ranging from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores are calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.

Time frame
Week 6
3

Knee Injury and Osteoarthritis Outcome Score (KOOS)

KOOS is a knee-specific instrument, developed to assess patients' opinion about their knee and associated problems. The five patient-relevant subscales of KOOS are scored separately: Pain (9 items); Symptoms (7 items); ADL Function (17 items); Sport and Recreation Function (5 items); Quality of Life (4 items). Patients rank each item using a 5-piont Likert scale ranging from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores are calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.

Time frame
Week 12
4

Knee Injury and Osteoarthritis Outcome Score (KOOS)

KOOS is a knee-specific instrument, developed to assess patients' opinion about their knee and associated problems. The five patient-relevant subscales of KOOS are scored separately: Pain (9 items); Symptoms (7 items); ADL Function (17 items); Sport and Recreation Function (5 items); Quality of Life (4 items). Patients rank each item using a 5-piont Likert scale ranging from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores are calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.

Time frame
Week 60

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

Orcosa Inc.

Collaborator

Source ClinicalTrials.gov
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