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Efficacy of a Controlled Short-term Trial of Cannabidiol (CBD) Ingestion on Reducing Symptomatic Response and Facilitating Recovery After Induced Muscle Injury
Phase 2 trial testing Active CBD in Muscle Injury in 34 participants. Completed in 21 March 2024.
| Lead sponsor | University of Florida |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 34 |
| Start date | 1 March 2021 |
| Primary completion | 21 March 2024 |
| Estimated completion | 21 March 2024 |
| Sites | 1 location across United States |
University of Florida
Adults 18 to 35, any sex, with Muscle Injury or Recovery. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
A muscle soreness inventory will be used to self-report the level of soreness. The muscle soreness inventory consists of rating soreness on a visual analog scale (VAS). A 10cm line is drawn with 0 (no soreness) on the left pole and 10 (extreme soreness) on the right pole.
| Group | Value | 95% CI |
|---|---|---|
| Active CBD-extract | 0.0 | ± 0 |
| Vehicle-Control (Placebo) | 0.0 | ± 0 |
A muscle soreness inventory will be used to self-report the level of soreness. The muscle soreness inventory consists of rating soreness on a visual analog scale (VAS). A 10cm line is drawn with 0 (no soreness) on the left pole and 10 (extreme soreness) on the right pole.
| Group | Value | 95% CI |
|---|---|---|
| Active CBD-extract | 4.0 | ± 7.4 |
| Vehicle-Control (Placebo) | 2.3 | ± 5.9 |
A muscle soreness inventory will be used to self-report the level of soreness. The muscle soreness inventory consists of rating soreness on a visual analog scale (VAS). A 100mm line is drawn with 0 (no soreness) on the left pole and 100 (extreme soreness) on the right pole.
| Group | Value | 95% CI |
|---|---|---|
| Active CBD-extract | 47.8 | ± 27.3 |
| Vehicle-Control (Placebo) | 61.6 | ± 22.3 |
Disability will be measured using the Lower Extremity Functional Scale (LEFS). LEFS score = SUM (points for all 20 activities) Interpretation: Minimum score: 0 Maximum score: 80 The lower the score the greater the disability.
| Group | Value | 95% CI |
|---|---|---|
| Active CBD-extract | 77.2 | ± 5.4 |
| Vehicle-Control (Placebo) | 76.7 | ± 4.6 |
Disability will be measured using the Lower Extremity Functional Scale (LEFS). LEFS score = SUM (points for all 20 activities) Interpretation: Minimum score: 0 Maximum score: 80 The lower the score the greater the disability.
| Group | Value | 95% CI |
|---|---|---|
| Active CBD-extract | 77.1 | ± 4.8 |
| Vehicle-Control (Placebo) | 75.9 | ± 5.4 |
Disability will be measured using the Lower Extremity Functional Scale (LEFS). LEFS score = SUM (points for all 20 activities) Interpretation: Minimum score: 0 Maximum score: 80 The lower the score the greater the disability.
| Group | Value | 95% CI |
|---|---|---|
| Active CBD-extract | 67.7 | ± 13.2 |
| Vehicle-Control (Placebo) | 60.1 | ± 27.4 |
20 item, 5-point rating scale that assesses 4 theoretically distinct components of pain-related anxiety including cognitive anxiety (items 1 to 5), fear of pain (items 6 to 10), escape/avoidance behavior (items 11 to 15), and physiological anxiety (items 16 to 20). Each subscale is worth 20 points. Subscales are combined to compute total score. The total scale ranges from 0 to 100; higher scores indicate worse outcome.
| Group | Value | 95% CI |
|---|---|---|
| Active CBD-extract | 39.5 | ± 15.4 |
| Vehicle-Control (Placebo) | 49.9 | ± 22.1 |
20 item, 5-point rating scale that assesses 4 theoretically distinct components of pain-related anxiety including cognitive anxiety (items 1 to 5), fear of pain (items 6 to 10), escape/avoidance behavior (items 11 to 15), and physiological anxiety (items 16 to 20). Each subscale is worth 20 points. Subscales are combined to compute total score. The total scale ranges from 0 to 100; higher scores indicate worse outcome.
| Group | Value | 95% CI |
|---|---|---|
| Active CBD-extract | 39.1 | ± 16.9 |
| Vehicle-Control (Placebo) | 47.9 | ± 21.4 |
13-item, 5-point rating scale used to assess different thoughts that may be associated with experiencing pain. The PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0 - 52. The PCS subscales are computed by summing the responses to the following items: Rumination: Sum of items 8, 9, 10, 11; Magnification: Sum of items 6, 7, 13; and Helplessness: Sum of items 1, 2, 3, 4, 5, 12; higher scores indicate worse outcome.
| Group | Value | 95% CI |
|---|---|---|
| Active CBD-extract | 21.1 | ± 6.5 |
| Vehicle-Control (Placebo) | 26.4 | ± 11.7 |
13-item, 5-point rating scale used to assess different thoughts that may be associated with experiencing pain. The PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0 - 52. The PCS subscales are computed by summing the responses to the following items: Rumination: Sum of items 8, 9, 10, 11; Magnification: Sum of items 6, 7, 13; and Helplessness: Sum of items 1, 2, 3, 4, 5, 12; higher scores indicate worse outcome.
| Group | Value | 95% CI |
|---|---|---|
| Active CBD-extract | 21.3 | ± 7.5 |
| Vehicle-Control (Placebo) | 25.4 | ± 11.2 |
13-item, 5-point rating scale used to assess different thoughts that may be associated with experiencing pain. The PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0 - 52. The PCS subscales are computed by summing the responses to the following items: Rumination: Sum of items 8, 9, 10, 11; Magnification: Sum of items 6, 7, 13; and Helplessness: Sum of items 1, 2, 3, 4, 5, 12; higher scores indicate worse outcome.
| Group | Value | 95% CI |
|---|---|---|
| Active CBD-extract | 21.4 | ± 10.1 |
| Vehicle-Control (Placebo) | 23.9 | ± 10.3 |
9-item, 5-point rating scale to quantify fear of specific situations that normally produce pain. Each subscale contains 3 items, so the possible range of scores for each subscale is 3 through 15. Subscales are combined to compute total score. The Total score has a range of 9 through 45; higher scores indicate worse outcome.
| Group | Value | 95% CI |
|---|---|---|
| Active CBD-extract | 23.8 | ± 5.4 |
| Vehicle-Control (Placebo) | 21.3 | ± 5.7 |
We aim to determine the efficacy of a controlled short-term trial of CBD ingestion for reducing symptomatic response and facilitating recovery following induced muscle injury. We will assess, in serial fashion, symptomatic response, functional limitations and recovery of the quadriceps muscle following induced injury in which CBD oil (or placebo) will be delivered using a sublingual route of administration during a 15-day pre-injury consumption and post-injury recovery phase. A double-blind, randomized, two-arm study design will be used and participants will be randomly assigned to either an active dose (n=15) or vehicle control group (n=15). The clinical outcomes include measures of muscular pain and disability along with measures of pain-related fear and anxiety.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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