Active CBD
Participants will be provided a viscous liquid in a bottle with a syringe dropper containing CBD-extract oil at concentrations of 2000mg/30mL (high).
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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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2025-08-06
What this record can show
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Registry facts
Current research has shown evidence that phytocannabinoids may have a promising therapeutic potential in a variety of physical and psychological ailments, and cannabidiol (CBD) is of particular interest due to its positive safety profile, non-intoxicating effects and widespread capabilities in a number of musculoskeletal diseases. Three primary reasons people consume CBD on a global basis, in addition to the fact that it is non-intoxicating, are for symptomatic (pain) relief, anxiety reduction, and improved sleep quality. Very little is known about CBD and how it functions in the body from both an efficacy and mechanistic perspective, especially in humans. There is a large consumer base for this product that will be expanding exponentially in the next few years. Most of the evidence available is anecdotal from the personal testimony of consumers. 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 selected doses of 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). Our clinical outcomes include measures of muscular pain and disability along with measures of pain-related fear and anxiety. Our laboratory-based study design is desirable and advantageous because it is a controlled method of tracking individuals using an experimental model of injury that is translatable to clinical populations. This exploratory study will provide preliminary data needed to support the hypotheses of a planned larger scale application.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Participants will be provided a viscous liquid in a bottle with a syringe dropper containing CBD-extract oil at concentrations of 2000mg/30mL (high).
2000mg/30mLParticipants will be provided a viscous liquid in a bottle with a syringe dropper containing placebo containing no CBD oil (0mg/30 mL).
Source-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
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 | N | Value | Spread / interval |
|---|---|---|---|
| Active CBD-extract | 15 | 0.0 | 0 |
| Vehicle-Control (Placebo) | 13 | 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 | N | Value | Spread / interval |
|---|---|---|---|
| Active CBD-extract | 15 | 4.0 | 7.4 |
| Vehicle-Control (Placebo) | 13 | 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 | N | Value | Spread / interval |
|---|---|---|---|
| Active CBD-extract | 15 | 47.8 | 27.3 |
| Vehicle-Control (Placebo) | 13 | 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 | N | Value | Spread / interval |
|---|---|---|---|
| Active CBD-extract | 15 | 77.2 | 5.4 |
| Vehicle-Control (Placebo) | 15 | 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 | N | Value | Spread / interval |
|---|---|---|---|
| Active CBD-extract | 15 | 77.1 | 4.8 |
| Vehicle-Control (Placebo) | 15 | 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 | N | Value | Spread / interval |
|---|---|---|---|
| Active CBD-extract | 15 | 67.7 | 13.2 |
| Vehicle-Control (Placebo) | 15 | 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 | N | Value | Spread / interval |
|---|---|---|---|
| Active CBD-extract | 15 | 39.5 | 15.4 |
| Vehicle-Control (Placebo) | 13 | 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 | N | Value | Spread / interval |
|---|---|---|---|
| Active CBD-extract | 15 | 39.1 | 16.9 |
| Vehicle-Control (Placebo) | 13 | 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 | N | Value | Spread / interval |
|---|---|---|---|
| Active CBD-extract | 15 | 21.1 | 6.5 |
| Vehicle-Control (Placebo) | 13 | 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 | N | Value | Spread / interval |
|---|---|---|---|
| Active CBD-extract | 15 | 21.3 | 7.5 |
| Vehicle-Control (Placebo) | 13 | 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 | N | Value | Spread / interval |
|---|---|---|---|
| Active CBD-extract | 15 | 21.4 | 10.1 |
| Vehicle-Control (Placebo) | 13 | 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 | N | Value | Spread / interval |
|---|---|---|---|
| Active CBD-extract | 15 | 23.8 | 5.4 |
| Vehicle-Control (Placebo) | 13 | 21.3 | 5.7 |
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 | N | Value | Spread / interval |
|---|---|---|---|
| Active CBD-extract | 15 | 21.5 | 5.0 |
| Vehicle-Control (Placebo) | 13 | 18.8 | 7.1 |
maximum voluntary force produced during a static muscle contraction
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Active CBD-extract | 13 | 138.5 | 23.3 |
| Vehicle-Control (Placebo) | 12 | 129.3 | 42.1 |
maximum voluntary force produced during a static muscle contraction measured in Newton-meters.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Active CBD-extract | 13 | 122.4 | 41.2 |
| Vehicle-Control (Placebo) | 12 | 102.4 | 32.6 |
maximum voluntary force produced during a static muscle contraction measured as Newton-meters.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Active CBD-extract | 13 | 128.4 | 50.2 |
| Vehicle-Control (Placebo) | 12 | 121.0 | 44.7 |
| Milestone | Active CBD-extract | Vehicle-Control (Placebo) |
|---|---|---|
| STARTED | 17 | 17 |
| COMPLETED | 15 | 14 |
| NOT COMPLETED | 2 | 3 |
Eligibility
primary outcomes
Time frame: Baseline (Day 1)
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.
Time frame: Pre-exercise (Day 10)
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.
Time frame: Post-exercise (Day 12)
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.
Time frame: Baseline (Day 1)
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.
Time frame: Pre-exercise (Day 10)
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.
Time frame: Post-exercise (Day 12)
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.
secondary outcomes
Time frame: Pre-exercise (Day 10)
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.
Time frame: Post-exercise (Day 15)
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.
Time frame: Baseline (Day 1)
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.
Time frame: Pre-exercise (Day 10)
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.
Time frame: Post-exercise (Day 15)
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.
Time frame: Baseline (Day 1)
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.
Time frame: Pre-exercise (Day 10)
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.
Time frame: Pre-exercise (Day 10)
maximum voluntary force produced during a static muscle contraction
Time frame: Post-exercise (Day 12)
maximum voluntary force produced during a static muscle contraction measured in Newton-meters.
Time frame: Post-exercise (Day 15)
maximum voluntary force produced during a static muscle contraction measured as Newton-meters.
Publications