CBD for Post-Surgery Shoulder Pain

(CBD Trial)

Overseen By David N Armond, BS

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: The Methodist Hospital Research Institute

Must not be taking: Narcotics, CNS depressants

Disqualifiers: Liver disease, Substance abuse, Psychiatric disorder, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but you cannot participate if you are taking certain medications like valproate, clobazam, narcotics, or drugs affecting specific enzymes. If you are on other medications, you may be monitored for side effects.

What data supports the effectiveness of the drug Epidiolex (CBD) for post-surgery shoulder pain?

There is no direct evidence from the provided research that supports the effectiveness of Epidiolex (CBD) for post-surgery shoulder pain. However, some studies suggest CBD may have potential for pain relief in other conditions, but more research is needed to confirm its effectiveness for post-surgery pain. ^{1 2 3 4 5}

Is CBD safe for humans?

CBD, including its pharmaceutical form Epidiolex, has been studied for safety in various conditions. It is generally considered safe, but some people may experience side effects like skin rash. Further research is needed to fully understand its safety profile. ^{1 3 5 6 7}

How does CBD differ from other treatments for post-surgery shoulder pain?

CBD (cannabidiol) is unique because it is a non-psychoactive compound derived from cannabis that may help manage pain without the addictive risks associated with opioids. Unlike traditional pain medications, CBD works by interacting with the body's endocannabinoid system, which plays a role in regulating pain and inflammation. ^{8 9 10 11 12}

What is the purpose of this trial?

The goal of the study is to learn if Epidiolex (cannabidiol) works as a additional pain medication in patients who have had orthopedic shoulder surgery. It is also to learn about safe dosages and identify any side effects after surgery. Researchers will compare Epidiolex to a placebo solution to see if Epidiolex lowers pain after shoulder surgery. Participants will: * track their pain and what medications they use every day in a provided pain diary. A researchers will call every seven days to check on the participant and diary. * Complete two short surveys. Once before surgery and once after. * Have bloodwork tested after surgery

Research Team

Patrick McCulloch, MD

Principal Investigator

The Methodist Hospital Research Institute

Eligibility Criteria

This trial is for individuals with shoulder osteoarthritis or rotator cuff injuries who are undergoing orthopedic surgery. Participants must be willing to track their pain daily, complete surveys before and after surgery, and have bloodwork done post-surgery.

Inclusion Criteria

If a subject is of reproductive potential, they must be on effective contraception one month prior, during treatment, and one month following treatment.

I will be given standard anesthesia during my surgery.

I am having shoulder surgery, such as joint replacement or rotator cuff repair.

Exclusion Criteria

History of marijuana/cannabidiol (not including topical) regular use within the past 6 months

History of substance/alcohol abuse

I am currently on medication that affects my brain's activity.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Epidiolex or placebo for 14 days post-surgery, tracking pain in a diary and completing surveys

2 weeks

Daily diary entries, 1 in-person visit, 2 phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a final safety monitoring screening and liver panel

1-2 weeks

1 in-person visit

Treatment Details

Interventions

• Epidiolex

Trial Overview The study aims to determine if Epidiolex (cannabidiol) can help manage pain as an additional medication following shoulder surgery. It will compare the effects of Epidiolex with a placebo by monitoring participants' reported pain levels and medication use.

Participant Groups

Group I: Epidiolex (cannabidiol) Experimental Treatment 1 Intervention

Patients randomized to the Epidiolex group will take 150mg of Epidiolex with food twice daily for 14 days beginning the day of surgery.

Group II: Placebo Placebo Group 1 Intervention

Patients randomized to the placebo group will take 150mg of oral placebo solution with food for 14 days beginning the day of surgery.

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials

299

Recruited

82,500+

Findings from Research

In a study of 109 patients who underwent total hip or knee replacement surgeries, 22% reported using cannabidiol (CBD) during their treatment period.

Despite the prevalence of CBD use, there was no significant difference in pain satisfaction between those who used CBD and those who did not, indicating a need for further research on the safety and efficacy of CBD in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rates of self-directed perioperative cannabidiol use in patients undergoing total hip or knee arthroplasty. Yu, JS., Premkumar, A., Liu, S., et al.[2021]

In a study involving 20 healthy volunteers, an 800-mg oral dose of cannabidiol (CBD) did not significantly reduce pain intensity or affect hyperalgesia and allodynia compared to a placebo, suggesting limited efficacy in acute pain management.

The study highlights the need for further research on different dosages and administration methods for CBD, as well as its potential role in combination with other treatments, before concluding its effectiveness for acute pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain response to cannabidiol in induced acute nociceptive pain, allodynia, and hyperalgesia by using a model mimicking acute pain in healthy adults in a randomized trial (CANAB I). Schneider, T., Zurbriggen, L., Dieterle, M., et al.[2023]

A single oral dose of 750 mg of cannabidiol (CBD) showed significantly increased exposure when taken with a high-fat/calorie meal, with a 3.8-fold increase in overall exposure (AUC0-∞) and a 5.2-fold increase in maximum concentration (Cmax) compared to fasting.

CBD was well-tolerated with no severe adverse events reported, indicating its safety in healthy adults, while its absorption was also enhanced by low-fat meals, whole milk, and alcohol, albeit to a lesser extent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 1, randomized, pharmacokinetic trial of the effect of different meal compositions, whole milk, and alcohol on cannabidiol exposure and safety in healthy subjects. Crockett, J., Critchley, D., Tayo, B., et al.[2021]

In two case reports, patients experienced significant pain relief from a lumbar compression fracture and thoracic discomfort after using a transdermal CBD cream, suggesting its potential effectiveness for managing pain.

The CBD cream used in the cases demonstrated antisnociceptive and anti-inflammatory properties, indicating that hemp-derived CBD could be a valuable option for treating both acute and chronic pain, warranting further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol (CBD) as a treatment of acute and chronic back pain: A case series and literature review. Eskander, JP., Spall, J., Spall, A., et al.[2020]

Epidiolex, the only FDA-approved CBD-based drug, has been studied for its medicinal benefits and potential side effects across various clinical trials, focusing on both physiological and neurological conditions.

The review highlights that the outcomes of these trials can vary significantly based on the funding source, which may influence the reported efficacy and safety of Epidiolex and other CBD formulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol Drugs Clinical Trial Outcomes and Adverse Effects. Pauli, CS., Conroy, M., Vanden Heuvel, BD., et al.[2020]

Epidiolex® (cannabidiol) is an FDA-approved medication for treating epilepsy associated with Lennox-Gastaut and Dravet syndromes, showing promise for treatment-resistant epilepsy.

A case study of a 23-year-old female revealed a delayed skin rash related to Epidiolex®, highlighting the need to monitor for potential side effects even when they are rare in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidiolex-induced skin rash. Singh, J., Antimisiaris, MF.[2021]

In a randomized, double-blind, placebo-controlled trial involving 136 patients with hand osteoarthritis or psoriatic arthritis, cannabidiol (CBD) did not show a significant reduction in pain intensity compared to placebo after 12 weeks of treatment.

The study found no meaningful effects of CBD on secondary outcomes such as sleep quality, anxiety, or depression, indicating that CBD may not be an effective add-on therapy for pain management in these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol treatment in hand osteoarthritis and psoriatic arthritis: a randomized, double-blind, placebo-controlled trial. Vela, J., Dreyer, L., Petersen, KK., et al.[2022]

A study involving 118 patients showed that taking 1200 mg of gabapentin along with 400 mg of celecoxib before surgery significantly reduced postoperative pain and the need for opioid painkillers compared to using celecoxib alone.

The combination of gabapentin and celecoxib is recommended for patients undergoing elective subpectoral breast augmentation to effectively manage pain and minimize opioid use after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined preoperative use of celecoxib and gabapentin in the management of postoperative pain. Parsa, AA., Sprouse-Blum, AS., Jackowe, DJ., et al.[2022]

A 59-year-old woman experienced severe shoulder pain after an open pancreaticoduodenectomy, which did not respond to conventional pain management methods.

The application of a transnasal sphenopalatine ganglion block successfully resolved her shoulder pain, marking the first reported use of this treatment for such pain following this type of surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sphenopalatine ganglion block for ipsilateral shoulder pain following open pancreaticoduodenectomy. Levin, D., Acquadro, M., Cerasuolo, J., et al.[2022]

In a study of 80 patients after shoulder surgeries, those who underwent rotator cuff repair used significantly more opioids (18.4 pills) compared to those who had reverse shoulder arthroplasty (7.5 pills), indicating that the type of surgery affects opioid consumption.

Most patients (92.5%) stopped taking narcotics by day 14, with 75% having excess pills left over, suggesting effective pain management and highlighting risk factors like tobacco use and psychiatric history that may lead to increased opioid needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing opioid consumption in the 30-day post-operative period following shoulder surgery: are we over prescribing? Patel, MS., Updegrove, GF., Singh, AM., et al.[2021]

Neural tissue mobilization significantly improved sensory-motor impairments in breast cancer survivors with lymphedema compared to conventional physiotherapy, as shown by a substantial improvement in the mTNS score (p<0.0001).

The study involved 100 breast cancer survivors aged 30-65, and while both treatment protocols improved pain and range of motion, neural tissue mobilization was more effective, especially in patients with mild to moderate lymphedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Neural Tissue Mobilization on Sensory-Motor Impairments in Breast Cancer Survivors with Lymphedema: An Experimental Study. Joshi, D., Shah, S., Shinde, SB., et al.[2023]

Preoperative opioid use is a significant predictor of persistent opioid use after shoulder surgery, highlighting the need for careful counseling about the risks of continued opioid dependence and its impact on recovery.

Patients undergoing surgery for shoulder instability may not experience significant pain postoperatively unless the surgery is related to pain, such as in cases of SLAP tears, indicating that the reasons for surgery can influence pain management and opioid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial Commentary: How to Reduce Postoperative Shoulder Pain in Your Practice-Stick to Instability and Opioid-Naive Patients. Westermann, RW., Shamrock, A., Day, M.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Rates of self-directed perioperative cannabidiol use in patients undergoing total hip or knee arthroplasty. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Pain response to cannabidiol in induced acute nociceptive pain, allodynia, and hyperalgesia by using a model mimicking acute pain in healthy adults in a randomized trial (CANAB I). [2023]

3. United States pubmed.ncbi.nlm.nih.gov

A phase 1, randomized, pharmacokinetic trial of the effect of different meal compositions, whole milk, and alcohol on cannabidiol exposure and safety in healthy subjects. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Cannabidiol (CBD) as a treatment of acute and chronic back pain: A case series and literature review. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Cannabidiol Drugs Clinical Trial Outcomes and Adverse Effects. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Epidiolex-induced skin rash. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Cannabidiol treatment in hand osteoarthritis and psoriatic arthritis: a randomized, double-blind, placebo-controlled trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Combined preoperative use of celecoxib and gabapentin in the management of postoperative pain. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Sphenopalatine ganglion block for ipsilateral shoulder pain following open pancreaticoduodenectomy. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Characterizing opioid consumption in the 30-day post-operative period following shoulder surgery: are we over prescribing? [2021]

11. Thailand pubmed.ncbi.nlm.nih.gov

Effect of Neural Tissue Mobilization on Sensory-Motor Impairments in Breast Cancer Survivors with Lymphedema: An Experimental Study. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Editorial Commentary: How to Reduce Postoperative Shoulder Pain in Your Practice-Stick to Instability and Opioid-Naive Patients. [2020]