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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Epidiolex (cannabidiol) can reduce pain after shoulder surgery and aims to determine safe dosages and potential side effects. Researchers will compare Epidiolex to a placebo to assess its effectiveness in managing post-surgery pain. Participants will log daily pain levels and medication use, complete two surveys, and undergo post-surgery blood tests. The trial suits individuals undergoing certain shoulder surgeries, such as rotator cuff repair, who are not currently using marijuana or certain medications. As a Phase 1, Phase 2 trial, this research seeks to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking pain management research.

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.

Is there any evidence suggesting that Epidiolex is likely to be safe for humans?

Research has shown that Epidiolex, a type of cannabidiol (CBD), is generally safe for use. One study used CBD to help manage pain after minor surgeries without affecting recovery. Another study found that using CBD for pain during shoulder surgery did not alter patients' pain perception or reports.

Studies also suggest that CBD might help reduce the need for opioids, though the level of pain relief can vary. Importantly, a recent study found that CBD tablets reduced pain after shoulder surgery without any safety issues.

Epidiolex has FDA approval for other uses, indicating it is usually well-tolerated. However, as this is an early-stage trial, it remains important to determine safe dosages and any potential side effects after surgery. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for shoulder pain?

Unlike the standard pain relief options for post-surgery shoulder pain, such as opioids and NSAIDs, Epidiolex is derived from cannabidiol (CBD), a non-psychoactive compound found in cannabis. Researchers are excited about this treatment because it offers a novel mechanism of action by potentially interacting with the body's endocannabinoid system to reduce pain and inflammation. Additionally, Epidiolex is administered orally, which may offer a more convenient and potentially safer alternative to current treatments that often come with a risk of addiction or adverse side effects.

What evidence suggests that Epidiolex might be an effective treatment for post-surgery shoulder pain?

Research shows that cannabidiol (CBD), the main ingredient in Epidiolex, can help reduce pain after shoulder surgery. In this trial, participants will receive either Epidiolex or a placebo at random. A recent study found that patients using CBD reported less pain and greater satisfaction immediately after rotator cuff surgery. Another study found that CBD did not cause major side effects or interfere with pain management during surgery. While early research suggests CBD might also aid bone healing and reduce swelling, more studies on people are needed to confirm these effects. Overall, evidence suggests CBD could be a promising option for managing shoulder pain after surgery. ^{1 2 3 4 5}

Who Is on the Research Team?

Patrick McCulloch, MD

Principal Investigator

The Methodist Hospital Research Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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® (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]

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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10846110/

Cannabidiol for Postoperative Pain Control After Arthroscopic ... Cannabidiol (CBD) has been shown recently to positively affect patient pain and satisfaction immediately after arthroscopic rotator cuff repair (ARCR).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06381791

CBD for Pain Following Orthopedic Shoulder Surgery 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.

3. aaos.org aaos.org/aaosnow/2024/monday/research/research04/

Study Reports No Functional Deficits Associated with CBD ... In this study, utilizing CBD for pain management during ARCR surgery did not lead to notable impairments in terms of patient-reported pain, ...

4. academic.oup.com academic.oup.com/painmedicine/advance-article/doi/10.1093/pm/pnaf110/8238175

Cannabis and cannabidiol for postoperative pain ... Preclinical studies have also shown enhanced bone healing and reduced proinflammatory cytokine release with CBD administration, though data in the human ...

5. cannabisevidence.org cannabisevidence.org/cbd-tablet-seems-to-relieve-pain-after-shoulder-surgery-study-finds/

CBD tablet seems to relieve pain after shoulder surgery ... A tablet formulated with cannabidiol, or CBD, reduces pain after shoulder surgery, with no safety concerns, a study presented Friday during ...