Effect of Topical CBD Cream for Degenerative Hallux Disorders

Status Terminated

Clinical Trial Summary

Hallux rigidus and hallux valgus are chronic forefoot conditions associated with pain, inflammation and functional impairment. Topical cannabidiol (CBD) cream has been shown to decrease inflammation, swelling, and pain response in arthritis models with minimal side effects, although the intervention has never been studied in hallux valgus or hallux rigidus. The purpose of this study is to determine if topical CBD cream is an effective treatment for pain secondary to hallux rigidus and hallux valgus.

Clinical Trial Description

Hallux rigidus and hallux valgus are chronic forefoot conditions associated with pain, inflammation and functional impairment. While operative interventions exist, nonoperative modalities are the mainstay of treatment for most patients. Options include shoe wear modification, manual and physical therapy, intraarticular injection of corticosteroids or sodium hyaluronate, oral nonsteroidal anti-inflammatories, and foot orthoses. Oral anti-inflammatories are the most effective non-operative strategy, but unfortunately, are associated with major adverse side effects and are contraindicated in many patients. Topical cannabidiol (CBD) cream has been shown to decrease inflammation, swelling, and pain response in arthritis models with minimal side effects, although the intervention has never been studied in hallux valgus or hallux rigidus. This prospective randomized trial will compare topical CBD cream vs placebo cream for the treatment of pain secondary to hallux valgus and hallux rigidus. The primary outcome of interest in the change in pre and post-treatment Visual Analog System (VAS) pain scores. VAS pain score is a measurement on a continuum of values of pain intensity. The purpose of this study is to determine if topical CBD cream is an effective treatment for pain secondary to hallux rigidus and hallux valgus. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04103814
Study type	Interventional
Source	Rush University Medical Center
Contact
Status	Terminated
Phase	Phase 2/Phase 3
Start date	October 20, 2019
Completion date	May 15, 2023

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT04473196` - The Effect of Weight Bearing on Patient Outcomes Following 1st MTP Joint Fusion	N/A
Recruiting	`NCT05587569` - Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)	N/A
Recruiting	`NCT05555459` - Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation	N/A
Completed	`NCT02121119` - Lidocaine Versus Bupivacaine in Ambulatory Continuous Block With Elastomeric Pump	Phase 4
Enrolling by invitation	`NCT00600899` - Home Infusors for Analgesia After Foot Surgery	Phase 4
Completed	`NCT05579054` - Translation, Validity, and Reliability of the Foot Posture Index (FPI-6) - Turkish Version
Terminated	`NCT05082012` - Early Weight-Bearing After the Lapiplasty Mini-Incision Procedure (Mini3D)	N/A
Recruiting	`NCT05051709` - Can Hypermobility of First Ray Affect Surgical Treatment of Hallux Valgus	N/A
Recruiting	`NCT04716140` - Prospective Study: The Effect on Clinical Outcome After Treatment of MTP Cartilage Lesions in Hallux Valgus Surgery	N/A
Active, not recruiting	`NCT04145882` - Efficacy of Additional Osteotomies to Correct Hallux Valgus	N/A
Completed	`NCT04468555` - Hallux Valgus Manual Therapy Based on Global Postural Reeducation.	N/A
Terminated	`NCT03257540` - Early Weight-Bearing After Lapidus Arthrodesis
Completed	`NCT03846687` - Validation of Patient Reported Outcome Measures for Use in Hallux Valgus
Completed	`NCT04365712` - Osteotomy of the 1st Metatarsal for Hallux Valgus Using Pneumatic Oscillating Saw or Piezoelectric Scalpel	N/A
Recruiting	`NCT02282956` - Ultrasound Guided Single Shot Block of Posterior Tibial Nerve for Postoperative Pain Relief After Hallux Valgus Surgery	Phase 4
Withdrawn	`NCT01555216` - Continuous Tibial Nerve Block Versus Single Shot Tibial Nerve Block	N/A
Completed	`NCT00683137` - Analgesic Efficacy And Safety of Valdecoxib For Treatment Of Post-Surgical Pain From Bunionectomy Surgery	Phase 3
Completed	`NCT03423498` - The Toe-spread-out Exercise in Patients With Hallux Valgus and Without the Deformity	N/A
Not yet recruiting	`NCT06076655` - Hallux Valgus Treatment Developed for Children With Cerebral Palsy	N/A
Recruiting	`NCT02915822` - COSMIC Study - Comparing Open Scarf/Akin Osteotomy and Minimally Invasive Chevron/Akin. A Feasibility Study	N/A