Home-Based Quadriceps Isometric Exercise for Knee Osteoarthritis Pain

NCT07445568 | Completed

• 1 other identifier: UVM-KOAISO-01-2025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Knee osteoarthritis is a common cause of pain and reduced mobility in older adults. Many people have limited access to supervised rehabilitation programs, highlighting the need for simple and safe home-based treatment options. This study evaluates whether a brief home-based quadriceps isometric exercise program can reduce knee pain in community-dwelling older adults. Participants perform short daily muscle contractions of the thigh muscles for 28 days. In addition, participants are assigned to receive one of four topical formulations (placebo, cannabidiol, arnica, or a combination of cannabidiol and arnica) to explore whether these products modify the exercise response. The primary outcome is change in knee pain intensity measured using a visual analog scale. Secondary outcomes include adherence and safety. This pilot study aims to assess the feasibility, safety, and preliminary effectiveness of this low-cost and easily accessible strategy to inform future larger clinical trials.

Conditions

Older Adults (60 - 85 Years Old); OA Knee

Keywords

Isometric exercise; Home-based rehabilitation; Physical therapy; Non-pharmacological treatment; Pain management; Topical cannabidiol; Arnica montana

Outcome Measures

Primary Outcomes (1)

• Change from baseline in knee pain intensity measured by Visual Analog Scale (VAS)

  Knee pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain). The primary endpoint is the change from baseline to Day 28. Higher scores indicate greater pain.

  Baseline to Day 28

Secondary Outcomes (4)

• Change from baseline in quadriceps isometric strength

  Baseline to Day 28

• Change from baseline in body composition

  Baseline to Day 28

• Exercise and topical treatment adherence

  Throughout the 28-day intervention

• Adverse events

  Baseline to Day 28

Study Arms (8)

Arm Title Placebo Topical + Isometric Exercise

EXPERIMENTAL

Participants received placebo topical gel twice daily plus daily home-based quadriceps isometric exercise for 28 days.

Drug: Placebo Topical Gel; Behavioral: Home-based Quadriceps Isometric Exercise

Placebo Topical Only

EXPERIMENTAL

Participants received placebo topical gel twice daily without exercise.

Drug: Placebo Topical Gel

CBD Topical + Isometric Exercise

EXPERIMENTAL

Participants received cannabidiol topical formulation twice daily plus daily home-based quadriceps isometric exercise.

Drug: Cannabidiol (CBD) Topical Gel; Behavioral: Home-based Quadriceps Isometric Exercise

CBD Topical Only

EXPERIMENTAL

Participants received cannabidiol topical formulation twice daily without exercise.

Drug: Cannabidiol (CBD) Topical Gel

Arnica Topical + Isometric Exercise

EXPERIMENTAL

Participants received Arnica montana topical formulation twice daily plus daily home-based quadriceps isometric exercise.

Drug: Arnica montana Topical Gel; Behavioral: Home-based Quadriceps Isometric Exercise

Arnica Topical Only

EXPERIMENTAL

Participants received Arnica montana topical formulation twice daily without exercise.

Drug: Arnica montana Topical Gel

CBD + Arnica Topical + Exercise

EXPERIMENTAL

Participants received combined cannabidiol and Arnica montana topical formulation twice daily plus daily home-based quadriceps isometric exercise.

Behavioral: Home-based Quadriceps Isometric Exercise; Drug: CBD + Arnica Topical Gel

CBD + Arnica Topical Only

EXPERIMENTAL

Participants received combined cannabidiol and Arnica montana topical formulation twice daily without exercise.

Drug: CBD + Arnica Topical Gel

Interventions

Home-based Quadriceps Isometric Exercise BEHAVIORAL

Daily home-based quadriceps isometric exercise protocol consisting of three sets of 10-second near-maximal voluntary contractions with rest intervals, performed for 28 days.

Arm Title Placebo Topical + Isometric Exercise; Arnica Topical + Isometric Exercise; CBD + Arnica Topical + Exercise; CBD Topical + Isometric Exercise

Placebo Topical Gel DRUG

Placebo topical formulation without active pharmacological ingredients, applied twice daily to the affected knee for 28 days.

Arm Title Placebo Topical + Isometric Exercise; Placebo Topical Only

Cannabidiol (CBD) Topical Gel DRUG

Topical cannabidiol formulation applied twice daily to the affected knee for 28 days.

CBD Topical + Isometric Exercise; CBD Topical Only

Arnica montana Topical Gel DRUG

Topical Arnica montana formulation applied twice daily to the affected knee for 28 days.

Arnica Topical + Isometric Exercise; Arnica Topical Only

CBD + Arnica Topical Gel DRUG

combined cannabidiol and arnica formulation applied twice daily

CBD + Arnica Topical + Exercise; CBD + Arnica Topical Only

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Adults aged 65 years or older
• Clinical diagnosis of chronic knee osteoarthritis according to American College of Rheumatology criteria
• Knee pain for ≥3 months
• Baseline knee pain intensity ≥4 on a 10-cm Visual Analog Scale (VAS)
• Ability to walk independently with or without assistive devices
• Ability to understand study procedures and provide written informed consent

You may not qualify if:

• Recent knee surgery or intra-articular injection within the last 3 months
• Planned knee surgery during the study period
• Severe neurological or cardiovascular conditions limiting exercise participation
• Skin lesions or hypersensitivity to topical formulations
• Current use of topical analgesics on the target knee
• Cognitive impairment preventing adherence to the protocol
• Participation in another clinical trial within the last 30 days

Sponsors & Collaborators

• Universidad del Valle de México, Campus Cuernavaca: lead

Study Sites (1)

Hospital Regional de Alta Especialidad "Centenario de la Revolución Mexicana" - ISSSTE, Servicio de Alimentación y Nutrición Clínica

Xochitepec, Morelos, 62790, Mexico

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Agnosia

Interventions

Cannabidiol; Gels

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were blinded to topical treatment allocation through identical packaging and appearance of formulations. Investigators responsible for data collection were not involved in treatment assignment. Exercise allocation could not be blinded due to the nature of the intervention, and outcomes were self-reported.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were randomized to a 4×2 factorial design. Four topical treatment conditions (placebo, cannabidiol, arnica, cannabidiol plus arnica) were combined with two exercise conditions (home-based quadriceps isometric exercise vs no exercise), resulting in eight parallel intervention groups.

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: March 3, 2026
• Study Start: September 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: November 1, 2025
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)