OA Knee, Older Adults (60 - 85 Years Old)
Conditions
Keywords
Isometric exercise, Home-based rehabilitation, Physical therapy, Non-pharmacological treatment, Pain management, Topical cannabidiol, Arnica montana
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.
Detailed description
This study is a prospective randomized 4×2 factorial pilot trial conducted in community-dwelling older adults with symptomatic knee osteoarthritis. The purpose is to evaluate the feasibility, safety, and preliminary effectiveness of a brief home-based quadriceps isometric exercise program for short-term pain reduction, and to explore whether topical cannabidiol (CBD), arnica, or their combination modify the exercise response. Participants are randomly assigned to one of four topical treatment groups (placebo, CBD, arnica, or CBD + arnica) and stratified to either an exercise or no-exercise condition, resulting in eight factorial subgroups. Randomization is computer-generated with allocation concealment using sequentially numbered opaque sealed envelopes. The intervention period lasts 28 days. Participants allocated to the exercise condition perform daily quadriceps isometric contractions at home consisting of three sets of 10-second near-maximal voluntary contractions with rest intervals, requiring approximately 6 minutes per day. Topical formulations are applied twice daily to the affected knee. Adherence is monitored using daily logs. The primary outcome is change in knee pain intensity measured using a Visual Analog Scale (VAS) at day 28. Secondary outcomes include feasibility indicators (adherence and retention), safety (adverse events), and exploratory changes in anthropometric and body composition measures. Analyses are exploratory and include factorial ANCOVA adjusted for baseline values to estimate main effects of exercise and topical treatment, as well as interaction effects. Effect sizes are calculated to aid clinical interpretation. As a pilot study, results are intended to inform the design and sample size estimation of future adequately powered randomized controlled trials evaluating low-cost, home-based rehabilitation strategies for older adults with knee osteoarthritis.
Interventions
Placebo topical formulation without active pharmacological ingredients, applied twice daily to the affected knee for 28 days.
DRUGCannabidiol (CBD) Topical Gel
Topical cannabidiol formulation applied twice daily to the affected knee for 28 days.
DRUGArnica montana Topical Gel
Topical Arnica montana formulation applied twice daily to the affected knee for 28 days.
BEHAVIORALHome-based Quadriceps Isometric Exercise
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.
DRUGCBD + Arnica Topical Gel
combined cannabidiol and arnica formulation applied twice daily
Sponsors
Universidad del Valle de México, Campus Cuernavaca
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in knee pain intensity measured by Visual Analog Scale (VAS) | Baseline to Day 28 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in quadriceps isometric strength | Baseline to Day 28 | Maximal voluntary isometric quadriceps strength will be measured using handheld dynamometry. The outcome will be expressed as peak force (kg or N). Change from baseline to Day 28 will be analyzed. |
| Change from baseline in body composition | Baseline to Day 28 | Lean mass and fat mass will be assessed using bioelectrical impedance analysis. Change from baseline to Day 28 will be evaluated. |
| Exercise and topical treatment adherence | Throughout the 28-day intervention | Adherence will be calculated as the percentage of prescribed sessions/applications completed according to daily logs. |
| Adverse events | Baseline to Day 28 | Frequency and type of adverse events related to topical formulations or exercise will be recorded. |
Countries
Mexico
Outcome results
None listed