NCT04784065

A Pilot Randomized Controlled Trial for Hand Osteoarthritis

Completed NA Results posted Last updated 28 August 2025

What this trial tests

NA trial testing Hand orthosis in Hand Osteoarthritis in 33 participants. Completed in 1 April 2024.

Timeline

11 February 2021

Primary endpoint
1 April 2024

1 April 2024

Quick facts

Lead sponsor	Baylor College of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	33
Start date	11 February 2021
Primary completion	1 April 2024
Estimated completion	1 April 2024
Sites	2 locations across United States

Drugs / interventions tested

• Hand orthosis

Conditions studied

• Hand Osteoarthritis — all drugs for Hand Osteoarthritis →

Sponsor

Baylor College of Medicine

Who can join

Eligibility, any sex, with Hand Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Visual Analog Scale (VAS) for Pain in the More Symptomatic Hand That Includes the Most Symptomatic DIP Joint by 24 Weeks of Use of Traction Therapy With Standard of Care Treatment for Hand OA to Establish Efficacy of Traction Therapy. Primary · 24 week follow up

An assessment of pain intensity in a given hand. - high values are worse outcomes. Minimum score = 0 Maximum score = 100

Group	Value	95% CI
Treatment Arm With Control Orthosis	-16.1	-31.3 – -0.8
Treatment Arm With Experimental Orthosis	-15.7	-30.0 – -1.4

The Primary Structure Endpoint Will be Change in Sum of the Kellgren and Lawrence Score of All Distal InterPhalangeal Joints in the Hand That Was Placed in an Orthosis Over 24 Weeks. Primary · 24 week follow up

An assessment of radiographic OA severity. (high values are worse outcomes) Minimum score = 0 Maximum score = 16

Group	Value	95% CI
Treatment Arm With Control Orthosis	0	± 0
Treatment Arm With Experimental Orthosis	0	± 0

The Functional Index for Hand Osteoarthritis (FIHOA) Secondary · 24 week follow up

An assessment of hand function. (high values are worse outcomes) Minumum score = 0 Maximum score = 30

Group	Value	95% CI
Treatment Arm With Control Orthosis	0.6	-2.9 – 4.2
Treatment Arm With Experimental Orthosis	-2.6	-5.1 – -0.2

The Disabilities of Arm Shoulder and Hand (DASH) Secondary · 24 week follow up

An assessment of hand disability. (high values are worse outcomes) Minimum score = 30 Maximum score = 150

Group	Value	95% CI
Treatment Arm With Control Orthosis	0.9	-6.9 – 8.7
Treatment Arm With Experimental Orthosis	-9.9	-17.9 – -2.0

Functional Dexterity Test Secondary · 24 week follow up

An assessment of hand functional dexterity. (high values are worse outcomes) Measure of the number of seconds it takes for the participant to complete a series of activities. Penalty scores are assigned if the quality of the activity performed is imperfect. Minimum score = 0 Maximum score = indefinite

Group	Value	95% CI
Treatment Arm With Control Orthosis	-3.8	-11.8 – 4.3
Treatment Arm With Experimental Orthosis	-6.4	-11.0 – -1.9

Grip Strength Secondary · 24 week follow up

An assessment of the amount of force that can be applied with grip. (low values are worse outcomes)

Group	Value	95% CI
Treatment Arm With Control Orthosis	3.1	-0.5 – 6.7
Treatment Arm With Experimental Orthosis	5.3	1.5 – 9.1

Pinch Strength Secondary · 24 week follow up

An assessment of the amount of force that can be applied with pinching between thumb and the 2nd and 3rd fingers. (low values are worse outcomes)

Group	Value	95% CI
Treatment Arm With Control Orthosis	0.4	-1.3 – 2.0
Treatment Arm With Experimental Orthosis	0.2	-0.8 – 1.3

The Number of DIP Joints That Exhibit Tenderness in the Study Hand Secondary · 24 week follow up

The number of DIP joints that exhibit tenderness (dichotomously assessed - yes/no) in the study hand. (high values are worse outcomes) Minimum score = 0 Maximum score = 4

Group	Value	95% CI
Treatment Arm With Control Orthosis	-0.2	-0.7 – 0.4
Treatment Arm With Experimental Orthosis	-0.4	-1.1 – 0.2

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment Arm With Control Orthosis

Serious: 0/17 (0%)

Deaths: 0/17

Treatment Arm With Experimental Orthosis

Serious: 0/16 (0%)

Deaths: 0/16

Other adverse events (8 terms — click to expand)

Reaction	System	Treatment Arm With Control…	Treatment Arm With Experim…
Discomfort from the orthosis	Musculoskeletal and connective tissue disorders	—	—
Numbness/Tingling	Nervous system disorders	—	—
Skin Erythema	Skin and subcutaneous tissue disorders	—	—
Skin blistering	Skin and subcutaneous tissue disorders	—	—
Fall	Nervous system disorders	—	—
Elective surgery to repair incisional hernia	Eye disorders	—	—
Thoracic spine pain	Musculoskeletal and connective tissue disorders	—	—
Knee injury	Musculoskeletal and connective tissue disorders	—	—

Data from ClinicalTrials.gov NCT04784065 adverse events section.

Sponsor's own description

This is a study involving people receiving care at the Michael E. DeBakey VA Medical Center, Houston Texas. We are studying people who have hand osteoarthritis (the most common form of arthritis that involves the hand) and testing treatments for the condition with the hope that we can help to improve hand pain as well as limit the damage that occurs related to the arthritis. People who choose to participate, are randomly assigned to one of two treatments, both expected to be helpful.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.