Trial Outcomes & Findings for A Pilot Randomized Controlled Trial for Hand Osteoarthritis (NCT NCT04784065)
NCT ID: NCT04784065
Last Updated: 2025-08-28
Results Overview
An assessment of pain intensity in a given hand. - high values are worse outcomes. Minimum score = 0 Maximum score = 100
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
33 participants
Primary outcome timeframe
24 week follow up
Results posted on
2025-08-28
Participant Flow
Participant milestones
| Measure |
Treatment Arm With Control Orthosis
Identical resting hand orthosis to what the traction arm received without the finger trap modifications.
The participants were asked to continue the orthosis schedule for the full 24 weeks of the study. Besides the resting hand orthosis, the SOC treatment included a thermal modality, activity modification/ joint protection education, and range of motion exercises.
|
Treatment Arm With Experimental Orthosis
A resting orthosis that was modified to allow for convenient application of finger traps. A finger trap was customized to the most symptomatic DIP and any other digit that the participant requested.
The participants were asked to continue the orthosis schedule for the full 24 weeks of the study. Besides the resting hand orthosis, the SOC treatment included a thermal modality, activity modification/ joint protection education, and range of motion exercises.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
|
Overall Study
COMPLETED
|
8
|
13
|
|
Overall Study
NOT COMPLETED
|
9
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot Randomized Controlled Trial for Hand Osteoarthritis
Baseline characteristics by cohort
| Measure |
Treatment Arm With Control Orthosis
n=17 Participants
Identical resting hand orthosis to what the traction arm received without the finger trap modifications.
The participants were asked to continue the orthosis schedule for the full 24 weeks of the study. Besides the resting hand orthosis, the SOC treatment included a thermal modality, activity modification/ joint protection education, and range of motion exercises.
|
Treatment Arm With Experimental Orthosis
n=16 Participants
A resting orthosis that was modified to allow for convenient application of finger traps. A finger trap was customized to the most symptomatic DIP and any other digit that the participant requested.
The participants were asked to continue the orthosis schedule for the full 24 weeks of the study. Besides the resting hand orthosis, the SOC treatment included a thermal modality, activity modification/ joint protection education, and range of motion exercises.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.5 Years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
65.2 Years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
65.8 Years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Study Hand VAS
|
69.3 Units on a scale
STANDARD_DEVIATION 18.9 • n=5 Participants
|
59.4 Units on a scale
STANDARD_DEVIATION 20.0 • n=7 Participants
|
64.5 Units on a scale
STANDARD_DEVIATION 19.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: 24 week follow upPopulation: All randomized participants
An assessment of pain intensity in a given hand. - high values are worse outcomes. Minimum score = 0 Maximum score = 100
Outcome measures
| Measure |
Treatment Arm With Control Orthosis
n=17 Participants
Identical resting hand orthosis to what the traction arm received without the finger trap modifications.
The participants were asked to continue the orthosis schedule for the full 24 weeks of the study. Besides the resting hand orthosis, the SOC treatment included a thermal modality, activity modification/ joint protection education, and range of motion exercises.
|
Treatment Arm With Experimental Orthosis
n=16 Participants
A resting orthosis that was modified to allow for convenient application of finger traps. A finger trap was customized to the most symptomatic DIP and any other digit that the participant requested.
The participants were asked to continue the orthosis schedule for the full 24 weeks of the study. Besides the resting hand orthosis, the SOC treatment included a thermal modality, activity modification/ joint protection education, and range of motion exercises.
|
|---|---|---|
|
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.
|
-16.1 units on a scale
Interval -31.3 to -0.8
|
-15.7 units on a scale
Interval -30.0 to -1.4
|
PRIMARY outcome
Timeframe: 24 week follow upPopulation: Those participants at the Houston site who were randomized.
An assessment of radiographic OA severity. (high values are worse outcomes) Minimum score = 0 Maximum score = 16
Outcome measures
| Measure |
Treatment Arm With Control Orthosis
n=11 Participants
Identical resting hand orthosis to what the traction arm received without the finger trap modifications.
The participants were asked to continue the orthosis schedule for the full 24 weeks of the study. Besides the resting hand orthosis, the SOC treatment included a thermal modality, activity modification/ joint protection education, and range of motion exercises.
|
Treatment Arm With Experimental Orthosis
n=12 Participants
A resting orthosis that was modified to allow for convenient application of finger traps. A finger trap was customized to the most symptomatic DIP and any other digit that the participant requested.
The participants were asked to continue the orthosis schedule for the full 24 weeks of the study. Besides the resting hand orthosis, the SOC treatment included a thermal modality, activity modification/ joint protection education, and range of motion exercises.
|
|---|---|---|
|
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.
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 24 week follow upPopulation: All those randomized.
An assessment of hand function. (high values are worse outcomes) Minumum score = 0 Maximum score = 30
Outcome measures
| Measure |
Treatment Arm With Control Orthosis
n=17 Participants
Identical resting hand orthosis to what the traction arm received without the finger trap modifications.
The participants were asked to continue the orthosis schedule for the full 24 weeks of the study. Besides the resting hand orthosis, the SOC treatment included a thermal modality, activity modification/ joint protection education, and range of motion exercises.
|
Treatment Arm With Experimental Orthosis
n=16 Participants
A resting orthosis that was modified to allow for convenient application of finger traps. A finger trap was customized to the most symptomatic DIP and any other digit that the participant requested.
The participants were asked to continue the orthosis schedule for the full 24 weeks of the study. Besides the resting hand orthosis, the SOC treatment included a thermal modality, activity modification/ joint protection education, and range of motion exercises.
|
|---|---|---|
|
The Functional Index for Hand Osteoarthritis (FIHOA)
|
0.6 units on a scale
Interval -2.9 to 4.2
|
-2.6 units on a scale
Interval -5.1 to -0.2
|
SECONDARY outcome
Timeframe: 24 week follow upPopulation: All those randomized.
An assessment of hand disability. (high values are worse outcomes) Minimum score = 30 Maximum score = 150
Outcome measures
| Measure |
Treatment Arm With Control Orthosis
n=17 Participants
Identical resting hand orthosis to what the traction arm received without the finger trap modifications.
The participants were asked to continue the orthosis schedule for the full 24 weeks of the study. Besides the resting hand orthosis, the SOC treatment included a thermal modality, activity modification/ joint protection education, and range of motion exercises.
|
Treatment Arm With Experimental Orthosis
n=16 Participants
A resting orthosis that was modified to allow for convenient application of finger traps. A finger trap was customized to the most symptomatic DIP and any other digit that the participant requested.
The participants were asked to continue the orthosis schedule for the full 24 weeks of the study. Besides the resting hand orthosis, the SOC treatment included a thermal modality, activity modification/ joint protection education, and range of motion exercises.
|
|---|---|---|
|
The Disabilities of Arm Shoulder and Hand (DASH)
|
0.9 units on a scale
Interval -6.9 to 8.7
|
-9.9 units on a scale
Interval -17.9 to -2.0
|
SECONDARY outcome
Timeframe: 24 week follow upPopulation: All participants who were randomized.
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
Outcome measures
| Measure |
Treatment Arm With Control Orthosis
n=17 Participants
Identical resting hand orthosis to what the traction arm received without the finger trap modifications.
The participants were asked to continue the orthosis schedule for the full 24 weeks of the study. Besides the resting hand orthosis, the SOC treatment included a thermal modality, activity modification/ joint protection education, and range of motion exercises.
|
Treatment Arm With Experimental Orthosis
n=16 Participants
A resting orthosis that was modified to allow for convenient application of finger traps. A finger trap was customized to the most symptomatic DIP and any other digit that the participant requested.
The participants were asked to continue the orthosis schedule for the full 24 weeks of the study. Besides the resting hand orthosis, the SOC treatment included a thermal modality, activity modification/ joint protection education, and range of motion exercises.
|
|---|---|---|
|
Functional Dexterity Test
|
-3.8 seconds
Interval -11.8 to 4.3
|
-6.4 seconds
Interval -11.0 to -1.9
|
SECONDARY outcome
Timeframe: 24 week follow upPopulation: All randomized.
An assessment of the amount of force that can be applied with grip. (low values are worse outcomes)
Outcome measures
| Measure |
Treatment Arm With Control Orthosis
n=17 Participants
Identical resting hand orthosis to what the traction arm received without the finger trap modifications.
The participants were asked to continue the orthosis schedule for the full 24 weeks of the study. Besides the resting hand orthosis, the SOC treatment included a thermal modality, activity modification/ joint protection education, and range of motion exercises.
|
Treatment Arm With Experimental Orthosis
n=16 Participants
A resting orthosis that was modified to allow for convenient application of finger traps. A finger trap was customized to the most symptomatic DIP and any other digit that the participant requested.
The participants were asked to continue the orthosis schedule for the full 24 weeks of the study. Besides the resting hand orthosis, the SOC treatment included a thermal modality, activity modification/ joint protection education, and range of motion exercises.
|
|---|---|---|
|
Grip Strength
|
3.1 pounds
Interval -0.5 to 6.7
|
5.3 pounds
Interval 1.5 to 9.1
|
SECONDARY outcome
Timeframe: 24 week follow upPopulation: All randomized.
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)
Outcome measures
| Measure |
Treatment Arm With Control Orthosis
n=17 Participants
Identical resting hand orthosis to what the traction arm received without the finger trap modifications.
The participants were asked to continue the orthosis schedule for the full 24 weeks of the study. Besides the resting hand orthosis, the SOC treatment included a thermal modality, activity modification/ joint protection education, and range of motion exercises.
|
Treatment Arm With Experimental Orthosis
n=16 Participants
A resting orthosis that was modified to allow for convenient application of finger traps. A finger trap was customized to the most symptomatic DIP and any other digit that the participant requested.
The participants were asked to continue the orthosis schedule for the full 24 weeks of the study. Besides the resting hand orthosis, the SOC treatment included a thermal modality, activity modification/ joint protection education, and range of motion exercises.
|
|---|---|---|
|
Pinch Strength
|
0.4 pounds
Interval -1.3 to 2.0
|
0.2 pounds
Interval -0.8 to 1.3
|
SECONDARY outcome
Timeframe: 24 week follow upPopulation: All randomized
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
Outcome measures
| Measure |
Treatment Arm With Control Orthosis
n=17 Participants
Identical resting hand orthosis to what the traction arm received without the finger trap modifications.
The participants were asked to continue the orthosis schedule for the full 24 weeks of the study. Besides the resting hand orthosis, the SOC treatment included a thermal modality, activity modification/ joint protection education, and range of motion exercises.
|
Treatment Arm With Experimental Orthosis
n=16 Participants
A resting orthosis that was modified to allow for convenient application of finger traps. A finger trap was customized to the most symptomatic DIP and any other digit that the participant requested.
The participants were asked to continue the orthosis schedule for the full 24 weeks of the study. Besides the resting hand orthosis, the SOC treatment included a thermal modality, activity modification/ joint protection education, and range of motion exercises.
|
|---|---|---|
|
The Number of DIP Joints That Exhibit Tenderness in the Study Hand
|
-0.2 score on a scale
Interval -0.7 to 0.4
|
-0.4 score on a scale
Interval -1.1 to 0.2
|
Adverse Events
Treatment Arm With Control Orthosis
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Treatment Arm With Experimental Orthosis
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Arm With Control Orthosis
n=17 participants at risk
Identical resting hand orthosis to what the traction arm received without the finger trap modifications.
The participants were asked to continue the orthosis schedule for the full 24 weeks of the study. Besides the resting hand orthosis, the SOC treatment included a thermal modality, activity modification/ joint protection education, and range of motion exercises.
|
Treatment Arm With Experimental Orthosis
n=16 participants at risk
A resting orthosis that was modified to allow for convenient application of finger traps. A finger trap was customized to the most symptomatic DIP and any other digit that the participant requested.
The participants were asked to continue the orthosis schedule for the full 24 weeks of the study. Besides the resting hand orthosis, the SOC treatment included a thermal modality, activity modification/ joint protection education, and range of motion exercises.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Discomfort from the orthosis
|
29.4%
5/17 • Number of events 9 • 6 months
|
43.8%
7/16 • Number of events 9 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin Erythema
|
0.00%
0/17 • 6 months
|
6.2%
1/16 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin blistering
|
0.00%
0/17 • 6 months
|
6.2%
1/16 • Number of events 1 • 6 months
|
|
Nervous system disorders
Numbness/Tingling
|
29.4%
5/17 • Number of events 6 • 6 months
|
6.2%
1/16 • Number of events 1 • 6 months
|
|
Nervous system disorders
Fall
|
0.00%
0/17 • 6 months
|
6.2%
1/16 • Number of events 1 • 6 months
|
|
Eye disorders
Elective surgery to repair incisional hernia
|
0.00%
0/17 • 6 months
|
6.2%
1/16 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Thoracic spine pain
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/16 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Knee injury
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/16 • 6 months
|
Additional Information
Dr. Grace Lo, Associate Professor of Medicine
Baylor College of Medicine
Phone: 713-791-1414
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place