A Pilot Randomized Controlled Trial for Hand Osteoarthritis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Baylor College of Medicine
- Enrollment
- 33
- Locations
- 2
- Primary Endpoint
- 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.
Study Overview
Brief Summary
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.
Detailed Description
The research will be conducted at the following location(s):
Baylor College of Medicine, Baylor St. Luke's Medical Center (BSLMC), and Michael E. DeBakey Veterans Affairs Medical Center.
Participants of this study are consented for the study, randomized into one of two treatment groups for hand osteoarthritis, both expected to improve hand symptoms. At the beginning of the study, many questionnaires, a physical exam, photographs of the hands, some x-rays, on a limited few people, and MRI will be obtained. Then the participants will be provided treatments for hand osteoarthritis based on the group wo which they were randomly assigned. One aspect of one of the treatments is viewed as experimental but the risks related to the treatment are considered to be low, so the risk-benefit ratio for participation in this study are good. We see patients in follow up more frequently during the first month, and then at 3 months and then 6 months of follow up. At the final visit, we will repeat the xrays and the MRIs.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
The occupational therapists fabricating the orthoses used the study are the only ones not blinded in this study. The participants, principal investigator, and research assistants are all blinded to the treatment allocation.
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Enrolled to receive medical care at the Michael E. DeBakey VA Medical Center
- •At least 3 joints affected by distal interphalangeal (DIP) nodal hand OA
- •DIP nodal hand OA will be defined as Heberden's nodes on physical exam.
- •Sufficiently severe frequent pain of at least one DIP
- •Frequent pain: pain on most days of the month for at least one month in the last year.
- •Minimum VAS pain severity of 40 on a 0 - 100 scale
Exclusion Criteria
- •History or current inflammatory arthritides (examples: gout, psoriatic arthritis, and rheumatoid arthritis)
- •Prior surgery on the DIP joints
- •Planned surgery for the DIP joints
- •Pregnancy
Arms & Interventions
Treatment arm with control 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.
Intervention: Hand orthosis (Device)
Treatment arm with experimental orthosis
An 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.
Intervention: Hand orthosis (Device)
Outcomes
Primary Outcomes
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.
Time Frame: 24 week follow up
An assessment of pain intensity in a given hand. - high values are worse outcomes. Minimum score = 0 Maximum score = 100
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.
Time Frame: 24 week follow up
An assessment of radiographic OA severity. (high values are worse outcomes) Minimum score = 0 Maximum score = 16
Secondary Outcomes
- The Disabilities of Arm Shoulder and Hand (DASH)(24 week follow up)
- Functional Dexterity Test(24 week follow up)
- Grip Strength(24 week follow up)
- Pinch Strength(24 week follow up)
- The Number of DIP Joints That Exhibit Tenderness in the Study Hand(24 week follow up)
- Grip Strength(24 week follow up)
- The Functional Index for Hand Osteoarthritis (FIHOA)(24 week follow up)
- The Disabilities of Arm Shoulder and Hand (DASH)(24 week follow up)
- Functional Dexterity Test(24 week follow up)
- Pinch Strength(24 week follow up)
- The Number of DIP Joints That Exhibit Tenderness in the Study Hand(24 week follow up)
Investigators
Grace Hsiao-Wei Lo
Associate Professor
Baylor College of Medicine