Hand osteoarthritis (OA) is a common problem and is associated with substantial functional limitations. To date, few therapies are effective in reducing pain in hand OA; and most are only based on expert opinion. Although nodal hand OA has traditionally not been viewed as a biomechanically driven the disease, there is growing evidence that indeed it is. OA in the knee, a disease long known to be biomechanically driven, can be treated with distraction, a therapy where external hardware are surgically placed preventing joint motion, providing intra-articular negative pressure, and increasing the joint space. People awaiting knee total knee arthroplasty receiving distraction have reduced pain, growth of new articular cartilage, and delay and sometimes complete avoidance of arthroplasty. Unfortunately, distraction is associated with serious attendant adverse events including a 10% rate of pulmonary emboli despite anticoagulation and an 85% rate of pin site infection, limiting widespread use of this treatment. Nevertheless, it is an important proof of concept that unloading an OA joint may allow structure and symptom improvement. Since distraction has both symptom and structure benefit in knee OA, then traction therapy, using non-invasive finger traps, may have similar benefits for hand OA without attendant complications. Thus, we propose a pilot randomized controlled trial of traction on 100 participants recruited from the Michael E. DeBakey VA Medical Center with at least 3 joints affected by distal interphalangeal (DIP) nodal hand OA, with at least one symptomatic joint. Participants will be randomized into two groups (1) standard of care or (2) traction with finger traps plus standard of care.
Specific aim 1 : Feasibility of a static hand based orthosis to apply finger traps. We will assess the logistics of creating and using such a treatment.
Specific aim 2. Proof of concept. On a small subsample we will obtain radiographs to assess whether increased joint space is achieved with finger traction.
Specific aim 3. Symptomatic and functional outcomes. At baseline, and 1, 3, and 6 month follow up visits, we will assess outcomes of the Australian Canadian Hand OA Index (AUSCAN) pain scale, the visual analog scale pain scale, the AUSCAN function subscale, the Functional Index for Hand Osteoarthritis (FIHOA), the Disabilities of the Arm, Shoulder, and Hand (DASH), a hand dexterity test, grip and pinch strength, and tenderness on joint palpation.
Specific aim 4. Imaging outcomes. To assess structural benefits of traction therapy, on all participants, bilateral hand radiographs at baseline and at 6 months will be used to assess changes in Kellgren and Lawrence scores, joint space narrowing, and osteophyte scores and the Verbruggen-Veys score. On a limited sample, high resolution MRI imaging at baseline and at 6 months will evaluate whether there are greater benefits to the traction splint arm compared to the control arm. If we are able to support feasibility, proof of concept, symptomatic/functional and structural improvement of traction therapy, these findings will power a definitive R01 study to address efficacy and clinical utility of this treatment.

Public Health Relevance

Hand osteoarthritis (OA) is a common problem with few effective treatments, but recent evidence suggests that taking pressure off a joint with OA may reduce symptoms and allow damaged structures to heal. Finger traps are medical devices that are already used to take pressure off joints for different conditions, so we plan to perform a small study to get a sense of whether using finger traps for hand OA is a practical therapy and whether it reduces symptoms and allows damaged structures to heal. If we find this use of finger practical and beneficial, we will use results from this study to justify a larger study to confirm these findings.

Agency
National Institute of Health (NIH)
Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Type
Exploratory/Developmental Grants (R21)
Project #
5R21AR072358-03
Application #
10071865
Study Section
Arthritis and Musculoskeletal and Skin Diseases Clinical Trials Review Committee (AMSC)
Program Officer
Zheng, Xincheng
Project Start
2019-01-15
Project End
2021-11-30
Budget Start
2020-12-01
Budget End
2021-11-30
Support Year
3
Fiscal Year
2021
Total Cost
Indirect Cost
Name
Baylor College of Medicine
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
051113330
City
Houston
State
TX
Country
United States
Zip Code
77030