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Strengthening of the First Dorsal Interosseous for Thumb Carpometacarpal Osteoarthritis

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03177577
First Posted: June 6, 2017
Last Update Posted: June 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Neal Chung-Jen Chen, Massachusetts General Hospital
  Purpose
To determine the effect of first dorsal interosseus (FDI) strengthening in patients with thumb carpometacarpal (CMC) osteoarthritis.

Condition Intervention
Thumb Osteoarthritis First Dorsal Interosseous Strengthening Device: Splint Device: Splint with strengthening exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Strengthening of the First Dorsal Interosseous for Thumb Carpometacarpal Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Neal Chung-Jen Chen, Massachusetts General Hospital:

Primary Outcome Measures:
  • Difference in 3-point chuck strength at 12 weeks [ Time Frame: At enrollment and 12 week follow up ]
    Investigators will measure the pinch strength by placing a pinch meter between the pad of the thumb and pad of the index and middle finger. The investigators will compare the change in 3 point chuck strength between the two cohorts after 12 weeks of treatment.

  • Difference in Lateral pinch strength at 12 weeks [ Time Frame: At enrollment and 12 week follow up ]
    The investigators will measure lateral pinch strength by placing a pinch meter between the pad of the thumb and lateral surface of the index finger. The investigators will compare the change in lateral pinch strength between the two cohorts after 12 weeks of treatment.

  • Visual Analog Scale (VAS) for Pain [ Time Frame: At enrollment and 12 week follow up ]
    The Visual Analog Scale for Pain measures the amount of pain on a scale from 0, no pain, to 10, worst possible pain. The investigators will compare the change in pain between the two cohorts after 12 weeks of treatment.

  • Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Computer Adaptive Test (CAT) at 12 weeks [ Time Frame: At Enrollment and 12 week follow up ]
    A computerized assessment of depression measured at enrollment. The average T score of the U.S. population is 50, so the T score reported compares the study population to the U.S. population, where a T score greater than 50 is worse than the average and a T score less than 50 is better than the average. The investigators will compare the change in PROMIS Upper Extremity between the two cohorts after 12 weeks of treatment.


Estimated Enrollment: 30
Actual Study Start Date: December 29, 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Splint Only
Subjects with carpometacarpal (CMC) osteoarthritis treated by splinting of their thumb.
Device: Splint
Subjects will use a splint custom-made by Massachusetts General Hospital Occupational Therapists as part of standard care for treatment of carpometacarpal (CMC) osteoarthritis.
Active Comparator: Splint with first dorsal interosseous (FDI) strengthening
Subjects with carpometacarpal (CMC) osteoarthritis treated by splinting of their thumb combined with first dorsal interosseous (FDI) strengthening stabilization exercises.
Device: Splint with strengthening exercises
Subjects will use a splint custom-made by Massachusetts General Hospital Occupational Therapists as part of standard care for treatment of carpometacarpal (CMC) osteoarthritis and will also be taught two first dorsal interosseous (FDI) strengthening exercises.

Detailed Description:

Thumb CMC osteoarthritis is a normal part of aging. Most patients are able to adapt to symptoms of pain and disability, other patients might benefit from non-operative interventions; e.g. splinting, corticosteroid injections, pain medication, and multiple hand exercises.

The dorsal ligament complex is one of the components for stability of the thumb CMC joint. These ligaments specifically create stability for pinch and grip during the final phase of opposition. Both, the opponens pollicis (OP) and the first dorsal interosseous (FDI) play a key role in centralizing the metacarpal on the trapezium. A retrospective study showed that a dynamic stability modeled approach, including targeting the FDI, reduced pain and improved function in patients with thumb CMC osteoarthritis. Recently, another study demonstrated that reduction of radial subluxation - the thumb metacarpal versus the trapezium CMC joint - was achieved by contraction of the dynamic stabilizers of the healthy hand, specifically with the focus on the FDI.

More clinical research is needed to determine if there are efficacious (effective and low-cost) evidence-based exercise programs for pain reduction and functional improvement in patients with thumb CMC osteoarthritis. The investigators are interested in the effect of FDI strengthening in patients with thumb CMC osteoarthritis. Therefore, the investigators hypothesized that there is no difference in the change of lateral pinch strength at 12 weeks between patients treated with a splint versus patients treated with a splint and FDI strengthening for thumb CMC osteoarthritis. We also tested the same hypothesis for 3-point chuck strength, VAS for pain, and PROMIS Upper Extremity CAT.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years old
  • English-speaking
  • Splint treatment for thumb carpometacarpal (CMC) osteoarthritis

Exclusion Criteria:

  • Less than 18 years old
  • Rheumatoid Arthritis or post-traumatic carpometacarpal (CMC) osteoarthritis
  • Patients that received a corticosteroid injection during the appointment for treatment of thumb carpometacarpal (CMC) osteoarthritis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03177577


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital