Strengthening of the First Dorsal Interosseous for Thumb Carpometacarpal Osteoarthritis

NCT03177577 | Completed

• 1 other identifier: 2016P002710
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the effect of first dorsal interosseus (FDI) strengthening in patients with thumb carpometacarpal (CMC) osteoarthritis.

Conditions

Thumb Osteoarthritis; First Dorsal Interosseous Strengthening

Outcome Measures

Primary Outcomes (4)

• Difference in 3-point chuck strength at 12 weeks

  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.

  At enrollment and 12 week follow up

• Difference in Lateral pinch strength at 12 weeks

  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.

  At enrollment and 12 week follow up

• Visual Analog Scale (VAS) for Pain

  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.

  At enrollment and 12 week follow up

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Computer Adaptive Test (CAT) at 12 weeks

  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.

  At Enrollment and 12 week follow up

Study Arms (2)

Splint Only

PLACEBO COMPARATOR

Subjects with carpometacarpal (CMC) osteoarthritis treated by splinting of their thumb.

Device: Splint

Splint with first dorsal interosseous (FDI) strengthening

ACTIVE COMPARATOR

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

Interventions

Splint DEVICE

Subjects will use a splint custom-made by Massachusetts General Hospital Occupational Therapists as part of standard care for treatment of carpometacarpal (CMC) osteoarthritis.

Splint Only

Splint with strengthening exercises DEVICE

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.

Splint with first dorsal interosseous (FDI) strengthening

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (4)

• Sodha S, Ring D, Zurakowski D, Jupiter JB. Prevalence of osteoarthrosis of the trapeziometacarpal joint. J Bone Joint Surg Am. 2005 Dec;87(12):2614-2618. doi: 10.2106/JBJS.E.00104.

  PMID: 16322609 BACKGROUND

• Edmunds JO. Traumatic dislocations and instability of the trapeziometacarpal joint of the thumb. Hand Clin. 2006 Aug;22(3):365-92. doi: 10.1016/j.hcl.2006.05.001.

  PMID: 16843802 BACKGROUND

• O'Brien VH, Giveans MR. Effects of a dynamic stability approach in conservative intervention of the carpometacarpal joint of the thumb: a retrospective study. J Hand Ther. 2013 Jan-Mar;26(1):44-51; quiz 52. doi: 10.1016/j.jht.2012.10.005. Epub 2012 Nov 21.

  PMID: 23177671 BACKGROUND

• McGee C, O'Brien V, Van Nortwick S, Adams J, Van Heest A. First dorsal interosseous muscle contraction results in radiographic reduction of healthy thumb carpometacarpal joint. J Hand Ther. 2015 Oct-Dec;28(4):375-80; quiz 381. doi: 10.1016/j.jht.2015.06.002. Epub 2015 Jun 27.

  PMID: 26209165 BACKGROUND

MeSH Terms

Interventions

Splints

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Officials

• Neal Chen, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 6, 2017
• Study Start: December 29, 2016
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)