Thumb OsteoarthritisNCT03177577
Strengthening of the First Dorsal Interosseous for Thumb Carpometacarpal Osteoarthritis
A study testing Splint and Splint with strengthening exercises in people with Thumb Osteoarthritis and First Dorsal Interosseous Strengthening, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
To determine the effect of first dorsal interosseus (FDI) strengthening in patients with thumb carpometacarpal (CMC) osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thumb Osteoarthritis, First Dorsal Interosseous Strengthening
- What is being tested?
- Splint and Splint with strengthening exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Dec 2016to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old
- English-speaking
- Splint treatment for thumb carpometacarpal (CMC) osteoarthritis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
To determine the effect of first dorsal interosseus (FDI) strengthening in patients with thumb carpometacarpal (CMC) osteoarthritis.
Read the 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.
- Being tested
- Splint, Splint with strengthening exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SplintDevice
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 with strengthening exercisesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Splint Only | Placebo comparator | Subjects with carpometacarpal (CMC) osteoarthritis treated by splinting of their thumb. Receives: 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. Receives: Device: Splint with strengthening exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Enrollment and 12 week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start29 Dec 2016
- Primary completionJun 2025
- Study completionSep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Thumb OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neal Chung-Jen Chen, Massachusetts General Hospital
- Investigators
- Neal Chen, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177577
- Sponsor's protocol ID
- 2016P002710
- Status last verified
- Nov 2025
- First submitted
- 2 Jun 2017
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Publications
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.
PubMed 16322609Edmunds 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.
PubMed 16843802O'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.
PubMed 23177671McGee 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.
PubMed 26209165
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening of the First Dorsal Interosseous for Thumb Carpometacarpal Osteoarthritis
- ClinicalTrials.gov ID
- NCT03177577
- Acronym / sponsor ID
- 2016P002710
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 29 Dec 2016 (actual)
- Primary completion
- Jun 2025 (actual)
- Study completion
- Sep 2025 (actual)
- First posted
- 6 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the effect of first dorsal interosseus (FDI) strengthening in patients with thumb carpometacarpal (CMC) osteoarthritis.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Splint Only | Placebo comparator | Device: SplintSubjects with carpometacarpal (CMC) osteoarthritis treated by splinting of their thumb. |
| Splint with first dorsal interosseous (FDI) strengthening | Active comparator | Device: Splint with strengthening exercisesSubjects with carpometacarpal (CMC) osteoarthritis treated by splinting of their thumb combined with first dorsal interosseous (FDI) strengthening stabilization exercises. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years old
- English-speaking
- Splint treatment for thumb carpometacarpal (CMC) osteoarthritis
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SplintSubjects will use a splint custom-made by Massachusetts General Hospital Occupational Therapists as part of standard care for treatment of carpometacarpal (CMC) osteoarthritis. | Device | Splint Only |
| Splint with strengthening exercisesSubjects 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. | Device | Splint with first dorsal interosseous (FDI) strengthening |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Background: PubMed 16322609Sodha 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.
- Background: PubMed 16843802Edmunds 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.
- Background: PubMed 23177671O'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.
- Background: PubMed 26209165McGee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neal Chen, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Splint and Splint with strengthening exercises in people with Thumb Osteoarthritis and First Dorsal Interosseous Strengthening, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in 3-point chuck strength at 12 weeks (time frame: At enrollment and 12 week follow up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03177577, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.