Strengthening of the First Dorsal Interosseous for Thumb Carpometacarpal Osteoarthritis
Primary Purpose
Thumb Osteoarthritis, First Dorsal Interosseous Strengthening
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Splint
Splint with strengthening exercises
Sponsored by
About this trial
This is an interventional treatment trial for Thumb Osteoarthritis
Eligibility 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
Sites / Locations
- Massachusetts General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Splint Only
Splint with first dorsal interosseous (FDI) strengthening
Arm Description
Subjects with carpometacarpal (CMC) osteoarthritis treated by splinting of their thumb.
Subjects with carpometacarpal (CMC) osteoarthritis treated by splinting of their thumb combined with first dorsal interosseous (FDI) strengthening stabilization exercises.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03177577
First Posted
June 2, 2017
Last Updated
March 16, 2023
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03177577
Brief Title
Strengthening of the First Dorsal Interosseous for Thumb Carpometacarpal Osteoarthritis
Official Title
Strengthening of the First Dorsal Interosseous for Thumb Carpometacarpal Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 29, 2016 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thumb Osteoarthritis, First Dorsal Interosseous Strengthening
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Splint Only
Arm Type
Placebo Comparator
Arm Description
Subjects with carpometacarpal (CMC) osteoarthritis treated by splinting of their thumb.
Arm Title
Splint with first dorsal interosseous (FDI) strengthening
Arm Type
Active Comparator
Arm Description
Subjects with carpometacarpal (CMC) osteoarthritis treated by splinting of their thumb combined with first dorsal interosseous (FDI) strengthening stabilization exercises.
Intervention Type
Device
Intervention Name(s)
Splint
Intervention Description
Subjects will use a splint custom-made by Massachusetts General Hospital Occupational Therapists as part of standard care for treatment of carpometacarpal (CMC) osteoarthritis.
Intervention Type
Device
Intervention Name(s)
Splint with strengthening exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in 3-point chuck strength at 12 weeks
Description
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.
Time Frame
At enrollment and 12 week follow up
Title
Difference in Lateral pinch strength at 12 weeks
Description
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.
Time Frame
At enrollment and 12 week follow up
Title
Visual Analog Scale (VAS) for Pain
Description
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.
Time Frame
At enrollment and 12 week follow up
Title
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Computer Adaptive Test (CAT) at 12 weeks
Description
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.
Time Frame
At Enrollment and 12 week follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neal Chen, MD
Phone
617-726-4700
Email
nchen1@partners.org
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel Cross, BA
Phone
6177261569
Email
rcross3@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal Chen, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neal Chen, MD
Phone
617-726-4700
Email
nchen1@partners.org
First Name & Middle Initial & Last Name & Degree
Rachel Cross, BA
Phone
6177261569
Email
rcross3@mgh.harvard.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16322609
Citation
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.
Results Reference
background
PubMed Identifier
16843802
Citation
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.
Results Reference
background
PubMed Identifier
23177671
Citation
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.
Results Reference
background
PubMed Identifier
26209165
Citation
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.
Results Reference
background
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Strengthening of the First Dorsal Interosseous for Thumb Carpometacarpal Osteoarthritis
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