Trapeziometacarpal (TMC) ArthrosisNCT01775670
Off-the-Shelf Splints Versus Occupational Therapy Splints for Treatment of Trapeziometacarpal Arthrosis
A study testing Off-the-shelf splint and OT Splint in people with Trapeziometacarpal (TMC) Arthrosis, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The specific aim is to compare the effectiveness of Off-the-Shelf splints and splints provided by Occupational Therapy for treatment of trapeziometacarpal (TMC) arthrosis. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Trapeziometacarpal (TMC) Arthrosis
- What is being tested?
- Off-the-shelf splint and OT Splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Jan 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 40 years of age and older
- Clinical or radiological diagnosis of TMC arthrosis by MD
- English fluency and literacy
Who cannot join
- Prior surgical treatment of TMC arthrosis on same side
- Prior treatment of TMC arthrosis on same side with a splint during the last two months
- Prior injury of the trapeziometacarpal joint
- Rheumatoid arthritis
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The specific aim is to compare the effectiveness of Off-the-Shelf splints and splints provided by Occupational Therapy for treatment of trapeziometacarpal (TMC) arthrosis.
Read the detailed description
Trapeziometacarpal (TMC) arthrosis is so common, particularly in women, that it should be considered a normal part of the aging process. Overall radiographic prevalence of TMC arthrosis has been described to be as high as 91% in patients older than eighty years of age. It increases steadily from the age of 41 years, more rapidly in women than in men. Another study, conducted in the Netherlands, showed that in a population of 55 years and older, 67% of women and 55% of men had radiographic signs of arthrosis of the hand. It also found that the distal interphalangeal (DIP) joints are most commonly affected (47%), followed by the TMC joint (36%). However, it has been reported that in symptomatic arthrosis, TMC arthrosis contributes more to pain and disability than arthrosis of the interphalangeal joints. Psychosocial factors have been recognized as the strongest determinants of highly variable pain intensity and arm-specific disability. The pathophysiologic and psychosocial differences between patients who present to the doctor for treatment and those who do not are incompletely understood.
A hand-based thumb spica splint with the interphalangeal (IP) joint free is a specific nonoperative palliative treatment for TMC arthrosis. The goals of splint wear are improved comfort and function. The data regarding specific splint materials are limited, but suggest that shorter more flexible splints are preferred by patients and equally effective. Recently, the investigators looked into if there was a difference between thermoplast and neoprene hand-based thumb spica splints for treatment of TMC arthrosis. The neoprene splint was rated more comfortable than the thermoplast splint but otherwise there was no difference.
To the investigators' knowledge no studies have looked at the added value of occupational therapy in splint treatment for TMC arthrosis. The investigators believe that the time spent by occupational therapists (OTs) coaching patients on adaptive and palliative measures is valuable in addition to their technical skills but the investigators cannot draw any conclusions until the investigators research this in a prospective trial.
The investigators propose a two arm unblinded, randomized (1:1) controlled trial to evaluate if there is a difference between prefabricated off-the-shelf splints and splints provided by an OT with standard care coaching. The investigators want to determine if there is a difference in arm-specific disability, average pain, and satisfaction at an average of 2 months between splints provided by an OT and prefabricated off-the-shelf splints.
- Conditions
- Trapeziometacarpal (TMC) Arthrosis
- Being tested
- Off-the-shelf splint, OT Splint
- Keywords
- Arthrosis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Off-the-shelf splintDevice
Subjects will use an off-the-shelf splint
OT SplintDevice
Subjects will use a splint custom-made by Massachusetts General Hospital Occupational Therapists.
| Study group | Role | What they receive |
|---|---|---|
| Off-the-Shelf Splint | Experimental | Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis. Receives: Device: Off-the-shelf splint |
| OT Splint | Active comparator | Subjects in this arm will be managed with a custom-made splint made by the Massachusetts General Hospital Occupational Therapists. Receives: Device: OT Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH)
The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability. The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks.
Measured: At enrollment
Change From the Baseline in the Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) at 2 Months After Enrollment
The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability. The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks. This was measured 2-month after treatment.
Measured: 2 months after enrollment
Thumb Pain at Enrollment
11-point ordinal pain scale to assess the amount of pain. The scale range is from 0-10, where 0 is no pain at all and 10 is the worst pain ever had.
Measured: At enrollment
Average Satisfaction With the Splint 2 Months After Enrollment
Average satisfaction with splint treatment will be assessed 2 months after enrollment. 11-point ordinal pain scale to assess the amount of satisfaction. The scale range for satisfaction is from 0-10, where 0 is dissatisfaction and 10 is complete satisfaction with the splint.
Measured: At 2 months after enrollment
Average Pain 2 Months After Enrollment
Average pain will be assessed 2 months after enrollment. 11-point ordinal pain scale to assess the amount of pain. The scale range for pain is from 0-10, where 0 is no pain and 10 is the worst pain.
Measured: At 2 months after enrollment
Secondary outcomes (6)
Patient Reported Outcomes Measurement Information System (PROMIS) - Depression
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.
Measured: At Enrollment
PROMIS Pain - Interference
A computerized assessment of pain interference 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.
Measured: At Enrollment
Thumb Metacarpophalangeal (MCP) Joint in Resting Position (Degrees)
Measurements of thumb metacarpophalangeal (MCP) joint in resting position.
Measured: At Enrollment
Thumb MCP in Pinch Position (Degrees)
Measurements of thumb MCP in pinch position.
Measured: At Enrollment
Thumb Pinch Strength
Measurement of thumb pinch strength using a pinch meter. Subjects place the pinch meter between their thumb and index finger and pinch down to record the pinch strength.
Measured: At Enrollment
Thumb Grip Strength
Grip strength of the affected hand was measured at enrollment using a dynamometer. The subject squeezes the handle of the dynamometer to maximum capability to measure grip strength. Each subject completed the grip strength measurement 3 times on the affected hand to get an average grip strength of the affected hand.
Measured: At Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: Due to the principal investigator leaving the institution and slow enrollment, we have decided to close the study prior to study completion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Trapeziometacarpal (TMC) ArthrosisStudies 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
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David C. Ring, MD, Massachusetts General Hospital
- Investigators
- David C Ring, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01775670
- Sponsor's protocol ID
- 1
- Status last verified
- Apr 2017
- First submitted
- 22 Jan 2013
- Last updated
- 15 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Off-the-Shelf Splints Versus Occupational Therapy Splints for Treatment of Trapeziometacarpal Arthrosis
- ClinicalTrials.gov ID
- NCT01775670
- Acronym / sponsor ID
- 1
- Conditions
- Trapeziometacarpal (TMC) Arthrosis
- Keywords
- Arthrosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the principal investigator leaving the institution and slow enrollment, we have decided to close the study prior to study completion
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 25 Jan 2013 (estimated)
- Results
- Posted 15 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The specific aim is to compare the effectiveness of Off-the-Shelf splints and splints provided by Occupational Therapy for treatment of trapeziometacarpal (TMC) arthrosis.
Detailed description
Trapeziometacarpal (TMC) arthrosis is so common, particularly in women, that it should be considered a normal part of the aging process. Overall radiographic prevalence of TMC arthrosis has been described to be as high as 91% in patients older than eighty years of age. It increases steadily from the age of 41 years, more rapidly in women than in men. Another study, conducted in the Netherlands, showed that in a population of 55 years and older, 67% of women and 55% of men had radiographic signs of arthrosis of the hand. It also found that the distal interphalangeal (DIP) joints are most commonly affected (47%), followed by the TMC joint (36%). However, it has been reported that in symptomatic arthrosis, TMC arthrosis contributes more to pain and disability than arthrosis of the interphalangeal joints. Psychosocial factors have been recognized as the strongest determinants of highly variable pain intensity and arm-specific disability. The pathophysiologic and psychosocial differences between patients who present to the doctor for treatment and those who do not are incompletely understood.
A hand-based thumb spica splint with the interphalangeal (IP) joint free is a specific nonoperative palliative treatment for TMC arthrosis. The goals of splint wear are improved comfort and function. The data regarding specific splint materials are limited, but suggest that shorter more flexible splints are preferred by patients and equally effective. Recently, the investigators looked into if there was a difference between thermoplast and neoprene hand-based thumb spica splints for treatment of TMC arthrosis. The neoprene splint was rated more comfortable than the thermoplast splint but otherwise there was no difference.
To the investigators' knowledge no studies have looked at the added value of occupational therapy in splint treatment for TMC arthrosis. The investigators believe that the time spent by occupational therapists (OTs) coaching patients on adaptive and palliative measures is valuable in addition to their technical skills but the investigators cannot draw any conclusions until the investigators research this in a prospective trial.
The investigators propose a two arm unblinded, randomized (1:1) controlled trial to evaluate if there is a difference between prefabricated off-the-shelf splints and splints provided by an OT with standard care coaching. The investigators want to determine if there is a difference in arm-specific disability, average pain, and satisfaction at an average of 2 months between splints provided by an OT and prefabricated off-the-shelf splints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Off-the-Shelf Splint | Experimental | Device: Off-the-shelf splintSubjects in this arm will be managed with off-the-shelf splints for TMC arthrosis. |
| OT Splint | Active comparator | Device: OT SplintSubjects in this arm will be managed with a custom-made splint made by the Massachusetts General Hospital Occupational Therapists. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 40 years of age and older
- Clinical or radiological diagnosis of TMC arthrosis by MD
- English fluency and literacy
Key exclusion criteria (5 listed)
- Prior surgical treatment of TMC arthrosis on same side
- Prior treatment of TMC arthrosis on same side with a splint during the last two months
- Prior injury of the trapeziometacarpal joint
- Rheumatoid arthritis
- Pregnant women.
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 |
|---|---|---|
| Off-the-shelf splintSubjects will use an off-the-shelf splint | Device | Off-the-Shelf Splint |
| OT SplintSubjects will use a splint custom-made by Massachusetts General Hospital Occupational Therapists. | Device | OT Splint |
Primary outcome
Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH)
Time frame: At enrollment
The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability. The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks.
Change From the Baseline in the Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) at 2 Months After Enrollment
Time frame: 2 months after enrollment
The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability. The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks. This was measured 2-month after treatment.
Thumb Pain at Enrollment
Time frame: At enrollment
11-point ordinal pain scale to assess the amount of pain. The scale range is from 0-10, where 0 is no pain at all and 10 is the worst pain ever had.
Average Satisfaction With the Splint 2 Months After Enrollment
Time frame: At 2 months after enrollment
Average satisfaction with splint treatment will be assessed 2 months after enrollment. 11-point ordinal pain scale to assess the amount of satisfaction. The scale range for satisfaction is from 0-10, where 0 is dissatisfaction and 10 is complete satisfaction with the splint.
Average Pain 2 Months After Enrollment
Time frame: At 2 months after enrollment
Average pain will be assessed 2 months after enrollment. 11-point ordinal pain scale to assess the amount of pain. The scale range for pain is from 0-10, where 0 is no pain and 10 is the worst pain.
6 secondary outcomes
Patient Reported Outcomes Measurement Information System (PROMIS) - Depression
Time frame: At Enrollment
PROMIS Pain - Interference
Time frame: At Enrollment
Thumb Metacarpophalangeal (MCP) Joint in Resting Position (Degrees)
Time frame: At Enrollment
Thumb MCP in Pinch Position (Degrees)
Time frame: At Enrollment
Thumb Pinch Strength
Time frame: At Enrollment
Thumb Grip Strength
Time frame: At Enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Trapeziometacarpal (TMC) Arthrosis
Not yet recruitingObservational study
Early Functional Response as a Predictor of Clinical Outcomes in Hand Rehabilitation: A Prospective Feasibility Study Using a Digital Monitoring System
Hand, Hand Therapy
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.
David C Ring, MD, PhD 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 Off-the-shelf splint and OT Splint in people with Trapeziometacarpal (TMC) Arthrosis, 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 5 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: stopped early, as of the sponsor's last update on 15 May 2017. 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. 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?
Yes. Results are posted in the registry (first posted 15 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) (time frame: At enrollment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2017; AzTrials last refreshed its copy on 30 Oct 2026.