Arthritis WristNCT04297943
Orthotic Management of CMC Osteoarthritis
A study testing Orthosis fabrication, Thermal Sensor Monitoring of Orthosis Use and 4D CT Scan in people with Arthritis Wrist, run by Western University, Canada.
Trial summary
This study will investigate the effectiveness of 3D printed splints for the treatment of thumb osteoarthritis (CMC OA). Currently, these splints are made by Occupational Therapists and Physical Therapists out of low temperature plastic, and formed on the patient's hand. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis Wrist
- What is being tested?
- Orthosis fabrication, Thermal Sensor Monitoring of Orthosis Use and 4D CT Scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2020to 31 May 2022
- 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
- All patients with a diagnosis of CMC OA
Who cannot join
- Language barriers Cognitive barriers Previous thumb metacarpal fracture Advanced scapho-trapezial OA
- -
About this study
Official title: The Effectiveness of 3D Printed, Low Temperature Thermoplastic, and Prefabricated Orthoses in the Management of Thumb Carpo-metacarpal Osteoarthritis: A Randomized, Controlled Trial.
This study will investigate the effectiveness of 3D printed splints for the treatment of thumb osteoarthritis (CMC OA). Currently, these splints are made by Occupational Therapists and Physical Therapists out of low temperature plastic, and formed on the patient's hand. 3D printed splints involve taking a photographic scan of the hand and creating a digital file of the splint. This is then printed and fit on the patient. This study will compare the effectiveness of these methods of splint fabrication. Our outcomes will include measurements of pain relief, adherence, patient satisfaction, muscle contraction and CT imaging during pinch tasks to measure the ability of these splint types to support the CMC joint.
Read the detailed description
This study will be prospective, randomized, controlled trial. Patients will be identified for potential inclusion by the surgeons at HULC. The standard of clinical care is for diagnosis of CMC is to perform X-rays of the hand and this is done routinely. Based on these images and clinical evaluation, surgeons will establish a diagnosis of CMC, and provide a grading of severity based on the Eaton/Littler Classification on a referral pad. Eligible participants will then be asked to attend the Clinical Research Laboratory within HULC, where one of the co-investigators listed will present the letter of information and obtain informed consent. Patients who agree to participate will be asked to complete 3 functional outcomes questionnaires (i.e. DASH, PRWHE, and VAS pain scale). Bilateral wrist and thumb range of motion, lateral and tripod pinch strength, and grip strength will also be assessed.
Following the initial assessment, patients will be randomized into one of two groups. Patients will be stratified based on their initial referral by the hand surgeon according to CMC OA severity results to ensure that equal numbers of participants fall into each treatment arm based on the Eaton Classification of their CMC OA. After randomization, patients will attend splinting visit #1 (based on scheduling availability) either the Hand Therapy Department at St. Joseph's Health Care London or Hand Therapy Canada, a private clinic in London. Regardless of group allocation or location of therapy visit, patients will not be charged for their therapy visits or for their splint.
Splinting Visit #1
Group one will be fit with a low temperature custom thermoplastic brace at one of the aforementioned clinic locations and then booked for a follow up appointment in the clinical research laboratory at SJHC two weeks later.
Group two will have their hand placed in a scanner that takes multiple photographs of the hand and reconstructs these photos into a single 3 dimensional computer image. From there, one of the co-investigators (MS) will "draw" the splint, and send to a 3D printer. Patients will come back to a clinic location for fitting, and will then follow up 2 weeks after splint fitting at the clinical research laboratory 2 weeks later.
Regardless of group allocation, each splint will have a temperature sensor placed into the splint. This sensor is similar to a watch battery and collects and records several thousand temperature readings on pre-set intervals. Participants will be told that the the sensor records data on position of the hand in space, but in fact, recording the temperature will provide information about adherence with the splinting program.
CT Scan
Patients undergo a 4D CT scan of bilateral thumb CMC joints. This will include scans at rest, while performing lateral pinch of 2kg, 5kg, and maximum pinch (if greater than 5kg). They will then apply their splint, and these images will be repeated while wearing the splint.
Follow Up Visits
Participants will be asked to wear their splint during most functional activities for 8 weeks, with the goal of wearing their splint for at least half of their waking hours. They will be asked to keep a daily logbook of the amount of time spent in the splint and will keep these records until the 2-month visit. All participants will return to therapy once every 2 weeks. The purpose of these follow up visits will be to download the data from the temperature sensors and to ensure there is no skin irritation or evidence of any skin breakdown from splint use.
2-month visit
At 2 months, participants will be asked to repeat the three functional outcomes questionnaires and will have their ROM and strength re-tested as in visit #1. They will also have a surface EMG recording of their muscle contractions while in the splint. At this point, the sensors will be removed from the splints for final analysis. Patients will also turn in their logbooks of splint usage, and complete a splinting satisfaction questionnaire. They will then attend a second visit to the CT scanner for a repeat imaging session exactly as listed above.
Final Visit
Participants will be call back to the clinic for a final evaluation at 12 months. At this point, all measures will be repeated with the exception of the CT scans.
- Conditions
- Arthritis Wrist
- Being tested
- Orthosis fabrication, Thermal Sensor Monitoring of Orthosis Use, 4D CT Scan
- Keywords
- arthritis, orthotics
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthosis fabricationDevice
see summary
Thermal Sensor Monitoring of Orthosis UseDevice
see summary
4D CT ScanDiagnostic test
see summary
| Study group | Role | What they receive |
|---|---|---|
| 3D Orthosis | Active comparator | See summary Receives: Device: Orthosis fabrication; Device: Thermal Sensor Monitoring of Orthosis Use; Diagnostic Test: 4D CT Scan |
| Custom Thermoplastic Orthosis | Active comparator | See summary Receives: Device: Orthosis fabrication; Device: Thermal Sensor Monitoring of Orthosis Use; Diagnostic Test: 4D CT Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Disabilities of the Arm Shoulder and Hand Questionnaire.
Patient reported outcome measure
Measured: Initial Visit, at 2 month visit, and at 1 year
Change in Pain
VAS scale for pain
Measured: Initial Visit, at 2 month visit, and at 1 year
4D CT Scan Changes
Effectiveness of Orthosis to stabilize CMC while pinching
Measured: At enrolment and again 2 months later
Secondary outcomes (3)
Adherence
Measured via log book and temperature sensors
Measured: Measured at 2 month visit, with data downloaded biweekly
Orthosis Satisfaction Survey
Assessment of participants satisfaction with orthosis
Measured: At 2 month visit and at 1 year
Change in Pinch strength
Pinch gauge measurements
Measured: Measured in CT scans at enrolment and at 2 month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start1 May 2020 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis WristStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Healthcare Foundation, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297943
- Sponsor's protocol ID
- 115441
- Status last verified
- Feb 2020
- First submitted
- 24 Feb 2020
- Last updated
- 6 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of 3D Printed, Low Temperature Thermoplastic, and Prefabricated Orthoses in the Management of Thumb Carpo-metacarpal Osteoarthritis: A Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT04297943
- Acronym / sponsor ID
- 115441
- Conditions
- Arthritis Wrist
- Keywords
- arthritis, orthotics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- St. Joseph's Healthcare Foundation, Canadian Institutes of Health Research (CIHR)
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 6 Mar 2020 (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.
This study will investigate the effectiveness of 3D printed splints for the treatment of thumb osteoarthritis (CMC OA). Currently, these splints are made by Occupational Therapists and Physical Therapists out of low temperature plastic, and formed on the patient's hand. 3D printed splints involve taking a photographic scan of the hand and creating a digital file of the splint. This is then printed and fit on the patient. This study will compare the effectiveness of these methods of splint fabrication. Our outcomes will include measurements of pain relief, adherence, patient satisfaction, muscle contraction and CT imaging during pinch tasks to measure the ability of these splint types to support the CMC joint.
Detailed description
This study will be prospective, randomized, controlled trial. Patients will be identified for potential inclusion by the surgeons at HULC. The standard of clinical care is for diagnosis of CMC is to perform X-rays of the hand and this is done routinely. Based on these images and clinical evaluation, surgeons will establish a diagnosis of CMC, and provide a grading of severity based on the Eaton/Littler Classification on a referral pad. Eligible participants will then be asked to attend the Clinical Research Laboratory within HULC, where one of the co-investigators listed will present the letter of information and obtain informed consent. Patients who agree to participate will be asked to complete 3 functional outcomes questionnaires (i.e. DASH, PRWHE, and VAS pain scale). Bilateral wrist and thumb range of motion, lateral and tripod pinch strength, and grip strength will also be assessed.
Following the initial assessment, patients will be randomized into one of two groups. Patients will be stratified based on their initial referral by the hand surgeon according to CMC OA severity results to ensure that equal numbers of participants fall into each treatment arm based on the Eaton Classification of their CMC OA. After randomization, patients will attend splinting visit #1 (based on scheduling availability) either the Hand Therapy Department at St. Joseph's Health Care London or Hand Therapy Canada, a private clinic in London. Regardless of group allocation or location of therapy visit, patients will not be charged for their therapy visits or for their splint.
Splinting Visit #1
Group one will be fit with a low temperature custom thermoplastic brace at one of the aforementioned clinic locations and then booked for a follow up appointment in the clinical research laboratory at SJHC two weeks later.
Group two will have their hand placed in a scanner that takes multiple photographs of the hand and reconstructs these photos into a single 3 dimensional computer image. From there, one of the co-investigators (MS) will "draw" the splint, and send to a 3D printer. Patients will come back to a clinic location for fitting, and will then follow up 2 weeks after splint fitting at the clinical research laboratory 2 weeks later.
Regardless of group allocation, each splint will have a temperature sensor placed into the splint. This sensor is similar to a watch battery and collects and records several thousand temperature readings on pre-set intervals. Participants will be told that the the sensor records data on position of the hand in space, but in fact, recording the temperature will provide information about adherence with the splinting program.
CT Scan
Patients undergo a 4D CT scan of bilateral thumb CMC joints. This will include scans at rest, while performing lateral pinch of 2kg, 5kg, and maximum pinch (if greater than 5kg). They will then apply their splint, and these images will be repeated while wearing the splint.
Follow Up Visits
Participants will be asked to wear their splint during most functional activities for 8 weeks, with the goal of wearing their splint for at least half of their waking hours. They will be asked to keep a daily logbook of the amount of time spent in the splint and will keep these records until the 2-month visit. All participants will return to therapy once every 2 weeks. The purpose of these follow up visits will be to download the data from the temperature sensors and to ensure there is no skin irritation or evidence of any skin breakdown from splint use.
2-month visit
At 2 months, participants will be asked to repeat the three functional outcomes questionnaires and will have their ROM and strength re-tested as in visit #1. They will also have a surface EMG recording of their muscle contractions while in the splint. At this point, the sensors will be removed from the splints for final analysis. Patients will also turn in their logbooks of splint usage, and complete a splinting satisfaction questionnaire. They will then attend a second visit to the CT scanner for a repeat imaging session exactly as listed above.
Final Visit
Participants will be call back to the clinic for a final evaluation at 12 months. At this point, all measures will be repeated with the exception of the CT scans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D Orthosis | Active comparator | Device: Orthosis fabrication, Device: Thermal Sensor Monitoring of Orthosis Use, Diagnostic Test: 4D CT ScanSee summary |
| Custom Thermoplastic Orthosis | Active comparator | Device: Orthosis fabrication, Device: Thermal Sensor Monitoring of Orthosis Use, Diagnostic Test: 4D CT ScanSee summary |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with a diagnosis of CMC OA
Key exclusion criteria (2 listed)
- Language barriers Cognitive barriers Previous thumb metacarpal fracture Advanced scapho-trapezial OA
- -
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 |
|---|---|---|
| Orthosis fabricationsee summary | Device | 3D Orthosis, Custom Thermoplastic Orthosis |
| Thermal Sensor Monitoring of Orthosis Usesee summary | Device | 3D Orthosis, Custom Thermoplastic Orthosis |
| 4D CT Scansee summary | Diagnostic test | 3D Orthosis, Custom Thermoplastic Orthosis |
Primary outcome
Change in Disabilities of the Arm Shoulder and Hand Questionnaire.
Time frame: Initial Visit, at 2 month visit, and at 1 year
Patient reported outcome measure
Change in Pain
Time frame: Initial Visit, at 2 month visit, and at 1 year
VAS scale for pain
4D CT Scan Changes
Time frame: At enrolment and again 2 months later
Effectiveness of Orthosis to stabilize CMC while pinching
3 secondary outcomes
Adherence
Time frame: Measured at 2 month visit, with data downloaded biweekly
Orthosis Satisfaction Survey
Time frame: At 2 month visit and at 1 year
Change in Pinch strength
Time frame: Measured in CT scans at enrolment and at 2 month visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Arthritis Wrist
Recruiting
Vibratory Anesthesia on Pain Following Corticosteroid Injections
Bilateral Arthritis of Wrist, Tendinopathy
Not yet recruiting
Effects of Paraffin Wax Therapy and Dry Cupping on Pain and Wrist Function in Patients With Rheumatoid Arthritis
Rheumatic Arthritis
Recruiting
Web-based Rehabilitation After Surgical Salvage Procedures for Wrist Osteoarthritis
Wrist Osteoarthritis
Not yet recruiting
Understanding Patient Preferences When Deciding on a Voluntary Musculoskeletal Test
Non-traumatic Musculoskeletal Conditions, Carpal Tunnel Syndrome (CTS)
Recruiting
Effect of Lavender Aromatherapy Massage on Pain and Wrist Mobility in Rheumatoid Arthritis
Rheumatoid Arthritis (RA)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Orthosis fabrication, Thermal Sensor Monitoring of Orthosis Use and 4D CT Scan in people with Arthritis Wrist, run by Western University, Canada.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Change in Disabilities of the Arm Shoulder and Hand Questionnaire. (time frame: Initial Visit, at 2 month visit, and at 1 year). The study lists 3 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 6 Mar 2020.