The Comorbidity Between the Trigger Digit and Carpal Tunnel SyndromeNCT04072692
Investigation of the Relation Between Trigger Digit and Carpal Tunnel Syndrome
A study testing Hybrid rehabilitation training, Traditional rehabilitation training and Wearable anti-bowstringing orthosis (WABO) in people with The Comorbidity Between the Trigger Digit and Carpal Tunnel Syndrome, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to comprehend the association between the trigger digit and carpal tunnel syndrome based on the quantification of the tendon and nerve characteristics. It includes three parts. The first part is an observational study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- The Comorbidity Between the Trigger Digit and Carpal Tunnel Syndrome
- What is being tested?
- Hybrid rehabilitation training, Traditional rehabilitation training and Wearable anti-bowstringing orthosis (WABO)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Apr 2016to 13 Jun 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects without any history musculoskeletal diseases
- Patients with carpal tunnel release surgery
Who cannot join
- Subjects with fracture or surgery in the upper extremity.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to comprehend the association between the trigger digit and carpal tunnel syndrome based on the quantification of the tendon and nerve characteristics. It includes three parts.
The first part is an observational study. The aim of the first part is to attempts to measure the gliding and morphological characteristics of the flexor tendons and median nerve in the longitudinal or cross-sectional directions via the ultrasonographical images incorporating with the motion capture experiment of the wrist and fingers. The gliding and morphological features of the tendons and nerve will be compared under different postures or movement patterns of the wrist and hand.
Read more
The second part is an interventional study. The aim of the first part is to establishes a novel hybrid rehabilitation protocol which combines the tendon gliding exercise with nerve mobilization to treat either the trigger digit or the carpal tunnel syndrome. A randomized controlled trial to investigate the short-term treatment effect and the follow-up examination will be carried out as well.
The third part is an observational study. The aim of the first part is to investigate the effects of carpal tunnel release on the hand performances from functional perspectives. In addition, a novel wrist orthosis will be developed to eliminate the bowstringing effect of the flexor tendons after carpal tunnel release.
- Being tested
- Hybrid rehabilitation training, Traditional rehabilitation training, Wearable anti-bowstringing orthosis (WABO)
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid rehabilitation trainingOther
Hybrid rehabilitation training is modified tendon gliding exercise with median nerve mobilization.
Traditional rehabilitation trainingOther
Traditional rehabilitation training uses traditional physiotherapy, such as splint, therapeutic ultrasound and electrotherapy.
Wearable anti-bowstringing orthosis (WABO)Other
WABO is a custom-designed orthosis to restrict the bowstringing effect of the flexor tendon in the carpal tunnel.
| Study group | Role | What they receive |
|---|---|---|
| 1st part: The gliding properties of the tendons | No intervention | No intervention. Subjects are measured by ultrasound under 5 different postures of the hand for forty minutes. |
| 1st part: The gliding properties of the median nerve | No intervention | No intervention. Subjects are measured by ultrasound under under 6 different postures of the wrist and hand and 5 different movement patterns of the wrist and hand for forty minutes. |
| 2nd part: New hybrid rehabilitation strategy | Experimental | The program includes pre-test, 8 times training, post-test and follow-up test.
For pre-test, subjects perform the specific hand movement under different exerting force conditions and 4 different angles of phalangeal joints and be asked to do Phalen test, Grip strength test, Pinch test and SWMT test. It takes 40 minutes.
For post-test, the same procedure is repeated again after completing all training.
For follow-up, the same procedure is repeated again 6 months after completing all training.
After pre-test, 8 times hybrid rehabilitation training are asked. There are two times in a week, and all training will be completed in one month. Each time will take forty minutes. Receives: Other: Hybrid rehabilitation training |
| 2nd part: Traditional strategy | Experimental | The program includes pre-test, 8 times training, post-test and follow-up test.
For pre-test, subjects perform the specific hand movement under different exerting force conditions and 4 different angles of phalangeal joints and be asked to do Phalen test, Grip strength test, Pinch test and SWMT test. It takes 40 minutes.
For post-test, the same procedure is repeated again after completing all training.
For follow-up, the same procedure is repeated again 6 months after completing all training.
After pre-test, 8 times traditional rehabilitation training are asked. There are two times in a week, and all training will be completed in one month. Each time will take forty minutes. Receives: Other: Traditional rehabilitation training |
| 3rd part: The effect of carpal tunnel release | No intervention | No intervention. The program includes pre-test, post-test and two times follow-up tests. For pre-test, subjects perform the mechanical properties of the flexor tendon assessment and functional assessment of both hands before carpal tunnel release surgery. It takes 40 minutes. For post-test, subjects perform the functional assessment of both hands one week after carpal tunnel release surgery. It takes 20 minutes. For first follow-up, subjects perform the mechanical properties of the flexor tendon assessment and functional assessment of both hands one month after carpal tunnel release surgery. It takes 40 minutes. For second follow-up, subjects perform the mechanical properties of the flexor tendon assessment and functional assessment of both hands two month after carpal tunnel release surgery. It takes 40 minutes. |
| 3rd part: Wearable anti-bowstringing orthosis (WABO) | Experimental | The program includes pre-test, post-test and two times follow-up tests.
For pre-test, subjects perform the mechanical properties of the flexor tendon assessment and functional assessment of both hands before carpal tunnel release surgery. It takes 40 minutes.
Subjects wear WABO in the morning and a splint at night within a week after carpal tunnel release surgery.
For post-test, subjects perform the functional assessment of both hands with and without wearing WABO and a splint one week after carpal tunnel release surgery. It takes 40 minutes.
From the third weeks after carpal tunnel release surgery, subjects wear WABO only in the morning.
For first follow-up, the same procedure in pre-test is repeated again one month after carpal tunnel release surgery. It takes 40 minutes.
For second follow-up, the same procedure in pre-test is repeated again two month after carpal tunnel release surgery. Receives: Other: Wearable anti-bowstringing orthosis (WABO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the gliding features of tendons
The gliding features of tendons is measured by ultrasound images of the flexor tendons
Measured: baseline, 1 month, 6 months
Change in the gliding features of median nerve
The gliding features of median nerve is measured by ultrasound images of the flexor tendons
Measured: baseline, 1 month, 6 months
Change in the grip strength
Grip strength is measured by a grip strength meter.
Measured: baseline, 1 month, 6 months
Change in the pinch force
Three types of pinch force are measured by a pinch gauge.
Measured: baseline, 1 month, 6 months
Change in the threshold value of sensitivity
Threshold value of sensitivity is examined by using Semmes-Weinstein Monofilament testing.
Measured: baseline, 1 month, 6 months
Change in the mechanical properties of the flexor tendons
The mechanical properties are examined by measuring torque value contributed by the flexor tendons and movements of the flexor tendons
Measured: baseline, 1 month, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start26 Apr 2016
- Primary completion13 Jun 2019
- Study completion13 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Comorbidity Between the Trigger Digit and Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072692
- Sponsor's protocol ID
- A-ER-103-404
- Status last verified
- Aug 2019
- First submitted
- 27 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relation Between Trigger Digit and Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT04072692
- Acronym / sponsor ID
- A-ER-103-404
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 26 Apr 2016 (actual)
- Primary completion
- 13 Jun 2019 (actual)
- Study completion
- 13 Jun 2019 (actual)
- First posted
- 28 Aug 2019 (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.
The purpose of this study is to comprehend the association between the trigger digit and carpal tunnel syndrome based on the quantification of the tendon and nerve characteristics. It includes three parts.
The first part is an observational study. The aim of the first part is to attempts to measure the gliding and morphological characteristics of the flexor tendons and median nerve in the longitudinal or cross-sectional directions via the ultrasonographical images incorporating with the motion capture experiment of the wrist and fingers. The gliding and morphological features of the tendons and nerve will be compared under different postures or movement patterns of the wrist and hand.
The second part is an interventional study. The aim of the first part is to establishes a novel hybrid rehabilitation protocol which combines the tendon gliding exercise with nerve mobilization to treat either the trigger digit or the carpal tunnel syndrome. A randomized controlled trial to investigate the short-term treatment effect and the follow-up examination will be carried out as well.
The third part is an observational study. The aim of the first part is to investigate the effects of carpal tunnel release on the hand performances from functional perspectives. In addition, a novel wrist orthosis will be developed to eliminate the bowstringing effect of the flexor tendons after carpal tunnel release.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1st part: The gliding properties of the tendons | No intervention | –No intervention. Subjects are measured by ultrasound under 5 different postures of the hand for forty minutes. |
| 1st part: The gliding properties of the median nerve | No intervention | –No intervention. Subjects are measured by ultrasound under under 6 different postures of the wrist and hand and 5 different movement patterns of the wrist and hand for forty minutes. |
| 2nd part: New hybrid rehabilitation strategy | Experimental | Other: Hybrid rehabilitation trainingThe program includes pre-test, 8 times training, post-test and follow-up test. For pre-test, subjects perform the specific hand movement under different exerting force conditions and 4 different angles of phalangeal joints and be asked to do Phalen test, Grip strength test, Pinch test and SWMT test. It takes 40 minutes. For post-test, the same procedure is repeated again after completing all training. For follow-up, the same procedure is repeated again 6 months after completing all training. After pre-test, 8 times hybrid rehabilitation training are asked. There are two times in a week, and all training will be completed in one month. Each time will take forty minutes. |
| 2nd part: Traditional strategy | Experimental | Other: Traditional rehabilitation trainingThe program includes pre-test, 8 times training, post-test and follow-up test. For pre-test, subjects perform the specific hand movement under different exerting force conditions and 4 different angles of phalangeal joints and be asked to do Phalen test, Grip strength test, Pinch test and SWMT test. It takes 40 minutes. For post-test, the same procedure is repeated again after completing all training. For follow-up, the same procedure is repeated again 6 months after completing all training. After pre-test, 8 times traditional rehabilitation training are asked. There are two times in a week, and all training will be completed in one month. Each time will take forty minutes. |
| 3rd part: The effect of carpal tunnel release | No intervention | –No intervention. The program includes pre-test, post-test and two times follow-up tests. For pre-test, subjects perform the mechanical properties of the flexor tendon assessment and functional assessment of both hands before carpal tunnel release surgery. It takes 40 minutes. For post-test, subjects perform the functional assessment of both hands one week after carpal tunnel release surgery. It takes 20 minutes. For first follow-up, subjects perform the mechanical properties of the flexor tendon assessment and functional assessment of both hands one month after carpal tunnel release surgery. It takes 40 minutes. For second follow-up, subjects perform the mechanical properties of the flexor tendon assessment and functional assessment of both hands two month after carpal tunnel release surgery. It takes 40 minutes. |
| 3rd part: Wearable anti-bowstringing orthosis (WABO) | Experimental | Other: Wearable anti-bowstringing orthosis (WABO)The program includes pre-test, post-test and two times follow-up tests. For pre-test, subjects perform the mechanical properties of the flexor tendon assessment and functional assessment of both hands before carpal tunnel release surgery. It takes 40 minutes. Subjects wear WABO in the morning and a splint at night within a week after carpal tunnel release surgery. For post-test, subjects perform the functional assessment of both hands with and without wearing WABO and a splint one week after carpal tunnel release surgery. It takes 40 minutes. From the third weeks after carpal tunnel release surgery, subjects wear WABO only in the morning. For first follow-up, the same procedure in pre-test is repeated again one month after carpal tunnel release surgery. It takes 40 minutes. For second follow-up, the same procedure in pre-test is repeated again two month after carpal tunnel release surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy subjects without any history musculoskeletal diseases
- Patients with carpal tunnel release surgery
Key exclusion criteria (1 listed)
- Subjects with fracture or surgery in the upper extremity.
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 |
|---|---|---|
| Hybrid rehabilitation trainingHybrid rehabilitation training is modified tendon gliding exercise with median nerve mobilization. | Other | 2nd part: New hybrid rehabilitation strategy |
| Traditional rehabilitation trainingTraditional rehabilitation training uses traditional physiotherapy, such as splint, therapeutic ultrasound and electrotherapy. | Other | 2nd part: Traditional strategy |
| Wearable anti-bowstringing orthosis (WABO)WABO is a custom-designed orthosis to restrict the bowstringing effect of the flexor tendon in the carpal tunnel. | Other | 3rd part: Wearable anti-bowstringing orthosis (WABO) |
Primary outcome
Change in the gliding features of tendons
Time frame: baseline, 1 month, 6 months
The gliding features of tendons is measured by ultrasound images of the flexor tendons
Change in the gliding features of median nerve
Time frame: baseline, 1 month, 6 months
The gliding features of median nerve is measured by ultrasound images of the flexor tendons
Change in the grip strength
Time frame: baseline, 1 month, 6 months
Grip strength is measured by a grip strength meter.
Change in the pinch force
Time frame: baseline, 1 month, 6 months
Three types of pinch force are measured by a pinch gauge.
Change in the threshold value of sensitivity
Time frame: baseline, 1 month, 6 months
Threshold value of sensitivity is examined by using Semmes-Weinstein Monofilament testing.
Change in the mechanical properties of the flexor tendons
Time frame: baseline, 1 month, 6 months
The mechanical properties are examined by measuring torque value contributed by the flexor tendons and movements of the flexor tendons
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 28 Aug 2019.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid rehabilitation training, Traditional rehabilitation training and Wearable anti-bowstringing orthosis (WABO) in people with The Comorbidity Between the Trigger Digit and Carpal Tunnel Syndrome, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 2 inclusion and 1 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 28 Aug 2019. 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 Taiwan. 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?
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?
Change in the gliding features of tendons (time frame: baseline, 1 month, 6 months). The study lists 6 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 28 Aug 2019.