Carpal Tunnel SyndromeNCT06131996
The Effect of Splints in Pregnant Women With Carpal Tunnel Syndrome
A study testing Volar supported splint and elastic splint in people with Carpal Tunnel Syndrome and Pregnancy Related, run by Mardin Artuklu University at 1 site in Turkey (Türkiye).
Trial summary
It is aimed to compare the effect of two different splints on carpal tunnel syndrome in pregnant individuals after 4 weeks of use. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Carpal Tunnel Syndrome, Pregnancy Related, Splints
- What is being tested?
- Volar supported splint and elastic splint
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 30 Dec 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being in the last trimester of pregnancy,
- Having a diagnosis of CTS,
- Positive Tinnel and Phalen tests,
- Pain, tenderness, and numbness symptoms in the median nerve neurodynamic test,
- pain of at least 4 severity according to VAS,
- Edema due to pregnancy
Who cannot join
- Individuals in the 1st or 2nd trimester of pregnancy,
- Those with pain complaints below 4 according to VAS,
- Those with a history of CTS before pregnancy,
- Those who had undergone surgery in the hand-wrist region
- Those diagnosed with cervical disc herniation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Volar-assisted and Elastic Wrist Splints on Edema, Pain, Grip Strength and Functionality in Pregnant Women With Carpal Tunnel Syndrome
It is aimed to compare the effect of two different splints on carpal tunnel syndrome in pregnant individuals after 4 weeks of use.
Read the detailed description
Carpal tunnel syndrome (CTS) is a common musculoskeletal problem in pregnancy. The aim of this study is to compare the effects of rigid and elastic wrist splints on edema, pain levels, grip strength, and upper extremity functionality in pregnant women with CTS.
Pregnant women in the last trimester of pregnancy who were diagnosed with CTS were included in the study.
- Conditions
- Carpal Tunnel Syndrome, Pregnancy Related, Splints
- Being tested
- Volar supported splint, elastic splint
- 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.
Volar supported splintOther
participants used volar supported splint during sleep for 4 weeks. Exercise was performed at home for a total of 12 sessions, three sessions per week.
elastic splintOther
participants used velastic splint during sleep for 4 weeks. Exercise was performed at home for a total of 12 sessions, three sessions per week
| Study group | Role | What they receive |
|---|---|---|
| Volar-assisted splint group | Active comparator | Participants used volar supported splint during sleep for 4 weeks. Exercise was performed at home for a total of 12 sessions, three sessions per week. Receives: Other: Volar supported splint |
| Elastic splint group | Active comparator | Participants used velastic splint during sleep for 4 weeks. Exercise was performed at home for a total of 12 sessions, three sessions per week. Receives: Other: elastic splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH)
Q-DASH questionnaire is applied to evaluate upper extremity-related functionality and symptoms. Each item provides 5 response options and the overall score is calculated from the item scores. 0, no loss of function; 100 is interpreted as the most severe loss of function.
Measured: before intervention and 4 weeks after intervention
The Boston Questionnaire (BA)
The Boston Questionnaire (BA) is specific to Carpal Tunnel Syndrome (CTS) and consists of two different scales that evaluate symptom severity and functional capacity.The scoring of each item varies between 1 and 5. The average score is obtained by dividing the total score by the number of items and ranges from 1 to 5. A high score indicates low functional capacity. Mean scores are calculated separately for symptom severity and functional capacity. The symptom score consists of 11 items and the function score consists of 8 items.
Measured: before intervention and 4 weeks after intervention
Grip strength
Grip strength was measured with the Jamar hand dynamometer, which is recommended by the American Association of Hand Therapists (AETD) and whose validity and reliability have been confirmed in many studies.According to the measurement procedure, three repeated measurements were made for hand grip strength and the results were recorded in kilograms.
Measured: before intervention and 4 weeks after intervention
Volumetric measurement
The water flooding method, which is considered the gold standard in the measurement of extremity volume and is preferred in the evaluation of edematous hand or foot volume, was used in this study.With this measurement method, the amount of overflowing water volume between the affected and unaffected extremities was compared and the amount of edema was determined.
Measured: before intervention and 4 weeks after intervention
Visual Analog Scale (VAS)
The pain levels were measured by the Visual Analog Scale (VAS).It is scored between 0-10 cm. A high score indicates high pain.
Measured: before intervention and 4 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start1 Feb 2022
- Primary completion1 Oct 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- 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
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mardin Artuklu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Funda Mete Cavus, Mardin Artuklu University
- Investigators
- Funda CAVUS, Study director, MARDİN ARTUKLU UNİVERSİTY, VOCATIONAL SCHOOL OF HEALTH SERVICES,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131996
- Sponsor's protocol ID
- 2021/007
- Status last verified
- Nov 2023
- First submitted
- 2 Nov 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- 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 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Volar-assisted and Elastic Wrist Splints on Edema, Pain, Grip Strength and Functionality in Pregnant Women With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT06131996
- Acronym / sponsor ID
- 2021/007
- Conditions
- Carpal Tunnel Syndrome, Pregnancy Related, Splints
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Mardin Artuklu UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 15 Nov 2023 (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.
It is aimed to compare the effect of two different splints on carpal tunnel syndrome in pregnant individuals after 4 weeks of use.
Detailed description
Carpal tunnel syndrome (CTS) is a common musculoskeletal problem in pregnancy. The aim of this study is to compare the effects of rigid and elastic wrist splints on edema, pain levels, grip strength, and upper extremity functionality in pregnant women with CTS.
Pregnant women in the last trimester of pregnancy who were diagnosed with CTS were included in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volar-assisted splint group | Active comparator | Other: Volar supported splintParticipants used volar supported splint during sleep for 4 weeks. Exercise was performed at home for a total of 12 sessions, three sessions per week. |
| Elastic splint group | Active comparator | Other: elastic splintParticipants used velastic splint during sleep for 4 weeks. Exercise was performed at home for a total of 12 sessions, three sessions per week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Being in the last trimester of pregnancy,
- Having a diagnosis of CTS,
- Positive Tinnel and Phalen tests,
- Pain, tenderness, and numbness symptoms in the median nerve neurodynamic test,
- pain of at least 4 severity according to VAS,
Key exclusion criteria (5 listed)
- Individuals in the 1st or 2nd trimester of pregnancy,
- Those with pain complaints below 4 according to VAS,
- Those with a history of CTS before pregnancy,
- Those who had undergone surgery in the hand-wrist region
- Those diagnosed with cervical disc herniation
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 |
|---|---|---|
| Volar supported splintparticipants used volar supported splint during sleep for 4 weeks. Exercise was performed at home for a total of 12 sessions, three sessions per week. | Other | Volar-assisted splint group |
| elastic splintparticipants used velastic splint during sleep for 4 weeks. Exercise was performed at home for a total of 12 sessions, three sessions per week | Other | Elastic splint group |
Primary outcome
Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH)
Time frame: before intervention and 4 weeks after intervention
Q-DASH questionnaire is applied to evaluate upper extremity-related functionality and symptoms. Each item provides 5 response options and the overall score is calculated from the item scores. 0, no loss of function; 100 is interpreted as the most severe loss of function.
The Boston Questionnaire (BA)
Time frame: before intervention and 4 weeks after intervention
The Boston Questionnaire (BA) is specific to Carpal Tunnel Syndrome (CTS) and consists of two different scales that evaluate symptom severity and functional capacity.The scoring of each item varies between 1 and 5. The average score is obtained by dividing the total score by the number of items and ranges from 1 to 5. A high score indicates low functional capacity. Mean scores are calculated separately for symptom severity and functional capacity. The symptom score consists of 11 items and the function score consists of 8 items.
Grip strength
Time frame: before intervention and 4 weeks after intervention
Grip strength was measured with the Jamar hand dynamometer, which is recommended by the American Association of Hand Therapists (AETD) and whose validity and reliability have been confirmed in many studies.According to the measurement procedure, three repeated measurements were made for hand grip strength and the results were recorded in kilograms.
Volumetric measurement
Time frame: before intervention and 4 weeks after intervention
The water flooding method, which is considered the gold standard in the measurement of extremity volume and is preferred in the evaluation of edematous hand or foot volume, was used in this study.With this measurement method, the amount of overflowing water volume between the affected and unaffected extremities was compared and the amount of edema was determined.
Visual Analog Scale (VAS)
Time frame: before intervention and 4 weeks after intervention
The pain levels were measured by the Visual Analog Scale (VAS).It is scored between 0-10 cm. A high score indicates high pain.
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 15 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Carpal Tunnel Syndrome
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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.
Funda CAVUS study director
MARDİN ARTUKLU UNİVERSİTY, VOCATIONAL SCHOOL OF HEALTH SERVICES,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volar supported splint and elastic splint in people with Carpal Tunnel Syndrome and Pregnancy Related, run by Mardin Artuklu University at 1 site in Turkey (Türkiye).
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 6 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: finished, as of the sponsor's last update on 15 Nov 2023. 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 Turkey (Türkiye). 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?
Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH) (time frame: before intervention and 4 weeks after intervention). 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 Nov 2023.