Carpal Tunnel SyndromeNCT06464809
Treatment Intervention of Patients With Carpal Tunnel Syndrome (CTS)
A study testing kinesio taping (KT) in people with Carpal Tunnel Syndrome, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study was to investigate the effectiveness of KT versus TENS combining self-myofascial stretching in treatment of CTS through clinical, functional assessment and sensory measurements. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- kinesio taping (KT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Sep 2014to 30 Dec 2015
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- numbness and tingling in the median nerve territory of the hand.
- nocturnal paresthesia.
- induction test (Tinel's sign and Phalen's test) showing a positive finding.,
- is defined as mild and moderate CTS according to nerve conduction studies (NCSs).
Who cannot join
- is defined severe CTS symptoms.
- are currently pregnant or have any secondary entrapment neuropathy (e.g., diabetes, inflammatory arthritis, hypothyroidism, previous wrist trauma).
- cervical radiculopathy or polyneuropathy.
- previous history of carpal tunnel decompression surgery.
- corticosteroid injection into the carpal tunnel.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Effects of Transcutaneous Electrical Nerve Stimulation and Kinesio Taping on Hand Functions for Patients With Carpal Tunnel Syndrome
The purpose of this study was to investigate the effectiveness of KT versus TENS combining self-myofascial stretching in treatment of CTS through clinical, functional assessment and sensory measurements.
Primary hypothesis The KT group has a more substantial improvement in hand grip, pain relief, enhancing proprioceptive sensitivity and dexterity compare to the TENS group. treatment program,
Read the detailed description
Objective: To compare the effectiveness of a home-based treatment program involving Kinesio taping (KT) or transcutaneous electrical nerve stimulation (TENS) among carpal tunnel syndrome (CTS) patients.
Methods:
30 participants with CTS were enrolled, age range, 30 to 60 years. The participants who met the inclusion criteria were randomized into one of two treatment groups: KT group and TENS group. Participants were blinded to the treatments used in the other group.
Patients with CTS received aforementioned treatments compared with reliable qualitative and quantitative evaluation tools before and after 4-week treatment, as well as at a additional 4-week follow-up. The main parameters include the Symptom Severity Scale (SSS) and Functional Status Scale (FSS), hand grip and key pinch strengths, two-point discrimination (2PD), Modified Moberg pick-up test (MMPUT), and Pain assessment (visual analog scale, VAS).
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- kinesio taping (KT)
- Keywords
- Carpal tunnel syndrome, home-based treatment program, kinesio taping, paresthesia, thenar eminence
- Medical subject headings
- Carpal Tunnel Syndrome, Paresthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kinesio taping (KT)Other
Also called transcutaneous electrical nerve stimulation (TENS)
| Study group | Role | What they receive |
|---|---|---|
| kinesio taping (KT) group | Experimental | Three precut KT I strips with a width of 5 cm were used. The first strip is applied with the subject's wrist in fully extended hand position. Middle and ring fingers through the holes with the base of the tape as anchored to the knuckles, and then the tape was applied with 15%-25% tension covering the palm and the wrist, and the remainder of the tape without any tension from the wrist up to the forearm. The same process is repeated for the second I-strip, which was applied from the dorsum of the hand to wrist while the wrist in a downward flexed position. The final strip was applied to the carpal tunnel region with 25%-35% tension. Receives: Other: kinesio taping (KT) |
| transcutaneous electrical nerve stimulation (TENS) group | Active comparator | A portable TENS unit (Gem-Stim, Gemore Technology Co., LTD. Taiwan) was used, and delivered a bi-phasic symmetric waveform at a continuous frequency of 100 Hz and phase duration of 200 µsec. The intensity was gradually adjusted up to a strong but comfortable l level, as reported by the subject. Two electrodes were placed 2 cm apart, respectively attached to the carpal ligament of the affected side and the proximal end along the direction of the median nerve. Receives: Other: kinesio taping (KT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The SSS and FSS of the Boston Carpal Tunnel Questionnaire (BCTQ)
Assess symptoms and functional status. The SSS subscale includes 11 items assessing pain, paresthesia, numbness, weakness, nocturnal symptoms and over-all functional status. The FSS subscale includes 8 items assessing the hand function during common daily activities. Each item is scored on a 5-point scale (1-5), from 1(no symptoms) to 5 (the worst symptoms) for SSS, and from 1 (no difficulty) to 5 (cannot perform the activity at all) for FSS. The overall SSS and FSS scores are calculated as the mean of the scores for 11 and 8 individual items respectively, such that the higher the score obtained, the worse the SSS or FSS.
Measured: pre-intervention, 4-week intervention, and 4-week follow-up.
Hand grip and key pinch strengths
pinch strength included palmar, three-jaw chuck, tip, and lateral pinches.
Measured: pre-intervention, 4-week intervention, and 4-week follow-up.
Two-point discrimination (2PD)
cutaneous sensory perception threshold. The larger the value of distance, the worse the sensory ability.
Measured: pre-intervention, 4-week intervention, and 4-week follow-up.
Modified Moberg pick-up test (MMPUT)
hand dexterity. The shorter the time, the more dexterity the hand.
Measured: pre-intervention, 4-week intervention, and 4-week follow-up.
The visual analog scale (VAS)
pain measurement. 100 mm straight line, with 0 mm on the far left and 100 mm on the far right, 0 mm positions It is not painful, and 100 mm is extremely painful.
Measured: pre-intervention, 4-week intervention, and 4-week follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start24 Sep 2014
- Primary completion30 Nov 2015
- Study completion30 Dec 2015
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.
- More trials run by China Medical 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a prospective, randomized-controlled trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Principal investigator, Wei-Hsien Hong, China Medical University Hospital
- Investigators
- Wei-Hsien Hong, PhD, Principal investigator, China Medical University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464809
- Sponsor's protocol ID
- CMUH103-REC3-072
- Status last verified
- Jun 2024
- First submitted
- 4 Jun 2024
- Last updated
- 18 Jun 2024
- 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 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Effects of Transcutaneous Electrical Nerve Stimulation and Kinesio Taping on Hand Functions for Patients With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT06464809
- Acronym / sponsor ID
- CMUH103-REC3-072
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal tunnel syndrome, home-based treatment program, kinesio taping, paresthesia, thenar eminence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 24 Sep 2014 (actual)
- Primary completion
- 30 Nov 2015 (actual)
- Study completion
- 30 Dec 2015 (actual)
- First posted
- 18 Jun 2024 (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 was to investigate the effectiveness of KT versus TENS combining self-myofascial stretching in treatment of CTS through clinical, functional assessment and sensory measurements.
Primary hypothesis The KT group has a more substantial improvement in hand grip, pain relief, enhancing proprioceptive sensitivity and dexterity compare to the TENS group. treatment program,
Detailed description
Objective: To compare the effectiveness of a home-based treatment program involving Kinesio taping (KT) or transcutaneous electrical nerve stimulation (TENS) among carpal tunnel syndrome (CTS) patients.
Methods:
30 participants with CTS were enrolled, age range, 30 to 60 years. The participants who met the inclusion criteria were randomized into one of two treatment groups: KT group and TENS group. Participants were blinded to the treatments used in the other group.
Patients with CTS received aforementioned treatments compared with reliable qualitative and quantitative evaluation tools before and after 4-week treatment, as well as at a additional 4-week follow-up. The main parameters include the Symptom Severity Scale (SSS) and Functional Status Scale (FSS), hand grip and key pinch strengths, two-point discrimination (2PD), Modified Moberg pick-up test (MMPUT), and Pain assessment (visual analog scale, VAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This was a prospective, randomized-controlled trial.
| Arm | Type | Receives |
|---|---|---|
| kinesio taping (KT) group | Experimental | Other: kinesio taping (KT)Three precut KT I strips with a width of 5 cm were used. The first strip is applied with the subject's wrist in fully extended hand position. Middle and ring fingers through the holes with the base of the tape as anchored to the knuckles, and then the tape was applied with 15%-25% tension covering the palm and the wrist, and the remainder of the tape without any tension from the wrist up to the forearm. The same process is repeated for the second I-strip, which was applied from the dorsum of the hand to wrist while the wrist in a downward flexed position. The final strip was applied to the carpal tunnel region with 25%-35% tension. |
| transcutaneous electrical nerve stimulation (TENS) group | Active comparator | Other: kinesio taping (KT)A portable TENS unit (Gem-Stim, Gemore Technology Co., LTD. Taiwan) was used, and delivered a bi-phasic symmetric waveform at a continuous frequency of 100 Hz and phase duration of 200 µsec. The intensity was gradually adjusted up to a strong but comfortable l level, as reported by the subject. Two electrodes were placed 2 cm apart, respectively attached to the carpal ligament of the affected side and the proximal end along the direction of the median nerve. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- numbness and tingling in the median nerve territory of the hand.
- nocturnal paresthesia.
- induction test (Tinel's sign and Phalen's test) showing a positive finding.,
- is defined as mild and moderate CTS according to nerve conduction studies (NCSs).
Key exclusion criteria (5 listed)
- is defined severe CTS symptoms.
- are currently pregnant or have any secondary entrapment neuropathy (e.g., diabetes, inflammatory arthritis, hypothyroidism, previous wrist trauma).
- cervical radiculopathy or polyneuropathy.
- previous history of carpal tunnel decompression surgery.
- corticosteroid injection into the carpal tunnel.
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 |
|---|---|---|
| kinesio taping (KT)Also: transcutaneous electrical nerve stimulation (TENS) | Other | kinesio taping (KT) group, transcutaneous electrical nerve stimulation (TENS) group |
Primary outcome
The SSS and FSS of the Boston Carpal Tunnel Questionnaire (BCTQ)
Time frame: pre-intervention, 4-week intervention, and 4-week follow-up.
Assess symptoms and functional status. The SSS subscale includes 11 items assessing pain, paresthesia, numbness, weakness, nocturnal symptoms and over-all functional status. The FSS subscale includes 8 items assessing the hand function during common daily activities. Each item is scored on a 5-point scale (1-5), from 1(no symptoms) to 5 (the worst symptoms) for SSS, and from 1 (no difficulty) to 5 (cannot perform the activity at all) for FSS. The overall SSS and FSS scores are calculated as the mean of the scores for 11 and 8 individual items respectively, such that the higher the score obtained, the worse the SSS or FSS.
Hand grip and key pinch strengths
Time frame: pre-intervention, 4-week intervention, and 4-week follow-up.
pinch strength included palmar, three-jaw chuck, tip, and lateral pinches.
Two-point discrimination (2PD)
Time frame: pre-intervention, 4-week intervention, and 4-week follow-up.
cutaneous sensory perception threshold. The larger the value of distance, the worse the sensory ability.
Modified Moberg pick-up test (MMPUT)
Time frame: pre-intervention, 4-week intervention, and 4-week follow-up.
hand dexterity. The shorter the time, the more dexterity the hand.
The visual analog scale (VAS)
Time frame: pre-intervention, 4-week intervention, and 4-week follow-up.
pain measurement. 100 mm straight line, with 0 mm on the far left and 100 mm on the far right, 0 mm positions It is not painful, and 100 mm is extremely painful.
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 18 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Wei-Hsien Hong, PhD principal investigator
China Medical University, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing kinesio taping (KT) in people with Carpal Tunnel Syndrome, run by China Medical 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 4 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 18 Jun 2024. 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?
The SSS and FSS of the Boston Carpal Tunnel Questionnaire (BCTQ) (time frame: pre-intervention, 4-week intervention, and 4-week follow-up.). 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 18 Jun 2024.