Carpal Tunnel Syndrome TreatmentNCT05997823
Dorsovolar Kinesiotape in Carpal Tunnel Syndrome
A study testing kinesiotape and home exercises in people with Carpal Tunnel Syndrome Treatment, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to compare the short- and medium-term efficacy of dorso-volar kinesiotape (KT) added to home exercises (HE) with sham-KT and HE alone in the treatment of mild or moderate carpal tunnel syndrome (CTS) in terms of pain, symptom severity, function, grip strength, and electrophysiological parameters. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome Treatment
- What is being tested?
- kinesiotape and home exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 29 Jul 2023
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pain or numbness radiating to the palm for at least 6 weeks,
- at least one positive Tinel's, Phalen's, or carpal compression test on physical examination, and
- mild/moderate CTS on EMG examination.
Who cannot join
- Metabolic disease (diabetes, rheumatoid arthritis, thyroid disease),
- systemic or malignant disease, history of trauma, fracture or surgery to the wrist,
- physical therapy programs, surgical procedures, injections or KT applications to the wrist for CTS treatment in the past year,
- severe thenar atrophy,
- C6-C7 radiculopathy among CTS differential diagnoses,
- cervical spondylosis, thoracic outlet syndrome, entrapment of the median nerve above the wrist,
- polyneuropathy or traumatic injury to the median nerve,
- rashes or open wounds on the skin of the wrist and forearm that could prevent treatment with kinesiology taping
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Sciences University, Kocaeli Derince Training and Research Hospital
Kocaeli, Deince
About this study
Official title: Is Dorso-Volar Kinesiotape Added to the Home Exercise Program Effective in the Treatment of Carpal Tunnel Syndrome?-Prospective Randomized Controlled Study
This study aimed to compare the short- and medium-term efficacy of dorso-volar kinesiotape (KT) added to home exercises (HE) with sham-KT and HE alone in the treatment of mild or moderate carpal tunnel syndrome (CTS) in terms of pain, symptom severity, function, grip strength, and electrophysiological parameters.
- Conditions
- Carpal Tunnel Syndrome Treatment
- Being tested
- kinesiotape, home exercises
- Keywords
- carpal tunnel syndromes, kinesiotape, electromyography, median neuropathy, muscle strength, pain
- Medical subject headings
- Carpal Tunnel Syndrome, Median Neuropathy, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kinesiotapeOther
The button hole technique was used for area correction during the KT application (Figure 1). Two I-tapes were applied, one from the medial epicondyle to the proximal phalanx on the palmar side and the other from the lateral epicondyle to the proximal phalanx on the dorsal side. The area where the phalanges are located was marked, and two hole was drilled in the center.After cleaning the skin with alcohol, the tape to be applied to the palmar side was passed over the 3rd and 4th fingers, and the patient was asked to perform radial deviation and wrist extension
home exercisesOther
home exercises
| Study group | Role | What they receive |
|---|---|---|
| home exercises | Active comparator | Not described Receives: Other: home exercises |
| sham-KT and home exercises | Experimental | Not described Receives: Other: kinesiotape; Other: home exercises |
| dorso-volar KT and home exercises | Experimental | Not described Receives: Other: kinesiotape; Other: home exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrodiagnostic Evaluation
Superficial recording electrodes were placed in the abductor pollicis brevis (APB) muscles (recording stimulus distance 5 cm) for median nerve motor conduction and in the abductor digiti minimi (ADM) muscles (recording stimulus distance 5 cm) for ulnar nerve motor conduction.Superficial recording electrodes were placed on the 3rd finger for median nerve sensory conduction (recording stimulus distance 13 cm) and on the 5th finger for ulnar nerve sensory conduction (recording stimulus distance 11 cm).The ground electrode was placed between the recording and stimulus electrodes for all electrophysiological tests.Sensory latency, amplitude, and conduction velocity of the median nerve and motor latency, amplitude, and conduction velocity were recorded
Measured: 30 minutes
Hand Strength
A Jamar hand dynamometer (Baseline ® hydraulic hand dynamometer, Irvington, NY, USA) was used to measure handgrip strength.
Measured: 10 minutes
Pain Evaluation
A 10-point visual analog scale (VAS) was used to rate pain. Patients were asked to rate the pain they felt at rest, at night, and with movement with a number ranging from 0 (no pain) to 10 (very severe), VAS movement, VAS night, and VAS rest
Measured: 5 minutes
Finger Strength
A pinch meter (Baseline ® hydraulic pinch gauge, Irvington, NY, USA) was used to evaluate lateral grip strength (LGS) and pinch grip strength
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start1 Jan 2023
- Primary completion1 Jul 2023
- Study completion29 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel Syndrome TreatmentStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Cihan, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997823
- Sponsor's protocol ID
- 2023/11-08
- Status last verified
- Jan 2024
- First submitted
- 11 Aug 2023
- Last updated
- 29 Jan 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 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Dorso-Volar Kinesiotape Added to the Home Exercise Program Effective in the Treatment of Carpal Tunnel Syndrome?-Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05997823
- Acronym / sponsor ID
- 2023/11-08
- Conditions
- Carpal Tunnel Syndrome Treatment
- Keywords
- carpal tunnel syndromes, kinesiotape, electromyography, median neuropathy, muscle strength, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 29 Jul 2023 (actual)
- First posted
- 18 Aug 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.
This study aimed to compare the short- and medium-term efficacy of dorso-volar kinesiotape (KT) added to home exercises (HE) with sham-KT and HE alone in the treatment of mild or moderate carpal tunnel syndrome (CTS) in terms of pain, symptom severity, function, grip strength, and electrophysiological parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| home exercises | Active comparator | Other: home exercises |
| sham-KT and home exercises | Experimental | Other: kinesiotape, Other: home exercises |
| dorso-volar KT and home exercises | Experimental | Other: kinesiotape, Other: home exercises |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- pain or numbness radiating to the palm for at least 6 weeks,
- at least one positive Tinel's, Phalen's, or carpal compression test on physical examination, and
- mild/moderate CTS on EMG examination.
Key exclusion criteria (8 listed)
- Metabolic disease (diabetes, rheumatoid arthritis, thyroid disease),
- systemic or malignant disease, history of trauma, fracture or surgery to the wrist,
- physical therapy programs, surgical procedures, injections or KT applications to the wrist for CTS treatment in the past year,
- severe thenar atrophy,
- C6-C7 radiculopathy among CTS differential diagnoses,
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 |
|---|---|---|
| kinesiotapeThe button hole technique was used for area correction during the KT application (Figure 1). Two I-tapes were applied, one from the medial epicondyle to the proximal phalanx on the palmar side and the other from the lateral epicondyle to the proximal phalanx on the dorsal side. The area where the phalanges are located was marked, and two hole was drilled in the center.After cleaning the skin with alcohol, the tape to be applied to the palmar side was passed over the 3rd and 4th fingers, and the patient was asked to perform radial deviation and wrist extension | Other | dorso-volar KT and home exercises, sham-KT and home exercises |
| home exerciseshome exercises | Other | dorso-volar KT and home exercises, home exercises, sham-KT and home exercises |
Primary outcome
Electrodiagnostic Evaluation
Time frame: 30 minutes
Superficial recording electrodes were placed in the abductor pollicis brevis (APB) muscles (recording stimulus distance 5 cm) for median nerve motor conduction and in the abductor digiti minimi (ADM) muscles (recording stimulus distance 5 cm) for ulnar nerve motor conduction.Superficial recording electrodes were placed on the 3rd finger for median nerve sensory conduction (recording stimulus distance 13 cm) and on the 5th finger for ulnar nerve sensory conduction (recording stimulus distance 11 cm).The ground electrode was placed between the recording and stimulus electrodes for all electrophysiological tests.Sensory latency, amplitude, and conduction velocity of the median nerve and motor latency, amplitude, and conduction velocity were recorded
Hand Strength
Time frame: 10 minutes
A Jamar hand dynamometer (Baseline ® hydraulic hand dynamometer, Irvington, NY, USA) was used to measure handgrip strength.
Pain Evaluation
Time frame: 5 minutes
A 10-point visual analog scale (VAS) was used to rate pain. Patients were asked to rate the pain they felt at rest, at night, and with movement with a number ranging from 0 (no pain) to 10 (very severe), VAS movement, VAS night, and VAS rest
Finger Strength
Time frame: 10 minutes
A pinch meter (Baseline ® hydraulic pinch gauge, Irvington, NY, USA) was used to evaluate lateral grip strength (LGS) and pinch grip strength
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 29 Jan 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.
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 kinesiotape and home exercises in people with Carpal Tunnel Syndrome Treatment, run by Selcuk 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 3 inclusion and 8 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 29 Jan 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 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?
Electrodiagnostic Evaluation (time frame: 30 minutes). The study lists 4 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 29 Jan 2024.