Carpal Tunnel SyndromeNCT04993703
Effect of Kinesiotaping and Night Splinting in Patients With Carpal Tunnel Syndome
A study testing Kinesiotaping and Night Splinting in people with Carpal Tunnel Syndrome, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Carpal tunnel syndrome (CTS) which is defined as a symptomatic compression neuropathy of the median nerve at the level of the wrist. Different types of splints are used for improving the function and decreasing the pain intensity and symptoms in the rehabilitation of patients with CTS. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Kinesiotaping and Night Splinting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Aug 2021to 20 Feb 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- This study included patients with moderate CTS, confirmed by electroneurographic examination.
- did not recruit any treatment (including physiotherapy or surgical release)
Who cannot join
- Patients suffer from the thenar muscle atrophy.
- Patients with mild CTS.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Ankara, 06100
About this study
Official title: Comparison of Short-term Effect of the Kinesiotaping and Night Splinting in Patients With Carpal Tunnel Syndrome
Carpal tunnel syndrome (CTS) which is defined as a symptomatic compression neuropathy of the median nerve at the level of the wrist.
Different types of splints are used for improving the function and decreasing the pain intensity and symptoms in the rehabilitation of patients with CTS.
However effectiveness of treatment by taping has never been investigated in physiotherapy and rehabilitation.
The aim of this study was to compare the short-term effect of conventional physiotherapy only, and also kinesio taping and night splinting in patients with CTS.
Read the detailed description
Carpal tunnel syndrome (CTS) which is defined as a symptomatic compression neuropathy of the median nerve at the level of the wrist.It is considered as the most common disabling neuromuscular condition of the upper extremities.
Night splints are used in conjunction with the conservative intervention to improve the function and decrease the pain intensity and paresthesia in the rehabilitation of patients with carpal tunnel syndrome. However effectiveness of treatment by kinesiotaping has never been investigated.
The aim of this study was to compare the short-term effect of conventional physiotherapy only, and also kinesio taping and night splinting in addition to conventional physiotherapy in the rehabilitation of patients with CTS.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Kinesiotaping, Night Splinting, Control Group
- Keywords
- carpal tunnel syndrome, night splinting, kinesiotaping, physiotherapy and rehabilitation
- 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.
KinesiotapingOther
A total of 20 sessions physiotherapy sessions including hot pack, ultrasound, kinesiotaping and exercise program (tendon and nerve gliding exercises=2 times per day 3 sets of ten repetitions) will be applied.times per day 3sets of ten repetitions) will be applied.
Night SplintingOther
A total of 20 sessions physiotherapy sessions including hot pack, ultrasound, night splinting and exercise program (tendon and nerve gliding exercises=2 times per day 3 sets of ten repetitions) will be applied.
Control GroupOther
A total of 20 sessions physiotherapy sessions including hot pack, ultrasound and exercise program (tendon and nerve gliding exercises=2 times per day 3 sets of ten repetitions) will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Kinesiotaping | Experimental | A total of 20 sessions physiotherapy sessions including hot pack, ultrasound and exercise program (tendon and nerve gliding exercises=2 times per day 3sets of ten repetitions) will be applied.
Additionally for this group, kinesiotaping will be applied by using carpal tunnel technique including button hole and I band technique of space correction; and with 25-50% tension in center of tape over dorsal carpal tunnel at the end of the each session. Patients will request to keep kinesiotaping at nights throughout the study. Receives: Other: Kinesiotaping |
| Night splinting | Experimental | A total of 20 sessions physiotherapy sessions including hot pack, ultrasound and exercise program (tendon and nerve gliding exercises=2 times per day 3sets of ten repetitions) will be applied.
Additionally, night splinting will be advised. Patients will request to keep their splints at nights throughout the study. Receives: Other: Night Splinting |
| Control group | Experimental | A total of 20 sessions physiotherapy sessions including hot pack, ultrasound and exercise program (tendon and nerve gliding exercises=2 times per day 3sets of ten repetitions) will be applied. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional impairment
functional impairment will be assessed by using Boston Carpal Tunnel Questionnaire. The score consisted of two sub-scales; The Symptom Severity Scale including 11 questions and The Functional Capacity Scale including 8 questions. Each scale score is calculated by the average values of the questions. The scores vary between "1-point" to "5-point". High score indicates severe symptoms and impaired functional capacity.
Measured: functional impairment will be recorded at baseline and 4-week follow-up
Secondary outcomes (2)
pain intensity
pain intensity will be assessed by using Visual Analog Scale at rest, activity and at night.
All patients were asked to mark their pain level that corresponds to their pain intensity on the line between "0=no pain" and "100=the worst pain imaginable".
Measured: change from baseline to 4-week follow-up will be recorded
paresthesia
Paresthesia will be assessed by using Visual Analog Scale at rest, activity and at night.
All patients were asked to mark their paresthesia level that corresponds to their paresthesia intensity on the line between "0=no paresthesia" and "100=the worst paresthesia imaginable".
Measured: change from baseline to 4-week follow-up will be recorded
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start10 Aug 2021
- Primary completion10 Nov 2021
- Study completion20 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leyla Eraslan, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993703
- Sponsor's protocol ID
- HEK 12/57
- Status last verified
- Mar 2022
- First submitted
- 8 Jul 2021
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Eraslan L, Baltaci G. Effectiveness of Kinesio Taping and Night Splinting Along With Physical Therapy Intervention on Symptoms and Functionality: A Double-Blind Randomized Controlled Trial for Moderate Carpal Tunnel Syndrome. Am J Phys Med Rehabil. 2023 Nov 1;102(11):975-983. doi: 10.1097/PHM.0000000000002252. Epub 2023 Mar 29.
PubMed 37026822
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Short-term Effect of the Kinesiotaping and Night Splinting in Patients With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT04993703
- Acronym / sponsor ID
- HEK 12/57
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- carpal tunnel syndrome, night splinting, kinesiotaping, physiotherapy and rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 10 Nov 2021 (actual)
- Study completion
- 20 Feb 2022 (actual)
- First posted
- 6 Aug 2021 (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.
Carpal tunnel syndrome (CTS) which is defined as a symptomatic compression neuropathy of the median nerve at the level of the wrist.
Different types of splints are used for improving the function and decreasing the pain intensity and symptoms in the rehabilitation of patients with CTS.
However effectiveness of treatment by taping has never been investigated in physiotherapy and rehabilitation.
The aim of this study was to compare the short-term effect of conventional physiotherapy only, and also kinesio taping and night splinting in patients with CTS.
Detailed description
Carpal tunnel syndrome (CTS) which is defined as a symptomatic compression neuropathy of the median nerve at the level of the wrist.It is considered as the most common disabling neuromuscular condition of the upper extremities.
Night splints are used in conjunction with the conservative intervention to improve the function and decrease the pain intensity and paresthesia in the rehabilitation of patients with carpal tunnel syndrome. However effectiveness of treatment by kinesiotaping has never been investigated.
The aim of this study was to compare the short-term effect of conventional physiotherapy only, and also kinesio taping and night splinting in addition to conventional physiotherapy in the rehabilitation of patients with CTS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kinesiotaping | Experimental | Other: KinesiotapingA total of 20 sessions physiotherapy sessions including hot pack, ultrasound and exercise program (tendon and nerve gliding exercises=2 times per day 3sets of ten repetitions) will be applied. Additionally for this group, kinesiotaping will be applied by using carpal tunnel technique including button hole and I band technique of space correction; and with 25-50% tension in center of tape over dorsal carpal tunnel at the end of the each session. Patients will request to keep kinesiotaping at nights throughout the study. |
| Night splinting | Experimental | Other: Night SplintingA total of 20 sessions physiotherapy sessions including hot pack, ultrasound and exercise program (tendon and nerve gliding exercises=2 times per day 3sets of ten repetitions) will be applied. Additionally, night splinting will be advised. Patients will request to keep their splints at nights throughout the study. |
| Control group | Experimental | Other: Control GroupA total of 20 sessions physiotherapy sessions including hot pack, ultrasound and exercise program (tendon and nerve gliding exercises=2 times per day 3sets of ten repetitions) will be applied. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- This study included patients with moderate CTS, confirmed by electroneurographic examination.
- did not recruit any treatment (including physiotherapy or surgical release)
Key exclusion criteria (2 listed)
- Patients suffer from the thenar muscle atrophy.
- Patients with mild CTS.
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 |
|---|---|---|
| KinesiotapingA total of 20 sessions physiotherapy sessions including hot pack, ultrasound, kinesiotaping and exercise program (tendon and nerve gliding exercises=2 times per day 3 sets of ten repetitions) will be applied.times per day 3sets of ten repetitions) will be applied. | Other | Kinesiotaping |
| Night SplintingA total of 20 sessions physiotherapy sessions including hot pack, ultrasound, night splinting and exercise program (tendon and nerve gliding exercises=2 times per day 3 sets of ten repetitions) will be applied. | Other | Night splinting |
| Control GroupA total of 20 sessions physiotherapy sessions including hot pack, ultrasound and exercise program (tendon and nerve gliding exercises=2 times per day 3 sets of ten repetitions) will be applied. | Other | Control group |
Primary outcome
functional impairment
Time frame: functional impairment will be recorded at baseline and 4-week follow-up
functional impairment will be assessed by using Boston Carpal Tunnel Questionnaire. The score consisted of two sub-scales; The Symptom Severity Scale including 11 questions and The Functional Capacity Scale including 8 questions. Each scale score is calculated by the average values of the questions. The scores vary between "1-point" to "5-point". High score indicates severe symptoms and impaired functional capacity.
2 secondary outcomes
pain intensity
Time frame: change from baseline to 4-week follow-up will be recorded
paresthesia
Time frame: change from baseline to 4-week follow-up will be recorded
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 23 Mar 2022.
- Derived from this study: PubMed 37026822Eraslan L, Baltaci G. Effectiveness of Kinesio Taping and Night Splinting Along With Physical Therapy Intervention on Symptoms and Functionality: A Double-Blind Randomized Controlled Trial for Moderate Carpal Tunnel Syndrome. Am J Phys Med Rehabil. 2023 Nov 1;102(11):975-983. doi: 10.1097/PHM.0000000000002252. Epub 2023 Mar 29.
- Individual participant dataSharing planned: Undecided
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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 Kinesiotaping and Night Splinting in people with Carpal Tunnel Syndrome, run by Hacettepe 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 2 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: finished, as of the sponsor's last update on 23 Mar 2022. 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?
functional impairment (time frame: functional impairment will be recorded at baseline and 4-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04993703, which also lists 1 linked publication.
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 23 Mar 2022.