Carpal Tunnel SyndromeNCT05405647
Extra Corporeal Shock Wave Versus Kinesio Tape in Carpal Tunnel Syndrome
A study testing Shock wave Therapy and kinesio tape in people with Carpal Tunnel Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
This study would be conducted to answer the following question: was there any difference between the effects of Shock wave versus Kinesio Tape in the treatment of carpal tunnel syndrome for post-menopausal women. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Shock wave Therapy and kinesio tape
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2021to 30 Jan 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 Any age
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- -Age was ranged from 45 - 55 years old
- All subjects would not take analgesics by another route during the study.
Who cannot join
- Patients had previous carpal tunnel release.
- Skin over sensitivity of some patients to the tape.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extra Corporeal Shock Wave Versus Kinesio Tape in the Treatment of Carpal Tunnel Syndrome for Post Menopausal Women
This study would be conducted to answer the following question: was there any difference between the effects of Shock wave versus Kinesio Tape in the treatment of carpal tunnel syndrome for post-menopausal women.
Read the detailed description
Fifty menopausal women with mild to moderate CTS were selected randomly from outpatient clinic of the physical therapy department of El khazendara general hospital, Age was ranged from 45 - 55 years old.
Group A, consisted of 25 patients who received a program of 6 session of Shock wave Therapy on the affected wrist,5 minute per session. Group B Represented the control group, it consisted of 25 patients who received a program of kinesio tape application on the affected wrist for 3 days.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Shock wave Therapy, kinesio tape
- Keywords
- shock wave, kinesio tape, carpal tunnel syndrome
- 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.
Shock wave TherapyDevice
a program of 6 session of Shock wave Therapy on the affected wrist,5 minute per session and a frequency of 5 Hz., 1 sessions per week for 6 weeks.
kinesio tapeDevice
kinesio tape application on the affected wrist for 3 days and then one day off and then another 3 days each week for 6weeks.
| Study group | Role | What they receive |
|---|---|---|
| shock wave therapy | Experimental | received a program of 6 session of Shock wave Therapy on the affected wrist,5 minute per session, and a frequency of 5 Hz., 1 sessions per week for 6 weeks. Receives: Device: Shock wave Therapy; Device: kinesio tape |
| kinesio tape | Experimental | kinesio tape application on the affected wrist for 3 days and then one day off and then another 3 days each week for 6 weeks. Receives: Device: Shock wave Therapy; Device: kinesio tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Computerized electromyography
2 channel version with EMG/NCV/EP system, It was used to measure median motor distal latency (MMDL) before treatment and after 6 weeks of treatment for all patients
Measured: 6 weeks
Secondary outcomes (1)
Boston carpal tunnel questionnaire
The overall score for the functional-status scale was the mean of the ratings on the 8 daily activities. In this study BCTQ was translated and filled by the therapist
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start1 Jul 2021
- Primary completion29 Jan 2022
- Study completion30 Jan 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.
- More trials run by Cairo 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
- Model description
- Fifty menopausal women with mild to moderate CTS will be selected randomly from outpatient clinic of the physical therapy department of El khazendara general hospital, Shobra to participate in this study,Group A: Represented the study group, it consisted of 25 patients who received a program of 6 session of Shock wave Therapy on the affected wrist,5 minute per session. Group B: Represented the control group, it consisted of 25 patients who received a program of kinesio tape application on the affected wrist for 3 days .
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Ebrahim El Refaye, Woman's Health University Hospital, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405647
- Sponsor's protocol ID
- Cairo Un115
- Status last verified
- Jun 2022
- First submitted
- 1 Jun 2022
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extra Corporeal Shock Wave Versus Kinesio Tape in the Treatment of Carpal Tunnel Syndrome for Post Menopausal Women
- ClinicalTrials.gov ID
- NCT05405647
- Acronym / sponsor ID
- Cairo Un115
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- shock wave, kinesio tape, carpal tunnel syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 29 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 6 Jun 2022 (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 would be conducted to answer the following question: was there any difference between the effects of Shock wave versus Kinesio Tape in the treatment of carpal tunnel syndrome for post-menopausal women.
Detailed description
Fifty menopausal women with mild to moderate CTS were selected randomly from outpatient clinic of the physical therapy department of El khazendara general hospital, Age was ranged from 45 - 55 years old.
Group A, consisted of 25 patients who received a program of 6 session of Shock wave Therapy on the affected wrist,5 minute per session. Group B Represented the control group, it consisted of 25 patients who received a program of kinesio tape application on the affected wrist for 3 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Fifty menopausal women with mild to moderate CTS will be selected randomly from outpatient clinic of the physical therapy department of El khazendara general hospital, Shobra to participate in this study,Group A: Represented the study group, it consisted of 25 patients who received a program of 6 session of Shock wave Therapy on the affected wrist,5 minute per session. Group B: Represented the control group, it consisted of 25 patients who received a program of kinesio tape application on the affected wrist for 3 days .
| Arm | Type | Receives |
|---|---|---|
| shock wave therapy | Experimental | Device: Shock wave Therapy, Device: kinesio tapereceived a program of 6 session of Shock wave Therapy on the affected wrist,5 minute per session, and a frequency of 5 Hz., 1 sessions per week for 6 weeks. |
| kinesio tape | Experimental | Device: Shock wave Therapy, Device: kinesio tapekinesio tape application on the affected wrist for 3 days and then one day off and then another 3 days each week for 6 weeks. |
Who may qualify
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- -Age was ranged from 45 - 55 years old
- All subjects would not take analgesics by another route during the study.
Key exclusion criteria (2 listed)
- Patients had previous carpal tunnel release.
- Skin over sensitivity of some patients to the tape.
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 |
|---|---|---|
| Shock wave Therapya program of 6 session of Shock wave Therapy on the affected wrist,5 minute per session and a frequency of 5 Hz., 1 sessions per week for 6 weeks. | Device | kinesio tape, shock wave therapy |
| kinesio tapekinesio tape application on the affected wrist for 3 days and then one day off and then another 3 days each week for 6weeks. | Device | kinesio tape, shock wave therapy |
Primary outcome
Computerized electromyography
Time frame: 6 weeks
2 channel version with EMG/NCV/EP system, It was used to measure median motor distal latency (MMDL) before treatment and after 6 weeks of treatment for all patients
1 secondary outcome
Boston carpal tunnel questionnaire
Time frame: 6 weeks
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 7 Jun 2022.
- 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 Shock wave Therapy and kinesio tape in people with Carpal Tunnel Syndrome, run by Cairo University at 1 site in Egypt.
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 7 Jun 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 Egypt. 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?
Computerized electromyography (time frame: 6 weeks). 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 7 Jun 2022.