Carpal Tunnel SyndromeNCT06555926
Effect of Acupressure on Carpal Tunnel Syndrome in Pregnant Women
A study testing Acupressure and advices for relieving carpal tunnel syndrome in people with Carpal Tunnel Syndrome, run by Cairo University.
Trial summary
This study will be conducted to investigate the effect of acupressure on carpal tunnel syndrome in pregnant women. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Acupressure and advices for relieving carpal tunnel syndrome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Dec 2024
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women who are clinically diagnosed as having carpal tunnel syndrome .
- Their age will be ranged from 20 to 35years old.
- Their body mass index will not exceed 30kg/m2.
- All of them are in their 3rd trimester of pregnancy.(28-40weeks)
- All of them suffer from mild and moderate CTS.
- Degree of carpal tunnel pain will be 2 or more on Visual Analogue scale.
Who cannot join
- Dermatological abnormalities in the skin of acupionts.
- Internal fixation at the area of acupressure application.
- Smokers .
- Metabolic diseases such as Diabetes mellitus.
- Females who had history of fracture or trauma to the hand .
Trial locations and contacts
No sites are listed yet.
About this study
This study will be conducted to investigate the effect of acupressure on carpal tunnel syndrome in pregnant women.
Read the detailed description
The pregnant women are more prone to develop carpal tunnel syndrome because they retain more fluid during the later stages of their pregnancies. The more fluid retained , the more swelling occurs , squeezing the nerves that run through the hand and finger. Also most women who experience pain, numbness and tingling in the hand for the first time due to pregnancy have no idea that they have carpal tunnel syndrome.
Given the importance of treating CTS and preventing the limitations caused by this syndrome, and since it can turn into a debilitating disease if left untreated, acupressure can be recommended as a safe and noninvasive technique for reducing the severity of clinical symptoms.
Till now, there is no previous studies explored the effect of acupressure on carpal tunnel syndrome in pregnant women. So, this study will be conducted to provide new information about the efficacy of acupressure in management of carpal tunnel syndrome in pregnant women, which will help such pregnant women to overcome this problem and will add new evidence to the field of physical therapy.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Acupressure, advices for relieving 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.
AcupressureOther
The pregnant women will receive acupressure on the (Pc-6/Lung-7 )acupoints one minute for each point with 3 repetitions on both side( about 30minutes /session),2 times per week in addition to advices for 12 weeks.
advices for relieving carpal tunnel syndromeOther
The pregnant women will receive advices for 12 weeks as follows:
- Avoid heavy lifting.
- Avoid repetitive tasks.
- Sit on chairs with armrests and elevate affected hand on the armrest
- Avoid sleeping on the side of the affected hand.
- Keep the wrist in a neutral (straight) position.
- Avoid positions of full flexion and extension.
- Reduce general swelling by:
- eating less salty food .
- elevating legs when sitting .
- wearing compression garments.
- Apply cold water over the wrist.
| Study group | Role | What they receive |
|---|---|---|
| Acupressure group | Experimental | The pregnant women will receive acupressure and advice for 12 weeks Receives: Other: Acupressure; Other: advices for relieving carpal tunnel syndrome |
| Advice group | Active comparator | The pregnant women will receive advice only for 12 weeks Receives: Other: advices for relieving carpal tunnel syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pain severity
The pain intensity will be assessed for all participants in both groups before and after treatment through VAS. It is a 10 cm horizontal line on which the participant's pain intensity will be represented by a point between the extremes of "no pain at all" and "worst imaginable pain". Each participant will be asked to mark a point on a VAS line between the extremes that related to her current pain intensity
Measured: 12 weeks
median nerve conduction study
Computerized Electromyography (Dantce): ATOENINIES neuro screen system will be used to perform median nerve conduction study before and after the treatment program for all participants in both groups
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study startAug 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bassant Hesham Ahmed, Cairo University
- Investigators
- Azza Nashed, professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555926
- Sponsor's protocol ID
- P.T.REC/012/005286
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupressure on Carpal Tunnel Syndrome in Pregnant Women
- ClinicalTrials.gov ID
- NCT06555926
- Acronym / sponsor ID
- P.T.REC/012/005286
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 15 Aug 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.
This study will be conducted to investigate the effect of acupressure on carpal tunnel syndrome in pregnant women.
Detailed description
The pregnant women are more prone to develop carpal tunnel syndrome because they retain more fluid during the later stages of their pregnancies. The more fluid retained , the more swelling occurs , squeezing the nerves that run through the hand and finger. Also most women who experience pain, numbness and tingling in the hand for the first time due to pregnancy have no idea that they have carpal tunnel syndrome.
Given the importance of treating CTS and preventing the limitations caused by this syndrome, and since it can turn into a debilitating disease if left untreated, acupressure can be recommended as a safe and noninvasive technique for reducing the severity of clinical symptoms.
Till now, there is no previous studies explored the effect of acupressure on carpal tunnel syndrome in pregnant women. So, this study will be conducted to provide new information about the efficacy of acupressure in management of carpal tunnel syndrome in pregnant women, which will help such pregnant women to overcome this problem and will add new evidence to the field of physical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupressure group | Experimental | Other: Acupressure, Other: advices for relieving carpal tunnel syndromeThe pregnant women will receive acupressure and advice for 12 weeks |
| Advice group | Active comparator | Other: advices for relieving carpal tunnel syndromeThe pregnant women will receive advice only for 12 weeks |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pregnant women who are clinically diagnosed as having carpal tunnel syndrome .
- Their age will be ranged from 20 to 35years old.
- Their body mass index will not exceed 30kg/m2.
- All of them are in their 3rd trimester of pregnancy.(28-40weeks)
- All of them suffer from mild and moderate CTS.
Key exclusion criteria (5 listed)
- Dermatological abnormalities in the skin of acupionts.
- Internal fixation at the area of acupressure application.
- Smokers .
- Metabolic diseases such as Diabetes mellitus.
- Females who had history of fracture or trauma to the hand .
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 |
|---|---|---|
| AcupressureThe pregnant women will receive acupressure on the (Pc-6/Lung-7 )acupoints one minute for each point with 3 repetitions on both side( about 30minutes /session),2 times per week in addition to advices for 12 weeks. | Other | Acupressure group |
| advices for relieving carpal tunnel syndromeThe pregnant women will receive advices for 12 weeks as follows: * Avoid heavy lifting. * Avoid repetitive tasks. * Sit on chairs with armrests and elevate affected hand on the armrest * Avoid sleeping on the side of the affected hand. * Keep the wrist in a neutral (straight) position. * Avoid positions of full flexion and extension. * Reduce general swelling by: * eating less salty food . * elevating legs when sitting . * wearing compression garments. * Apply cold water over the wrist. | Other | Acupressure group, Advice group |
Primary outcome
Assessment of pain severity
Time frame: 12 weeks
The pain intensity will be assessed for all participants in both groups before and after treatment through VAS. It is a 10 cm horizontal line on which the participant's pain intensity will be represented by a point between the extremes of "no pain at all" and "worst imaginable pain". Each participant will be asked to mark a point on a VAS line between the extremes that related to her current pain intensity
median nerve conduction study
Time frame: 12 weeks
Computerized Electromyography (Dantce): ATOENINIES neuro screen system will be used to perform median nerve conduction study before and after the treatment program for all participants in both groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Individual participant dataSharing planned: Yes
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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.
Azza Nashed, professor study chair
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure and advices for relieving carpal tunnel syndrome in people with Carpal Tunnel Syndrome, run by Cairo University.
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: status not confirmed, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact bassant ahmed, Master (+201141292300, besobassant88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pain severity (time frame: 12 weeks). The study lists 2 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 Aug 2024.