Carpal Tunnel Syndrome PregnancyNCT06209918
Effect of Bioptron Light on Carpal Tunnel Syndrome(BLCTS)
A study testing bioptron light therapy and wrist brace in people with Carpal Tunnel Syndrome Pregnancy, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study is to investigate the effect of bioptron light therapy on pregnancy related carpal tunnel syndrome Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Carpal Tunnel Syndrome Pregnancy
- What is being tested?
- bioptron light therapy and wrist brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 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 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant females clinically daignosed with carpal tunnel syndrome at least 1 month
- age will range from (25-35) years.
- body mass index (BMI) will be (BMI ≤ 35 kg/m2)
Who cannot join
- history of neurologic disease
- hand surgery
- hand trauma,
- diabetes mellitus
- cervical spondylosis
- osteoarthritis of cervical spine and wrist joint
Show all 9Show fewer
- chronic renal failure
- heart failure
- connective tissue disorders
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sara Magdy Ahmed
Giza
Sara Ma Ahmed, lecturer, 01063998331, saramagdy87@cu.edu.eg
About this study
Official title: Effect of Bioptron Light Therapy on Pregnancy Related Carpal Tunnel Syndrome
The purpose of this study is to investigate the effect of bioptron light therapy on pregnancy related carpal tunnel syndrome
Read the detailed description
Carpal tunnel syndrome (CTS) is a symptomatic compression neuropathy of the median nerve at the level of the wrist, characterized by hand pain, numbness, and tingling in the distribution of the median nerve (thumb, index, middle finger, and the radial side of the ring finger) and a reduction in grip strength and hand function. The severity of symptoms can be clinically categorized into mild, moderate, and severe Bioptron phototherapy acts as a "sterile" trigger on human in vitro isolated peripheral blood mononuclear cells (PBMCs), affecting their cytokine production and driving the immune response towards an anti-inflammatory/reparative profile and representing a non-pharmaceutical and non-invasive option for several clinical conditionsA randomized control study, the women will be randomly assigned into two groups, (31 women for each group) equal in number. Group (A) will include 31 women will receive Bioptron light combined with advice and patient education (10 minutes per session, 3 sessions per week, for 4 weeks). Group (B) will be receiving advice only for same duration as group (A)
- Conditions
- Carpal Tunnel Syndrome Pregnancy
- Being tested
- bioptron light therapy, wrist brace
- Keywords
- Bioptron light therapy, Phototherapy, 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.
bioptron light therapyDevice
patient will be sitting on comfortable chair with the hand placed on an armrest in an extended and supinated position. Firstly, the skin over the wrist area will be exposed and cleaned by alcohol to achieve maximal penetration of light. Then, the bioptron device will be held perpendicular to the surface of the treated area, at a distance of 10 cm.
wrist braceDevice
will keep the wrist in a neutral position, not bent back or bent down too far
| Study group | Role | What they receive |
|---|---|---|
| group that recieve bioptron light and advice and patient education | Experimental | patients will recieve bioptron light therapy for 10 minutes per session, 3 sessions per week, for 4 weeks. Receives: Device: bioptron light therapy |
| control group that recieve advice and patient education and wrist brace | Other | will keep the wrist in a neutral position, not bent back or bent down too far Receives: Device: wrist brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nerve conduction studies (NCS)
assess sensory and motor nerve conduction velocity,gf and sensory nerve action potential
Measured: 4 weeks
Secondary outcomes (1)
Visual analogue scale
assess pain intensity
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start1 Jul 2023
- Primary completion1 Jul 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 Syndrome PregnancyStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Magdy Ahmed, Cairo University
- Investigators
- Sara Ma Ahmed, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209918
- Sponsor's protocol ID
- P.T.REC/012/003875
- Status last verified
- Jan 2024
- First submitted
- 21 Jul 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bioptron Light Therapy on Pregnancy Related Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT06209918
- Acronym / sponsor ID
- P.T.REC/012/003875
- Conditions
- Carpal Tunnel Syndrome Pregnancy
- Keywords
- Bioptron light therapy, Phototherapy, Carpal tunnel syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 18 Jan 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 is to investigate the effect of bioptron light therapy on pregnancy related carpal tunnel syndrome
Detailed description
Carpal tunnel syndrome (CTS) is a symptomatic compression neuropathy of the median nerve at the level of the wrist, characterized by hand pain, numbness, and tingling in the distribution of the median nerve (thumb, index, middle finger, and the radial side of the ring finger) and a reduction in grip strength and hand function. The severity of symptoms can be clinically categorized into mild, moderate, and severe Bioptron phototherapy acts as a "sterile" trigger on human in vitro isolated peripheral blood mononuclear cells (PBMCs), affecting their cytokine production and driving the immune response towards an anti-inflammatory/reparative profile and representing a non-pharmaceutical and non-invasive option for several clinical conditionsA randomized control study, the women will be randomly assigned into two groups, (31 women for each group) equal in number. Group (A) will include 31 women will receive Bioptron light combined with advice and patient education (10 minutes per session, 3 sessions per week, for 4 weeks). Group (B) will be receiving advice only for same duration as group (A)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group that recieve bioptron light and advice and patient education | Experimental | Device: bioptron light therapypatients will recieve bioptron light therapy for 10 minutes per session, 3 sessions per week, for 4 weeks. |
| control group that recieve advice and patient education and wrist brace | Other | Device: wrist bracewill keep the wrist in a neutral position, not bent back or bent down too far |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant females clinically daignosed with carpal tunnel syndrome at least 1 month
- age will range from (25-35) years.
- body mass index (BMI) will be (BMI ≤ 35 kg/m2)
Key exclusion criteria (9 listed)
- history of neurologic disease
- hand surgery
- hand trauma,
- diabetes mellitus
- cervical spondylosis
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 |
|---|---|---|
| bioptron light therapypatient will be sitting on comfortable chair with the hand placed on an armrest in an extended and supinated position. Firstly, the skin over the wrist area will be exposed and cleaned by alcohol to achieve maximal penetration of light. Then, the bioptron device will be held perpendicular to the surface of the treated area, at a distance of 10 cm. | Device | group that recieve bioptron light and advice and patient education |
| wrist bracewill keep the wrist in a neutral position, not bent back or bent down too far | Device | control group that recieve advice and patient education and wrist brace |
Primary outcome
Nerve conduction studies (NCS)
Time frame: 4 weeks
assess sensory and motor nerve conduction velocity,gf and sensory nerve action potential
1 secondary outcome
Visual analogue scale
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
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.
Sara Ma Ahmed, lecturer principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bioptron light therapy and wrist brace in people with Carpal Tunnel Syndrome Pregnancy, 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 3 inclusion and 9 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 18 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Ma Ahmed, lecturer (01063998331, saramagdy87@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nerve conduction studies (NCS) (time frame: 4 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 18 Jan 2024.