Carpal Tunnel SyndromeNCT05260593
Effect of Phonophoresis With Vitamin B12 on CTS
A study testing Vitamin B12 phonophoresis, Wrist splint and tendon and nerve gliding exercises in people with Carpal Tunnel Syndrome, run by October 6 University at 1 site in Egypt.
Trial summary
The purpose of this study is to investigate efficacy of phonophoresis with vitamin B12 on median nerve distal latency, pain level and hand grip strength in patients with carpal tunnel syndrome. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Vitamin B12 phonophoresis, Wrist splint and tendon and nerve gliding exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Mar 2022to 15 Aug 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- at least Fifty Four patients with Mild to moderate CTS.
- Age will range between 18 to 60 years old.
- All patients will have Body mass index between 18.5 and 29.9 kg/m2.
- Diagnosed by a physician according to American Association of Electrodiagnostic recent guidelines. (Jablecki et al., 2002).
- A positive clinical provocative tests for CTS (Tinel test and Phalen test),
- Patients with history of pain, paresthesia or numbness in the median nerve distribution, nocturnal pain, and night waking.
Who cannot join
- Diabetic patients.
- Hypertension patients.
- Pregnant women
- Cardiovascular patients
- Patients with cervical spondylosis
- Patients with cervical disc prolapse
- Patients with Thoracic outlet syndrome
- Patients with Carpal tunnel release surgery
Trial locations and contacts
1 site in 1 country.
Egypt1 site
October 6 University Hospital
Al Ḩayy Ath Thāmin, Giza Governorate, 12611
About this study
Official title: Effectiveness of Phonophoresis With Vitamin B12 on Patients With Mild to Moderate Carpal Tunnel Syndrome: A Randomized Controlled Trial
The purpose of this study is to investigate efficacy of phonophoresis with vitamin B12 on median nerve distal latency, pain level and hand grip strength in patients with carpal tunnel syndrome. At least Fifty four Patients from both sexes will be recruited for this study from various hospitals in 6th October city
- Group A (n = 27): will receive Phonophoresis with Vitamin B12 gel.
- Group B (n = 27): will receive placebo phonophoresis with Vitamin B12 gel.
Median nerve distal latency, hand grip strength and numerical pain rating scale will be measured at baseline and after 3 weeks.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Vitamin B12 phonophoresis, Placebo Vitamin B12 phonophoresis, Wrist splint, tendon and nerve gliding exercises
- 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.
Vitamin B12 phonophoresisDevice
Therapeutic pulsed ultrasound using Phyaction UbMF ultrasound device in presence of vitamin B12 gel will be applied over the wrist. The following parameters will be used: intensity of 1.0 W/cm2 at a 1MHz frequency for 5 minutes and pulsed (25%) ultrasound waves to transfer the vitamin B12 gel. This therapy will be applied for 5 min/session, 5 d/wk, for 3 weeks.
Placebo Vitamin B12 phonophoresisDevice
Therapeutic pulsed ultrasound using Phyaction UbMF ultrasound device in presence of Vitamin B12 will be applied over the wrist. The ultrasound probe will be held over the wrist using topical gel containing Vitamin B12 which was the same as in group A. Ultrasound device will seem to be working for 5 min period with light-off position. This therapy will be applied for 5 min/session, 5 d/wk, for 3 weeks.
Wrist splintDevice
Patients were instructed to wear a neutral volar splint at night and while performing strenuous activities during the day for 5 weeks. Patients were given forms in order to check if they won't be compliant to the splint application and will be asked to bring the forms at the post treatment evaluation. Patients who won't check the form more than once a week will be regarded as non-compliant to splinting.
tendon and nerve gliding exercisesOther
During tendon-gliding exercises, the fingers will be placed in five discrete positions (straight, hook, fist, tabletop, and straight fist). During the median nerve-gliding exercise, six different hand and wrist positions will be used to mobilize the median nerve. During these exercises, the patient must maintain the neck and the shoulder in neutral position with a supinated forearm and elbow flexed 90 degrees. Each position must be maintained for 5 seconds. Each exercise will be repeated 10 times at each session and patients will be encouraged to apply exercise 3-5 times per day for 5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Vit. B12 Phonophoresis group) | Experimental | Patients in group (A) will receive phonophoresis with Vitamin B12. Therapeutic pulsed ultrasound using Phyaction UbMF ultrasound device in presence of vitamin B12 gel will be applied over the wrist. The following parameters will be used: intensity of 1.0 W/cm2 at a 1MHz frequency for 5 minutes and pulsed (25%) ultrasound waves to transfer the vitamin B12 gel. This therapy will be applied for 5 min/session, 5 d/wk, for 3 weeks. Receives: Device: Vitamin B12 phonophoresis; Device: Wrist splint; Other: tendon and nerve gliding exercises |
| Group B (Placebo-Phonophoresis with Vitamin B12) | Placebo comparator | Patients in group (A) will receive placebo phonophoresis with Vitamin B12 gel. Therapeutic pulsed ultrasound using Phyaction UbMF ultrasound device in presence of Vitamin B12 gel will be applied over the wrist. The ultrasound probe will be held over the wrist using topical gel containing Vitamin B12 which was the same as in group A. Ultrasound device will seem to be working for 5 min period with light-off position. This therapy will be applied for 5 min/session, 5 d/wk, for 3 weeks. Receives: Device: Placebo Vitamin B12 phonophoresis; Device: Wrist splint; Other: tendon and nerve gliding exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Distal latency of median nerve sensory distal latency
The Median sensory nerve (SNDL) distal latency was measured according to the American Association of Electrodiagnostic Medicine (AAEM) guidelines with a Neuropack S1 MEB-9004 Nihon Koden (Japan). All measurements were performed in a room with the temperature kept at 25C.
Measured: Baseline and after 3 Weeks
Changes in Distal latency of median nerve motor distal latency
The Median motor nerve (MNDL) distal latency was measured according to the American Association of Electrodiagnostic Medicine (AAEM) guidelines with a Neuropack S1 MEB-9004 Nihon Koden (Japan). All measurements were performed in a room with the temperature kept at 25C.
Measured: Baseline and after 3 Weeks
Secondary outcomes (2)
Changes in hand grip strength
The hand grip strength (measured in Kilograms) was evaluated by the same investigator. Grip strength was tested by using Jamar hand held dynamometer following the American Society of Hand Therapists guidelines. The patient's arm was positioned with the shoulder adducted and neutrally rotated, the elbow was flexed at 90, the forearm and wrist were neutrally positioned while the participant was sitting. Patients were instructed to squeeze the handle as hard as they could, do maximal grip contraction for 2-5 s.
Measured: Baseline and after 3 Weeks
Changes in numeric pain rating scale (NPRS)
An 11-point Numerical Pain Rating Scale (NPRS; 0 = no pain, 10 = maximum pain) was used to assess the patients' levels of hand pain pre and post treatment.
Measured: Baseline and after 3 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start16 Mar 2022
- Primary completion22 Jul 2022 (estimated)
- Study completion15 Aug 2022 (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.
- 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
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy Ali Hassan ElMeligie, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260593
- Sponsor's protocol ID
- VB12CTS
- Status last verified
- May 2022
- First submitted
- 10 Feb 2022
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Phonophoresis With Vitamin B12 on Patients With Mild to Moderate Carpal Tunnel Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05260593
- Acronym / sponsor ID
- VB12CTS
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 22 Jul 2022 (estimated)
- Study completion
- 15 Aug 2022 (estimated)
- First posted
- 2 Mar 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.
The purpose of this study is to investigate efficacy of phonophoresis with vitamin B12 on median nerve distal latency, pain level and hand grip strength in patients with carpal tunnel syndrome. At least Fifty four Patients from both sexes will be recruited for this study from various hospitals in 6th October city
- Group A (n = 27): will receive Phonophoresis with Vitamin B12 gel.
- Group B (n = 27): will receive placebo phonophoresis with Vitamin B12 gel.
Median nerve distal latency, hand grip strength and numerical pain rating scale will be measured at baseline and after 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Vit. B12 Phonophoresis group) | Experimental | Device: Vitamin B12 phonophoresis, Device: Wrist splint, Other: tendon and nerve gliding exercisesPatients in group (A) will receive phonophoresis with Vitamin B12. Therapeutic pulsed ultrasound using Phyaction UbMF ultrasound device in presence of vitamin B12 gel will be applied over the wrist. The following parameters will be used: intensity of 1.0 W/cm2 at a 1MHz frequency for 5 minutes and pulsed (25%) ultrasound waves to transfer the vitamin B12 gel. This therapy will be applied for 5 min/session, 5 d/wk, for 3 weeks. |
| Group B (Placebo-Phonophoresis with Vitamin B12) | Placebo comparator | Device: Placebo Vitamin B12 phonophoresis, Device: Wrist splint, Other: tendon and nerve gliding exercisesPatients in group (A) will receive placebo phonophoresis with Vitamin B12 gel. Therapeutic pulsed ultrasound using Phyaction UbMF ultrasound device in presence of Vitamin B12 gel will be applied over the wrist. The ultrasound probe will be held over the wrist using topical gel containing Vitamin B12 which was the same as in group A. Ultrasound device will seem to be working for 5 min period with light-off position. This therapy will be applied for 5 min/session, 5 d/wk, for 3 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- at least Fifty Four patients with Mild to moderate CTS.
- Age will range between 18 to 60 years old.
- All patients will have Body mass index between 18.5 and 29.9 kg/m2.
- Diagnosed by a physician according to American Association of Electrodiagnostic recent guidelines. (Jablecki et al., 2002).
- A positive clinical provocative tests for CTS (Tinel test and Phalen test),
Key exclusion criteria (8 listed)
- Diabetic patients.
- Hypertension patients.
- Pregnant women
- Cardiovascular patients
- Patients with 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 |
|---|---|---|
| Vitamin B12 phonophoresisTherapeutic pulsed ultrasound using Phyaction UbMF ultrasound device in presence of vitamin B12 gel will be applied over the wrist. The following parameters will be used: intensity of 1.0 W/cm2 at a 1MHz frequency for 5 minutes and pulsed (25%) ultrasound waves to transfer the vitamin B12 gel. This therapy will be applied for 5 min/session, 5 d/wk, for 3 weeks. | Device | Group A (Vit. B12 Phonophoresis group) |
| Placebo Vitamin B12 phonophoresisTherapeutic pulsed ultrasound using Phyaction UbMF ultrasound device in presence of Vitamin B12 will be applied over the wrist. The ultrasound probe will be held over the wrist using topical gel containing Vitamin B12 which was the same as in group A. Ultrasound device will seem to be working for 5 min period with light-off position. This therapy will be applied for 5 min/session, 5 d/wk, for 3 weeks. | Device | Group B (Placebo-Phonophoresis with Vitamin B12) |
| Wrist splintPatients were instructed to wear a neutral volar splint at night and while performing strenuous activities during the day for 5 weeks. Patients were given forms in order to check if they won't be compliant to the splint application and will be asked to bring the forms at the post treatment evaluation. Patients who won't check the form more than once a week will be regarded as non-compliant to splinting. | Device | Group A (Vit. B12 Phonophoresis group), Group B (Placebo-Phonophoresis with Vitamin B12) |
| tendon and nerve gliding exercisesDuring tendon-gliding exercises, the fingers will be placed in five discrete positions (straight, hook, fist, tabletop, and straight fist). During the median nerve-gliding exercise, six different hand and wrist positions will be used to mobilize the median nerve. During these exercises, the patient must maintain the neck and the shoulder in neutral position with a supinated forearm and elbow flexed 90 degrees. Each position must be maintained for 5 seconds. Each exercise will be repeated 10 times at each session and patients will be encouraged to apply exercise 3-5 times per day for 5 weeks. | Other | Group A (Vit. B12 Phonophoresis group), Group B (Placebo-Phonophoresis with Vitamin B12) |
Primary outcome
Changes in Distal latency of median nerve sensory distal latency
Time frame: Baseline and after 3 Weeks
The Median sensory nerve (SNDL) distal latency was measured according to the American Association of Electrodiagnostic Medicine (AAEM) guidelines with a Neuropack S1 MEB-9004 Nihon Koden (Japan). All measurements were performed in a room with the temperature kept at 25C.
Changes in Distal latency of median nerve motor distal latency
Time frame: Baseline and after 3 Weeks
The Median motor nerve (MNDL) distal latency was measured according to the American Association of Electrodiagnostic Medicine (AAEM) guidelines with a Neuropack S1 MEB-9004 Nihon Koden (Japan). All measurements were performed in a room with the temperature kept at 25C.
2 secondary outcomes
Changes in hand grip strength
Time frame: Baseline and after 3 Weeks
Changes in numeric pain rating scale (NPRS)
Time frame: Baseline and after 3 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- 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 Vitamin B12 phonophoresis, Wrist splint and tendon and nerve gliding exercises in people with Carpal Tunnel Syndrome, run by October 6 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 6 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: status not confirmed, as of the sponsor's last update on 10 May 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. Some participants in this study may receive a placebo. 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?
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?
Changes in Distal latency of median nerve sensory distal latency (time frame: Baseline and after 3 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 10 May 2022.