Effect of Phonophoresis With Vitamin B12 on CTS

NCT ID: NCT05260593

Last Updated: 2022-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-16
• Study Completion Date: 2022-08-15

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A (Vit. B12 Phonophoresis group)

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.

Group Type: EXPERIMENTAL

Vitamin B12 phonophoresis

Intervention Type: DEVICE

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.

Wrist splint

Intervention Type: DEVICE

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 exercises

Intervention Type: OTHER

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.

Group B (Placebo-Phonophoresis with Vitamin B12)

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.

Group Type: PLACEBO_COMPARATOR

Placebo Vitamin B12 phonophoresis

Intervention Type: DEVICE

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 splint

Intervention Type: DEVICE

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 exercises

Intervention Type: OTHER

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.

Interventions

Vitamin B12 phonophoresis

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.

Intervention Type: DEVICE

Placebo Vitamin B12 phonophoresis

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.

Intervention Type: DEVICE

Wrist splint

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.

Intervention Type: DEVICE

tendon and nerve gliding exercises

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. at least Fifty Four patients with Mild to moderate CTS.

2. Age will range between 18 to 60 years old.

3. All patients will have Body mass index between 18.5 and 29.9 kg/m2.

4. Diagnosed by a physician according to American Association of Electrodiagnostic recent guidelines. (Jablecki et al., 2002).

5. A positive clinical provocative tests for CTS (Tinel test and Phalen test),

6. Patients with history of pain, paresthesia or numbness in the median nerve distribution, nocturnal pain, and night waking.

Exclusion Criteria

1. Diabetic patients.

2. Hypertension patients.

3. Pregnant women

4. Cardiovascular patients

5. Patients with cervical spondylosis

6. Patients with cervical disc prolapse

7. Patients with Thoracic outlet syndrome

8. Patients with Carpal tunnel release surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

October 6 University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Magdy Ali Hassan ElMeligie

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

October 6 University Hospital

Al Ḩayy Ath Thāmin, Giza Governorate, Egypt

Countries

Egypt

Other Identifiers

VB12CTS

Identifier Type: -

Identifier Source: org_study_id