Effect of Phonophoresis With Vitamin B12 on CTS

October 6 University

Status: Unknown

Conditions: Carpal Tunnel Syndrome

Treatments: Device: Placebo Vitamin B12 phonophoresis; Device: Vitamin B12 phonophoresis; Other: tendon and nerve gliding exercises; Device: Wrist splint

Study type: Interventional

Funder types: Other

Identifiers

NCT05260593

VB12CTS

Details and patient eligibility

About

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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 2 patient groups, including a placebo group

Group A (Vit. B12 Phonophoresis group)

Experimental group

Description:

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.

Treatment:

Other: tendon and nerve gliding exercises

Device: Wrist splint

Device: Vitamin B12 phonophoresis

Group B (Placebo-Phonophoresis with Vitamin B12)

Placebo Comparator group

Description:

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.

Treatment:

Other: tendon and nerve gliding exercises

Device: Placebo Vitamin B12 phonophoresis

Device: Wrist splint