Effect of Phonophoresis With Vitamin B12 on CTS

NCT05260593 | Unknown

• 1 other identifier: VB12CTS
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and after 3 Weeks

Secondary Outcomes (2)

• Changes in hand grip strength

  Baseline and after 3 Weeks

• Changes in numeric pain rating scale (NPRS)

  Baseline and after 3 Weeks

Study Arms (2)

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.

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.

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

Interventions

Vitamin B12 phonophoresis 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.

Group A (Vit. B12 Phonophoresis group)

Placebo Vitamin B12 phonophoresis 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.

Group B (Placebo-Phonophoresis with Vitamin B12)

Wrist splint 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.

Group A (Vit. B12 Phonophoresis group); Group B (Placebo-Phonophoresis with Vitamin B12)

tendon and nerve gliding exercises 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 A (Vit. B12 Phonophoresis group); Group B (Placebo-Phonophoresis with Vitamin B12)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• October 6 University: lead

Study Sites (1)

October 6 University Hospital

Al Ḩayy Ath Thāmin, Giza Governorate, 12611, Egypt

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: March 2, 2022
• Study Start: March 16, 2022
• Primary Completion: July 22, 2022
• Study Completion: August 15, 2022
• Last Updated: May 10, 2022

Record last verified: 2022-05

Locations

EG (1)