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Effect of Phonophoresis With Vitamin B12 on CTS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05260593
Recruitment Status : Active, not recruiting
First Posted : March 2, 2022
Last Update Posted : May 10, 2022
Sponsor:
Information provided by (Responsible Party):
Mohamed Magdy Ali Hassan ElMeligie, October 6 University

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.


Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Device: Vitamin B12 phonophoresis Device: Placebo Vitamin B12 phonophoresis Device: Wrist splint Other: tendon and nerve gliding exercises Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Phonophoresis With Vitamin B12 on Patients With Mild to Moderate Carpal Tunnel Syndrome: A Randomized Controlled Trial
Actual Study Start Date : March 16, 2022
Estimated Primary Completion Date : July 22, 2022
Estimated Study Completion Date : August 15, 2022


Arm Intervention/treatment
Experimental: 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.
Device: 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.

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.

Other: 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.

Placebo Comparator: 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.
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.

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.

Other: 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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Changes in hand grip strength [ Time Frame: Baseline and after 3 Weeks ]
    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.

  2. Changes in numeric pain rating scale (NPRS) [ Time Frame: Baseline and after 3 Weeks ]
    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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05260593


Locations
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Egypt
October 6 University Hospital
Al Ḩayy Ath Thāmin, Giza, Egypt, 12611
Sponsors and Collaborators
October 6 University
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Responsible Party: Mohamed Magdy Ali Hassan ElMeligie, Principal investigator, October 6 University
ClinicalTrials.gov Identifier: NCT05260593    
Other Study ID Numbers: VB12CTS
First Posted: March 2, 2022    Key Record Dates
Last Update Posted: May 10, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Vitamins
Hydroxocobalamin
Vitamin B 12
Vitamin B Complex
Micronutrients
Physiological Effects of Drugs
Hematinics