Back to resultsEffect of Phonophoresis With Vitamin B12 on CTS
Primary Purpose
Carpal Tunnel Syndrome
Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Vitamin B12 phonophoresis
Placebo Vitamin B12 phonophoresis
Wrist splint
tendon and nerve gliding exercises
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- October 6 University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group A (Vit. B12 Phonophoresis group)
Group B (Placebo-Phonophoresis with Vitamin B12)
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05260593
Brief Title
Effect of Phonophoresis With Vitamin B12 on CTS
Official Title
Effectiveness of Phonophoresis With Vitamin B12 on Patients With Mild to Moderate Carpal Tunnel Syndrome: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 16, 2022 (Actual)
Primary Completion Date
July 22, 2022 (Anticipated)
Study Completion Date
August 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A (Vit. B12 Phonophoresis group)
Arm Type
Experimental
Arm 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.
Arm Title
Group B (Placebo-Phonophoresis with Vitamin B12)
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Vitamin B12 phonophoresis
Intervention Description
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
Intervention Name(s)
Placebo Vitamin B12 phonophoresis
Intervention Description
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
Intervention Name(s)
Wrist splint
Intervention Description
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
Other
Intervention Name(s)
tendon and nerve gliding exercises
Intervention Description
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 Measure Information:
Title
Changes in Distal latency of median nerve sensory distal latency
Description
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.
Time Frame
Baseline and after 3 Weeks
Title
Changes in Distal latency of median nerve motor distal latency
Description
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.
Time Frame
Baseline and after 3 Weeks
Secondary Outcome Measure Information:
Title
Changes in hand grip strength
Description
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.
Time Frame
Baseline and after 3 Weeks
Title
Changes in numeric pain rating scale (NPRS)
Description
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.
Time Frame
Baseline and after 3 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Facility Information:
Facility Name
October 6 University Hospital
City
Al Ḩayy Ath Thāmin
State/Province
Giza
ZIP/Postal Code
12611
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Phonophoresis With Vitamin B12 on CTS
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