Effectiveness of Phonophoresis With Vitamin B12 on Patients With Mild to Moderate Carpal Tunnel Syndrome: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Changes in Distal latency of median nerve motor distal latency
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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/m
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: tendon and nerve gliding exercises (Other)
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.
干预措施: Vitamin B12 phonophoresis (Device)
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.
干预措施: Wrist splint (Device)
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.
干预措施: Placebo Vitamin B12 phonophoresis (Device)
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.
干预措施: Wrist splint (Device)
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.
干预措施: tendon and nerve gliding exercises (Other)
结局指标
主要结局
Changes in Distal latency of median nerve motor distal latency
时间窗: 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.
Changes in Distal latency of median nerve sensory distal latency
时间窗: 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.
次要结局
- Changes in numeric pain rating scale (NPRS)(Baseline and after 3 Weeks)
- Changes in hand grip strength(Baseline and after 3 Weeks)
研究者
Mohamed Magdy Ali Hassan ElMeligie
Principal investigator
October 6 University