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The aim of this study is to compare the clinical efficacy and safety of ultrasound-guided pulsed radiofrequency and hyaluronidase hydrodissection in the treatment of carpal tunnel syndrome. This research seeks to evaluate both techniques in terms of pain relief, functional improvement, nerve conduction parameters, and potential complications, in order to identify the more effective minimally invasive approach for managing carpal tunnel syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (PRF Group) | Active Comparator | Group A (PRF Group): will Receive ultrasound-guided pulsed radiofrequency to the median nerve at the carpal tunnel. |
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| Group B (HD Group) | Active Comparator | Group B (HD Group): will Receive ultrasound-guided hydrodissection of the median nerve using hyaluronidase solution. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed Radiofrequency | Procedure | Pulsed Radiofrequency: Top neuropole needle 100-mm with a 10-mm active tip will be advanced with ultrasound guidance using the in-plane technique towards the median nerve. Sensory and motor stimulation will be tested when the needle is close to the median nerve. During sensory stimulation (50 Hz; 1-ms pulsed width; 0-3.0 volt), the patients will report paresthesia in the distal fingers. After performing a motor stimulation (2 Hz; 1-ms pulsed width; 0-3.0 volt), contractions of the thenar muscle will be observed. PRF lesion will then be carried out for 6 min, pulse width of 5 MS, 5 pulses per second and 35 volts at 42°C. |
| Measure | Description | Time Frame |
|---|---|---|
| Onset time of significant pain relief | The VAS will be used to quantify pain on the scale of 0 (no pain) to 10 (extremely severe pain). Onset time will be defined as the day when the VAS score declined by 40% or more | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) | BCTQ is the most used questionnaire in clinical studies for evaluation of the symptom severity and functional status of patients with CTS [9]. Symptom severity is rated based on 11 questions scored from 1 point (mildest) to 5 points (most severe), and the functional status is evaluated with 8 questions scored from 1 point (no difficulty with activity) to 5 points (cannot perform the activity at all) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amany Mahmoud Mohamed, resident | Contact | 01095062277 | amany_mahmoud_post@med.sohag.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Sohag University | Sohag | Sohag Governorate | Egypt |
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D061208 | Pulsed Radiofrequency Treatment |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D000078702 | Radiofrequency Therapy |
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| Hyaluronidase Hydrodissection | Procedure | Hyaluronidase Hydrodissection: The patient will sit facing the examiner with the forearm supinated and semiflexed at 90°, and the wrist placed on the examination couch with semi extended fingers. The injection for a 5 mL volume of HD 1500 IU will be done under complete sterile conditions. A 26-gauge needle will be introduced from the lateral side toward the midline, using the in-plane approach to target the median nerve in the carpal tunnel using the ulnar approach. Ultrasonographic visualization of the needle tip will be continuous, the injection was done gradually, and the needle will be advanced dissecting the flexor retinaculum away from the median nerve via gradual drug infiltration. |
|
| 1 week and 1, 3, 6 months |
| Cross-sectional area (CSA) | CSA of the median nerve will be measured at the proximal inlet of the carpal tunnel (at the level of the pisiform bone) by the same physician. The patients hold their wrists in a neutral position with the palm up and the fingers semi-extended. CSA will be measured three times, and the mean will be used for the analysis. Typically, a CSA greater than 9-10 mm2 at the wrist is considered suggestive of carpal tunnel syndrome. The ultrasonographic evaluation of median nerve CSA has high sensitivity (89%) and specificity (83%) for the diagnosis of CTS. This will be done at baseline and then at 1-, 3-, and 6-months post-injection. All measurements will be performed three times, and the mean of the three measurements was used for further statistical analyses | baseline and then at 1-, 3-, and 6-months |
| Sensory nerve conduction velocity (SNCV) | The antidromic SNCV of the median nerve will be measured in all subjects. All examinations will be performed by the same physician in the same room maintained at a constant temperature of 25°C. Skin temperature on the hand and wrist will be maintained between 32.0 and 34.0°C. Active and reference ring electrodes will be placed over the 2nd proximal and distal interphalangeal joints. The median nerve will be stimulated at the wrist between the palmar longus and flexor carpal radialis tendon at approximately 14 cm from the active electrode. will performed at baseline and 1, 3, and 6months post-injection. | baseline and 1, 3, and 6months post-injection |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
| D012046 | Rehabilitation |