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This clinical trial aims to evaluate the effect of a single local platelet-rich plasma injection Versus local steroid injection in treating mild idiopathic carpal tunnel syndrome regarding pain relief and function improvement and electrophysiological studies of the median nerve as a baseline and during a follow-up period of 3 months.
The main question[s] it aims to answer are:
Participants will have:
Researchers will compare the efficacy of a single PRP local injection compared to a single corticosteroid local injection for treating mild idiopathic CTS using nerve conduction studies (NCS), Visual Analog Scale (VAS), and Boston Carpal Tunnel Questionnaire (BCTQ) as objective and subjective outcome measures.
Carpal tunnel syndrome (CTS) is the most known entrapment neuropathy. Diagnosis of CTS is clinical, which could be confirmed by nerve conduction study (NCS). Non-operative management is the first line of treatment, including splitting, antiinflammatory, and neurotonics.
There is evidence of improvement in CTS after local corticosteroid injection, but complications are still recorded [5]. Platelet-rich plasma (PRP) is a novel, promising treatment providing growth factors for nerve regeneration and inflammation relief. This field needs further evaluation and analysis compared to traditional local steroid injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Active Comparator | Local corticosteroid injection in group I: 1 ml of triamcinolone acetonide (40 milligram/1.0 mL) was locally injected in the wrist using a 25-gauge needle, which was slowly inserted 1 cm proximal to the distal wrist-flexion crease just on the radial side of the palmaris longus tendon. The injection was held if the patient experienced pain or a sensation of pins and needles in the median nerve distribution. |
|
| Group II | Active Comparator | Local PRP injection in group II: 2 ml of PRP was injected using the same technique of corticosteroid local injection after 2-step centrifugation of the patient's blood using a specific device. Non-steroidal anti-inflammatory drugs were avoided for two weeks before and after the procedure to prevent the possibility of inhibition of platelet function. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Local corticosteroid injection | Drug | Local corticosteroid injection;1 ml of triamcinolone acetonide 40 milligram/1.0 mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual analog scale | The pain severity was determined by the patients, on a scale of 0 (no pain) to 10 (agonizing pain) | before and after three months from injection time |
| Symptom severity scale of the Boston Carpal Tunnel Questionnaire | Pain severity evaluation | before and after three months from injection time |
| Functional severity scale of the Boston Carpal Tunnel Questionnaire | Hand function evaluation | before and after three months from injection time |
| Median nerve sensory peak latency | Sensory conduction evaluation of median nerve | before and after three months from injection time |
| Median nerve distal motor latency | Motor conduction evaluation of the median nerve. | before and after three months from injection time |
| Median nerve sensory amplitude | Sensory conduction evaluation of the median nerve | before and after three months from injection time |
| Median nerve motor amplitude | Motor conduction evaluation of the median nerve. | before and after three months from injection time |
| Median nerve sensory conduction velocity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saga F El-Gazzar | Menoufia University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Menoufia University | Shibīn al Kawm | Menoufia | Egypt |
Patient enrollment started June 2017 to early January 2019
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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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A prospective, interventional, comparative double-blinded study.
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| Platelet-rich Plasma Local injection | Drug | Platelet-rich Plasma (From 2-step centrifugation of patient blood) Local injection. |
|
Sensory conduction evaluation of the median nerve |
| before and after three months from injection time |
| Median nerve motor conduction velocity | Motor conduction evaluation of the median nerve. | before and after three months from injection time |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |