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Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. The technique of perineural injection therapy (PIT) is now commonly used for peeling the nerve from surrounding soft tissue (called nerve hydrodissection), which may help to reduce neuro-inflammation, ischemic damage and allow impulse transmission.
The objective of this study is to evaluate the efficacy of ultrasound guided insulin plus Sodium Hyaluronate injection in reducing symptoms caused by carpal tunnel syndrome.
In this randomized clinical trial, 90 patients with both a clinical and electromyographic diagnosis of mild to moderate carpal tunnel syndrome will be recruited from Assiut University Hospital (AUH). After obtaining written informed consent, patients will be randomized into three groups. Group A, patients will receive ultrasound-guided PIT with 10 IU of crystalline insulin; Group B, patients will receive ultrasound-guided PIT with 20 mg of Sodium Hyaluronate; Group C, patients will receive ultrasound-guided PIT with 10 IU of crystalline insulin and 20 mg of Sodium Hyaluronate. The primary outcome will be the Boston Carpal Tunnel Syndrome Questionnaire - Symptom Severity Scale at baseline, 1 month and 3 months post injection. All participants, investigator, outcomes assessor will be blinded (Triple blind)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin and Sodium Hyaluronate Ultrasound guided injection | Experimental | Subjects will receive Ultrasound guided injection of 10 IU of crystalline insulin and 20 mg of Sodium Hyaluronate |
|
| Insulin Ultrasound guided injection | Active Comparator | Subjects will receive Ultrasound guided injection of 10 IU of crystalline insulin |
|
| Sodium Hyaluronate Ultrasound guided injection | Active Comparator | Subjects will receive Ultrasound guided injection of 20 mg of Sodium Hyaluronate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin | Drug | Ultrasound guided perineural injection therapy (PIT) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Boston Carpal Tunnel Syndrome Questionnaire - Symptom Severity Scale | Boston carpal tunnel syndrome questionnaire - SSS is patient-based questionnaire for measurement of CTS severity which include11 questions to evaluate the symptom severity. Each question ranges from 1 to 5 with a higher score indicating a higher degree of disability. | Baseline, 1 month, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Boston Carpal Tunnel Syndrome Questionnaire - Functional Status Scale | Boston carpal tunnel syndrome questionnaire - FSS is patient-based questionnaire for measurement of CTS functional disability which include 8 items to evaluate the functional status scale (FSS). Each item ranges from 1 to 5 with a higher score indicating a higher degree of disability. | Baseline, 1 month, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction (Likert scale) | Likert scale with the grade 1 means that the patient's satisfaction was 30%, grade 2, the patient's satisfaction was 30-50%, grade 3, the satisfaction was 50-80%, and grade 4 was 80%, Grades 3 and 4 were defined as "overall satisfied" | 1month, 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Khaled O Aboshaera, MD | Contact | 01003012229 | khalednao26@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Khaled O Aboshaera, MD | Assistant Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medicine | Asyut | 71111 | Egypt |
|
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18809959 | Background | Smith J, Wisniewski SJ, Finnoff JT, Payne JM. Sonographically guided carpal tunnel injections: the ulnar approach. J Ultrasound Med. 2008 Oct;27(10):1485-90. doi: 10.7863/jum.2008.27.10.1485. | |
| 31209710 | Background | Kamel SR, Sadek HA, Hamed A, Sayed OA, Mahmud MH, Mohamed FA, El Sagher GM, Aly LH. Ultrasound-guided insulin injection for carpal tunnel syndrome in type 2 diabetes mellitus patients. Clin Rheumatol. 2019 Oct;38(10):2933-2940. doi: 10.1007/s10067-019-04638-7. Epub 2019 Jun 17. |
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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 |
|---|---|
| D007328 | Insulin |
| D006820 | Hyaluronic Acid |
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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|
| Sodium Hyaluronate | Drug | Ultrasound guided perineural injection therapy (PIT) |
|
|
| Ultrasound | Device | Philips Neuromuscular Ultrasound |
|
| Neuropathic pain Visual Analog Scale (VAS) | Digital pain severity or paresthesia/dysthesia was evaluated using visual analog scale (VAS). Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain. | Baseline, 1 month, 3 months |
| U/S measured medial nerve mean CSA | Ultrasound measured medial nerve mean cross sectional area at the Pisiform bone level | Baseline, 1 month, 3 months |
| U/S measured medial nerve CSA difference | Ultrasound measured medial nerve cross sectional area difference between pronator | Baseline, 1 month, 3 months |
| U/S hyper-vascularization of medial nerve percentage | Percentage of Ultrasound hyper-vascularization of medial nerve in carpal tunnel | Baseline, 1 month, 3 months |
| Sensory nerve conduction velocity of the median nerve | Antidromic sensory nerve conduction velocity of the median nerve | Baseline, 1 month, 3 months |
| 19802878 | Background | Apel PJ, Ma J, Callahan M, Northam CN, Alton TB, Sonntag WE, Li Z. Effect of locally delivered IGF-1 on nerve regeneration during aging: an experimental study in rats. Muscle Nerve. 2010 Mar;41(3):335-41. doi: 10.1002/mus.21485. |
| 24075279 | Background | Ten Broek RPG, Stommel MWJ, Strik C, van Laarhoven CJHM, Keus F, van Goor H. Benefits and harms of adhesion barriers for abdominal surgery: a systematic review and meta-analysis. Lancet. 2014 Jan 4;383(9911):48-59. doi: 10.1016/S0140-6736(13)61687-6. Epub 2013 Sep 27. |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |