Combined Effect of Insulin and Sodium Hyaluronate Injection Guided by Ultrasound in Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

— PIT  

Official title:

Combined Effect of Insulin and Sodium Hyaluronate Injection Guided by Ultrasound in Carpal Tunnel Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04142411
• Other study ID #: AssiutUKAboshaera01
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: November 2019
• Est. completion date: August 2020

Study information

• Verified date: October 2019
• Source: Assiut University
• Contact: Khaled O Aboshaera, MD
• Phone: 01003012229
• Email: khalednao26[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: August 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Aged 18 to 65

• Understanding written and spoken Arabic consent

• Diagnostic of carpal tunnel syndrome: Classic of probable based on the Katz Hand Diagram and mild to moderate based on the electrodiagnosis studies

Exclusion Criteria:

• Diseases known to cause carpal tunnel syndrome: Diabetes mellitus, hypothyroidism, connective tissue disease, rheumatic disease and moderate or severe chronic renal impairment

• Secondary diagnosis based on the ultrasound: arthrosynovial cyst, flexor tenosynovitis, ganglion

• Constant symptoms in medial nerve area

• Thenar eminence atrophy

• Cervical radiculopathy

• Brachial plexopathy

• Thoracic outlet syndrome

• Polyneuropathy

• Pregnancy

• Cognitive disorder

• Anticoagulant therapy

• Carpal tunnel injection in the last 6 months

• Ancient ipsilateral wrist fracture

• Ancient ipsilateral wrist surgery

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Drug:
• Insulin
Ultrasound guided perineural injection therapy (PIT)
• Sodium Hyaluronate
Ultrasound guided perineural injection therapy (PIT)

Device:
• Ultrasound
Philips Neuromuscular Ultrasound

Locations

Country	Name	City	State
Egypt	Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

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 Jun 17. doi: 10.1007/s10067-019-04638-7. [Epub ahead of print] — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	U/S measured medial nerve CSA difference	Ultrasound measured medial nerve cross sectional area difference between pronator	Baseline, 1 month, 3 months
Secondary	U/S hyper-vascularization of medial nerve percentage	Percentage of Ultrasound hyper-vascularization of medial nerve in carpal tunnel	Baseline, 1 month, 3 months
Secondary	Sensory nerve conduction velocity of the median nerve	Antidromic sensory nerve conduction velocity of the median nerve	Baseline, 1 month, 3 months