Clinical trial NCT04142411: Combined Effect of Insulin and Sodium Hyaluronate Injection Guided by Ultrasound in Carpal Tunnel Syndrome
Official title: Combined Effect of Insulin and Sodium Hyaluronate Injection Guided by Ultrasound in Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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)

Eligibility criteria: 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

Primary outcomes:
measure: Boston Carpal Tunnel Syndrome Questionnaire - Symptom Severity Scale
timeFrame: Baseline, 1 month, 3 months
Secondary outcomes:
measure: Boston Carpal Tunnel Syndrome Questionnaire - Functional Status Scale
timeFrame: Baseline, 1 month, 3 months
measure: Neuropathic pain Visual Analog Scale (VAS)
timeFrame: Baseline, 1 month, 3 months
measure: U/S measured medial nerve mean CSA
timeFrame: Baseline, 1 month, 3 months
measure: U/S measured medial nerve CSA difference
timeFrame: Baseline, 1 month, 3 months
measure: U/S hyper-vascularization of medial nerve percentage
timeFrame: Baseline, 1 month, 3 months
measure: Sensory nerve conduction velocity of the median nerve
timeFrame: Baseline, 1 month, 3 months
Other outcomes:
measure: Patient satisfaction (Likert scale)
timeFrame: 1month, 3 months
Locations:
city: Assiut
country: Egypt
facility: Medicine
Study officials:
affiliation: Assistant Professor
name: Khaled O Aboshaera, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.7863/jum.2008.27.10.1485.
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 Oct;38(10):2933-2940. doi: 10.1007/s10067-019-04638-7. Epub 2019 Jun 17.
citation: 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.
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.