Combined Effect of Insulin and Sodium Hyaluronate Injection Guided by Ultrasound in Carpal Tunnel Syndrome
PIT
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Nov 2019
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2019
CompletedFirst Posted
Study publicly available on registry
October 29, 2019
CompletedStudy Start
First participant enrolled
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedOctober 29, 2019
October 1, 2019
6 months
October 18, 2019
October 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Boston Carpal Tunnel Syndrome Questionnaire - Functional Status Scale
Baseline, 1 month, 3 months
Neuropathic pain Visual Analog Scale (VAS)
Baseline, 1 month, 3 months
U/S measured medial nerve mean CSA
Baseline, 1 month, 3 months
U/S measured medial nerve CSA difference
Baseline, 1 month, 3 months
U/S hyper-vascularization of medial nerve percentage
Baseline, 1 month, 3 months
- +1 more secondary outcomes
Other Outcomes (1)
Patient satisfaction (Likert scale)
1month, 3 months
Study Arms (3)
Insulin and Sodium Hyaluronate Ultrasound guided injection
EXPERIMENTALSubjects will receive Ultrasound guided injection of 10 IU of crystalline insulin and 20 mg of Sodium Hyaluronate
Insulin Ultrasound guided injection
ACTIVE COMPARATORSubjects will receive Ultrasound guided injection of 10 IU of crystalline insulin
Sodium Hyaluronate Ultrasound guided injection
ACTIVE COMPARATORSubjects will receive Ultrasound guided injection of 20 mg of Sodium Hyaluronate
Interventions
Ultrasound guided perineural injection therapy (PIT)
Ultrasound guided perineural injection therapy (PIT)
Philips Neuromuscular Ultrasound
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medicine
Asyut, 71111, Egypt
Related Publications (4)
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.
PMID: 18809959BACKGROUNDKamel 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.
PMID: 31209710BACKGROUNDApel 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.
PMID: 19802878BACKGROUNDTen 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.
PMID: 24075279BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Khaled O Aboshaera, MD
Assistant Professor
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 18, 2019
First Posted
October 29, 2019
Study Start
November 1, 2019
Primary Completion
May 1, 2020
Study Completion
August 1, 2020
Last Updated
October 29, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share