search
Back to results

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

Primary Purpose

Carpal Tunnel Syndrome

Status
Unknown status
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Insulin
Sodium Hyaluronate
Ultrasound
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Insulin and Sodium Hyaluronate Ultrasound guided injection

Insulin Ultrasound guided injection

Sodium Hyaluronate Ultrasound guided injection

Arm Description

Subjects will receive Ultrasound guided injection of 10 IU of crystalline insulin and 20 mg of Sodium Hyaluronate

Subjects will receive Ultrasound guided injection of 10 IU of crystalline insulin

Subjects will receive Ultrasound guided injection of 20 mg of Sodium Hyaluronate

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
U/S measured medial nerve mean CSA
Ultrasound measured medial nerve mean cross sectional area at the Pisiform bone level
U/S measured medial nerve CSA difference
Ultrasound measured medial nerve cross sectional area difference between pronator
U/S hyper-vascularization of medial nerve percentage
Percentage of Ultrasound hyper-vascularization of medial nerve in carpal tunnel
Sensory nerve conduction velocity of the median nerve
Antidromic sensory nerve conduction velocity of the median nerve

Full Information

First Posted
October 18, 2019
Last Updated
October 25, 2019
Sponsor
Assiut University
search

1. Study Identification

Unique Protocol Identification Number
NCT04142411
Brief Title
Combined Effect of Insulin and Sodium Hyaluronate Injection Guided by Ultrasound in Carpal Tunnel Syndrome
Acronym
PIT
Official Title
Combined Effect of Insulin and Sodium Hyaluronate Injection Guided by Ultrasound in Carpal Tunnel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2019 (Anticipated)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Insulin and Sodium Hyaluronate Ultrasound guided injection
Arm Type
Experimental
Arm Description
Subjects will receive Ultrasound guided injection of 10 IU of crystalline insulin and 20 mg of Sodium Hyaluronate
Arm Title
Insulin Ultrasound guided injection
Arm Type
Active Comparator
Arm Description
Subjects will receive Ultrasound guided injection of 10 IU of crystalline insulin
Arm Title
Sodium Hyaluronate Ultrasound guided injection
Arm Type
Active Comparator
Arm Description
Subjects will receive Ultrasound guided injection of 20 mg of Sodium Hyaluronate
Intervention Type
Drug
Intervention Name(s)
Insulin
Other Intervention Name(s)
Crystalline Insulin
Intervention Description
Ultrasound guided perineural injection therapy (PIT)
Intervention Type
Drug
Intervention Name(s)
Sodium Hyaluronate
Other Intervention Name(s)
Hyalgan
Intervention Description
Ultrasound guided perineural injection therapy (PIT)
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
Philips Neuromuscular Ultrasound
Primary Outcome Measure Information:
Title
Boston Carpal Tunnel Syndrome Questionnaire - Symptom Severity Scale
Description
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.
Time Frame
Baseline, 1 month, 3 months
Secondary Outcome Measure Information:
Title
Boston Carpal Tunnel Syndrome Questionnaire - Functional Status Scale
Description
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.
Time Frame
Baseline, 1 month, 3 months
Title
Neuropathic pain Visual Analog Scale (VAS)
Description
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.
Time Frame
Baseline, 1 month, 3 months
Title
U/S measured medial nerve mean CSA
Description
Ultrasound measured medial nerve mean cross sectional area at the Pisiform bone level
Time Frame
Baseline, 1 month, 3 months
Title
U/S measured medial nerve CSA difference
Description
Ultrasound measured medial nerve cross sectional area difference between pronator
Time Frame
Baseline, 1 month, 3 months
Title
U/S hyper-vascularization of medial nerve percentage
Description
Percentage of Ultrasound hyper-vascularization of medial nerve in carpal tunnel
Time Frame
Baseline, 1 month, 3 months
Title
Sensory nerve conduction velocity of the median nerve
Description
Antidromic sensory nerve conduction velocity of the median nerve
Time Frame
Baseline, 1 month, 3 months
Other Pre-specified Outcome Measures:
Title
Patient satisfaction (Likert scale)
Description
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"
Time Frame
1month, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Khaled O Aboshaera, MD
Phone
01003012229
Email
khalednao26@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khaled O Aboshaera, MD
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medicine
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khaled O Aboshaera, MD
Phone
01003012229
Email
khalednao26@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18809959
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.
Results Reference
background
PubMed Identifier
31209710
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.
Results Reference
background
PubMed Identifier
19802878
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.
Results Reference
background
PubMed Identifier
24075279
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs