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Carpal Tunnel SyndromeEarly Phase 1PITNCT04142411

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

A Early Phase 1 study testing Insulin, Sodium Hyaluronate and Ultrasound in people with Carpal Tunnel Syndrome, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Carpal Tunnel Syndrome
What is being tested?
Insulin, Sodium Hyaluronate and Ultrasound
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteEgypt
Study dates
Nov 2019to Aug 2020
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Khaled O Aboshaera, MD contact

01003012229

khalednao26@gmail.com

Egypt1 site

  • Medicine

    Asyut, 71111

    Khaled O Aboshaera, MD, 01003012229, khalednao26@gmail.com

Other trials in Egypt

About this study

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.

Read the 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)

Being tested
Insulin, Sodium Hyaluronate, Ultrasound
Medical subject headings
Carpal Tunnel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InsulinDrug

    Also called Crystalline Insulin

    Ultrasound guided perineural injection therapy (PIT)

  • Sodium HyaluronateDrug

    Also called Hyalgan

    Ultrasound guided perineural injection therapy (PIT)

  • UltrasoundDevice

    Philips Neuromuscular Ultrasound

Study groups in NCT04142411
Study groupRoleWhat they receive
Insulin and Sodium Hyaluronate Ultrasound guided injectionExperimentalSubjects will receive Ultrasound guided injection of 10 IU of crystalline insulin and 20 mg of Sodium Hyaluronate
Receives: Drug: Insulin; Drug: Sodium Hyaluronate; Device: Ultrasound
Insulin Ultrasound guided injectionActive comparatorSubjects will receive Ultrasound guided injection of 10 IU of crystalline insulin
Receives: Drug: Insulin; Device: Ultrasound
Sodium Hyaluronate Ultrasound guided injectionActive comparatorSubjects will receive Ultrasound guided injection of 20 mg of Sodium Hyaluronate
Receives: Drug: Sodium Hyaluronate; Device: Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 1 month, 3 months

Secondary outcomes (6)

  1. 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.

    Measured: Baseline, 1 month, 3 months

  2. 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.

    Measured: Baseline, 1 month, 3 months

  3. U/S measured medial nerve mean CSA

    Ultrasound measured medial nerve mean cross sectional area at the Pisiform bone level

    Measured: Baseline, 1 month, 3 months

  4. U/S measured medial nerve CSA difference

    Ultrasound measured medial nerve cross sectional area difference between pronator

    Measured: Baseline, 1 month, 3 months

  5. U/S hyper-vascularization of medial nerve percentage

    Percentage of Ultrasound hyper-vascularization of medial nerve in carpal tunnel

    Measured: Baseline, 1 month, 3 months

  6. Sensory nerve conduction velocity of the median nerve

    Antidromic sensory nerve conduction velocity of the median nerve

    Measured: Baseline, 1 month, 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2019
  2. Study startNov 2019 (estimated)
  3. Primary completionMay 2020 (estimated)
  4. Study completionAug 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04142411
Sponsor's protocol ID
AssiutUKAboshaera01
Acronym
PIT
Status last verified
Oct 2019
First submitted
18 Oct 2019
Last updated
29 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 18809959

  • 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.

    PubMed 31209710

  • 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.

    PubMed 19802878

  • 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.

    PubMed 24075279

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Insulin, Sodium Hyaluronate and Ultrasound in people with Carpal Tunnel Syndrome, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Khaled O Aboshaera, MD (01003012229, khalednao26@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Boston Carpal Tunnel Syndrome Questionnaire - Symptom Severity Scale (time frame: Baseline, 1 month, 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04142411, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2019.

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