Carpal Tunnel Syndrome
Conditions
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)
Interventions
DRUGInsulin
Ultrasound guided perineural injection therapy (PIT)
DRUGSodium Hyaluronate
Ultrasound guided perineural injection therapy (PIT)
DEVICEUltrasound
Philips Neuromuscular Ultrasound
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Boston Carpal Tunnel Syndrome Questionnaire - Symptom Severity Scale | Baseline, 1 month, 3 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Boston Carpal Tunnel Syndrome Questionnaire - Functional Status Scale | Baseline, 1 month, 3 months | 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) | Baseline, 1 month, 3 months | 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 | Baseline, 1 month, 3 months | Ultrasound measured medial nerve mean cross sectional area at the Pisiform bone level |
| U/S hyper-vascularization of medial nerve percentage | Baseline, 1 month, 3 months | Percentage of Ultrasound hyper-vascularization of medial nerve in carpal tunnel |
| Sensory nerve conduction velocity of the median nerve | Baseline, 1 month, 3 months | Antidromic sensory nerve conduction velocity of the median nerve |
| U/S measured medial nerve CSA difference | Baseline, 1 month, 3 months | Ultrasound measured medial nerve cross sectional area difference between pronator |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction (Likert scale) | 1month, 3 months | 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 |
Countries
Egypt
Contacts
Primary ContactKhaled O Aboshaera, MD
Outcome results
None listed