Carpal Tunnel Syndrome Clinical Trial
Official title:
Efficacy of Ultrasound-Guided Hydrodissection in Patients With Carpal Tunnel Syndrome
Verified date | January 2024 |
Source | Afyonkarahisar Health Sciences University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of our study is to determine the effectiveness of US-guided hydrodissection of the median nerve in different contents and volumes in patients diagnosed with mild to moderate carpal tunnel syndrome.
Status | Completed |
Enrollment | 80 |
Est. completion date | January 10, 2024 |
Est. primary completion date | December 20, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 60 Years |
Eligibility | Inclusion Criteria: - Presence of symptoms of carpal tunnel syndrome, including nocturnal, postural, or movement-related paresthesias +/- pain in the median nerve distribution area in the hand for more than 3 months - Presence of mild to moderate carpal tunnel syndrome proven by electrophysiological study - Loss of sensation with numbness in the median nerve-innervated areas of the hand, weakness of the median nerve-innervated thenar muscles - Positive Phalen test and/or Tinel sign Exclusion Criteria: - Patients who can mimic the diagnosis of carpal tunnel syndrome, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome - Patients who have had an injection into the carpal tunnel in the last 6 months - Patients with thenar muscle atrophy - History of Carpal tunnel surgery - Regular use of systemic nonsteroidal anti-inflammatory drugs and corticosteroids - Pregnancy - Rheumatoid arthritis, systemic lupus erythematosus, gout, systemic sclerosis, dermatomyositis, polymyositis - Presence of malignancy - Presence of active infection |
Country | Name | City | State |
---|---|---|---|
Turkey | Afyonkarahisar Health Sciences University | Afyonkarahi?sar |
Lead Sponsor | Collaborator |
---|---|
Afyonkarahisar Health Sciences University |
Turkey,
Babaei-Ghazani A, Forogh B, Raissi GR, Ahadi T, Eftekharsadat B, Yousefi N, Rahimi-Dehgolan S, Moradi K. Ultrasound-Guided Corticosteroid Injection in Carpal Tunnel Syndrome: Comparison Between Radial and Ulnar Approaches. J Pain Res. 2020 Jun 26;13:1569-1578. doi: 10.2147/JPR.S248600. eCollection 2020. — View Citation
Chang KV, Wu WT, Ozcakar L. Ultrasound imaging and guidance in peripheral nerve entrapment: hydrodissection highlighted. Pain Manag. 2020 Mar;10(2):97-106. doi: 10.2217/pmt-2019-0056. Epub 2020 Mar 12. — View Citation
Lam KHS, Hung CY, Chiang YP, Onishi K, Su DCJ, Clark TB, Reeves KD. Ultrasound-Guided Nerve Hydrodissection for Pain Management: Rationale, Methods, Current Literature, and Theoretical Mechanisms. J Pain Res. 2020 Aug 4;13:1957-1968. doi: 10.2147/JPR.S247208. eCollection 2020. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Analog Scale (VAS) | Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity. | up to 12th week | |
Secondary | Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) | The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) is a frequently used questionnaire for CTS that includes 2 components. It evaluates for grading under two sub-headings: symptom severity scale (11 questions) and functional status scale (8 questions). Scores range from 0 to 5 for each question; 0 represents no difficulty during the activity, 5 represents extremely severe dysfunction. | up to 12th week | |
Secondary | Cross-sectional area of the Median Nerve (CSA) | The cross-sectional area (CSA) of the median nerve will be used for analysis by the mean value of 3 measurements made with an electronic caliper at the same level as the injection site (scaphoid-pisiform level).
CSA values increase as clinical findings worsen. |
up to 12th week | |
Secondary | Electrophysiological Evaluation | Antidromic sensory nerve conduction velocity and distal motor latency of the median nerve will be measured in all patients. All measurements will be made 3 times and the average value will be taken. To diagnose CTS electrophysiologically; The median nerve peak sensory conduction velocity recorded antidromically from the second finger should be slower than 41.25 m/sec, the conduction velocity should be slower than 34 m/sec in the mixed nerve conduction study in the palm-wrist segment (8 cm), and/or recordings from the APB (abductor pollicis brevis) muscle DML (distal motor latency) was determined to be longer than 3.8 ms with stimulation of the median nerve from the wrist segment (5 cm). | up to 12th week | |
Secondary | Hand and Finger Grip Strength Assessment | The hand grip strength of the participants will be measured with the "Jamar Hand Dynamometer". Measurements will be made with the shoulder in adduction and neutral rotation adjacent to the trunk, elbow 90 degrees flexed, wrist 0-30 degrees dorsiflexion and 0-15 degrees ulnar deviation with thumb up. Finger grip strength will be evaluated with the "Jamar Digital Pinchmeter". Patients will be placed in the sitting position with the wrist in 90° flexion and the forearm in the neutral position. Measurements will be made bilaterally in three different positions as lateral, palmar and fingertip grips. Patients will be asked to squeeze with maximum force and each measurement will be made three times, and their averages will be recorded in kg. The dynamometer has a dual scale readout which displays isometric grip force from 0-90 kg. Higher scores means better grip strength. | up to 12th week |
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