Clinical trial NCT05637684: Low Intensity Ultrasound in Patients With Carpal Tunnel Syndrome
Official title: Influence of Low Intensity Pulsed Ultrasound on Enhancing Biostimulation of Median Nerve in Patients With Chronic Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 52
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: TREATMENT

Brief summary: To investigate the influence of low intensity pulsed ultrasound on Pain level, pinch grip strength, sensory distal latency of the median nerve, motor distal latency of the median nerve and hand function in patients with chronic carpal tunnel syndrome

Detailed description: Carpal tunnel syndrome (CTS) is an entrapment neuropathy caused by compression of the median nerve as it travels through the wrist's carpal tunnel. It is the most common nerve entrapment neuropathy, accounting for 90% of all neuropathies. Early symptoms of carpal tunnel syndrome include pain, numbness, and paresthesia. These symptoms typically present, with some variability, in the thumb, index finger, middle finger, and the radial half (thumb side) of the ring finger. Pain also can radiate up the affected arm. With further progression, hand weakness, decreased fine motor coordination, clumsiness, and thenar atrophy can occur.

Low-intensity ultrasound (LIU) and low-intensity pulsed ultrasound (LIPUS) are known to have positive effects on dentin genesis, cell proliferation, protein synthesis, collagen synthesis, membrane permeability, and integrin expression and to increase cytosolic calcium levels.

Eligibility criteria: Inclusion Criteria:

1. 26 male and 26 female patients have unilateral with mild to moderate CTS in dominant hand diagnosed and referred by physician.
2. Age will be ranged from 30-50 years
3. All patients have body mass index between 18.5 and 24.9 kg/m2
4. Median nerve sensory distal latency \> 3.5 millisecond but not more than 4.5 millisecond, motor distal latency longer than 4.2 millisecond but not exceed 6.5 millisecond.
5. Positive clinical manifestation (pain, paresthesia in the distribution of the median nerve for 6 months, positive Tinel's and Phalen's sign)

Exclusion Criteria:

1. Patients with diabetes mellitus ( type I or type II),
2. Patients with hypothyroidism
3. Patients with rheumatoid disease
4. Patients with renal disease
5. Patients with polyneuropathy
6. patients with cervical radiculopathy
7. Patients with wrist arthritis , wrist fracture and acute trauma
8. Patients with Carpal tunnel release surgery
9. Patients with outlet syndrome
10. thenar muscle atrophy -

Primary outcomes:
measure: median nerve sensory distal latency
timeFrame: 4 WEEKS
measure: median nerve motor distal latency
timeFrame: 4 WEEKS
measure: pinch grip strength
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy Cairo University
state: Dokki
Study officials:
affiliation: Cairo University
name: FAHD A HASSAN
role: PRINCIPAL_INVESTIGATOR
References: