Clinical trial NCT05838807: Thermal and Pulsed Ultrasound for Carpal Tunnel Syndrome
Official title: The Effects of Thermal and Pulsed Ultrasound on Pain and Function in Individuals With Carpal Tunnel Syndrome: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Median Neuropathy, Carpal Tunnel
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 92
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be a level II randomized controlled trial with a parallel group design. Participants will be randomized to receive one of four interventions: thermal ultrasound, pulsed ultrasound, a combination of both, or a placebo treatment. Participants will receive their assigned treatment for 10 minutes, three times per week, for 4 weeks.
Primary purpose: TREATMENT

Brief summary: This study will be a Randomized controlled trial with a sample size of at least 100 individuals with carpal tunnel syndrome. Participants will be randomized to receive either thermal ultrasound, pulsed ultrasound, a combination of both, or a placebo treatment for 10 minutes, three times per week, for 4 weeks. Outcome measures will include pain intensity, functional status, and nerve conduction studies. Outcome measures will be assessed at baseline, 4 weeks, and 8 weeks.


Eligibility criteria: Inclusion Criteria:

1. Adults aged 30-60 years old
2. Diagnosis of carpal tunnel syndrome based on clinical symptoms and nerve conduction studies, including:

   * Symptoms of pain, numbness, and tingling in the hand and/or fingers, particularly the thumb, index, and middle fingers
   * Positive Tinel's sign (tapping over the median nerve at the wrist elicits tingling or numbness in the hand)
   * Positive Phalen's maneuver (flexion of the wrist for 60 seconds elicits tingling or numbness in the hand)
   * Abnormal nerve conduction studies showing prolonged distal motor latency, and/or decreased amplitude of the median nerve

Exclusion Criteria:

1. Prior surgery for carpal tunnel syndrome
2. History of wrist or hand fracture in the past year
3. Pregnancy or planning to become pregnant during the study period
4. Active infection or skin condition in the treatment area
5. Known allergy to ultrasound gel or other components of the treatment
6. Use of corticosteroids or other medications that may affect nerve function within the past 3 months
7. Participation in another clinical trial within the past 30 days

Primary outcomes:
measure: Pain Intensity
timeFrame: Changes in pain intensity at baseline, 4 weeks after randomization, and 8 weeks after discharge.
measure: Functional Status
timeFrame: Changes in functional status at baseline, 4 weeks after randomization, and 8 weeks after discharge.
Secondary outcomes:
measure: Nerve Conduction Studies
timeFrame: Changes in nerve conduction studies at baseline, 4 weeks after randomization, and 8 weeks after discharge.
measure: Hand grip strength
timeFrame: Changes in hand grip strength at baseline, 4 weeks after randomization, and 8 weeks after discharge.
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: Outpatient clinic of faculty of physical therapy, Ahram Canadian University
state: Giza
Study officials:
affiliation: Faculty of Physical Therapy, Ahram Canadian University
name: Amal Fawzy, Ph.d
role: STUDY_CHAIR
References: