Effect of Different Doses of US in the Treatment of CTS
Effect of Different Doses of Therapeutic Ultrasound in the Treatment of Carpal Tunnel Syndrome
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this study was to investigate the effective dose of therapeutic ultrasound in the treatment of carpal tunnel syndrome on pain level, functional ability, motor and sensory nerve conduction parameters and pinch strength.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2023
CompletedFirst Posted
Study publicly available on registry
May 18, 2023
CompletedStudy Start
First participant enrolled
September 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedMarch 14, 2025
March 1, 2025
6 months
April 28, 2023
March 12, 2025
Conditions
Outcome Measures
Primary Outcomes (7)
symptoms severity and functional status
Symptoms severity and functional status were measured by Boston carpal tunnel syndrome questionnaire. The patients rated their ability to perform the activity on a scale that ranged from 1 (no difficulty with the activity) to 5 (cannot perform the activity at all).
Four weeks
median nerve motor distal latency
Electrodiagnostic tests were used to measure median nerve motor distal latency in milliseconds.
Four weeks
median nerve motor amplitude
Electrodiagnostic tests were used to measure motor amplitude in millivolt.
Four weeks
median nerve sensory distal latency
Electrodiagnostic tests were used to measure median nerve sensory distal latency in milliseconds.
Four weeks
median nerve sensory amplitude
Electrodiagnostic tests were used to measure sensory amplitude in millivolt
Four weeks
Pain intensity
Pain intensity was measured by visual analogue scale. Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
Four weeks
Pinch strength
Pinch dynamometer was used to measure pinch strength
Four weeks
Study Arms (4)
Control group
SHAM COMPARATOR(control group) It consisted of 15 subjects who received a program of 'sham' US application, so that the US device was working but not delivering any output plus traditional PT treatment for carpal tunnel syndrome which included hot packs, tendon glide and nerve glide exercises, US treatment sessions were performed for 6 min per session, once a day, three days a week, for a total of 4 weeks.
Low-dose group
EXPERIMENTAL(low-dose group) It consisted of 15 subjects who received a program of US treatments that was administered to the carpal tunnel area with pulsed mode at a frequency of 1 MHz with an intensity of 0.25 W/cm2 and a duty cycle of 1:4 plus traditional treatment.
Mid-dose group
EXPERIMENTAL(Mid-dose group) It consisted of 15 subjects who received a program of US treatments that was administered to the carpal tunnel area with pulsed mode at a frequency of 1 MHz with an intensity of 0.5 W/cm2 and a duty cycle of 1:4 plus traditional treatment.
High-dose group
EXPERIMENTAL(high-dose group) It consisted of 15 subjects who received a program of the same US equipment that was set at pulsed mode at a frequency of 1 MHz, intensity of 1.0W/ cm2 and a duty cycle of 1:4 plus traditional treatment.
Interventions
The patients received traditional physical therapy treatment for carpal tunnel syndrome, in the form of hot packs, tendon and nerve glide exercises, and wrist splint for 4 weeks.
US treatment sessions were performed for 6 min per session, once a day, three days a week, for a total of 4 weeks.
Eligibility Criteria
You may qualify if:
- Subject's age range was 25-55 years .
- Mild to moderate CTS, that is confirmed by neurologist or orthopedist based on results of physical examination and electrophysiological criteria; i. Mild CTS is characterized by sensory fibers involvement (sensory peak latency \> 3.6 milliseconds) with no motor fiber involvement (motor distal latency \< 4.1 milliseconds), provided that sensory nerve action potential (SNAP) is not absent.
- ii. Moderate CTS is characterized by involvement of both sensory and motor fibers, provided that neither of these two waves is absent .
- Pain intensity more than 5 in visual analogue scale (VAS).
You may not qualify if:
- History of any trauma on the hands, neck, and shoulders within 3 months of the study onset
- Cervical radiculopathy, peripheral polyneuropathy, or other neurological conditions.
- Patients suffering from severe CTS according to electrophysiological criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Ismailia Medical Complex
Ismailia, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ragia Mohamed Kamel, PhD
Professor, Cairo university
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- physical therapist
Study Record Dates
First Submitted
April 28, 2023
First Posted
May 18, 2023
Study Start
September 10, 2023
Primary Completion
March 1, 2024
Study Completion
April 1, 2024
Last Updated
March 14, 2025
Record last verified: 2025-03