Back to resultsThermal and Pulsed Ultrasound for Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndrome, Median Neuropathy, Carpal Tunnel
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Thermal Ultrasound
Pulsed Ultrasound
Combined Ultrasound
Placebo Ultrasound
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome
Eligibility Criteria
Inclusion Criteria: Adults aged 30-60 years old 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: Prior surgery for carpal tunnel syndrome History of wrist or hand fracture in the past year Pregnancy or planning to become pregnant during the study period Active infection or skin condition in the treatment area Known allergy to ultrasound gel or other components of the treatment Use of corticosteroids or other medications that may affect nerve function within the past 3 months Participation in another clinical trial within the past 30 days
Sites / Locations
- Outpatient clinic of faculty of physical therapy, Ahram Canadian UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Group A: Thermal Ultrasound Group
Group B: Pulsed Ultrasound Group:
Group C: Combination Group
Group D: Placebo Group
Arm Description
Outcomes
Primary Outcome Measures
Pain Intensity
This will be measured using the visual analogue scale (VAS), which is a valid and reliable tool for assessing pain intensity. The VAS is a 10-cm horizontal line with anchors of "no pain" and "worst pain imaginable," and participants will be asked to mark their level of pain intensity on the line.
Functional Status
his will be measured using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, which is a validated instrument for assessing upper extremity function. The DASH consists of 30 items assessing physical function, symptoms, and social-emotional aspects of disability, and scores range from 0 (no disability) to 100 (severe disability).
Secondary Outcome Measures
Nerve Conduction Studies
This will be assessed using nerve conduction studies (NCS), which are a validated tool for assessing nerve function in individuals with carpal tunnel syndrome. NCS will be used to measure median nerve sensory and motor distal latency in addition to the amplitude of the median nerve.
Hand grip strength
This will be measured using a handheld dynamometer, which is a validated tool for assessing grip strength in individuals with carpal tunnel syndrome. Participants will be asked to squeeze the dynamometer as hard as possible, and the highest value of three trials for each hand will be recorded.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05838807
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 28, 2023 (Actual)
Primary Completion Date
October 27, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahram Canadian University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome, Median Neuropathy, Carpal Tunnel
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes Assessor
Masking Description
In addition to the participants being blinded to the treatment they are receiving, the outcome assessors will also be blinded to the treatment assignment. This will ensure that the assessors are unbiased when measuring the outcome measures of pain intensity, functional status, and nerve conduction studies.
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A: Thermal Ultrasound Group
Arm Type
Experimental
Arm Title
Group B: Pulsed Ultrasound Group:
Arm Type
Experimental
Arm Title
Group C: Combination Group
Arm Type
Experimental
Arm Title
Group D: Placebo Group
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Thermal Ultrasound
Intervention Description
Participants in this group will receive thermal ultrasound treatment using a gel-coupled ultrasound probe that delivers continuous ultrasound waves at a frequency of 1 Mega Hertz. The ultrasound probe will be moved continuously over the affected wrist and hand region for 5 minutes per session, three times per week, for four weeks. The intensity of the ultrasound wave will be set at 1.0 W/cm2 applied for 5 minutes. The treatment will be administered three times per week, for four weeks.
Intervention Type
Device
Intervention Name(s)
Pulsed Ultrasound
Intervention Description
Participants in this group will receive pulsed ultrasound treatment using a gel-coupled ultrasound probe that delivers pulsed ultrasound waves at a frequency of 1 Mega Hertz. The ultrasound probe will be moved continuously over the affected wrist and hand region for 15 minutes with 25% duty cycle and intensity of 1.0 W/cm2.The treatment will be administered three times per week, for four weeks.
Intervention Type
Device
Intervention Name(s)
Combined Ultrasound
Intervention Description
Participants in this group will receive a combination of thermal and pulsed ultrasound treatments. The thermal ultrasound treatment will be administered first for 5 minutes, followed by the pulsed ultrasound treatment for another 15 minutes. The same parameters as described above will be used for each treatment modality. The combination treatment will be administered three times per week, for four weeks.
Intervention Type
Device
Intervention Name(s)
Placebo Ultrasound
Intervention Description
Participants in this group will receive a placebo ultrasound treatment that looks and feels identical to the active ultrasound treatments, but does not deliver any therapeutic effects. The placebo treatment will be administered using the same gel-coupled ultrasound probe for 15 minutes per session, three times per week, for four weeks, with the intensity set at 0 W/cm² and the temperature maintained at room temperature.
Primary Outcome Measure Information:
Title
Pain Intensity
Description
This will be measured using the visual analogue scale (VAS), which is a valid and reliable tool for assessing pain intensity. The VAS is a 10-cm horizontal line with anchors of "no pain" and "worst pain imaginable," and participants will be asked to mark their level of pain intensity on the line.
Time Frame
Changes in pain intensity at baseline, 4 weeks after randomization, and 8 weeks after discharge.
Title
Functional Status
Description
his will be measured using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, which is a validated instrument for assessing upper extremity function. The DASH consists of 30 items assessing physical function, symptoms, and social-emotional aspects of disability, and scores range from 0 (no disability) to 100 (severe disability).
Time Frame
Changes in functional status at baseline, 4 weeks after randomization, and 8 weeks after discharge.
Secondary Outcome Measure Information:
Title
Nerve Conduction Studies
Description
This will be assessed using nerve conduction studies (NCS), which are a validated tool for assessing nerve function in individuals with carpal tunnel syndrome. NCS will be used to measure median nerve sensory and motor distal latency in addition to the amplitude of the median nerve.
Time Frame
Changes in nerve conduction studies at baseline, 4 weeks after randomization, and 8 weeks after discharge.
Title
Hand grip strength
Description
This will be measured using a handheld dynamometer, which is a validated tool for assessing grip strength in individuals with carpal tunnel syndrome. Participants will be asked to squeeze the dynamometer as hard as possible, and the highest value of three trials for each hand will be recorded.
Time Frame
Changes in hand grip strength at baseline, 4 weeks after randomization, and 8 weeks after discharge.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults aged 30-60 years old
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:
Prior surgery for carpal tunnel syndrome
History of wrist or hand fracture in the past year
Pregnancy or planning to become pregnant during the study period
Active infection or skin condition in the treatment area
Known allergy to ultrasound gel or other components of the treatment
Use of corticosteroids or other medications that may affect nerve function within the past 3 months
Participation in another clinical trial within the past 30 days
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed M ElMeligie, Ph.d
Phone
+201064442032
Email
mohamed.elmeligie@acu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amal Fawzy, Ph.d
Organizational Affiliation
Faculty of Physical Therapy, Ahram Canadian University
Official's Role
Study Chair
Facility Information:
Facility Name
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
City
Al Ḩayy Ath Thāmin
State/Province
Giza
ZIP/Postal Code
3221405
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed M ElMeligie, Ph.d
Phone
01064442032
Email
mohamed.elmeligie@acu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The individual participant data (IPD) collected during this study will be available upon reasonable request. Requests for access to the data should be submitted via email to mohamed.elmeligie@acu.edu.eg. All requests will be reviewed by the study investigators to ensure that they are reasonable and consistent with the ethical principles of the study. Access to the data will be granted in compliance with applicable laws and regulations, and with appropriate safeguards to protect the privacy and confidentiality of study participants.
IPD Sharing Time Frame
During the trial and 1 year after the trial end.
IPD Sharing Access Criteria
via email to mohamed.elmeligie@acu.edu.eg
Learn more about this trial
Thermal and Pulsed Ultrasound for Carpal Tunnel Syndrome
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