Back to resultsUltrasound and Phonophoresis in Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ultrasound
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring carpal tunnel syndrome, steroid phonophoresis, ultrasound
Eligibility Criteria
Inclusion Criteria:
- Mild or moderate idiopathic carpal tunnel syndrome (without thenar atrophy or spontaneous activity on electrophysiological examination of the abductor pollicis brevis (APB) muscle)
Exclusion Criteria:
- The patients with medical problems (diabetes mellitus, hypothyroidism, rheumatic diseases, acute trauma, pregnancy etc.)
- cervical radiculopathy
- etiologic factors which predispose to or polyneuropathy
- reinnervation or fibrillation potentials in their abductor pollicis brevis muscles
- physical or medical therapy within 3 months for CTS and steroid injection applied
- experience CTS median nerve trauma and CTS surgery
- serious thenar atrophy and anesthesia
- contraindication in steroid treatment (steroid allergies, hypertension etc.)
- contraindication in ultrasonic therapy (bleeding disorders, acute inflammation of the joints, acute infections, cancer and precancerous lesions, arteriovenous circulatory disorders etc.)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
ultrasound
phonophoresis
placebo ultrasound
Arm Description
ultrasound : a frequency of 1 MHz and an intensity of 1 W/cm2, 5 days a week, a total of 10 sessions
an intensity of 1 W/cm2 and a frequency of 1 MHz and phonophoresis with 0.1% dexamethasone pomade,5 days a week, a total of 10 sessions
same ultrasound device as described above seemed to be working but without delivering any output, 5 days a week, a total of 10 sessions
Outcomes
Primary Outcome Measures
Visual Analogue Scale
Change from baseline in pain with Visual Analogue Scale:Patients were asked to express the pain felt by them using 0-10 scales, 0 no pain and 10 the most severe pain faced throughout their life.
Boston Symptom Severity Scale
Change from baseline in symptom severity with Boston Symptom Severity Scale:Patients were asked to choose an answer among five answers taking 1- 5 points in the questionnaires with 11 statements. Total point was divided into the number of statements and the score was determined and high scores were interpreted as increased symptom severity
Boston Functional Capacity Scale
Change from baseline in functional status with Boston Functional Capacity Scale:Patients were asked to choose an answer among five answers taking 1- 5 points in the questionnaires with 11 statements. Total point was divided into the number of statements and average score was determined and high scores were interpreted as functionality deformation in the hands
grip strength
Change from baseline in strength with grip strength:To assess the grip strength, baseline hydraulic hand dynamometer was used. 3 measurements were made for each patient and the average of them was calculated
electroneurophysiological evaluations
Change from baseline electroneurophysiological measurement:The median nerve motor conduction velocity(m/s) , the median nerve motor distal latency(ms), 2nd finger - palm median nerve sensory distal latency(ms), 2nd finger - palm median nerve sensory conduction velocity(m/s), median sensory nerve conduction velocity(m/s) and median nerve sensory distal latency between the wrist and palm(ms)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04499014
Brief Title
Ultrasound and Phonophoresis in Carpal Tunnel Syndrome
Official Title
Evaluation of the Effects of Steroid Phonophoresis and Therapeutic Ultrasound in Carpal Tunnel Syndrome: A Randomized Placebo - Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 14, 2014 (Actual)
Primary Completion Date
October 1, 2015 (Actual)
Study Completion Date
January 15, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eskisehir City Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
In this placebo-controlled, randomized, prospective study, the efficacy of ultrasonography (US) and steroid phonophoresis (PH) treatments was evaluated in patients with idiopathic carpal tunnel syndrome.
Detailed Description
Twenty-seven patients (46 hands) were admitted in this study. Patients were randomly divided three groups. The first group was ultrasound group, the second group was PH group and the third group was placebo US group. Continuous ultrasound with a frequency of 1 MHz, an intensity of 1.0 W/cm2 was used in the US and the PH groups. PH group received 0,1% dexamethasone. Placebo group received a frequency of 0 MHz, an intensity of 0 W/cm² ultrasound. Treatments were administered for 5 days a week, a total of 10 sessions. All patients also wore night splints during treatment. Visual Analogue Scale (VAS), Boston Symptom Severity Scale, Functional Capacity Scale, grip strength and electroneurophysiological evaluations were compared before the treatment, after the treatment and three months later.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
carpal tunnel syndrome, steroid phonophoresis, ultrasound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ultrasound
Arm Type
Experimental
Arm Description
ultrasound : a frequency of 1 MHz and an intensity of 1 W/cm2, 5 days a week, a total of 10 sessions
Arm Title
phonophoresis
Arm Type
Experimental
Arm Description
an intensity of 1 W/cm2 and a frequency of 1 MHz and phonophoresis with 0.1% dexamethasone pomade,5 days a week, a total of 10 sessions
Arm Title
placebo ultrasound
Arm Type
Placebo Comparator
Arm Description
same ultrasound device as described above seemed to be working but without delivering any output, 5 days a week, a total of 10 sessions
Intervention Type
Device
Intervention Name(s)
ultrasound
Other Intervention Name(s)
phonophoresis, placebo ultrasound
Intervention Description
5 days a week, a total of 10 sessions
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
Change from baseline in pain with Visual Analogue Scale:Patients were asked to express the pain felt by them using 0-10 scales, 0 no pain and 10 the most severe pain faced throughout their life.
Time Frame
three month
Title
Boston Symptom Severity Scale
Description
Change from baseline in symptom severity with Boston Symptom Severity Scale:Patients were asked to choose an answer among five answers taking 1- 5 points in the questionnaires with 11 statements. Total point was divided into the number of statements and the score was determined and high scores were interpreted as increased symptom severity
Time Frame
three month
Title
Boston Functional Capacity Scale
Description
Change from baseline in functional status with Boston Functional Capacity Scale:Patients were asked to choose an answer among five answers taking 1- 5 points in the questionnaires with 11 statements. Total point was divided into the number of statements and average score was determined and high scores were interpreted as functionality deformation in the hands
Time Frame
three month
Title
grip strength
Description
Change from baseline in strength with grip strength:To assess the grip strength, baseline hydraulic hand dynamometer was used. 3 measurements were made for each patient and the average of them was calculated
Time Frame
three month
Title
electroneurophysiological evaluations
Description
Change from baseline electroneurophysiological measurement:The median nerve motor conduction velocity(m/s) , the median nerve motor distal latency(ms), 2nd finger - palm median nerve sensory distal latency(ms), 2nd finger - palm median nerve sensory conduction velocity(m/s), median sensory nerve conduction velocity(m/s) and median nerve sensory distal latency between the wrist and palm(ms)
Time Frame
three month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mild or moderate idiopathic carpal tunnel syndrome (without thenar atrophy or spontaneous activity on electrophysiological examination of the abductor pollicis brevis (APB) muscle)
Exclusion Criteria:
The patients with medical problems (diabetes mellitus, hypothyroidism, rheumatic diseases, acute trauma, pregnancy etc.)
cervical radiculopathy
etiologic factors which predispose to or polyneuropathy
reinnervation or fibrillation potentials in their abductor pollicis brevis muscles
physical or medical therapy within 3 months for CTS and steroid injection applied
experience CTS median nerve trauma and CTS surgery
serious thenar atrophy and anesthesia
contraindication in steroid treatment (steroid allergies, hypertension etc.)
contraindication in ultrasonic therapy (bleeding disorders, acute inflammation of the joints, acute infections, cancer and precancerous lesions, arteriovenous circulatory disorders etc.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burcu Ortanca
Organizational Affiliation
Eskişehir City Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Ultrasound and Phonophoresis in Carpal Tunnel Syndrome
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