Phonophoresis, Low-Level Laser Therapy and Exercise in the Treatment of Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Carpal Tunnel Syndrome
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Carpal tunnel syndrome, Phonophoresis, Low-Level Laser Therapy, Exercise, Electrophysiological, Ultrasonographical
Eligibility Criteria
Inclusion Criteria:
- age older than 18 years
- positive Tinel's sign or positive Phalen's sign
- pain or paresthesia in the median nerve course
- pain or paresthesia aggravated at night
- moderate CTS according to the American Association of Electrodiagnostic Medicine (AAEM) guidelines
Exclusion Criteria:
- metabolic diseases (including diabetes mellitus, thyroid and chronic kidney diseases)
- rheumatoid arthritis
- wrist trauma
- pregnancy
- corticosteroid treatment in the last 3 months
- physical or medical treatment in the last month
Sites / Locations
- Health Sciences University, Evliya Çelebi Training and Research Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Carpal tunnel syndrome
Arm Description
Patients with carpal tunnel syndrome were treated with phonophoresis, low level laser therapy and exercise.
Outcomes
Primary Outcome Measures
Body mass index
kg/m2
Secondary Outcome Measures
Duration of disease
months
Sex
female, male
The Boston Carpal Tunnel Questionnaire
Boston symptom severity scale and Boston functional status scale
visual analog scale (VAS)
visual analog scale at rest and visual analog scale on activity
Ultrasonographic parameters
cross-sectional area, flattening ratio
Electrophysiologic parameters
motor distal latancy, motor amplitude,sensory nerve velocity, sensory distal latancy,sensory amplitude
Full Information
NCT ID
NCT05213819
First Posted
December 28, 2021
Last Updated
January 17, 2022
Sponsor
Kutahya Health Sciences University
1. Study Identification
Unique Protocol Identification Number
NCT05213819
Brief Title
Phonophoresis, Low-Level Laser Therapy and Exercise in the Treatment of Carpal Tunnel Syndrome
Official Title
Additional Contribution of Phonophoresis and Low-Level Laser Therapy to Exercise in the Treatment of Carpal Tunnel Syndrome by Clinical, Electrophysiological and Ultrasonographical Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
February 20, 2013 (Actual)
Primary Completion Date
February 20, 2015 (Actual)
Study Completion Date
February 20, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kutahya Health Sciences University
4. Oversight
5. Study Description
Brief Summary
Carpal tunnel syndrome (CTS) is the most common peripheral nerve compression syndrome. There is insufficient evidence about the efficacy and superiority of conservative treatment methods. The purpose of this study was to evaluate the additional contribution of phonophoresis and Low-Level Laser Therapy (LLLT) to exercise in patients with the CTS.
Study design: A single-blind randomized controlled study. Methods: Forty-five patients with clinical and electrophysiologic evidence of moderate CTS were included in the study. The patients were randomized into three groups. Group 1 received phonophoresis and exercise, group 2 received LLLT and exercise and group 3 received exercise alone. All patients were evaluated electrophysiologically, clinically and ultrasonographically before treatment and 6th and 12th week after the treatment.
Detailed Description
45 patients in total (5 males, 40 females; mean age 50.2±10.0 years; ranged 26 to 69 years) having clinical and electrophysiologic findings of moderate CTS were examined. Inclusion criteria were as follows: age older than 18 years, positive Tinel's sign or positive Phalen's sign, pain or paresthesia in the median nerve course, pain or paresthesia aggravated at night and moderate CTS according to the American Association of Electrodiagnostic Medicine (AAEM) guidelines (10,11). Exclusion criteria were as follows: metabolic diseases (including diabetes mellitus, thyroid and chronic kidney diseases), rheumatoid arthritis, wrist trauma, pregnancy, corticosteroid treatment in the last 3 months, physical or medical treatment in the last month. The participants were randomly categorized into three groups with an indiscriminate number table as Group 1 (phonophoresis combined with exercise, n:15), Group 2 (LLLT combined with exercise, n:15) and Group 3 (exercise only, n:15).
Phonophoresis was administered to the course of carpal tunnel for 8 minutesfor every session at 3 MHz frequency and 1.0 W/cm2 intensity, pulsed mode (1:4) ultrasound having a transducer having a surface area of 1.4 cm2 (Sonicator 730, Metler Electronics, USA). Ketoprophen %2.5 gel was used. Patients underwent this therapy 5 days a week, for 3 weeks.
A Gal-Al-As diode laser device (Endolaser 476, Enraf Nonius, Hollanda) was the LLLT source having 30 mW power output and 830 nm wavelength. The probe irradiated 3 points in total on the volar side at the wrist. A one minute irradiation per point (3 minutes in total) was determined as the single dose of irradiation. The dose for every tender joint was 1.8 joule. The total and acculumated doses after 15 treatments were 5.4 and 81 joules, respectively. This therapy was applied 5 days a week, for 3 weeks.
All the individuals were asked to complete nerve and tendon gliding activities of Totten and Hunter (12). In addition, a book letex plaining the activities was provided to all individuals. Patients were called by phone weekly and they were checked and reminded about their exercises. For tendon gliding exercises, the fingers were formed into five seperate positions, as straight, hook, fist, table top, and straight fist. For the median nerve-gliding exercising, putting the hand and wrist in six seperate positions caused the mobilization of the median nerve. The neck and the shoulder were in a neutral position, and the elbow in supination and 90 degrees flexion over all these exercises. Each seperate position was uphold for 5 seconds. The exercising wasrepeated as five sessions every day. 10 repetitions of each exercising was made for every session, and exercise therapy lasted for 3 weeks.
Data including age, gender, body mass index (BMI) and disease duration (months) were recorded for all patients on admission.The most symptomatic hand was included in patients with bilateral CTS. Pain intensity in the rest and activity wasassessed by the visual analog scale (VAS), which the individuals could specify the pain evaulationon a 10 cm distance, between 0 (no pain) and 10 (the most intense pain).
The Boston Carpal Tunnel Questionnaire (BCTQ) is self-applied and assesses the symptom severity and functional status in CTS patients (13). BCTQ is including two subscales. The Boston Symptom Severity Scale (BSSS) consists of 11 questions and the Boston Functional Status Scale (BFSS) 8 questions. Each question is assessed on a 1-point (mildest pain) to 5-point (most intense pain) scoring system. The each scale's scoring was determined as the average of all items. Sezgin et al (14) has been validated the Turkish version of BCTQ.
Electrophysiologic examinations of all patients were performed at 22-24 °C room temperature using a 2-channel Dantec Keypoint Portable model electromyography (EMG) device of Alpine Biomed Company (Natus Medical Incorporated Corporate Headquarters 1501 Industrial Road San Carlos, CA 94070 USA). The band-pass filter was 20 Hz to 3 kHz, sweep speed velocity 2 ms/division, and gain 10 lV/division. Electrophysiological studies were performed according to the AAEM guidelines (10,11). The studies included an electromyographic investigation of the muscles of abductor pollicis brevis, adductor digiti minimi and flexor carpi radialis, and the median and ulnar nerves'motor and antidromic sensorial conduction velocities. In order to diagnose CTS, the electrophysiological criteria was determined as median nerve's distal motor latency of >4.2 ms from the wrist to abductor pollicis brevis, and the seperation between the median and ulnar sensorial distal latencies surpassing 0.5 ms.
CTS was categorized electrodiagnostically per the following criteria (15). 1- Mild CTS: Elongation (absolute or relative) and/or decrease in sensory action potential (SNAP) amplitude in sensory or mixed distal latency (DL) (orthodromic, antidromic, or palmar). 2- Moderate CTS: In addition to the above, elongation in the median motor DL. 3- Severe CTS: Together with the prolongation of median motor and sensory latencies, failure to obtain sensory or mixed action potentials or low amplitude compound muscle action potential (CMAP) or failure to obtain it, fibrillations, attenuation in full twitching in needle EMG, observing changes in motor unit potentials. Moderate CTS patients diagnosed by electrophysiological findings were included in the research.
Ultrasonographic studies were implemented using high-resolution US having a 12-3 MHz linear array transducer (Philips HDI Envisor; Philips Medical Systems, Bothell, WA, USA). The evaluations were made as all wrists in the neutral position as the palm being up and the fingers semi-extended. The median nerve'sfull course was determined within the carpal tunnel in the transverse and sagittal planes. The median nerve'scross-sectional area (CSA), transverse and anteroposterior diameters were evaluated at the pisiform bone level of proximal carpal tunnel, and its CSA was determined by a tracking approach in which the median nerve'smargin was quantified using electronic caliper. Distal carpal tunnel was not used for any measurements (16). Three measurement repetitions were made and the average of these values was determined for every wrist. The transverse diameter was divided by anterio-posterior diameter and the flattening ratio (FR) was calculated.
The researchers assessed ultrasonographic, electrodiagnostic and clinical examinations were blinded to assigned therapies and to each other. The same researchers determined all these parameters once again at the 6th and 12th weeks after the initiation.
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, Phonophoresis, Low-Level Laser Therapy, Exercise, Electrophysiological, Ultrasonographical
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Carpal tunnel syndrome
Arm Type
Other
Arm Description
Patients with carpal tunnel syndrome were treated with phonophoresis, low level laser therapy and exercise.
Intervention Type
Other
Intervention Name(s)
Carpal Tunnel Syndrome
Primary Outcome Measure Information:
Title
Body mass index
Description
kg/m2
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Duration of disease
Description
months
Time Frame
12 weeks
Title
Sex
Description
female, male
Time Frame
12 weeks
Title
The Boston Carpal Tunnel Questionnaire
Description
Boston symptom severity scale and Boston functional status scale
Time Frame
12 weeks
Title
visual analog scale (VAS)
Description
visual analog scale at rest and visual analog scale on activity
Time Frame
12 weeks
Title
Ultrasonographic parameters
Description
cross-sectional area, flattening ratio
Time Frame
12 weeks
Title
Electrophysiologic parameters
Description
motor distal latancy, motor amplitude,sensory nerve velocity, sensory distal latancy,sensory amplitude
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
26 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age older than 18 years
positive Tinel's sign or positive Phalen's sign
pain or paresthesia in the median nerve course
pain or paresthesia aggravated at night
moderate CTS according to the American Association of Electrodiagnostic Medicine (AAEM) guidelines
Exclusion Criteria:
metabolic diseases (including diabetes mellitus, thyroid and chronic kidney diseases)
rheumatoid arthritis
wrist trauma
pregnancy
corticosteroid treatment in the last 3 months
physical or medical treatment in the last month
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nazlı Karaman
Organizational Affiliation
Kütahya Health Sciences University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Sciences University, Evliya Çelebi Training and Research Hospital
City
Kütahya
State/Province
Merkez
ZIP/Postal Code
10440
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Phonophoresis, Low-Level Laser Therapy and Exercise in the Treatment of Carpal Tunnel Syndrome
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