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Clinical Trials/NCT05213819
NCT05213819CompletedNot Applicable

Additional Contribution of Phonophoresis and Low-Level Laser Therapy to Exercise in the Treatment of Carpal Tunnel Syndrome by Clinical, Electrophysiological and Ultrasonographical Evaluation

Kutahya Health Sciences University2 sites in 1 country45 target enrollmentStarted: February 20, 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
45
Locations
2
Primary Endpoint
Body mass index

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
26 Years to 69 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Body mass index

Time Frame: 12 weeks

kg/m2

Secondary Outcomes

  • Sex(12 weeks)
  • Duration of disease(12 weeks)
  • The Boston Carpal Tunnel Questionnaire(12 weeks)
  • visual analog scale (VAS)(12 weeks)
  • Electrophysiologic parameters(12 weeks)
  • Ultrasonographic parameters(12 weeks)

Investigators

Sponsor
Kutahya Health Sciences University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nazlı Karaman, MD

Principal Investigator

Kutahya Health Sciences University

Study Sites (2)

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