AzTrials
AzTrials

Carpal Tunnel SyndromeNCT05213819

Phonophoresis, Low-Level Laser Therapy and Exercise in the Treatment of Carpal Tunnel Syndrome

A study testing Carpal Tunnel Syndrome in people with Carpal Tunnel Syndrome, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 26 to 69 yearsHealthy volunteers can take part
Conditions the study is for
Carpal Tunnel Syndrome
What is being tested?
Carpal Tunnel Syndrome
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Feb 2013to 20 Feb 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 26 to 69 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Health Sciences University, Evliya Çelebi Training and Research Hospital

    Kütahya, Merkez, 10440

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
Carpal Tunnel Syndrome
Keywords
Carpal tunnel syndrome, Phonophoresis, Low-Level Laser Therapy, Exercise, Electrophysiological, Ultrasonographical
Medical subject headings
Carpal Tunnel Syndrome, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Carpal Tunnel SyndromeOther

Study groups in NCT05213819
Study groupRoleWhat they receive
Carpal tunnel syndromeOtherPatients with carpal tunnel syndrome were treated with phonophoresis, low level laser therapy and exercise.
Receives: Other: Carpal Tunnel Syndrome

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body mass index

    kg/m2

    Measured: 12 weeks

Secondary outcomes (6)
  1. Duration of disease

    months

    Measured: 12 weeks

  2. Sex

    female, male

    Measured: 12 weeks

  3. The Boston Carpal Tunnel Questionnaire

    Boston symptom severity scale and Boston functional status scale

    Measured: 12 weeks

  4. visual analog scale (VAS)

    visual analog scale at rest and visual analog scale on activity

    Measured: 12 weeks

  5. Ultrasonographic parameters

    cross-sectional area, flattening ratio

    Measured: 12 weeks

  6. Electrophysiologic parameters

    motor distal latancy, motor amplitude,sensory nerve velocity, sensory distal latancy,sensory amplitude

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2022
  2. Study start20 Feb 2013
  3. Primary completion20 Feb 2015
  4. Study completion20 Feb 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05213819
Sponsor's protocol ID
NCakil1
Status last verified
Jan 2022
First submitted
28 Dec 2021
Last updated
28 Jan 2022
Results posted
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Carpal Tunnel Syndrome in people with Carpal Tunnel Syndrome, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body mass index (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in