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).
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
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.
- Conditions
- Carpal Tunnel Syndrome
- 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 group | Role | What they receive |
|---|---|---|
| Carpal tunnel syndrome | Other | Patients 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.
Body mass index
kg/m2
Measured: 12 weeks
Secondary outcomes (6)
Duration of disease
months
Measured: 12 weeks
Sex
female, male
Measured: 12 weeks
The Boston Carpal Tunnel Questionnaire
Boston symptom severity scale and Boston functional status scale
Measured: 12 weeks
visual analog scale (VAS)
visual analog scale at rest and visual analog scale on activity
Measured: 12 weeks
Ultrasonographic parameters
cross-sectional area, flattening ratio
Measured: 12 weeks
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.
- First posted28 Jan 2022
- Study start20 Feb 2013
- Primary completion20 Feb 2015
- Study completion20 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazlı Karaman, MD, Kutahya Health Sciences University
- Investigators
- Nazlı Karaman, Principal investigator, Kütahya Health Sciences University
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05213819
- Acronym / sponsor ID
- NCakil1
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal tunnel syndrome, Phonophoresis, Low-Level Laser Therapy, Exercise, Electrophysiological, Ultrasonographical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 20 Feb 2013 (actual)
- Primary completion
- 20 Feb 2015 (actual)
- Study completion
- 20 Feb 2015 (actual)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carpal tunnel syndrome | Other | Other: Carpal Tunnel SyndromePatients with carpal tunnel syndrome were treated with phonophoresis, low level laser therapy and exercise. |
Who may qualify
- Ages
- 26 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- metabolic diseases (including diabetes mellitus, thyroid and chronic kidney diseases)
- rheumatoid arthritis
- wrist trauma
- pregnancy
- corticosteroid treatment in the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carpal Tunnel Syndrome | Other | Carpal tunnel syndrome |
Primary outcome
Body mass index
Time frame: 12 weeks
kg/m2
6 secondary outcomes
Duration of disease
Time frame: 12 weeks
Sex
Time frame: 12 weeks
The Boston Carpal Tunnel Questionnaire
Time frame: 12 weeks
visual analog scale (VAS)
Time frame: 12 weeks
Ultrasonographic parameters
Time frame: 12 weeks
Electrophysiologic parameters
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Individual participant dataSharing planned: Yes
Related trials for Carpal Tunnel Syndrome
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Effect of Progressive Gamified Motor Rehabilitation After Carpal Tunnel Release
Carpal Tunnel Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nazlı Karaman principal investigator
Kütahya Health Sciences University
1 site in 1 country: see every site and its status.
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.