Carpal Tunnel SyndromeNCT05863546
Effect of Different Doses of US in the Treatment of CTS
A study testing Traditional treatment and Therapeutic ultrasound in people with Carpal Tunnel Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study was to investigate the effective dose of therapeutic ultrasound in the treatment of carpal tunnel syndrome on pain level, functional ability, motor and sensory nerve conduction parameters and pinch strength. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Traditional treatment and Therapeutic ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2023to 1 Apr 2024
- 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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject's age range was 25-55 years .
- Mild to moderate CTS, that is confirmed by neurologist or orthopedist based on results of physical examination and electrophysiological criteria; i. Mild CTS is characterized by sensory fibers involvement (sensory peak latency > 3.6 milliseconds) with no motor fiber involvement (motor distal latency < 4.1 milliseconds), provided that sensory nerve action potential (SNAP) is not absent.
- Moderate CTS is characterized by involvement of both sensory and motor fibers, provided that neither of these two waves is absent .
- Pain intensity more than 5 in visual analogue scale (VAS).
Who cannot join
- History of any trauma on the hands, neck, and shoulders within 3 months of the study onset
- Cervical radiculopathy, peripheral polyneuropathy, or other neurological conditions.
- Patients suffering from severe CTS according to electrophysiological criteria
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Different Doses of Therapeutic Ultrasound in the Treatment of Carpal Tunnel Syndrome
The purpose of this study was to investigate the effective dose of therapeutic ultrasound in the treatment of carpal tunnel syndrome on pain level, functional ability, motor and sensory nerve conduction parameters and pinch strength.
Read the detailed description
Carpal tunnel syndrome (CTS) is among the most common peripheral neuropathies causing the median nerve compression as it crosses the carpal tunnel, with an estimated prevalence of about 4 - 5% of the general population. Patients suffering from this syndrome mainly complain about paresthesia (pain, numbness, and tingling) in the innervation area of the median nerve in the hand which could be accompanied by weakness and atrophy of thenar muscles.
Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy of the upper limb and a significant contributor to hand functional impairment and disability that could be treated through numerous approaches. Effective treatment options include conservative and surgical interventions.
Carpal Tunnel Syndrome (CTS) remains a puzzling and disabling condition present in 3.8% of the general population. CTS is the most well-known and frequent form of median nerve entrapment, and accounts for 90% of all entrapment neuropathies.
Physiotherapy modalities are used to help patients with CTS in many cases. They can both help to improve CTS symptoms as well as resolve the cause of the syndrome. Physiotherapy intervention may include special exercises, mobilizations, ergonomic interventions and advice for as well as electrotherapy modalities, aiming for the treatment and improvement of symptoms.
Ultrasound waves have anti-inflammatory properties, stimulating nerve regeneration and improving nerve conductivity.
The most common uses for US are to decrease soft tissue inflammation, increase tissue extensibility, enhance scar tissue remodeling, increase soft tissue healing, decrease pain, and decrease soft tissue swelling .
The issue of selecting the nature of the ultrasonic wave has not been finally resolved. A continuous wave is more often used to reduce pain and increase the elasticity of the tissue, while a pulsed wave mode is applied to reduce swelling and to eliminate inflammation. The rate of absorption, and thus the thermal effect, is based on the tissue type encountered, the frequency of the ultrasound beam, and the intensity (W/cm2) of the ultrasonic output.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Traditional treatment, Therapeutic ultrasound
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional treatmentOther
The patients received traditional physical therapy treatment for carpal tunnel syndrome, in the form of hot packs, tendon and nerve glide exercises, and wrist splint for 4 weeks.
Therapeutic ultrasoundDevice
US treatment sessions were performed for 6 min per session, once a day, three days a week, for a total of 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | (control group) It consisted of 15 subjects who received a program of 'sham' US application, so that the US device was working but not delivering any output plus traditional PT treatment for carpal tunnel syndrome which included hot packs, tendon glide and nerve glide exercises, US treatment sessions were performed for 6 min per session, once a day, three days a week, for a total of 4 weeks. Receives: Other: Traditional treatment; Device: Therapeutic ultrasound |
| Low-dose group | Experimental | (low-dose group) It consisted of 15 subjects who received a program of US treatments that was administered to the carpal tunnel area with pulsed mode at a frequency of 1 MHz with an intensity of 0.25 W/cm2 and a duty cycle of 1:4 plus traditional treatment. Receives: Other: Traditional treatment; Device: Therapeutic ultrasound |
| Mid-dose group | Experimental | (Mid-dose group) It consisted of 15 subjects who received a program of US treatments that was administered to the carpal tunnel area with pulsed mode at a frequency of 1 MHz with an intensity of 0.5 W/cm2 and a duty cycle of 1:4 plus traditional treatment. Receives: Other: Traditional treatment; Device: Therapeutic ultrasound |
| High-dose group | Experimental | (high-dose group) It consisted of 15 subjects who received a program of the same US equipment that was set at pulsed mode at a frequency of 1 MHz, intensity of 1.0W/ cm2 and a duty cycle of 1:4 plus traditional treatment. Receives: Other: Traditional treatment; Device: Therapeutic ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptoms severity and functional status
Symptoms severity and functional status were measured by Boston carpal tunnel syndrome questionnaire. The patients rated their ability to perform the activity on a scale that ranged from 1 (no difficulty with the activity) to 5 (cannot perform the activity at all).
Measured: Four weeks
median nerve motor distal latency
Electrodiagnostic tests were used to measure median nerve motor distal latency in milliseconds.
Measured: Four weeks
median nerve motor amplitude
Electrodiagnostic tests were used to measure motor amplitude in millivolt.
Measured: Four weeks
median nerve sensory distal latency
Electrodiagnostic tests were used to measure median nerve sensory distal latency in milliseconds.
Measured: Four weeks
median nerve sensory amplitude
Electrodiagnostic tests were used to measure sensory amplitude in millivolt
Measured: Four weeks
Pain intensity
Pain intensity was measured by visual analogue scale. Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
Measured: Four weeks
Pinch strength
Pinch dynamometer was used to measure pinch strength
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start10 Sep 2023
- Primary completion1 Mar 2024
- Study completion1 Apr 2024
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 Cairo 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia Gamal Mohamed, Cairo University
- Investigators
- Ragia Mohamed Kamel, PhD, Study chair, Professor, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863546
- Sponsor's protocol ID
- P.T.REC/012/003996
- Status last verified
- Mar 2025
- First submitted
- 28 Apr 2023
- Last updated
- 14 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Doses of Therapeutic Ultrasound in the Treatment of Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT05863546
- Acronym / sponsor ID
- P.T.REC/012/003996
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Sep 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 18 May 2023 (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.
The purpose of this study was to investigate the effective dose of therapeutic ultrasound in the treatment of carpal tunnel syndrome on pain level, functional ability, motor and sensory nerve conduction parameters and pinch strength.
Detailed description
Carpal tunnel syndrome (CTS) is among the most common peripheral neuropathies causing the median nerve compression as it crosses the carpal tunnel, with an estimated prevalence of about 4 - 5% of the general population. Patients suffering from this syndrome mainly complain about paresthesia (pain, numbness, and tingling) in the innervation area of the median nerve in the hand which could be accompanied by weakness and atrophy of thenar muscles.
Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy of the upper limb and a significant contributor to hand functional impairment and disability that could be treated through numerous approaches. Effective treatment options include conservative and surgical interventions.
Carpal Tunnel Syndrome (CTS) remains a puzzling and disabling condition present in 3.8% of the general population. CTS is the most well-known and frequent form of median nerve entrapment, and accounts for 90% of all entrapment neuropathies.
Physiotherapy modalities are used to help patients with CTS in many cases. They can both help to improve CTS symptoms as well as resolve the cause of the syndrome. Physiotherapy intervention may include special exercises, mobilizations, ergonomic interventions and advice for as well as electrotherapy modalities, aiming for the treatment and improvement of symptoms.
Ultrasound waves have anti-inflammatory properties, stimulating nerve regeneration and improving nerve conductivity.
The most common uses for US are to decrease soft tissue inflammation, increase tissue extensibility, enhance scar tissue remodeling, increase soft tissue healing, decrease pain, and decrease soft tissue swelling .
The issue of selecting the nature of the ultrasonic wave has not been finally resolved. A continuous wave is more often used to reduce pain and increase the elasticity of the tissue, while a pulsed wave mode is applied to reduce swelling and to eliminate inflammation. The rate of absorption, and thus the thermal effect, is based on the tissue type encountered, the frequency of the ultrasound beam, and the intensity (W/cm2) of the ultrasonic output.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Other: Traditional treatment, Device: Therapeutic ultrasound(control group) It consisted of 15 subjects who received a program of 'sham' US application, so that the US device was working but not delivering any output plus traditional PT treatment for carpal tunnel syndrome which included hot packs, tendon glide and nerve glide exercises, US treatment sessions were performed for 6 min per session, once a day, three days a week, for a total of 4 weeks. |
| Low-dose group | Experimental | Other: Traditional treatment, Device: Therapeutic ultrasound(low-dose group) It consisted of 15 subjects who received a program of US treatments that was administered to the carpal tunnel area with pulsed mode at a frequency of 1 MHz with an intensity of 0.25 W/cm2 and a duty cycle of 1:4 plus traditional treatment. |
| Mid-dose group | Experimental | Other: Traditional treatment, Device: Therapeutic ultrasound(Mid-dose group) It consisted of 15 subjects who received a program of US treatments that was administered to the carpal tunnel area with pulsed mode at a frequency of 1 MHz with an intensity of 0.5 W/cm2 and a duty cycle of 1:4 plus traditional treatment. |
| High-dose group | Experimental | Other: Traditional treatment, Device: Therapeutic ultrasound(high-dose group) It consisted of 15 subjects who received a program of the same US equipment that was set at pulsed mode at a frequency of 1 MHz, intensity of 1.0W/ cm2 and a duty cycle of 1:4 plus traditional treatment. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject's age range was 25-55 years .
- Mild to moderate CTS, that is confirmed by neurologist or orthopedist based on results of physical examination and electrophysiological criteria; i. Mild CTS is characterized by sensory fibers involvement (sensory peak latency > 3.6 milliseconds) with no motor fiber involvement (motor distal latency < 4.1 milliseconds), provided that sensory nerve action potential (SNAP) is not absent.
- Pain intensity more than 5 in visual analogue scale (VAS).
Key exclusion criteria (4 listed)
- History of any trauma on the hands, neck, and shoulders within 3 months of the study onset
- Cervical radiculopathy, peripheral polyneuropathy, or other neurological conditions.
- Patients suffering from severe CTS according to electrophysiological criteria
- -
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 |
|---|---|---|
| Traditional treatmentThe patients received traditional physical therapy treatment for carpal tunnel syndrome, in the form of hot packs, tendon and nerve glide exercises, and wrist splint for 4 weeks. | Other | Control group, High-dose group, Low-dose group, Mid-dose group |
| Therapeutic ultrasoundUS treatment sessions were performed for 6 min per session, once a day, three days a week, for a total of 4 weeks. | Device | Control group, High-dose group, Low-dose group, Mid-dose group |
Primary outcome
symptoms severity and functional status
Time frame: Four weeks
Symptoms severity and functional status were measured by Boston carpal tunnel syndrome questionnaire. The patients rated their ability to perform the activity on a scale that ranged from 1 (no difficulty with the activity) to 5 (cannot perform the activity at all).
median nerve motor distal latency
Time frame: Four weeks
Electrodiagnostic tests were used to measure median nerve motor distal latency in milliseconds.
median nerve motor amplitude
Time frame: Four weeks
Electrodiagnostic tests were used to measure motor amplitude in millivolt.
median nerve sensory distal latency
Time frame: Four weeks
Electrodiagnostic tests were used to measure median nerve sensory distal latency in milliseconds.
median nerve sensory amplitude
Time frame: Four weeks
Electrodiagnostic tests were used to measure sensory amplitude in millivolt
Pain intensity
Time frame: Four weeks
Pain intensity was measured by visual analogue scale. Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
Pinch strength
Time frame: Four weeks
Pinch dynamometer was used to measure pinch strength
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 14 Mar 2025.
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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.
Ragia Mohamed Kamel, PhD study chair
Professor, Cairo 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 Traditional treatment and Therapeutic ultrasound in people with Carpal Tunnel Syndrome, run by Cairo University at 1 site in Egypt.
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 4 inclusion and 4 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 14 Mar 2025. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
symptoms severity and functional status (time frame: Four weeks). The study lists 7 primary outcomes in all. 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 14 Mar 2025.