Ultrasound Evaluation of the Effect of Manual Lymph DrainageNCT05415618
Ultrasonographic Evaluation of the Effectiveness of Different Techniques
A study testing Manual lymphatic drainage, splint and Nerve gliding in people with Ultrasound Evaluation of the Effect of Manual Lymph Drainage and Effect of Manual Lymph Drainage on Carpal Tunnel Syndrome, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
Carpal tunnel syndrome (CTS) occurs as a result of compression of the median nerve under the transverse ligament along the carpal tunnel. The main cause of median nerve compression and carpal tunnel syndrome is increased volume in the carpal tunnel. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Ultrasound Evaluation of the Effect of Manual Lymph Drainage, Effect of Manual Lymph Drainage on Carpal Tunnel Syndrome
- What is being tested?
- Manual lymphatic drainage, splint and Nerve gliding
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Mar 2024to 30 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of mild to moderate carpal tunnel syndrome on electrodiagnostic examination
- Being between 20-55 years old
- Volunteering to participate in the treatment to be given
Who cannot join
- Have a systemic inflammatory disease
- Having any disease that may cause polyneuropathy, such as diabetes mellitus
- Cognitive impairment
- Receiving psychotherapy
- Having a pacemaker
- illiterate
Show all 11Show fewer
- Having a disease affecting the central nervous system
- Having a hearing problem
- Any skin disease that would contraindicate manual lymphatic drainage
- Arterial or venous circulatory disorders that would contraindicate manual lymphatic drainage
- NSAID drug use
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Science University Hospital
Kütahya, 43100
About this study
Official title: Clinical and Ultrasonographic Evaluation of Manual Lymphatic Drainage and Nerve Mobilization Techniques in Patients Diagnosed With Mild-Moderate Carpal Tunnel Syndrome
Carpal tunnel syndrome (CTS) occurs as a result of compression of the median nerve under the transverse ligament along the carpal tunnel. The main cause of median nerve compression and carpal tunnel syndrome is increased volume in the carpal tunnel. The pressure that edema puts on the nerve must be controlled in the early period. Edema that persists beyond the inflammatory process can contribute to the fibrotic stage, delay healing, and even cause complications such as pain and stiffness. Manual lymphatic drainage (MLD) is a specialized technique that involves gentle massage techniques and follows lymphatic pathways from proximal to distal and then from distal to proximal. On the basis of this concept; Increasing circulation by stimulating the lymph system, removing biochemical residues, reducing edema and pain, and regulating sympathetic and parasympathetic system responses. It is known that MLD rapidly regulates lymphatic circulation by creating a change in interstitial fluid pressure, thus preventing even arthrofibrotic tissue that may form after a traumatic situation, reducing edema that predisposes to pain, and increasing mobility. Nerve gliding exercises are another method used in treatment. By providing a sliding movement of the tendons and median nerve in the distal-proximal direction, mobilization of the surrounding soft tissues is achieved and dynamic ischemia is terminated. The aim of this study is to determine the effectiveness of manual lymphatic drainage and nerve mobilization on clinical and ultrasonographic findings in carpal tunnel syndrome.
- Conditions
- Ultrasound Evaluation of the Effect of Manual Lymph Drainage, Effect of Manual Lymph Drainage on Carpal Tunnel Syndrome
- Being tested
- Manual lymphatic drainage, splint, Nerve gliding
- Keywords
- ultrasonographic evaluation, carpal tunnel syndrome, manual lymph drainage, edema, pain
- Medical subject headings
- Carpal Tunnel Syndrome, Edema, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual lymphatic drainageOther
Manual lymphatic drainage will be applied 5 days a week for about 15 minutes every day for 4 weeks.
splintDevice
In splint treatment, a volar-supported splint that keeps the wrist in a neutral position will be preferred and it will be recommended to both groups to be used only at night for 4 weeks.
Nerve glidingOther
Median nerve gliding exercises as a home exercise program will be performed by the patient 5 days a week for 4 weeks. It will be performed in 6 different consecutive positions of the hand and wrist.
| Study group | Role | What they receive |
|---|---|---|
| Kontrol group | Active comparator | Not described Receives: Device: splint |
| MLD group | Experimental | Not described Receives: Other: Manual lymphatic drainage |
| Nerve gliding group | Experimental | Not described Receives: Other: Nerve gliding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonographic Evaluation
Median nerve diameter measurements and depths of the participants will be made by USG with a multifrequency (7-15 MHz) linear probe. With USG, the median CBF and its depth will be measured distally from the level of the scaphoid bone (wrist; carpal tunnel level) and the midpoint of the forearm.
Measured: 20 minutes
Evaluation of symptom severity and functional status
It will be assessed with the Boston Carpal Tunnel Questionnaire (BCTQ). 1. The symptom severity scale (BCTQSS) has 11 items that evaluate pain, paresthesia, and weakness. 2. The functional status scale (BCTQ-FS) evaluates the ability to perform manual activities with 8 items. Each item evaluates the increasing severity of symptoms or difficulty with a higher score.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start12 Mar 2024
- Primary completion12 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound Evaluation of the Effect of Manual Lymph DrainageStudies of the same condition, open and under way.
- More trials run by Selcuk 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Cihan, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415618
- Sponsor's protocol ID
- 2023-14/01
- Status last verified
- Mar 2024
- First submitted
- 8 Jun 2022
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Ultrasonographic Evaluation of Manual Lymphatic Drainage and Nerve Mobilization Techniques in Patients Diagnosed With Mild-Moderate Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT05415618
- Acronym / sponsor ID
- 2023-14/01
- Conditions
- Ultrasound Evaluation of the Effect of Manual Lymph Drainage, Effect of Manual Lymph Drainage on Carpal Tunnel Syndrome
- Keywords
- ultrasonographic evaluation, carpal tunnel syndrome, manual lymph drainage, edema, pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 12 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 13 Jun 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) occurs as a result of compression of the median nerve under the transverse ligament along the carpal tunnel. The main cause of median nerve compression and carpal tunnel syndrome is increased volume in the carpal tunnel. The pressure that edema puts on the nerve must be controlled in the early period. Edema that persists beyond the inflammatory process can contribute to the fibrotic stage, delay healing, and even cause complications such as pain and stiffness. Manual lymphatic drainage (MLD) is a specialized technique that involves gentle massage techniques and follows lymphatic pathways from proximal to distal and then from distal to proximal. On the basis of this concept; Increasing circulation by stimulating the lymph system, removing biochemical residues, reducing edema and pain, and regulating sympathetic and parasympathetic system responses. It is known that MLD rapidly regulates lymphatic circulation by creating a change in interstitial fluid pressure, thus preventing even arthrofibrotic tissue that may form after a traumatic situation, reducing edema that predisposes to pain, and increasing mobility. Nerve gliding exercises are another method used in treatment. By providing a sliding movement of the tendons and median nerve in the distal-proximal direction, mobilization of the surrounding soft tissues is achieved and dynamic ischemia is terminated. The aim of this study is to determine the effectiveness of manual lymphatic drainage and nerve mobilization on clinical and ultrasonographic findings in carpal tunnel syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kontrol group | Active comparator | Device: splint |
| MLD group | Experimental | Other: Manual lymphatic drainage |
| Nerve gliding group | Experimental | Other: Nerve gliding |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of mild to moderate carpal tunnel syndrome on electrodiagnostic examination
- Being between 20-55 years old
- Volunteering to participate in the treatment to be given
Key exclusion criteria (11 listed)
- Have a systemic inflammatory disease
- Having any disease that may cause polyneuropathy, such as diabetes mellitus
- Cognitive impairment
- Receiving psychotherapy
- Having a pacemaker
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 |
|---|---|---|
| Manual lymphatic drainageManual lymphatic drainage will be applied 5 days a week for about 15 minutes every day for 4 weeks. | Other | MLD group |
| splintIn splint treatment, a volar-supported splint that keeps the wrist in a neutral position will be preferred and it will be recommended to both groups to be used only at night for 4 weeks. | Device | Kontrol group |
| Nerve glidingMedian nerve gliding exercises as a home exercise program will be performed by the patient 5 days a week for 4 weeks. It will be performed in 6 different consecutive positions of the hand and wrist. | Other | Nerve gliding group |
Primary outcome
Ultrasonographic Evaluation
Time frame: 20 minutes
Median nerve diameter measurements and depths of the participants will be made by USG with a multifrequency (7-15 MHz) linear probe. With USG, the median CBF and its depth will be measured distally from the level of the scaphoid bone (wrist; carpal tunnel level) and the midpoint of the forearm.
Evaluation of symptom severity and functional status
Time frame: 10 minutes
It will be assessed with the Boston Carpal Tunnel Questionnaire (BCTQ). 1. The symptom severity scale (BCTQSS) has 11 items that evaluate pain, paresthesia, and weakness. 2. The functional status scale (BCTQ-FS) evaluates the ability to perform manual activities with 8 items. Each item evaluates the increasing severity of symptoms or difficulty with a higher score.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual lymphatic drainage, splint and Nerve gliding in people with Ultrasound Evaluation of the Effect of Manual Lymph Drainage and Effect of Manual Lymph Drainage on Carpal Tunnel Syndrome, run by Selcuk 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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 15 Mar 2024. 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?
Results are not available in the source record.
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?
Ultrasonographic Evaluation (time frame: 20 minutes). The study lists 2 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 15 Mar 2024.