Carpal Tunnel SyndromeNCT05394870
Clinical and Electrophysiological Evaluation of the Effectiveness for Manual Lymphatic Drainage
A study testing manual lymphatic drainage (massage) and Splint treatment in people with Carpal Tunnel Syndrome and Electrophysical Evaluation, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
When the other usage areas of the manual lymphatic drainage technique in the literature, except for the treatment of lymphedema, were examined recently, it was seen that it was also applied in orthopedic and neurological cases in a limited number of studies. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Carpal Tunnel Syndrome, Electrophysical Evaluation, Manual Lymphatic Drainage
- What is being tested?
- manual lymphatic drainage (massage) and Splint treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 10 Jun 2022
- 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 10Show 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 circulation disorder that would contraindicate manual lymphatic drainage
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Science University
Kütahya, Centrum, 43040
About this study
Official title: Clinical and Electrophysiological Evaluation of the Effectiveness of Manual Lymphatic Drainage in Patients With Mild-to-moderate Carpal Tunnel Syndrome
When the other usage areas of the manual lymphatic drainage technique in the literature, except for the treatment of lymphedema, were examined recently, it was seen that it was also applied in orthopedic and neurological cases in a limited number of studies. The aim of our study is to investigate the effectiveness of manual lymphatic drainage on clinical and electrophysiological findings in carpal tunnel syndrome
- Being tested
- manual lymphatic drainage (massage), Splint treatment
- 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.
manual lymphatic drainage (massage)Other
Patients will begin treatment with manual lymphatic drainage in the affected extremity. In this context, while the patients are in the supine hook position, lymph drainage will be applied first to the neck and then to the abdomen. After the stimulation of the central lymph nodes, the lymph circulation will be increased by stimulating the axillary lymph nodes of the relevant region. First, the proximal part will be drained and it will be advanced towards the distal. Drainage will be repeated depending on the edema at the distal forearm-wrist level.
Splint treatmentOther
The splint routinely given to patients diagnosed with mild to moderate carpal tunnel syndrome will be given to both groups in these patients
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Not described Receives: Other: manual lymphatic drainage (massage); Other: Splint treatment |
| control group | Active comparator | Not described Receives: Other: Splint treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
pressure pain threshold
Each evaluation will be repeated 3 times with 10 seconds between measurements, and the data will be recorded by taking the average of the last two measurements (15). The patients will be evaluated by measuring the transverse carpal ligament, radioulnar joint and extensor digitorum muscle with an algometer before and at the end of the treatment. measurements will be recorded in kg/cm2
Measured: 15 minutes
Boston Carpal Tunnel Questionnaire (BCTQ)
BCTQ, a self-report measure of CTS, evaluates two domains: 1. The symptom severity scale (BCTQSS) has 11 items that assess 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 high score.
Measured: 10 minutes
Electrodiagnostic evaluation
Median motor nerve latency, median motor nerve conduction velocity, compound muscle action potential amplitude will be measured at both levels. Median sensory nerve conduction studies will be performed by antidromic recording with a superficial electrode from the 3rd finger and a stimulus will be given from the wrist 14 cm proximal. Median sensory nerve latency, median sensory nerve conduction velocity and sensory nerve action potential will be calculated for both applications. nerve potentials will be calculated in m/sec
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start1 Apr 2022
- Primary completion1 Jun 2022
- Study completion10 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies 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
- 34 participants (actual)
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
- NCT05394870
- Sponsor's protocol ID
- 2022-03.02
- Status last verified
- Jul 2022
- First submitted
- 19 May 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Akdeniz Leblebicier M, Cihan E, Yaman F, Sahbaz Pirincci C, Ture A, Kavuncu V. Can manual lymphatic drainage be a new treatment option in mild-moderate carpal tunnel syndrome? A randomized controlled study. J Hand Ther. 2025 Jul-Sep;38(3):584-593. doi: 10.1016/j.jht.2024.12.020. Epub 2025 Feb 6.
PubMed 39919926
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Electrophysiological Evaluation of the Effectiveness of Manual Lymphatic Drainage in Patients With Mild-to-moderate Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT05394870
- Acronym / sponsor ID
- 2022-03.02
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 27 May 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.
When the other usage areas of the manual lymphatic drainage technique in the literature, except for the treatment of lymphedema, were examined recently, it was seen that it was also applied in orthopedic and neurological cases in a limited number of studies. The aim of our study is to investigate the effectiveness of manual lymphatic drainage on clinical and electrophysiological findings in carpal tunnel syndrome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: manual lymphatic drainage (massage), Other: Splint treatment |
| control group | Active comparator | Other: Splint treatment |
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 (10 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 drainage (massage)Patients will begin treatment with manual lymphatic drainage in the affected extremity. In this context, while the patients are in the supine hook position, lymph drainage will be applied first to the neck and then to the abdomen. After the stimulation of the central lymph nodes, the lymph circulation will be increased by stimulating the axillary lymph nodes of the relevant region. First, the proximal part will be drained and it will be advanced towards the distal. Drainage will be repeated depending on the edema at the distal forearm-wrist level. | Other | study group |
| Splint treatmentThe splint routinely given to patients diagnosed with mild to moderate carpal tunnel syndrome will be given to both groups in these patients | Other | control group, study group |
Primary outcome
pressure pain threshold
Time frame: 15 minutes
Each evaluation will be repeated 3 times with 10 seconds between measurements, and the data will be recorded by taking the average of the last two measurements (15). The patients will be evaluated by measuring the transverse carpal ligament, radioulnar joint and extensor digitorum muscle with an algometer before and at the end of the treatment. measurements will be recorded in kg/cm2
Boston Carpal Tunnel Questionnaire (BCTQ)
Time frame: 10 minutes
BCTQ, a self-report measure of CTS, evaluates two domains: 1. The symptom severity scale (BCTQSS) has 11 items that assess 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 high score.
Electrodiagnostic evaluation
Time frame: 15 minutes
Median motor nerve latency, median motor nerve conduction velocity, compound muscle action potential amplitude will be measured at both levels. Median sensory nerve conduction studies will be performed by antidromic recording with a superficial electrode from the 3rd finger and a stimulus will be given from the wrist 14 cm proximal. Median sensory nerve latency, median sensory nerve conduction velocity and sensory nerve action potential will be calculated for both applications. nerve potentials will be calculated in m/sec
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 6 Jul 2022.
- Derived from this study: PubMed 39919926Akdeniz Leblebicier M, Cihan E, Yaman F, Sahbaz Pirincci C, Ture A, Kavuncu V. Can manual lymphatic drainage be a new treatment option in mild-moderate carpal tunnel syndrome? A randomized controlled study. J Hand Ther. 2025 Jul-Sep;38(3):584-593. doi: 10.1016/j.jht.2024.12.020. Epub 2025 Feb 6.
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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.
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 (massage) and Splint treatment in people with Carpal Tunnel Syndrome and Electrophysical Evaluation, 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 10 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 6 Jul 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?
pressure pain threshold (time frame: 15 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05394870, which also lists 1 linked publication.
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 6 Jul 2022.