Carpal Tunnel SyndromeNCT05490420
Effects of Upper Extremity Manual Lymphatic Drainage on Symptom Severity, Hand Functions, Electrophysiological and Ultrasonographic Measurements in Carpal Tunnel Syndrome
A study testing manual lymphatic drainage (MLD) in people with Carpal Tunnel Syndrome, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
This study is aimed to investigate the effects of upper extremity manual lymphatic drainage, which is applied to remove edema from the carpal tunnel region in addition to conventional exercise therapy in Carpal tunnel syndrome patients on findings of clinical, ultrasonographic, and electrophysiological. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- manual lymphatic drainage (MLD)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Sep 2022to 30 Jul 2023
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- People aged between 40-60 years
- Having been diagnosed with carpal tunnel syndrome (CTS) at least 6 months ago or having symptoms related to carpal tunnel syndrome for at least 6 months
- Having mild (median nerve sensory conduction velocity below 40 m/sec) and moderate (median nerve sensory conduction velocity below 40 m/sec and median motor distal latency 4 ms and above) CTS according to electrophysiological findings
- Not having received medical treatment and/or physiotherapy for CTS in the last 6 months
Who cannot join
- Having cervical radiculopathy
- Having thoracic outlet syndrome
- Presence of systemic disease that may lead to CTS, such as diabetes or thyroid disease
- Pregnancy
- Presence of anemia
- Having a history of CTS surgery
Show all 9Show fewer
- Presence of radial or ulnar nerve sensory-motor lesions accompanying the present condition
- Presence of lymphedema
- Having severe (Sensory nerve action potential cannot be obtained) and severe (Sensory nerve action potential cannot be obtained, but combined muscle action potential is not present) CTS according to electrophysiological findings
Trial locations and contacts
1 site in 1 country.
About this study
This study is aimed to investigate the effects of upper extremity manual lymphatic drainage, which is applied to remove edema from the carpal tunnel region in addition to conventional exercise therapy in Carpal tunnel syndrome patients on findings of clinical, ultrasonographic, and electrophysiological.
Read the detailed description
Thirtyfour volunteer participants between aged 40 and 60 years, who met the inclusion criteria, will be included in the study. Participants will be randomly divided into two groups experimental and control groups. While the control group will receive only conventional exercises, the experimental group will receive both conventional exercises and upper extremity manual lymphatic drainage. A total of 3 measurements will be made before the treatment, after the treatment and 1 month after the end of the treatment. Symptom severity will be evaluated via Boston carpal tunnel syndrome questionnaire, grip strength via hand dynamometer, pressure pain threshold via digital algometer device, cross-sectional area of the median nerve via ultrasound, and median nerve conduction velocity via superficial EMG device.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- manual lymphatic drainage (MLD)
- Keywords
- carpal tunnel syndrome, manual lymphatic drainage, surface electromyography
- 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 (MLD)Other
MLD is a manual technique that is applied to the lymphatic system with a pressure of approximately 40-50mmHg and increases the working speed of lymphatic nodules/collectors. Its main purpose is to support microcirculation by accelerating lymphatic flow and to prevent/remove interstitial fluid accumulation that may cause fascial adhesions.
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | 17 participants who meet the inclusion criteria will be applied conventional exercise which includes nerve gliding and tendon gliding exercises. And also sham (placebo) upper extremity manual lymphatic drainage will be applied. Sham (placebo) manual lymphatic drainage will include only classical massage not manual lymphatic drainage techniques. Participants will be treated for a total of 6 weeks, 2 days a week. Each session will last approximately 20-30 minutes, and the exercises will be performed in 3 sets with 10 repetitions. Receives: Other: manual lymphatic drainage (MLD) |
| experimental | Experimental | 17 participants who meet the inclusion criteria will be applied both conventional exercise and upper manual lymphatic drainage (MLD). MLD is a manual technique that is applied to the lymphatic system with a pressure of approximately 40-50mmHg and increases the working speed of lymphatic nodules/collectors. Its main purpose is to support microcirculation by accelerating lymphatic flow and to prevent/remove interstitial fluid accumulation that may cause fascial adhesions. Within the scope of this research, an application will be made to cover the entire upper extremity lymphatic system. MLD will last approximately 20-30 minutes. Conventional exercise, which includes nerve gliding and tendon gliding exercises, will be performed in 3 sets with 10 repetitions. Participants will be treated for a total of 6 weeks, 2 days a week. Receives: Other: manual lymphatic drainage (MLD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom severity
1- Symptom severity will be evaulated with Boston carpal tunnel questionnaire (BCTQ). BCTQ comprises 11 items of Symptom Severity Scale (SSS) measuring pain, paresthesia, numbness, nocturnal symptoms and feeling of weakness plus another 8 items of Functional Status Scale (FSS) measuring difficulties in performing daily activities. Scales ranged from 1-5 representing normal to worst symptoms or disabilities. Higher scores indicate greater symptom severity and disability.
Measured: Change from baseline symptom severity at week 6 and 10.
Grip strength
2- Grip strength will be assessed with a digital hand dynamometer. The subject will seat with feet positioned on the floor, shoulder adducted, and the elbow bent at a 90-degree angle with the forearm parallel to the floor. Maximal isometric grip strength will be measured in kilograms. It is a reliable method for measuring grip strength.
Measured: Change from baseline grip strength at week 6 and 10.
Pressure pain threshold (PPT)
PPT, the minimal amount of pressure where a sense of pressure changes to pain, will be measured with an electronic algometer over the median nerve in the wrist area. The pressure will be applied approximately at a rate of 30 kPa/sec for 30 seconds. Participants will be instructed to press the switch when the sensation changed from pressure to pain.
Measured: Change from baseline pressure pain threshold at week 6 and 10.
Cross-sectional area of the median nerve
US images will be obtained by a neurologist trained in peripheral nerve US. The nerve will be imaged using a Biosound Esaote MyLab 70 equipped with an 18-MHZ linear-array transducer. The median nerve will be imaged in cross-section at the distal wrist crease (carpal tunnel inlet) and 12 cm proximal to this point in the forearm.
Measured: Change from baseline cross-sectional area of the median nerve at week 6 and 10.
Sensory Velocity of median nerve
Sensory Velocity of median nerve will be recorded with surface EMG using surface electrodes from the abductor pollicis brevis (APB) muscle by a neurologist using standard techniques.
Measured: Change from baseline Sensory Velocity of median nerve at week 6 and 10.
Motor velocity of median nerve
Motor Velocity of median nerve will be recorded with surface EMG using surface electrodes from the abductor pollicis brevis (APB) muscle by a neurologist using standard techniques
Measured: Change from baseline motor velocity of median nerve at week 6 and 10.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start5 Sep 2022
- Primary completion3 Jun 2023
- Study completion30 Jul 2023
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.
- 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
- Model description
- randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Mete, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490420
- Sponsor's protocol ID
- 2022/0344
- Status last verified
- Aug 2022
- First submitted
- 4 Aug 2022
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Upper Extremity Manual Lymphatic Drainage on Symptom Severity, Hand Functions, Electrophysiological and Ultrasonographic Measurements in Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT05490420
- Acronym / sponsor ID
- 2022/0344
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- carpal tunnel syndrome, manual lymphatic drainage, surface electromyography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 3 Jun 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 5 Aug 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.
This study is aimed to investigate the effects of upper extremity manual lymphatic drainage, which is applied to remove edema from the carpal tunnel region in addition to conventional exercise therapy in Carpal tunnel syndrome patients on findings of clinical, ultrasonographic, and electrophysiological.
Detailed description
Thirtyfour volunteer participants between aged 40 and 60 years, who met the inclusion criteria, will be included in the study. Participants will be randomly divided into two groups experimental and control groups. While the control group will receive only conventional exercises, the experimental group will receive both conventional exercises and upper extremity manual lymphatic drainage. A total of 3 measurements will be made before the treatment, after the treatment and 1 month after the end of the treatment. Symptom severity will be evaluated via Boston carpal tunnel syndrome questionnaire, grip strength via hand dynamometer, pressure pain threshold via digital algometer device, cross-sectional area of the median nerve via ultrasound, and median nerve conduction velocity via superficial EMG device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Other: manual lymphatic drainage (MLD)17 participants who meet the inclusion criteria will be applied conventional exercise which includes nerve gliding and tendon gliding exercises. And also sham (placebo) upper extremity manual lymphatic drainage will be applied. Sham (placebo) manual lymphatic drainage will include only classical massage not manual lymphatic drainage techniques. Participants will be treated for a total of 6 weeks, 2 days a week. Each session will last approximately 20-30 minutes, and the exercises will be performed in 3 sets with 10 repetitions. |
| experimental | Experimental | Other: manual lymphatic drainage (MLD)17 participants who meet the inclusion criteria will be applied both conventional exercise and upper manual lymphatic drainage (MLD). MLD is a manual technique that is applied to the lymphatic system with a pressure of approximately 40-50mmHg and increases the working speed of lymphatic nodules/collectors. Its main purpose is to support microcirculation by accelerating lymphatic flow and to prevent/remove interstitial fluid accumulation that may cause fascial adhesions. Within the scope of this research, an application will be made to cover the entire upper extremity lymphatic system. MLD will last approximately 20-30 minutes. Conventional exercise, which includes nerve gliding and tendon gliding exercises, will be performed in 3 sets with 10 repetitions. Participants will be treated for a total of 6 weeks, 2 days a week. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- People aged between 40-60 years
- Having been diagnosed with carpal tunnel syndrome (CTS) at least 6 months ago or having symptoms related to carpal tunnel syndrome for at least 6 months
- Having mild (median nerve sensory conduction velocity below 40 m/sec) and moderate (median nerve sensory conduction velocity below 40 m/sec and median motor distal latency 4 ms and above) CTS according to electrophysiological findings
- Not having received medical treatment and/or physiotherapy for CTS in the last 6 months
Key exclusion criteria (9 listed)
- Having cervical radiculopathy
- Having thoracic outlet syndrome
- Presence of systemic disease that may lead to CTS, such as diabetes or thyroid disease
- Pregnancy
- Presence of anemia
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 (MLD)MLD is a manual technique that is applied to the lymphatic system with a pressure of approximately 40-50mmHg and increases the working speed of lymphatic nodules/collectors. Its main purpose is to support microcirculation by accelerating lymphatic flow and to prevent/remove interstitial fluid accumulation that may cause fascial adhesions. | Other | Control, experimental |
Primary outcome
Symptom severity
Time frame: Change from baseline symptom severity at week 6 and 10.
1- Symptom severity will be evaulated with Boston carpal tunnel questionnaire (BCTQ). BCTQ comprises 11 items of Symptom Severity Scale (SSS) measuring pain, paresthesia, numbness, nocturnal symptoms and feeling of weakness plus another 8 items of Functional Status Scale (FSS) measuring difficulties in performing daily activities. Scales ranged from 1-5 representing normal to worst symptoms or disabilities. Higher scores indicate greater symptom severity and disability.
Grip strength
Time frame: Change from baseline grip strength at week 6 and 10.
2- Grip strength will be assessed with a digital hand dynamometer. The subject will seat with feet positioned on the floor, shoulder adducted, and the elbow bent at a 90-degree angle with the forearm parallel to the floor. Maximal isometric grip strength will be measured in kilograms. It is a reliable method for measuring grip strength.
Pressure pain threshold (PPT)
Time frame: Change from baseline pressure pain threshold at week 6 and 10.
PPT, the minimal amount of pressure where a sense of pressure changes to pain, will be measured with an electronic algometer over the median nerve in the wrist area. The pressure will be applied approximately at a rate of 30 kPa/sec for 30 seconds. Participants will be instructed to press the switch when the sensation changed from pressure to pain.
Cross-sectional area of the median nerve
Time frame: Change from baseline cross-sectional area of the median nerve at week 6 and 10.
US images will be obtained by a neurologist trained in peripheral nerve US. The nerve will be imaged using a Biosound Esaote MyLab 70 equipped with an 18-MHZ linear-array transducer. The median nerve will be imaged in cross-section at the distal wrist crease (carpal tunnel inlet) and 12 cm proximal to this point in the forearm.
Sensory Velocity of median nerve
Time frame: Change from baseline Sensory Velocity of median nerve at week 6 and 10.
Sensory Velocity of median nerve will be recorded with surface EMG using surface electrodes from the abductor pollicis brevis (APB) muscle by a neurologist using standard techniques.
Motor velocity of median nerve
Time frame: Change from baseline motor velocity of median nerve at week 6 and 10.
Motor Velocity of median nerve will be recorded with surface EMG using surface electrodes from the abductor pollicis brevis (APB) muscle by a neurologist using standard techniques
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 8 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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 (MLD) in people with Carpal Tunnel Syndrome, run by Istanbul Medeniyet 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 4 inclusion and 9 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 8 Sep 2023. 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. 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?
Symptom severity (time frame: Change from baseline symptom severity at week 6 and 10.). The study lists 6 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 8 Sep 2023.