Manual Lymphatic Drainage EffectsNCT06139445
Manual Lymphatic Drainage for Pain, Muscle Strength, and Sensation
A study testing Manual Lymphatic Drainage and Plasebo Group in people with Manual Lymphatic Drainage Effects, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
To evaluate the acute effect of MLD on pressure pain threshold (PPT), pain tolerance, tactile sensation, and muscle strength in healthy young adults. healthy young adults were included in the study. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Manual Lymphatic Drainage Effects
- What is being tested?
- Manual Lymphatic Drainage and Plasebo Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Nov 2023to 30 Nov 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being aged 18-30 years
- Volunteering to participate in the study
Who cannot join
- Having any skin disease
- Having a history of neurological and/or orthopedic disease
- Having a significant scar or burn tissue in the upper extremity
- Having any condition that would prevent communication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Manual Lymphatic Drainage on Pressure Pain Threshold, Pain Tolerance, Grip and Pinch Strength, and Two-point Discrimination
To evaluate the acute effect of MLD on pressure pain threshold (PPT), pain tolerance, tactile sensation, and muscle strength in healthy young adults.
healthy young adults were included in the study. Before and after MLD and plasebo touchs, the same physiotherapist performed PPT and pain tolerance measurements, muscle strength measurements with a hand dynamometer (Jamar®) and pinchmeter (Baseline®), and two-point discrimination (2PD) evaluation with an esthesiometer.
- Conditions
- Manual Lymphatic Drainage Effects
- Being tested
- Manual Lymphatic Drainage, Plasebo Group
- Keywords
- Manual lymphatic drainage, pain threshold, pain tolerance, two-point discrimination, muscle strength
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 (MLD), one of the components of complex decongestive physiotherapy, is a gentle massage technique with proven positive effects on lymphatic circulation. MLD can be applied to different parts of the body (e.g., arms, legs, neck, abdomen, and trunk), with a different technique for each region (stationary circle, scoop, pump, and rotary)
Plasebo GroupOther
random superficial touches not involved in any manual technique
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Not described Receives: Other: Manual Lymphatic Drainage |
| Plasebo Group | Placebo comparator | Not described Receives: Other: Plasebo Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
pressure pain threshold (PPT)
PPT measurements will be performed using a 1-cm2 surface algometer.The algometer will be positioned vertically and placed on the thenar, hypothenar, mid-ulnar, and biceps regions using the marked points. Measurements will be repeated three times. The average of these three measurements will be used for analysis.
Measured: 5 minutes
pain tolerance
pain tolerance measurements will be performed using a 1-cm2 surface algometer.The algometer will be positioned vertically and placed on the thenar, hypothenar, mid-ulnar, and biceps regions using the marked points.The highest tolerable pressure will be used in the measurement and it will be recorded.
Measured: 5 minutes
Evaluation of Hand Grip Strength
The Jamar will be used to measure hand grip strength.Three measurements will be made at one-minute intervals, and the average values will be recorded
Measured: 5 minutes
Evaluation Finger Pinch Strength
A pinchmeter (Baseline®) will be used to measure finger pinch strength. Three measurements will be made at one-minute intervals, and the average values will be recorded
Measured: 5 minutes
Two-point discrimination (2PD)
This evaluation will be performed using an esthesiometer with the participants in the sitting position with their eyes closed. Evaluation will be made from the biceps medial to the elbow. The contact time of the two-point stimulation will be adjusted to be approximately 1-2 seconds, and approximately 3-5 seconds will be waited between each stimulation. The shortest distance felt between two points provided the static 2PD value
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 posted18 Nov 2023
- Study start8 Nov 2023
- Primary completion20 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Manual Lymphatic Drainage EffectsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 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
- NCT06139445
- Sponsor's protocol ID
- 2023/25-05
- Status last verified
- Jan 2024
- First submitted
- 25 May 2023
- Last updated
- 29 Jan 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 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Manual Lymphatic Drainage on Pressure Pain Threshold, Pain Tolerance, Grip and Pinch Strength, and Two-point Discrimination
- ClinicalTrials.gov ID
- NCT06139445
- Acronym / sponsor ID
- 2023/25-05
- Conditions
- Manual Lymphatic Drainage Effects
- Keywords
- Manual lymphatic drainage, pain threshold, pain tolerance, two-point discrimination, muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 18 Nov 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.
To evaluate the acute effect of MLD on pressure pain threshold (PPT), pain tolerance, tactile sensation, and muscle strength in healthy young adults.
healthy young adults were included in the study. Before and after MLD and plasebo touchs, the same physiotherapist performed PPT and pain tolerance measurements, muscle strength measurements with a hand dynamometer (Jamar®) and pinchmeter (Baseline®), and two-point discrimination (2PD) evaluation with an esthesiometer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Manual Lymphatic Drainage |
| Plasebo Group | Placebo comparator | Other: Plasebo Group |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Being aged 18-30 years
- Volunteering to participate in the study
Key exclusion criteria (4 listed)
- Having any skin disease
- Having a history of neurological and/or orthopedic disease
- Having a significant scar or burn tissue in the upper extremity
- Having any condition that would prevent communication
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 (MLD), one of the components of complex decongestive physiotherapy, is a gentle massage technique with proven positive effects on lymphatic circulation. MLD can be applied to different parts of the body (e.g., arms, legs, neck, abdomen, and trunk), with a different technique for each region (stationary circle, scoop, pump, and rotary) | Other | Study Group |
| Plasebo Grouprandom superficial touches not involved in any manual technique | Other | Plasebo Group |
Primary outcome
pressure pain threshold (PPT)
Time frame: 5 minutes
PPT measurements will be performed using a 1-cm2 surface algometer.The algometer will be positioned vertically and placed on the thenar, hypothenar, mid-ulnar, and biceps regions using the marked points. Measurements will be repeated three times. The average of these three measurements will be used for analysis.
pain tolerance
Time frame: 5 minutes
pain tolerance measurements will be performed using a 1-cm2 surface algometer.The algometer will be positioned vertically and placed on the thenar, hypothenar, mid-ulnar, and biceps regions using the marked points.The highest tolerable pressure will be used in the measurement and it will be recorded.
Evaluation of Hand Grip Strength
Time frame: 5 minutes
The Jamar will be used to measure hand grip strength.Three measurements will be made at one-minute intervals, and the average values will be recorded
Evaluation Finger Pinch Strength
Time frame: 5 minutes
A pinchmeter (Baseline®) will be used to measure finger pinch strength. Three measurements will be made at one-minute intervals, and the average values will be recorded
Two-point discrimination (2PD)
Time frame: 10 minutes
This evaluation will be performed using an esthesiometer with the participants in the sitting position with their eyes closed. Evaluation will be made from the biceps medial to the elbow. The contact time of the two-point stimulation will be adjusted to be approximately 1-2 seconds, and approximately 3-5 seconds will be waited between each stimulation. The shortest distance felt between two points provided the static 2PD value
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 29 Jan 2024.
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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 and Plasebo Group in people with Manual Lymphatic Drainage Effects, 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 2 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 29 Jan 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. 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?
pressure pain threshold (PPT) (time frame: 5 minutes). The study lists 5 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 29 Jan 2024.