Manual Lymphatic DrainageNCT04324775
Comparison of Acute Effect of Different Manual Techniques on Muscle Fascia Stiffness
An observational study of Manual Lymphatic Drainage and Swedish Massage, run by Marmara University.
Trial summary
There are studies investigating the effect of different massage methods on muscle fascia stiffness but the results do not support each other. In addition, there is no study to investigate the effect of MLD on muscle fascia stiffness. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Manual Lymphatic Drainage, Swedish Massage, Muscle Fascia Stiffness
- What is being tested?
- Exercise + Manual Lymphatic Drainage and Exercise + Swedish massage
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 20 Apr 2020
- Phase
- Observational
- 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 25 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Volunteer woman healthy student between the ages of 18-25 with a subcutaneous fold thickness of the quadriceps muscle between 5 mm and 15 mm.
Who may be able to join
- Being health and woman
- No systemic problem preventing exercise
- Having sufficient level of perception to perceive commands
- BMI≤25
Who cannot join
- Having a history of injury and surgery through the Quadriceps femoris muscle in the last three months
- Having a disease that will affect myofascial structure features
- Having a disease that will affect normal body temperature
- Chronic pain in Quadriceps femoris muscle that has been going on for the last three months.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Acute Effect of Manual Lymph Drainage and Swedish Massage on Muscle Fascia Stiffness Applied After Exercise in Healthy Young Women
There are studies investigating the effect of different massage methods on muscle fascia stiffness but the results do not support each other. In addition, there is no study to investigate the effect of MLD on muscle fascia stiffness. The aim of this study is to determine the acute effect of MLD and classical (Swedish) massage (KM) on muscle fascia stiffness after exercise.
- Being tested
- Exercise + Manual Lymphatic Drainage, Exercise + Swedish massage
- Keywords
- MLD, massage, fascia, stiffness
- Medical subject headings
- Leukodystrophy, Metachromatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise + Manual Lymphatic DrainageOther
Quadriceps exercises with weight of 75%1 Max repetition and 8 repetionX3 sets Following exercises, manual lymphatic drainage applied to rectus femoris for 5 minutes
Exercise + Swedish massageOther
Quadriceps exercises with weight of 75%1 Max repetition and 8 repetionX3 sets Following exercises, swedish massage applied to rectus femoris for 5 minutes
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Exercise+Manual Lymphatic Drainage Receives: Other: Exercise + Manual Lymphatic Drainage | |
| Group 2 | Exercise+Swedish Massage Receives: Other: Exercise + Swedish massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of skin temperature
For thermal imaging, a 120-9-90 pixel resolution FLIR E5 camera thermal camera (FLIR Systems AB, Sweden) will be used, and Color Palette iron will be selected to display images. The video will be taken from a distance of 1 m at a speed of 8 photos / s.
Measured: Change from Baseline skin temperature at following exercises, at following MLD/SM application and at 10 minutes after the exercise
Evaluation of the mechanical properties of the muscle-1
Viscoelastic stiffness [N/m] will be measured in MyotonPro 3 (MYO, Tallin, Estonia).
Measured: Change from Baseline mechanical properties at following exercises, at following MLD/SM application and at 10 minutes after the exercise
Evaluation of the mechanical properties of the muscle-2
Change from Baseline mechanical properties at following exercises, at following MLD/SM application and at 10 minutes after the exercise
Measured: Oscillation frequency (Hz) will be measured in MyotonPro 3 (MYO, Tallin, Estonia)
Evaluation of the mechanical properties of the muscle-3
Mechanical stiffness (N/m) will be measured in MyotonPro 3 (MYO, Tallin, Estonia).
Measured: Change from Baseline mechanical properties at following exercises, at following MLD/SM application and at 10 minutes after the exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start1 Apr 2020 (estimated)
- Primary completion15 Apr 2020 (estimated)
- Study completion20 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Manual Lymphatic DrainageStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324775
- Sponsor's protocol ID
- 09.2019.968
- Status last verified
- Jan 2020
- First submitted
- 24 Mar 2020
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bakar Y, Coknaz H, Karli U, Semsek O, Serin E, Pala OO. Effect of manual lymph drainage on removal of blood lactate after submaximal exercise. J Phys Ther Sci. 2015 Nov;27(11):3387-91. doi: 10.1589/jpts.27.3387. Epub 2015 Nov 30.
PubMed 26696704Kong PW, Chua YH, Kawabata M, Burns SF, Cai C. Effect of Post-Exercise Massage on Passive Muscle Stiffness Measured Using Myotonometry - A Double-Blind Study. J Sports Sci Med. 2018 Nov 20;17(4):599-606. eCollection 2018 Dec.
PubMed 30479528Ogai R, Yamane M, Matsumoto T, Kosaka M. Effects of petrissage massage on fatigue and exercise performance following intensive cycle pedalling. Br J Sports Med. 2008 Oct;42(10):834-8. doi: 10.1136/bjsm.2007.044396. Epub 2008 Apr 2.
PubMed 18385196Eriksson Crommert M, Lacourpaille L, Heales LJ, Tucker K, Hug F. Massage induces an immediate, albeit short-term, reduction in muscle stiffness. Scand J Med Sci Sports. 2015 Oct;25(5):e490-6. doi: 10.1111/sms.12341. Epub 2014 Dec 8.
PubMed 25487283
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Acute Effect of Manual Lymph Drainage and Swedish Massage on Muscle Fascia Stiffness Applied After Exercise in Healthy Young Women
- ClinicalTrials.gov ID
- NCT04324775
- Acronym / sponsor ID
- 09.2019.968
- Keywords
- MLD, massage, fascia, stiffness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 15 Apr 2020 (estimated)
- Study completion
- 20 Apr 2020 (estimated)
- First posted
- 27 Mar 2020 (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.
There are studies investigating the effect of different massage methods on muscle fascia stiffness but the results do not support each other. In addition, there is no study to investigate the effect of MLD on muscle fascia stiffness. The aim of this study is to determine the acute effect of MLD and classical (Swedish) massage (KM) on muscle fascia stiffness after exercise.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Exercise + Manual Lymphatic DrainageExercise+Manual Lymphatic Drainage |
| Group 2 | – | Other: Exercise + Swedish massageExercise+Swedish Massage |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Volunteer woman healthy student between the ages of 18-25 with a subcutaneous fold thickness of the quadriceps muscle between 5 mm and 15 mm.
Key inclusion criteria (4 listed)
- Being health and woman
- No systemic problem preventing exercise
- Having sufficient level of perception to perceive commands
- BMI≤25
Key exclusion criteria (4 listed)
- Having a history of injury and surgery through the Quadriceps femoris muscle in the last three months
- Having a disease that will affect myofascial structure features
- Having a disease that will affect normal body temperature
- Chronic pain in Quadriceps femoris muscle that has been going on for the last three months.
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 |
|---|---|---|
| Exercise + Manual Lymphatic DrainageQuadriceps exercises with weight of 75%1 Max repetition and 8 repetionX3 sets Following exercises, manual lymphatic drainage applied to rectus femoris for 5 minutes | Other | Group 1 |
| Exercise + Swedish massageQuadriceps exercises with weight of 75%1 Max repetition and 8 repetionX3 sets Following exercises, swedish massage applied to rectus femoris for 5 minutes | Other | Group 2 |
Primary outcome
Measurement of skin temperature
Time frame: Change from Baseline skin temperature at following exercises, at following MLD/SM application and at 10 minutes after the exercise
For thermal imaging, a 120-9-90 pixel resolution FLIR E5 camera thermal camera (FLIR Systems AB, Sweden) will be used, and Color Palette iron will be selected to display images. The video will be taken from a distance of 1 m at a speed of 8 photos / s.
Evaluation of the mechanical properties of the muscle-1
Time frame: Change from Baseline mechanical properties at following exercises, at following MLD/SM application and at 10 minutes after the exercise
Viscoelastic stiffness [N/m] will be measured in MyotonPro 3 (MYO, Tallin, Estonia).
Evaluation of the mechanical properties of the muscle-2
Time frame: Oscillation frequency (Hz) will be measured in MyotonPro 3 (MYO, Tallin, Estonia)
Change from Baseline mechanical properties at following exercises, at following MLD/SM application and at 10 minutes after the exercise
Evaluation of the mechanical properties of the muscle-3
Time frame: Change from Baseline mechanical properties at following exercises, at following MLD/SM application and at 10 minutes after the exercise
Mechanical stiffness (N/m) will be measured in MyotonPro 3 (MYO, Tallin, Estonia).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Background: PubMed 26696704Bakar Y, Coknaz H, Karli U, Semsek O, Serin E, Pala OO. Effect of manual lymph drainage on removal of blood lactate after submaximal exercise. J Phys Ther Sci. 2015 Nov;27(11):3387-91. doi: 10.1589/jpts.27.3387. Epub 2015 Nov 30.
- Background: PubMed 30479528Kong PW, Chua YH, Kawabata M, Burns SF, Cai C. Effect of Post-Exercise Massage on Passive Muscle Stiffness Measured Using Myotonometry - A Double-Blind Study. J Sports Sci Med. 2018 Nov 20;17(4):599-606. eCollection 2018 Dec.
- Background: PubMed 18385196Ogai R, Yamane M, Matsumoto T, Kosaka M. Effects of petrissage massage on fatigue and exercise performance following intensive cycle pedalling. Br J Sports Med. 2008 Oct;42(10):834-8. doi: 10.1136/bjsm.2007.044396. Epub 2008 Apr 2.
- Results publication: PubMed 25487283Eriksson Crommert M, Lacourpaille L, Heales LJ, Tucker K, Hug F. Massage induces an immediate, albeit short-term, reduction in muscle stiffness. Scand J Med Sci Sports. 2015 Oct;25(5):e490-6. doi: 10.1111/sms.12341. Epub 2014 Dec 8.
- Individual participant dataSharing planned: No
Related trials for Manual Lymphatic Drainage
Not yet recruiting
Effects of Manual Lymphatic Drainage and Pressotherapy on Muscle Recovery After Eccentric Exercise in Physically Active Young Adults
Young Athletes
Recruiting
The LYMPH Trial - Microsurgical Versus Conservative Treatment of Chronic Breast Cancer Associated Lymphedema
Lymphedema, Breast Cancer
Not yet recruiting
The Effects of Manual Lymphatic Drainage and Self-Manual Lymphatic Drainage
Premenstrual Syndrome
Enrolling by invitation
Automated Manual Lymphatic Drainage Therapy to Improve Glymphatic Function in OSA Patients
Obstructive Sleep Apnea (OSA), OSA
Recruiting
Manual and Self-Lymphatic Drainage Combined With Exercise in Women With Lipedema
Lipedema
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Manual Lymphatic Drainage and Swedish Massage, run by Marmara University.
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: status not confirmed, as of the sponsor's last update on 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Yaşar Tatar (05323758895, yasartatar@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of skin temperature (time frame: Change from Baseline skin temperature at following exercises, at following MLD/SM application and at 10 minutes after the exercise). The study lists 4 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 NCT04324775, which also lists 4 linked publications.
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 27 Mar 2020.