MigraineEDLMMGNCT07425041
Effectiveness of Manual Lymphatic Drainage in the Physiotherapeutic Treatment of Migraine
A study testing Manual lymphatic drainage in people with Migraine, run by Camilo Jose Cela University at 1 site in Spain.
Trial summary
Migraine is a highly prevalent neurological disorder associated with recurrent headache, disability, and reduced quality of life. In addition to pain, migraine is frequently accompanied by autonomic dysfunction, psychological comorbidities, and sleep disturbances. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Migraine
- What is being tested?
- Manual lymphatic drainage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 20 Mar 2026to 1 Jul 2026
- 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
- Male or female, aged 20 to 55 years.
- Clinical diagnosis of migraine and experiencing migraine episodes with a minimum frequency of 4 times per month.
Who cannot join
- Participants with arterial hypertension who are taking antihypertensive medication.
- Participants currently taking prophylactic medication for migraine.
- Participants with fibromyalgia.
Trial locations and contacts
1 site in 1 country.
About this study
Migraine is a highly prevalent neurological disorder associated with recurrent headache, disability, and reduced quality of life. In addition to pain, migraine is frequently accompanied by autonomic dysfunction, psychological comorbidities, and sleep disturbances. Manual lymphatic drainage (MLD) is a physiotherapy technique that may influence pain perception and autonomic regulation by promoting lymphatic and venous return and facilitating parasympathetic activity.
The aim of this pilot clinical study is to evaluate the effectiveness of manual lymphatic drainage in patients with migraine. Participants will be allocated to an experimental group receiving manual lymphatic drainage or to a control group. Outcomes related to pain intensity, pressure pain thresholds, migraine-related disability, quality of life, psychological variables, sleep quality, and vital signs will be assessed at baseline, after the intervention, and during follow-up periods.
This study seeks to provide preliminary evidence on the feasibility and potential clinical effects of manual lymphatic drainage as a non-pharmacological physiotherapy approach for migraine management.
Read the detailed description
Migraine is a complex and episodic sensory disorder characterized by recurrent headache attacks, frequently accompanied by nausea, vomiting, photophobia, and phonophobia. It is one of the leading causes of disability worldwide and has a substantial impact on quality of life, work productivity, and psychosocial functioning. Migraine is more prevalent in women and is commonly associated with comorbid conditions such as anxiety, depression, sleep disturbances, and autonomic nervous system dysfunction.
From a pathophysiological perspective, migraine involves altered cortical and subcortical processing, activation of the trigeminovascular system, and neurogenic inflammation. The meninges, innervated by trigeminal afferents, play a central role in pain generation. In addition, emerging evidence highlights the importance of meningeal lymphatic drainage in cerebrospinal fluid clearance and immune regulation. Autonomic imbalance, typically characterized by reduced parasympathetic activity and relative sympathetic predominance between migraine attacks, further contributes to cardiovascular and stress-related manifestations in these patients.
Migraine management is multimodal and includes pharmacological and non-pharmacological strategies. Within physiotherapy, interventions such as manual therapy, exercise, neuromodulation, and soft tissue techniques have shown potential benefits. Manual lymphatic drainage is a gentle manual therapy technique aimed at stimulating lymphatic flow, reducing tissue congestion, facilitating the clearance of inflammatory mediators, and promoting parasympathetic activation. When applied to the cervical and craniofacial regions, manual lymphatic drainage may help reduce cranio-cervical congestion, modulate autonomic activity, and decrease musculoskeletal tension, all of which are relevant factors in migraine.
This study is designed as a pilot clinical study with a pre-post design and two parallel groups: an experimental group and a control group. A total of 20 participants diagnosed with migraine, aged between 20 and 55 years, will be recruited. Participants will be allocated by sex into the two study groups. The experimental group will receive manual lymphatic drainage applied to the neck and facial regions, delivered in two sessions per week over a three-week period (six sessions in total). The control group will not receive the experimental intervention.
Outcome measures will be collected at baseline (prior to the intervention), immediately after the completion of the intervention, and during follow-up at 15 days and one month post-intervention. Primary outcomes include pain intensity assessed by the Visual Analogue Scale, pressure pain thresholds measured by algometry, migraine-related disability assessed by the Migraine Disability Assessment questionnaire, and migraine impact on quality of life assessed by the Headache Impact Test (HIT-6). Secondary outcomes include migraine frequency, intensity, and duration recorded through a structured migraine diary, psychological variables (anxiety and depression), perceived stress, sleep quality, and vital signs (blood pressure and heart rate).
By assessing both immediate and short-term follow-up effects, this pilot study aims to explore the feasibility, safety, and potential clinical effects of manual lymphatic drainage in patients with migraine. The findings are intended to support the development of future controlled studies and to inform the potential inclusion of manual lymphatic drainage in physiotherapy protocols for migraine management.
- Conditions
- Migraine
- Being tested
- Manual lymphatic drainage
- Keywords
- Manual Lymphatic Drainage, Migraine
- Medical subject headings
- Migraine Disorders
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 is a manual therapy technique based on gentle maneuvers that aim to reduce swelling and pain.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | This group will receive manual lymphatic drainage sessions for the treatment of migraine. Receives: Other: Manual lymphatic drainage |
| Control group | No intervention | This group will serve as a control and will not receive manual lymphatic drainage sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity (Visual Analogue Scale, VAS)
Self-reported pain intensity measured using a 10-cm Visual Analogue Scale (VAS), anchored at 0 ("no pain") and 10 ("worst imaginable pain").
Measured: Baseline (pre-intervention), immediately post-intervention (after session 6; 3 weeks), 15-day follow-up, and 1-month follow-up.
Pressure pain threshold (PPT) at suboccipital region
Pressure Pain Threshold (PPT) assessed by algometry in the right and left suboccipital region (at the insertion of suboccipital muscles). Three consecutive measurements per site with 1-minute intervals; the mean value is used (units as recorded by the algometer, e.g., kg/cm²)
Measured: Baseline (pre-intervention), immediately post-intervention (after session 6; 3 weeks), 15-day follow-up, and 1-month follow-up.
Secondary outcomes (8)
Headache impact (Headache Impact Test-6, HIT-6)
Headache-related impact on daily life assessed with the HIT-6 questionnaire (6 items; total score range 36-78, higher scores indicate greater impact).
Measured: Baseline (pre-intervention), immediately post-intervention (after session 6; 3 weeks), 15-day follow-up, and 1-month follow-up
Migraine-related disability (Migraine Disability Assessment, MIDAS)
Migraine-related disability assessed with the MIDAS questionnaire (5 items) evaluating days of reduced activity/work/school/home and social activities over the previous 3 months; higher scores indicate greater disability.
Measured: Baseline (pre-intervention), immediately post-intervention (after session 6; 3 weeks), 15-day follow-up, and 1-month follow-up.
Migraine attack characteristics (structured migraine diary)
Headache/migraine characteristics recorded using a structured diary, including headache days (frequency), attack duration (hours and minutes), pain intensity (0-10 numeric rating), pain location, associated symptoms (e.g., nausea/vomiting, photophobia/phonophobia, aura/visual symptoms, paresthesia, speech difficulties), potential triggers (e.g., stress, sleep changes, dietary changes, menstruation), and acute medication use (yes/no, medication name and dose).
Measured: Baseline (pre-intervention), after session 2, after session 4, immediately post-intervention (after session 6), 15-day follow-up, and 1-month follow-up.
Baseline (pre-intervention), after session 2, after session 4, immediately post-intervention (after session 6), 15-day follow-up, and 1-month follow-up.
Anxiety and depression assessed with the Hospital Anxiety and Depression Scale (HADS; 14 items). It provides two subscales (Anxiety and Depression), each ranging from 0 to 21; higher scores indicate greater symptom severity.
Measured: Baseline (pre-intervention), immediately post-intervention (after session 6; 3 weeks), 15-day follow-up, and 1-month follow-up.
Perceived stress (Perceived Stress Scale-14, PSS-14)
Perceived stress over the previous month assessed with the Perceived Stress Scale (PSS-14; 14 items, 5-point response format from 0 "never" to 4 "very often"). Total score is calculated by reversing specified items and summing all items; higher scores indicate higher perceived stress.
Measured: Baseline (pre-intervention), immediately post-intervention (after session 6; 3 weeks), 15-day follow-up, and 1-month follow-up.
Sleep quality (Pittsburgh Sleep Quality Index, PSQI)
Sleep quality assessed with the Pittsburgh Sleep Quality Index (PSQI; 19 items forming 7 components scored 0-3). Global score ranges from 0 to 21; higher scores indicate poorer sleep quality.
Measured: Baseline (pre-intervention), immediately post-intervention (after session 6; 3 weeks), 15-day follow-up, and 1-month follow-up.
Blood pressure (systolic and diastolic, mmHg)
Resting systolic and diastolic blood pressure measured in mmHg using a validated automatic sphygmomanometer after 5 minutes seated rest.
Measured: Baseline (pre-intervention), pre- and post in firts week, pre- and post in second week, pre- and post in third week, 15-day follow-up, and 1-month follow-up.
Heart rate (beats/min)
Resting heart rate measured (beats per minute) using an automatic pulse oximeter after 5 minutes seated rest.
Measured: Baseline (pre-intervention), pre- and post in firts week, pre- and post in second week, pre- and post in third week, 15-day follow-up, and 1-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start20 Mar 2026
- Primary completion20 Apr 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Camilo Jose Cela University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edurne Úbeda D'Ocasar, Camilo Jose Cela University
- Investigators
- Edurne Úbeda Docasar, Doctor, Principal investigator, University Camilo José Cela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425041
- Sponsor's protocol ID
- UCJCDLMMG
- Acronym
- EDLMMG
- Status last verified
- Jul 2026
- First submitted
- 13 Feb 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Manual Lymphatic Drainage in the Physiotherapeutic Treatment of Migraine
- ClinicalTrials.gov ID
- NCT07425041
- Acronym / sponsor ID
- EDLMMG / UCJCDLMMG
- Conditions
- Migraine
- Keywords
- Manual Lymphatic Drainage, Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Camilo Jose Cela UniversityUniversity, hospital or other
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- 20 Apr 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 20 Feb 2026 (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.
Migraine is a highly prevalent neurological disorder associated with recurrent headache, disability, and reduced quality of life. In addition to pain, migraine is frequently accompanied by autonomic dysfunction, psychological comorbidities, and sleep disturbances. Manual lymphatic drainage (MLD) is a physiotherapy technique that may influence pain perception and autonomic regulation by promoting lymphatic and venous return and facilitating parasympathetic activity.
The aim of this pilot clinical study is to evaluate the effectiveness of manual lymphatic drainage in patients with migraine. Participants will be allocated to an experimental group receiving manual lymphatic drainage or to a control group. Outcomes related to pain intensity, pressure pain thresholds, migraine-related disability, quality of life, psychological variables, sleep quality, and vital signs will be assessed at baseline, after the intervention, and during follow-up periods.
This study seeks to provide preliminary evidence on the feasibility and potential clinical effects of manual lymphatic drainage as a non-pharmacological physiotherapy approach for migraine management.
Detailed description
Migraine is a complex and episodic sensory disorder characterized by recurrent headache attacks, frequently accompanied by nausea, vomiting, photophobia, and phonophobia. It is one of the leading causes of disability worldwide and has a substantial impact on quality of life, work productivity, and psychosocial functioning. Migraine is more prevalent in women and is commonly associated with comorbid conditions such as anxiety, depression, sleep disturbances, and autonomic nervous system dysfunction.
From a pathophysiological perspective, migraine involves altered cortical and subcortical processing, activation of the trigeminovascular system, and neurogenic inflammation. The meninges, innervated by trigeminal afferents, play a central role in pain generation. In addition, emerging evidence highlights the importance of meningeal lymphatic drainage in cerebrospinal fluid clearance and immune regulation. Autonomic imbalance, typically characterized by reduced parasympathetic activity and relative sympathetic predominance between migraine attacks, further contributes to cardiovascular and stress-related manifestations in these patients.
Migraine management is multimodal and includes pharmacological and non-pharmacological strategies. Within physiotherapy, interventions such as manual therapy, exercise, neuromodulation, and soft tissue techniques have shown potential benefits. Manual lymphatic drainage is a gentle manual therapy technique aimed at stimulating lymphatic flow, reducing tissue congestion, facilitating the clearance of inflammatory mediators, and promoting parasympathetic activation. When applied to the cervical and craniofacial regions, manual lymphatic drainage may help reduce cranio-cervical congestion, modulate autonomic activity, and decrease musculoskeletal tension, all of which are relevant factors in migraine.
This study is designed as a pilot clinical study with a pre-post design and two parallel groups: an experimental group and a control group. A total of 20 participants diagnosed with migraine, aged between 20 and 55 years, will be recruited. Participants will be allocated by sex into the two study groups. The experimental group will receive manual lymphatic drainage applied to the neck and facial regions, delivered in two sessions per week over a three-week period (six sessions in total). The control group will not receive the experimental intervention.
Outcome measures will be collected at baseline (prior to the intervention), immediately after the completion of the intervention, and during follow-up at 15 days and one month post-intervention. Primary outcomes include pain intensity assessed by the Visual Analogue Scale, pressure pain thresholds measured by algometry, migraine-related disability assessed by the Migraine Disability Assessment questionnaire, and migraine impact on quality of life assessed by the Headache Impact Test (HIT-6). Secondary outcomes include migraine frequency, intensity, and duration recorded through a structured migraine diary, psychological variables (anxiety and depression), perceived stress, sleep quality, and vital signs (blood pressure and heart rate).
By assessing both immediate and short-term follow-up effects, this pilot study aims to explore the feasibility, safety, and potential clinical effects of manual lymphatic drainage in patients with migraine. The findings are intended to support the development of future controlled studies and to inform the potential inclusion of manual lymphatic drainage in physiotherapy protocols for migraine management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Manual lymphatic drainageThis group will receive manual lymphatic drainage sessions for the treatment of migraine. |
| Control group | No intervention | –This group will serve as a control and will not receive manual lymphatic drainage sessions. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male or female, aged 20 to 55 years.
- Clinical diagnosis of migraine and experiencing migraine episodes with a minimum frequency of 4 times per month.
Key exclusion criteria (3 listed)
- Participants with arterial hypertension who are taking antihypertensive medication.
- Participants currently taking prophylactic medication for migraine.
- Participants with fibromyalgia.
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 is a manual therapy technique based on gentle maneuvers that aim to reduce swelling and pain. | Other | Experimental group |
Primary outcome
Pain intensity (Visual Analogue Scale, VAS)
Time frame: Baseline (pre-intervention), immediately post-intervention (after session 6; 3 weeks), 15-day follow-up, and 1-month follow-up.
Self-reported pain intensity measured using a 10-cm Visual Analogue Scale (VAS), anchored at 0 ("no pain") and 10 ("worst imaginable pain").
Pressure pain threshold (PPT) at suboccipital region
Time frame: Baseline (pre-intervention), immediately post-intervention (after session 6; 3 weeks), 15-day follow-up, and 1-month follow-up.
Pressure Pain Threshold (PPT) assessed by algometry in the right and left suboccipital region (at the insertion of suboccipital muscles). Three consecutive measurements per site with 1-minute intervals; the mean value is used (units as recorded by the algometer, e.g., kg/cm²)
8 secondary outcomes
Headache impact (Headache Impact Test-6, HIT-6)
Time frame: Baseline (pre-intervention), immediately post-intervention (after session 6; 3 weeks), 15-day follow-up, and 1-month follow-up
Migraine-related disability (Migraine Disability Assessment, MIDAS)
Time frame: Baseline (pre-intervention), immediately post-intervention (after session 6; 3 weeks), 15-day follow-up, and 1-month follow-up.
Migraine attack characteristics (structured migraine diary)
Time frame: Baseline (pre-intervention), after session 2, after session 4, immediately post-intervention (after session 6), 15-day follow-up, and 1-month follow-up.
Baseline (pre-intervention), after session 2, after session 4, immediately post-intervention (after session 6), 15-day follow-up, and 1-month follow-up.
Time frame: Baseline (pre-intervention), immediately post-intervention (after session 6; 3 weeks), 15-day follow-up, and 1-month follow-up.
Perceived stress (Perceived Stress Scale-14, PSS-14)
Time frame: Baseline (pre-intervention), immediately post-intervention (after session 6; 3 weeks), 15-day follow-up, and 1-month follow-up.
Sleep quality (Pittsburgh Sleep Quality Index, PSQI)
Time frame: Baseline (pre-intervention), immediately post-intervention (after session 6; 3 weeks), 15-day follow-up, and 1-month follow-up.
Blood pressure (systolic and diastolic, mmHg)
Time frame: Baseline (pre-intervention), pre- and post in firts week, pre- and post in second week, pre- and post in third week, 15-day follow-up, and 1-month follow-up.
Heart rate (beats/min)
Time frame: Baseline (pre-intervention), pre- and post in firts week, pre- and post in second week, pre- and post in third week, 15-day follow-up, and 1-month follow-up.
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 Jul 2026.
Related trials for Migraine
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
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.
Edurne Úbeda Docasar, Doctor principal investigator
University Camilo José Cela
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 in people with Migraine, run by Camilo Jose Cela University at 1 site in Spain.
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 3 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 Jul 2026. 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 Spain. 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?
Pain intensity (Visual Analogue Scale, VAS) (time frame: Baseline (pre-intervention), immediately post-intervention (after session 6; 3 weeks), 15-day follow-up, and 1-month follow-up.). 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 29 Jul 2026.