Effectiveness of Manual Lymphatic Drainage in the Physiotherapeutic Treatment of Migraine (EDLMMG)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Migraine
• Intervention / Treatment: Other: Manual lymphatic drainage

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edurne Úbeda Docasar, Doctor; Phone Number: +34918153131; Email: eubeda@ucjc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Participants with arterial hypertension who are taking antihypertensive medication.
• Participants currently taking prophylactic medication for migraine.
• Participants with fibromyalgia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; This group will receive manual lymphatic drainage sessions for the treatment of migraine.	Other: Manual lymphatic drainage; Manual lymphatic drainage is a manual therapy technique based on gentle maneuvers that aim to reduce swelling and pain.
No Intervention: Control group; This group will serve as a control and will not receive manual lymphatic drainage sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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").	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)	Baseline (pre-intervention), immediately post-intervention (after session 6; 3 weeks), 15-day follow-up, and 1-month follow-up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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).	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.	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.	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.	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.	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.	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.

Collaborators and Investigators

• Sponsor: Camilo Jose Cela University
• Investigators: Principal Investigator: Edurne Úbeda Docasar, Doctor, University Camilo José Cela

Study record dates

Study Major Dates

• Study Start (Estimated): March 20, 2026
• Primary Completion (Estimated): April 20, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: February 13, 2026
• First Submitted That Met QC Criteria: February 13, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Migraine; Manual Lymphatic Drainage
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Therapeutics; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Therapy, Soft Tissue; Musculoskeletal Manipulations; Massage; Drainage; Manual Lymphatic Drainage
• Other Study ID Numbers: UCJCDLMMG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No