Effectiveness of Manual Lymphatic Drainage in the Physiotherapeutic Treatment of Migraine

NCT07425041 | Not Yet Recruiting

• 1 other identifier: UCJCDLMMG
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Migraine

Keywords

Manual Lymphatic Drainage; Migraine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Headache impact (Headache Impact Test-6, HIT-6)

  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)

  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)

  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.

  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)

  Baseline (pre-intervention), immediately post-intervention (after session 6; 3 weeks), 15-day follow-up, and 1-month follow-up.

Study Arms (2)

Experimental group

EXPERIMENTAL

This group will receive manual lymphatic drainage sessions for the treatment of migraine.

Other: Manual lymphatic drainage

Control group

NO INTERVENTION

This group will serve as a control and will not receive manual lymphatic drainage sessions.

Interventions

Manual lymphatic drainage OTHER

Manual lymphatic drainage is a manual therapy technique based on gentle maneuvers that aim to reduce swelling and pain.

Experimental group

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Camilo Jose Cela University: lead

MeSH Terms

Conditions

Migraine Disorders

Interventions

Manual Lymphatic Drainage

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Drainage; Physical Therapy Modalities; Rehabilitation

Study Officials

• Edurne Úbeda Docasar, Doctor

  University Camilo José Cela

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edurne Úbeda Docasar, Doctor

CONTACT

+34918153131; eubeda@ucjc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 20, 2026
• Study Start: March 20, 2026
• Primary Completion: April 20, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02