Effectiveness of Manual Lymphatic Drainage in the Physiotherapeutic Treatment of Migraine

ConditionMigraine
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-55
SponsorCamilo Jose Cela University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Participants with arterial hypertension who are taking antihypertensive medication.

Participants currently taking prophylactic medication for migraine.

Participants with fibromyalgia.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Manual lymphatic drainage

    Other intervention

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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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").

Time frame
Baseline (pre-intervention), immediately post-intervention (after session 6; 3 weeks), 15-day follow-up, and 1-month follow-up.
2

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)

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

Secondary outcomes

1

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).

Time frame
Baseline (pre-intervention), immediately post-intervention (after session 6; 3 weeks), 15-day follow-up, and 1-month follow-up
2

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.

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

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).

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.
4

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.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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