NCT07425041

Effectiveness of Manual Lymphatic Drainage in the Physiotherapeutic Treatment of Migraine

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Camilo Jose Cela University · Academic / Other
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

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

Timeline

• Start date: 2026-03-20
• Primary completion: 2026-04-20
• Completion: 2026-08-01
• First posted: 2026-02-20
• Last updated: 2026-02-23