Manual Lymph Drainage in Individuals With Migraine

NCT05976399 | Completed

• 1 other identifier: MLD in Migraine
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In the literature, research into the examination of the effect of MLD on migraine is quite limited. Our study aimed to examine the effectiveness of manual lymph drainage and connective tissue massage treatments on neck pain and disability, sleep quality, pain threshold and severity, depression and quality of life.

Conditions

Manual Lymphatic Drainage

Keywords

Migraine; Manual Lymphatic Drainage; Connective Tissue Massage; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Pressure algometer (Dolorimeter)

  The pressure algometer was developed by Fischer to determine the perception of pressure and assess pain sensitivity. in our study, measurements with a dolorimeter were made from a total of 12 regions, including 6 on the right and 6 on the left. Selected 6 muscles were M. Temporalis anterior, M. Sternocleidomastoid, M. Scalenous anterior, M. Suboccipital, M. Levator scapula, and M. Trapezius (Upper).

  All individuals participating in the study were evaluated before and after the 6-week-long treatment

Secondary Outcomes (6)

• Neck Pain and Disability Scale

  All individuals participating in the study were evaluated before and after the 6-week-long treatment

• Visual Analog Scale

  All individuals participating in the study were evaluated before and after the 6-week-long treatment

• Pain diary

  in the study a pain diary were given 2 weeks before the initiation of treatment and after the 6-week-long treatment was completed

• Short Form-36

  All individuals participating in the study were evaluated before and after the 6-week-long treatment

• Back Depression Inventory

  All individuals participating in the study were evaluated before and after the 6-week-long treatment

Study Arms (2)

Manual lymph drainage group

ACTIVE COMPARATOR

The patients, who had filled out their pain diary before and submitted a consent form, were first evaluated before the treatment and then they lay on their back with their neck area open, paying attention to the protection of their privacy. Hand strokes, one of the basic techniques applied for treatment, were planned in accordance with the anatomy and physiology of the lymphatic system. MLD was applied to the lateral neck and face region in 5-7 repetitions so that the lymph collectors could give an adequate reaction to the application. The treatment was performed 2 days a week for 6 weeks, with a total of 12 sessions. Each session lasted 45 minutes.

Other: Manual Lymph Drainage

Connective tissue massage group

ACTIVE COMPARATOR

In participants in the CTM group, the treatment was started with the sacral region called the "basic region" and the whole back was treated. Pulls in the interscapular region were more intense than in other regions. After the interscapular region, the cervical, clavicular, and facial regions were also included in the treatment. The applications first started with the basic region and then progressed to the lower thoracic, scapular, and interscapular regions. Then, the cervical and clavicular regions were treated. In each region, the applications were performed three times on each of the right and left sides. While positioning the patients, we paid attention to their privacy and the temperature of the room where the treatment was carried out. A total of 12 sessions, which were conducted 2 days a week and took 6 weeks, were performed.

Other: Connective Tissue Massage

Interventions

Connective Tissue Massage OTHER

In participants in the CTM group, the treatment was started with the sacral region called the "basic region" and the whole back was treated. Pulls in the interscapular region were more intense than in other regions. After the interscapular region, the cervical, clavicular, and facial regions were also included in the treatment. Both short and long pulls were used according to the region during CTM. The applications first started with the basic region and then progressed to the lower thoracic, scapular, and interscapular regions. Then, the cervical and clavicular regions were treated. In each region, the applications were performed three times on each of the right and left sides. While positioning the patients, we paid attention to their privacy and the temperature of the room where the treatment was carried out. A total of 12 sessions, which were conducted 2 days a week and took 6 weeks, were performed.

Connective tissue massage group

Manual Lymph Drainage OTHER

The patients, who had filled out their pain diary before and submitted a consent form, were first evaluated before the treatment and then they lay on their back with their neck area open, paying attention to the protection of their privacy. Hand strokes, one of the basic techniques applied for treatment, were planned in accordance with the anatomy and physiology of the lymphatic system. MLD was applied to the lateral neck and face region in 5-7 repetitions so that the lymph collectors could give an adequate reaction to the application. The treatment was performed 2 days a week for 6 weeks, with a total of 12 sessions. Each session lasted 45 minutes.

Manual lymph drainage group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be able to read and write
• Diagnosis of migraine by a neurologist according to IHS criteria
• Be willing to participate in the study voluntarily signing an informed consent form
• Have good cognitive functioning
• Between the ages of 18 and 65
• Reported pain intensity of 40 mm or more according to VAS
• Headache (without allodynia) \<15 days per month

You may not qualify if:

• Had any of the contraindications of MLD for the general and neck region
• Had a history of neuromuscular disease,
• Had communication problems to the extent that prevented evaluation methods,
• Had headaches lasting \>15 days a month, were diagnosed with other types of headaches (cervicogenic type headache, tension-type headache),
• Were diagnosed with fibromyalgia or myofascial pain syndrome, exhibited whiplash and similar traumas
• Had severe depression symptoms according to the Beck depression inventory,
• Had a congenital musculoskeletal anomaly, received non-pharmacological migraine treatment (acupuncture, dry needling, etc.),

Sponsors & Collaborators

• Izmir Democracy University: lead

Study Sites (1)

Izmir Democracy University

Izmir, Karabağlar/İZMİR, 35140, Turkey (Türkiye)

Location

Related Publications (4)

• Goadsby PJ, Holland PR, Martins-Oliveira M, Hoffmann J, Schankin C, Akerman S. Pathophysiology of Migraine: A Disorder of Sensory Processing. Physiol Rev. 2017 Apr;97(2):553-622. doi: 10.1152/physrev.00034.2015.

  PMID: 28179394 BACKGROUND

• Goats GC, Keir KA. Connective tissue massage. Br J Sports Med. 1991 Sep;25(3):131-3. doi: 10.1136/bjsm.25.3.131.

  PMID: 1777777 BACKGROUND

• Happe S, Peikert A, Siegert R, Evers S. Erratum to: The efficacy of lymphatic drainage and traditional massage in the prophylaxis of migraine: a randomized, controlled parallel group study. Neurol Sci. 2016 Oct;37(10):1753. doi: 10.1007/s10072-016-2657-z. No abstract available.

  PMID: 27412032 BACKGROUND

• Yildirim Bulut B, Cinar Ozdemir O. Comparison of the efficacy of connective tissue massage and manual lymphatic drainage in patients with migraine: a randomized controlled trial. J Oral Facial Pain Headache. 2025 Sep;39(3):121-132. doi: 10.22514/jofph.2025.054. Epub 2025 Sep 12.

  PMID: 41070573 DERIVED

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

• Özlem Çinar Özdemir, Assoc.Dr

  Izmir Democracy University

  STUDY DIRECTOR

• Betül Yıldırım

  Siirt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The individuals to be included in the study were listed on the computer according to their application order, and then a randomization process was employed to divide them into two groups: the manual lymph drainage group and the connective tissue massage group. Individuals with odd-numbered positions were assigned to the manual lymph drainage group, while individuals with even-numbered positions were assigned to the connective tissue massage group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. prof

Model Details: The study included forty individuals with migraine. Participants' neck pain was evaluated with the Neck Pain and Disability Scale, pressure perceptions and pain sensitivity with an algometer, quality of life with the Short Form-3, and headaches with a pain diary kept for 15 days before and after treatment. Then, the individuals were randomly divided into two as the manual lymph drainage group and the connective tissue massage group. Both groups were treated for 45 minutes twice a week for 6 weeks. The groups were assessed before the treatment and at the end of 6 weeks.

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 4, 2023
• Study Start: June 6, 2019
• Primary Completion: October 15, 2020
• Study Completion: February 8, 2021
• Last Updated: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)