Manual Lymph Drainage in Individuals With Migraine

NCT ID: NCT05976399

Last Updated: 2023-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-06

Study Completion Date

2021-02-08

Brief Summary

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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.

Detailed Description

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Although there are evidence-based guidelines for clinical decision-making and reporting the care of patients with migraine, migraine management for the population is inadequate. Even among individuals who are correctly diagnosed, almost more than half of patients are not administered any acute or preventive treatment. Various invasive and non-invasive treatment options are available in the treatment of migraine. Relaxation training, exercise, cold application, massage, transcutaneous electrical nerve stimulation (TENS), biofeedback, manipulation and mobilization techniques, and trigger point therapy are some of the non-invasive treatment options used in migraine treatment. These treatments, which can be applied independently, can also be applied in combination with pharmacological treatments in some patients. In addition, the patient's knowledge about the disease makes it easier to manage the process and cope with the pain better.

Connective tissue massage (CTM) is a manipulative therapy method that is different from traditional massages in terms of both technical and physiological effects and has been used for diagnosis or treatment since 1928. Although the manipulative procedures applied target superficial connective and subcutaneous tissues, they also have effects on organs far from the local stimulation area. Another approach to migraine prophylaxis includes manual lymph drainage (MLD). It is considered that MLD causes sympathetic and parasympathetic effects and is similar to therapeutically effective relaxation therapy by reducing the hyperexcitability of the central system. With the parasympathetic effect it creates, it helps to reduce muscle pain and spasm, making it easier to cope with tension and stress. Reduction of the tension and stress factors may reduce the triggering of migraine and make it easier to cope with the current migraine. Recent studies have shown that the meningeal lymphatic system is located in the brain and that this system is a new way for the drainage of the cerebrospinal fluid.

In the literature, research into the examination of the effect of MLD on migraine is quite limited. We planned this randomized controlled trial to contribute to the reduction of pain and increase the quality of life of individuals with migraine by increasing the awareness of individuals working in this field in our country.

Conditions

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Manual Lymphatic Drainage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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Manual lymph drainage group

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.

Group Type ACTIVE_COMPARATOR

Manual Lymph Drainage

Intervention Type 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.

Connective tissue massage group

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.

Group Type ACTIVE_COMPARATOR

Connective Tissue Massage

Intervention Type 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.

Interventions

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Connective Tissue Massage

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.

Intervention Type OTHER

Manual Lymph Drainage

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.),
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Izmir Democracy University

OTHER

Sponsor Role lead

Responsible Party

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Özlem Çınar Özdemir

Assoc. prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Özlem Çinar Özdemir, Assoc.Dr

Role: STUDY_DIRECTOR

Izmir Democracy University

Betül Yıldırım

Role: PRINCIPAL_INVESTIGATOR

Siirt University

Locations

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Izmir Democracy University

Izmir, Karabağlar/İZMİR, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 28179394 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 1777777 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27412032 (View on PubMed)

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.

Reference Type DERIVED
PMID: 41070573 (View on PubMed)

Other Identifiers

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MLD in Migraine

Identifier Type: -

Identifier Source: org_study_id

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