Clinical trial NCT05976399: Manual Lymph Drainage in Individuals With Migraine
Official title: The Investigation of The Effectiveness Of Manual Lymph Drainage in Individuals With Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Manual Lymphatic Drainage
Keywords: Migraine
Manual Lymphatic Drainage
Connective Tissue Massage
Quality of Life
Lead sponsor: Izmir Democracy University
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.),

Primary outcomes:
measure: Pressure algometer (Dolorimeter)
timeFrame: All individuals participating in the study were evaluated before and after the 6-week-long treatment
Secondary outcomes:
measure: Neck Pain and Disability Scale
timeFrame: All individuals participating in the study were evaluated before and after the 6-week-long treatment
measure: Visual Analog Scale
timeFrame: All individuals participating in the study were evaluated before and after the 6-week-long treatment
measure: Pain diary
timeFrame: in the study a pain diary were given 2 weeks before the initiation of treatment and after the 6-week-long treatment was completed
measure: Short Form-36
timeFrame: All individuals participating in the study were evaluated before and after the 6-week-long treatment
measure: Back Depression Inventory
timeFrame: All individuals participating in the study were evaluated before and after the 6-week-long treatment
measure: The Pittsburgh Sleep Quality Index
timeFrame: All individuals participating in the study were evaluated before and after the 6-week-long treatment
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Izmir Democracy University
state: Karabağlar/İZMİR
Study officials:
affiliation: Izmir Democracy University
name: Özlem Çinar Özdemir, Assoc.Dr
role: STUDY_DIRECTOR
affiliation: Siirt University
name: Betül Yıldırım
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Goats GC, Keir KA. Connective tissue massage. Br J Sports Med. 1991 Sep;25(3):131-3. doi: 10.1136/bjsm.25.3.131.
citation: 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.