Clinical trial NCT06050382: Progressive Relaxation Training Effect On Pain, Activity And Social Participation In Women With Tension-Type Headache And Migraine
Official title: Investigation Of The Effect Of Progressive Relaxation Training On Pain Characteristics, Attack Frequency, Perception Of Activity Self-Efficiency And Social Participation In Women With Tension-Type Headache And Migraine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Chronic
Migraine Disorders
Tension-Type Headache
Keywords: pain
women
progressive relaxation training
participation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: The aim of this study was to investigate and compare the effects of PRT on pain characteristics, attack frequency, activity self-efficacy perception, and social participation in women with two different types of headaches, TTH and migraine.

Methods: A total of 58 women within the age range of 20 to 45 were screened for eligibility in terms of suitability for participation in the study. Two separate progressive relaxation training sessions were administered to two distinct groups: one comprised of women with TTH and the other consisting of women with migraine. Pre- and post-training assessments were conducted for both groups as follows. Both intervention groups were instructed and trained by a physiotherapist 2times a week for 30 minutes each over 6 weeks,

Detailed description: The International Headache Society (IHS) reported that approximately 90% of headaches consist of tension-type headache (TTH) and migraine, which are the primary type of headache, and affect approximately 50% of the population. The incidence of headaches and migraines is to peak at the age of 20-50, and is more common in women than in men. Recurrent tension-type headaches and migraine attacks negatively affect the quality of life of individuals, reducing working capacity and participation in social and family activities. Therefore, tension-type headaches and migraines cause significant social exclusion, loss of workforce and economic burden.

TTH and migraine impede personal care, productivity and leisure activities, which are an integral part of individuals' lives due to symptoms such as pain, fatigue, difficulty concentrating and/or dizziness. Participation in purposeful activities for individuals is an essential component of health and well-being. Activity self-efficiency is a definition that includes the sense of personal competence and satisfaction about the activities women engage in. When individuals engage in work, play, and daily life activities, women sustain, reinforce, shape, and modify women's capacities, beliefs, and tendencies. High self-efficiency perception can affect the sustainability of physical activity and the productivity of individuals. Both TTH and Migraine tend to occur during the most productive and high-capacity phase of life, between ages 25-55, affecting muscle groups used in daily life activities, potentially leading to limitations in participation, coping, and self-management skills among women. In this regard, it is important to study how tension-type headaches and migraines, which have significant social and individual effects, alter the self-sufficiency and perception of activity in women. Constant thinking of pain and avoiding physical activity can reveal dysfunction in individuals. Because of the individual-specific and complex structure of human roles, each individual suffering from a headache faces different limitations in fulfilling daily roles and social participation, depending on lifestyle and preferences. Thus, non-pharmacological treatments (physiotherapy practices, lifestyle changes, cognitive behavioral therapy, body awareness therapy) are recommended for women with TTH and migraine complaints to relax various muscle groups. One of these treatments is progressive relaxation training. PRT is defined as a method of voluntary, regular relaxation of large muscle groups in the human body with relaxation throughout the body. Specifically, applying PRT to muscle groups found in hands, arms, neck, shoulders, face, chest, abdomen, hips, feet, and fingers, which are most frequently utilized in daily life activities, enhances its benefits for individuals. In the literature, various studies reported that PRT improved occupational performance, participation in daily life activities and quality of life in addition to pain management in individuals with various chronic pains. According to the knowledge, there exists no study in the literature comparing the beneficial effects that PRT, one of the optimal treatments that can be applied in women with TTH or migraine, can have on these two distinct headache groups. Furthermore, studies examining the impact of PRT on activity self-efficacy perception and social participation are quite limited. The aim of this study is to investigate and compare the effects of PRT on pain characteristics, attack frequency, activity self-efficacy perception, and social participation in women with two different types of headaches, TTH and migraine. This study will enable clinicians working with women suffering from TTH and migraine to comprehensively evaluate them in clinical settings and provide more comprehensive intervention approaches to address challenges encountered in daily life.

Eligibility criteria: Inclusion Criteria:

* the ages of 20 and 45,
* having a diagnosis of TTH or migraine according to the International Classification of Headache Disorders (ICHD-II)(1), and
* expressing voluntary willingness to participate in this study.

Exclusion Criteria:

* having any pathology involving the cervical region such as disc herniation, radiculopathy, a history of surgery, tumor, or cyst,
* having received any form of physical therapy targeting the cervical region within the past 3 months,
* being pregnant or in the menopausal phase; not participating in at least 15% of the training sessions,
* having a mental disorder (being diagnosed with depression or using antidepressant medication),
* having a chronic, neurological, or rheumatic disorder; suffering from sinusitis, and being on continuous prophylactic medication for migraines

Primary outcomes:
measure: Occupational Self-Assessment (OSA):
timeFrame: up to 5 months
measure: World Health Organization Disability Assessment Schedule 2 (WHO-DAS II)
timeFrame: up to 5 months
measure: Pain Catastrophizing Scale (PCS):
timeFrame: up to 5 months
measure: Headache Impact Test-6:
timeFrame: up to 5 months
measure: Visual Analog Scale (VAS):
timeFrame: up to 5 months
Secondary outcomes:
measure: Migraine Disability Assessment Scale (MIDAS):
timeFrame: up to 5 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References: