Spinal Manipulation for Menstrual Symptoms and Sleep in Individuals with Primary Dysmenorrhea
- Conditions
- Primary DysmenorrheaDysmenorrhea
- Registration Number
- NCT06673537
- Lead Sponsor
- Narges Piri
- Brief Summary
The goal of this observational study is to evaluate if spinal manipulation (SM) combined with connective tissue massage (CTM) improves pain, menstrual symptoms, depression levels, and sleep quality in women with primary dysmenorrhea (PD). The main questions it aims to answer are:
Null Hypothesis (H0): SM has no effect on primary dysmenorrhea symptoms, pain severity, depression levels, or sleep quality.
Alternative Hypothesis (H1): SM has a significant effect on primary dysmenorrhea symptoms, pain severity, depression levels, and sleep quality.
Researchers will compare three groups to determine if the combined intervention improves menstrual health:
An intervention group receiving both KDM and SM applied to the abdominal and lumbar areas, A sham group receiving KDM with a sham SM procedure, A control group receiving no intervention.
Participants will:
Undergo three weekly sessions for one menstrual cycle (approximately three weeks), continuing for two cycles (six weeks total), Complete assessments on pain (VAS), menstrual symptoms (Menstrual Symptom Questionnaire), depression (Beck Depression Inventory), and sleep quality (Pittsburgh Sleep Quality Index) at the study's start and conclusion.
This study aims to provide new insights into the combined effects of KDM and SM on menstrual health, potentially guiding future rehabilitation interventions for PD.
- Detailed Description
After experiencing primary dysmenorrhea, many individuals report significant menstrual symptoms, including pain severity and sleep disturbances, which can lead to decreased quality of life and increased dependence on medication for relief. In chronic cases, individuals with moderate to severe menstrual pain often exhibit functional deficits, impacting their daily living activities. This highlights the necessity for effective rehabilitation strategies that address both symptom management and overall quality of life.
Current treatment approaches for primary dysmenorrhea focus on pharmacological interventions, lifestyle modifications, and physiotherapy. The primary aim is to reduce pain severity and improve sleep quality through targeted therapies. Techniques such as spinal manipulation and connective tissue massage (KDM) have shown promise in promoting pain relief and enhancing functional outcomes. However, these techniques may not be universally applicable to all patients, particularly those with significant menstrual pain and associated sleep disturbances.
As outlined, promoting functional recovery in individuals with primary dysmenorrhea is crucial; however, the role of spinal manipulation and other manual therapies in this recovery process remains underexplored. Rehabilitation strategies must be tailored to individual needs and severity of symptoms. This study proposes a novel approach that integrates spinal manipulation with connective tissue massage, aimed at providing comprehensive relief and facilitating recovery in individuals with primary dysmenorrhea.
The proposed intervention includes both spinal manipulation and KDM, administered by trained physiotherapists. This dual approach is designed to address pain at its source and improve overall musculoskeletal function. Evidence suggests that combined therapies may lead to enhanced neurophysiological responses, promoting both pain relief and functional improvements.
The underlying mechanisms of action for this combined approach may involve multiple pathways. Spinal manipulation may facilitate increased blood flow and reduce muscle tension, while KDM is thought to enhance tissue pliability and alleviate discomfort. Together, these interventions may induce neuroplastic changes, facilitating improved pain management and functional outcomes.
To date, studies on combined therapeutic approaches for primary dysmenorrhea have demonstrated promising results, including reduced pain severity and improved sleep quality. However, research specifically focusing on the synergistic effects of spinal manipulation and KDM remains limited. This study aims to evaluate the efficacy of this integrated approach on menstrual symptoms, pain severity, and sleep quality in individuals suffering from primary dysmenorrhea.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 75
- Being 18 years or older,
- Having primary dysmenorrhea according to the criteria specified in the Primary Dysmenorrhea Consensus Guide (1. Onset of pain 6 to 24 months after menarche, 2. Pain lasting between 8 to 72 hours, and 3. The most intense pain occurring on the 1st and/or 2nd day of menstruation),
- Having a regular menstrual cycle (28 ± 7 days).
- Having gastrointestinal, urogenital, autoimmune, or psychiatric disorders (serious psychiatric disorders that would prevent participation in the study),
- Having other chronic pain syndromes,
- Having given birth or a positive pregnancy test,
- Using an intrauterine device (IUD),
- Having undergone pelvic surgery,
- Having used chronic medications, including oral contraceptives or antidepressants, within at least 6 months prior to the study,
- Having irregular menstrual cycles (shorter than 21 days or longer than 35 days, and/or a cycle variation exceeding 4 days),
- Having a history of pathological conditions indicating secondary dysmenorrhea.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Visual Analog Scale (VAS) Baseline, post-intervention (approximately 6 weeks) The Visual Analog Scale (VAS) is a subjective measure used to assess the intensity of participants' pain. Participants are asked to indicate their perceived level of pain on a 10 cm line. One end of the line is marked as 0, indicating no pain, while the other end is marked as 10, representing unbearable pain.
Participants were instructed to mark the intensity of pain experienced during the first three days of their initial menstrual period before joining the study, as well as during the last menstrual period at the end of the study, on three separate VAS lines, with the highest value recorded. The VAS is considered a valid and reliable tool for measuring experimental and clinical pain, demonstrating high sensitivity in detecting changes in clinical pain treatment and small variations in pain intensity.Menstrual Symptom Questionnaire (MSQ) Baseline, post-intervention (approximately 6 weeks) The Menstrual Symptom Questionnaire (MSQ) is a 22-item five-point Likert-type questionnaire developed by Chesney and Tasto (1975) to assess menstrual pain and symptoms. In 2014, Güvenç and colleagues adapted this questionnaire into Turkish, ensuring its validity. The questionnaire consists of three subscales: menstrual pain symptoms, negative effects/somatic complaints, and coping strategies. The questionnaire is scored between 22 and 110, with an increase in the average score indicating a greater severity of menstrual symptoms. The questionnaire was administered face-to-face to participants before and after the study, and their responses were recorded.
- Secondary Outcome Measures
Name Time Method Pittsburgh Sleep Quality Index (PSQI) Baseline, post-intervention (approximately 6 weeks) The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire developed to assess sleep quality and disturbances over a one-month period. It consists of 19 self-rated questions and 5 questions rated by a bed partner or roommate. The PSQI was adapted into Turkish in 2014 by Güvenç and colleagues, ensuring its validity. The questionnaire evaluates seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Scores range from 0 to 21, with higher scores indicating worse sleep quality. The questionnaire was administered face-to-face to participants before and after the study, and their responses were recorded.
Beck Depression Inventory (BDI) Baseline, post-intervention (approximately 6 weeks) The Beck Depression Inventory (BDI) was used to assess the risk of depression and determine the level of depressive symptoms, with its Turkish validity and reliability established by Hisli. The inventory consists of 21 categories, each with four options. Each item is scored between 0 and 3, resulting in a total score ranging from 0 to 63. Scores are categorized as follows: 0-9 = Minimal depressive symptoms, 10-16 = Mild depressive symptoms, 17-29 = Moderate depressive symptoms, and 30-63 = Severe depressive symptoms. The questionnaire was administered face-to-face to participants before and after the study, and their responses were recorded.
Trial Locations
- Locations (2)
Istanbul University-Cerrahpasa
🇹🇷Istanbul, Turkey
IstanbulUC
🇹🇷Istanbul, Turkey