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Spinal Manipulation for Menstrual Symptoms and Sleep in Individuals with Primary Dysmenorrhea
Sponsor: Narges Piri
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.
Official title: The Effects of Spinal Manipulation on Menstrual Symptoms, Pain Severity, and Sleep Quality in Individuals with Primary Dysmenorrhea
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
75
Start Date
2024-09-16
Completion Date
2025-09-16
Last Updated
2024-11-05
Healthy Volunteers
No
Conditions
Interventions
Connective Tissue Massage (CTM)
Connective Tissue Massage (CTM) was administered to the lumbar and abdominal regions by an experienced physiotherapist three times a week for 15 minutes over six weeks. The treatment started from the predicted day of ovulation (cycle length minus 14 days) until the onset of the next menstrual period. Both short and long strokes were utilized during CTM. Each stroke was repeated three times, first on the right side and then on the left side, across all manipulated areas. During the manipulation, the tip of the middle finger remained in contact with the patient's skin. The finger was positioned at a 45° angle, with the distal interphalangeal joint in flexion, and was moved to create traction. During the lumbar region treatment, participants were instructed to sit upright with their hips, knees, and ankles flexed at 90°, ensuring that their thighs and feet were fully supported. For the abdominal region treatment, participants lay supine with pillows placed under their head and knees.
Spinal Manipulation
Spinal manipulation was performed by an experienced physiotherapist on the intervention group three times a week following Connective Tissue Massage (CTM). Participants in this group were positioned laterally, ensuring their lower leg remained straight and in contact with the treatment table. The contralateral or upper hip and knee were flexed and positioned so that they did not touch the table, allowing an unopposed force to be applied at the selected joint. Following CTM, manipulation was carried out with high-velocity, low-amplitude (HVLA) force applied bilaterally to all clinically relevant vertebral levels from T10 to L5 and the sacroiliac joints, accompanied by an audible sound from one or more joints.
Sham Spinal Manipulation
Sham spinal manipulation was administered by an experienced physiotherapist to the Sham Manipulation group three times a week following Connective Tissue Massage (CTM). In this group, participants were positioned laterally with their lower legs straight and in contact with the treatment table. The contralateral or upper hip and knee were flexed and positioned so that they did not touch the table, thereby allowing an unopposed force to be applied at the selected joint. Following CTM, low-amplitude force was applied bilaterally to all clinically relevant vertebral levels from T10 to L5 and the sacroiliac joints, without creating an audible sound.
Locations (2)
Istanbul University-Cerrahpasa
Istanbul, Istanbul, Turkey (Türkiye)
IstanbulUC
Istanbul, Istanbul, Turkey (Türkiye)