NCT06673537

Spinal Manipulation For Menstrual Symptoms and Sleep in Individuals With Primary Dysmenorrhea

The Effects of Spinal Manipulation on Menstrual Symptoms, Pain Severity, and Sleep Quality in Individuals With Primary Dysmenorrhea

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Istanbul University - Cerrahpasa · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 CTM and SM applied to the abdominal and lumbar areas, A sham group receiving CTM 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.

Conditions

• Primary Dysmenorrhea
• Dysmenorrhea

Interventions

Type	Name	Description
OTHER	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.
OTHER	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.
OTHER	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.

Timeline

• Start date: 2024-09-16
• Primary completion: 2025-03-17
• Completion: 2025-03-17
• First posted: 2024-11-05
• Last updated: 2026-04-15

Locations

2 sites across 1 country: Turkey (Türkiye)