Clinical trial NCT06673537: Spinal Manipulation for Menstrual Symptoms and Sleep in Individuals with Primary Dysmenorrhea
Official title: The Effects of Spinal Manipulation on Menstrual Symptoms, Pain Severity, and Sleep Quality in Individuals with Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Primary Dysmenorrhea
Dysmenorrhea
Keywords: Connective Tissue Massage
CTM
Spinal Manipulation
SP
Physiotherapy
Massage
Menstrual Pain
Rehabilitation
Complementary Therapy
Women's Health
Manual Therapy
Pain Relief
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: Rustem Mustafaoglu
First posted: 2024-11-05
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Baseline, post-intervention (approximately 6 weeks)
measure: Menstrual Symptom Questionnaire (MSQ)
timeFrame: Baseline, post-intervention (approximately 6 weeks)
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, post-intervention (approximately 6 weeks)
measure: Beck Depression Inventory (BDI)
timeFrame: Baseline, post-intervention (approximately 6 weeks)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
city: Istanbul
country: Turkey
facility: IstanbulUC
Study officials:
affiliation: Istanbul University-Cerrahpasa, Institute of Graduate Studies, Department of Physiotherapy and Rehabilitation
name: Narges PIRI, Bcs
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University-Cerrahpasa, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
name: Rüstem MUSTAFAOĞLU PT, PhD
role: STUDY_CHAIR
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