Spinal Manipulation for Menstrual Symptoms and Sleep in Individuals with Primary Dysmenorrhea

Last updated: November 2, 2024
Sponsor: Narges Piri
Overall Status: Active - Recruiting

Phase

N/A

Condition

Female Hormonal Deficiencies/abnormalities

Menstrual Disorders

Severe Premenstrual Symptom

Treatment

Connective Tissue Massage (CTM)

Sham Spinal Manipulation

Spinal Manipulation

Clinical Study ID

NCT06673537
2024/208
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Being 18 years or older,

  • Having primary dysmenorrhea according to the criteria specified in the PrimaryDysmenorrhea 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

Exclusion Criteria:

  • Having gastrointestinal, urogenital, autoimmune, or psychiatric disorders (seriouspsychiatric 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

Total Participants: 75
Treatment Group(s): 3
Primary Treatment: Connective Tissue Massage (CTM)
Phase:
Study Start date:
September 16, 2024
Estimated Completion Date:
September 16, 2025

Study 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.

Connect with a study center

  • Istanbul University-Cerrahpasa

    Istanbul, 34500
    Turkey

    Active - Recruiting

  • IstanbulUC

    Istanbul, 34500
    Turkey

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.