Image

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

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

Recruiting
18 years and older
Female
Phase N/A

Powered by AI

Overview

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.

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

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.

Study details
    Primary Dysmenorrhea
    Dysmenorrhea

NCT06673537

Narges Piri

30 August 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.