Pain Neuroscience Education and Biomedical Pain Education in Primary Dysmenorrhea

September 14, 2023 updated by: SERAP ÖZGÜL, Hacettepe University

Comparison of the Effects of Pain Neuroscience Education and Biomedical Pain Education in Primary Dysmenorrhea

The aim of this study was to compare the effects of biomedical pain education and pain neuroscience education, in addition to routine exercise training, on menstrual pain parameters (pain severity and duration, analgesic use), menstrual stress, somatosensory function, pain catastrophizing, pain beliefs, anxiety/depressive symptom level and quality of life in healthy individuals with primary dysmenorrhea.The design of the study is parallel group, randomized study. Individuals will be randomly assigned to one of the pain neuroscience education or biomedical pain education research arms.

In the literature, there is no study comparing the effects of pain neuroscience education and biomedical pain education in primary dysmenorrhea, which is a problem that affects women's lives significantly. It is important to reveal the effects of different pain trainings for effective pain management in primary dysmenorrhea.

Study Overview

Detailed Description

The aim of this study was to compare the effects of biomedical pain education and pain neuroscience education, in addition to routine exercise training, on menstrual pain parameters (pain severity and duration, analgesic use), menstrual stress, somatosensory function, pain catastrophizing, pain beliefs, anxiety/depressive symptom level and quality of life in healthy individuals with primary dysmenorrhea. The design of the study is parallel group, randomized study. The study sample consists of healthy individuals aged 18 years and older with primary dysmenorrhea symptoms.

Individuals will be randomly assigned to one of the two research arms. In addition to the exercise training, which includes stretching and relaxation exercises routinely used in the field of physiotherapy and rehabilitation in primary dysmenorrhea, the patients in the first research arm will be given pain neuroscience education once a week for 2 weeks.

In the second research arm, in addition to the exercise training that includes stretching and relaxation exercises routinely applied in the field of physiotherapy and rehabilitation in primary dysmenorrhea, biomedical pain education will be given once a week for 2 weeks.

Participants will be evaluated in terms of descriptive measurements and outcome measures 3 times in total, before the applications, immediately after the end of the application period, and 3 months after the end of the applications. The primary outcome measurement parameter of the study was determined as the Visual Analog Scale (VAS) score, which is used to determine the severity of menstrual pain. Secondary outcome measures are menstrual stress level to be evaluated with the Menstrual Distress Questionnaire, somatosensory function status to be evaluated with the Central Sensitization Inventory, pain catastrophizing state to be evaluated with the Menstrual Pain Specific Pain Catastrophizing Scale, pain beliefs status to be assessed with the Pain Beliefs Questionnaire, anxiety/depressive symptom level to be evaluated with Depression Anxiety Stress Scales-21 (DASS-21), quality of life to be evaluated with World Health Organization Quality of Life Scale-Short Form and perception of change to be evaluated by 5-point likert scale.

Sample size calculated by assuming a standard deviation of 1 with a minimum study power of 80% and predicting an equal distribution to the study arms; 19 individuals for the first research arm and 19 individuals for the second research arm, a total of 38 individuals were determined. The research will be terminated after all evaluations of all individuals participating in the study are completed, when the targeted sample size and power are reached.

In the literature, there is no study comparing the effects of pain neuroscience education and biomedical pain education in primary dysmenorrhea, which is a problem that affects women's lives significantly. It is important to reveal the effects of different pain trainings for effective pain management in primary dysmenorrhea.

Study Type

Interventional

Enrollment (Estimated)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Ankara, Turkey, 06100
        • Recruiting
        • Büşra Nur Erol
        • Sub-Investigator:
          • Ceren Gürşen, Assoc. Prof.
        • Sub-Investigator:
          • Sezcan Mümüşoğlu, Assoc. Prof.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Not having any known disease (systemic, metabolic, etc.),
  • Meeting the primary dysmenorrhea criteria specified in the Primary Dysmenorrhea Consensus Guide (onset of menstrual pain 6-24 months after menarche, menstrual pain lasting 8-72 hours, and the most severe menstrual pain felt on the 1st or 2nd day of menstruation),
  • Having a regular menstrual cycle (28± 7 days),
  • In the last 6 months, menstrual pain intensity is ≥ 4 cm according to the visual analog scale,
  • Nulligravid,
  • 18 years and over,
  • Volunteer healthy female individuals who consented to participate in the study, willing to be randomized, will be included.

Exclusion Criteria:

  • Pathological pelvic conditions including endometriosis, chronic pelvic inflammatory disease, adenomyosis, polycystic ovary syndrome, endometrial fibroids/polyps or sexually transmitted diseases,
  • History of pelvic or abdominal surgery
  • Using anti-depressants or anxiolytics because of their ability to modulate the sensation of pain,
  • Receiving alternative treatment,
  • Individuals using an intrauterine contraceptive device or birth control pill will not be included.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pain neuroscience education
In addition to the exercise training (stretching and relaxation exercises), which includes stretching and relaxation exercises routinely used in the field of physiotherapy and rehabilitation in primary dysmenorrhea, the patients in the pain neuroscience education arm will be given pain neuroscience education once a week for 2 weeks. Participants in the pain neuroscience education arm will be given pain neuroscience education once a week for 2 weeks after their first menstruation. The training will be repeated with a reminder session at the end of the 2nd menstruation.
Exercise training will be applied in the non-menstrual period during 2 menstrual cycles as stretching and relaxation exercises. Stretching exercises will include general stretching and specific stretching exercises and will take approximately 20 minutes in total. After the stretching exercises, relaxation exercise will be performed with diaphragmatic breathing for 10 minutes. The exercises will be performed with music accompanied by a physiotherapist once a week, and it will be recommended to do the exercises as a home program for 2 sessions a week.
Participants in the first research arm will be given pain neuroscience education once a week for 2 weeks after their first menstruation. The training will be repeated with a reminder session at the end of the 2nd menstruation.
Active Comparator: Biomedical pain education
In the biomedical pain education arm, in addition to the exercise training (stretching and relaxation exercises) that includes stretching and relaxation exercises routinely applied in the field of physiotherapy and rehabilitation in primary dysmenorrhea, biomedical pain education will be given once a week for 2 weeks. Participants in the biomedical pain education arm will be given biomedical pain education once a week for 2 weeks after their first menstruation. The training will be repeated with a reminder session at the end of the 2nd menstruation.
Exercise training will be applied in the non-menstrual period during 2 menstrual cycles as stretching and relaxation exercises. Stretching exercises will include general stretching and specific stretching exercises and will take approximately 20 minutes in total. After the stretching exercises, relaxation exercise will be performed with diaphragmatic breathing for 10 minutes. The exercises will be performed with music accompanied by a physiotherapist once a week, and it will be recommended to do the exercises as a home program for 2 sessions a week.
Participants in the second research arm will be given biomedical pain education once a week for 2 weeks after their first menstruation. The training will be repeated with a reminder session at the end of the 2nd menstruation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of menstrual pain
Time Frame: Change in severity of menstrual pain from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
Visual Analogue Scale (VAS): This scale is a 10cm horizontal line. 0= no pain/meaning no effect, 10= unbearable pain/ experiencing
Change in severity of menstrual pain from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Menstrual stress level
Time Frame: Change in level of menstrual stress from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
Menstrual Distress Questionnaire (MDQ): The scale consists of 47 menstrual symptoms and 8 sub-symptom groups. Complaints are scored from 0 to 4. 0=no symptoms, 1=little, 2=moderate, 3=severe, 4=very severe.
Change in level of menstrual stress from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
Somatosensory function status
Time Frame: Change in status of somatosensory function from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)

Central Sensitization Inventory (CSI): CSI consists of two parts. Part A contains 25 items that assess somatic and emotional health-related symptoms common in Central sensitization-related disorders.

Each item is graded on a 5-point scale from (0) "never" to (4) "always", with a maximum total score of 100. Higher scores indicate a higher degree of symptomatology. Section B includes 7 diagnoses of central sensitization syndromes (tension headaches/migraine, fibromyalgia, irritable bowel syndrome, restless legs syndrome, temporomandibular joint disorder, chronic fatigue syndrome, and multiple chemical sensitivities) and three additional diagnoses found to be associated with central sensitization ( depression, anxiety/panic attack, and neck injury); Participants were asked, together with the year of diagnosis, "Has any of the following conditions been diagnosed by a doctor?" contains the question.

Change in status of somatosensory function from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
Menstrual pain catastrophizing state
Time Frame: Change in state of menstrual pain catastrophizing from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
Pain Catastrophizing Scale: It has 13 items and consists of 3 sub-dimensions (helplessness, magnification and rumination). Questions are scored between 0-4. Subscales are determined by summing the scores of each item, and the total score (between 0 and 52 points) is calculated with the sum of all items. A higher score means a greater degree of catastrophization.
Change in state of menstrual pain catastrophizing from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
Menstrual pain beliefs status
Time Frame: Change in status of menstrual pain beliefs from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
Pain Beliefs Questionnaire (PBQ): It contains 12 items related to pain beliefs. PBQ-O is an 8-item subscale, and PBQ-P is a 4-item subscale. Organic beliefs sub-dimension consists of items 1, 2, 3, 5, 7, 8, 10 and 11, and psychological beliefs sub-dimension consists of items 4, 6, 9 and 12. Participants mark the appropriate answer for themselves on a 6-point response scale ranging from "always" to "never".
Change in status of menstrual pain beliefs from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
Anxiety/depressive symptom level
Time Frame: Change in level of anxiety/depressive symptom from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)

Depression Anxiety Stress Scales-21 (DASS-21): It is a valid measure for depression, anxiety, and stress in adults. Each of the three subscales contains 7 items; each is answered from zero (never) to three (always).

Higher scores indicate greater levels of depression, anxiety, and stress.

Change in level of anxiety/depressive symptom from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
Quality of life level
Time Frame: Change in level of quality of life from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
World Health Organization Quality of Life Scale-Short Form (WHOQOL-BREF): 442 / 5.000 Çeviri sonuçları The WHOQOl-BREF is a 26-item self-administered questionnaire and covers 4 dimensions of quality of life (6 items for psychological health, 7 items for physical health, 3 items for social relationships, and 8 items for environmental health). Except for 3 questions targeting pain and discomfort, need for medical treatment, and negative emotions, each question has response categories ranging from 1 to 5, and a high score indicates high quality of life.
Change in level of quality of life from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
Perception of change
Time Frame: Change in menstrual symptoms immediately after the end of 2 menstrual cycles (each cycle is 28± 7 days) and 3 months after the end of the interventions compared with baseline
5-point likert scale: Individuals' perception of subjective changes in menstrual pain and other menstrual symptoms with interventions will be evaluated. -2= much worse, -1= slightly worse, 0= no change, 1= slightly better, 2= much better. The changes in the menstrual symptoms of the individuals just after the end of the interventions and 3 months after the end of the interventions will be questioned when compared with the baseline.
Change in menstrual symptoms immediately after the end of 2 menstrual cycles (each cycle is 28± 7 days) and 3 months after the end of the interventions compared with baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Serap Özgül, Prof., Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2022

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

September 6, 2023

First Submitted That Met QC Criteria

September 14, 2023

First Posted (Actual)

September 18, 2023

Study Record Updates

Last Update Posted (Actual)

September 18, 2023

Last Update Submitted That Met QC Criteria

September 14, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • KA-22038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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