ClinicalTrials.gg
CompletedNCT06732778Updated Feb 17, 2025

Effectiveness of Pain Neuroscience Education in Women With Menstrual Pain

An interventional study of Pain Neuroscience Education (PNE) and Control Group (CG) in Pain Management and Dysmenorrhea (Disorder), sponsored by Uskudar University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-17.

Sponsored by Uskudar University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

Menstruation is the bleeding that starts with menarche and continues until menopause, along with hormonal changes in women of reproductive age, and is shed as the endometrium matures and is shed. Menstruation, which covers 30-35 years of a woman's life and occurs regularly every month, is a physiological process. Menstrual cycle problems are a condition that affects health and society all over the world and causes treatment to be sought. It is one of the most common menstrual cycle problems.

Dysmenorrhea is used synonymously with menstrual pain in clinics and practice. It is stated that approximately 40-50% of women experience dysmenorrhea and that it is more common in adolescents. Dysmenorrhea is a symptom that causes changes in women's physical activities and social roles, leading to a decrease in their quality of life. Dysmenorrhea usually manifests itself with symptoms such as pain and cramps in the back and lower abdomen, as well as nausea, vomiting, fatigue, irritability, appetite changes, diarrhea, and headache.

According to the literature, among the choices of women to cope with dysmenorrhea, manipulative and body-based practices (massage, relaxation exercises, acupuncture, aromatherapy, hot-cold applications, etc.), mind-body-based practices (meditation, yoga, hypnotherapy, hypnosis, music therapy, etc.), vitamin-mineral supplements and herbal therapies (vitamins B and E, magnesium, zinc, fennel/rose tea, black cohosh, etc.) and exercise programs are seen to be effective.

Read the detailed description

The first concepts of pain neuroscience education emerged in 2002 in a randomized controlled trial conducted by Lorimer Moseley for patients with low back pain. PNE has been given various names, including but not limited to pain biology education, pain neurophysiology education, neuroscientific pain education, and neuroscience education. In general, PNE is an educational intervention that aims to explain to the patient the neurophysiology of pain, nervous system sensitivity, nervous system plasticity, and psychosocial factors that contribute to the experience of persistent pain. This is accomplished through a series of intertreatment educational modules spread over a term. The modules include exposure to visual aids, examples, and metaphors to enhance patient understanding. The duration and frequency of educational sessions are not uniform in the literature; they range from 30 minutes to 4 hours. Pain neuroscience education connects the pathoanatomical model of tissue damage with the neurophysiological and psychosocial factors inherent in the experience of persistent pain. The goal is to help patients reconceptualize their pain experience by providing educational content that can reduce focus on anatomic damage, decrease fear avoidance, reduce kinesiophobia, and improve self-efficacy. The exact dosage, frequency, and content of a PNE intervention vary.

There are studies in the literature examining the effectiveness of PNE in chronic low back pain, chronic whiplash injury, chronic fatigue syndrome, and the postoperative and preoperative periods of lumbar surgery. No study was found using the pain neuroscience education method in clients with menstrual period pain.

The aim of this study was to investigate the effectiveness of pain neuroscience education on pain and quality of life in women with menstrual period pain.

02

Conditions studied

  • Pain Management
  • Dysmenorrhea (Disorder)

Keywords

  • dysmenorrhea
  • pain
  • quality of life
  • pain neuroscience education
03

In context

Agnosia

1,269 studies on the registry are indexed under Agnosia; 524 are open to participants now.

This study's enrollment of 74 is close to the median of 75 across 1,089 interventional studies indexed under Agnosia.

Browse Agnosia studies →

Lead sponsor

Uskudar University is the lead sponsor of 168 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Being over 18 years of age,
  • Not having a previous pregnancy,
  • Not having a history of pelvic infections
  • Not using hormonal contraception and intrauterine devices,
  • Having a menstrual period of 3-8 days and a menstrual cycle interval of 21-35 days,
  • Being willing to participate in the study.

Exclusion criteria

Exclusion Criteria:

  • Being under 18 years of age,
  • Having a previous pregnancy,
  • Having a history of pelvic infections
  • Using hormonal contraception and intrauterine devices,
  • Not having a menstrual period of 3-8 days and a menstrual cycle interval of 21-35 days,
  • Not being willing to participate in the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
74 participants (actual)

Study arms

  • Experimental
    Pain neuroscience education group (PNE)

    The cases in this group will be given online PNE training one week before menstruation.

    Other: Pain Neuroscience Education (PNE)

  • Other
    Control Group (CG)

    No training or application will be given to the control group

    Other: Control Group (CG)

Interventions

  • OtherPain Neuroscience Education (PNE)

    PNE was planned online for clients 1 week before menstruation in the form of speaking sessions in a presentation format. The training will be conveyed in relation to pain during menstruation. Visual aids, examples and metaphors will be used to improve patient understanding in the training. Ankle sprain picture, speeding bus picture, action potential picture, picture showing membrane resting potential, rusty nail picture, whole body nervous system picture, neuromatrix picture, lion and lion cub picture that helps explain stress responses, curious neighbors picture etc. will be used. The training session is planned to last between 2 and 4 hours. The distribution of pain neuroscience training topics will be implemented in the order given below, with 10 main headings. * Pain and the Biopsychosocial Model * Injury and pain are not equivalent, pain is a brain output rather than an input * Action potential, normal electrical activity of nerves and conduction * Biological process of ion chann

  • OtherControl Group (CG)

    The control group will not receive any training or practice.

06

What researchers measure

Primary outcomes

  1. Scale for Assessing the Impact of Dysmenorrhea on Daily Life (SAIDDL)

    The Scale for Assessing the Impact of Dysmenorrhea on Daily Life was prepared to determine and compare the extent to which daily life is affected by the pain experienced during menstruation. On the 3rd day of each menstrual period, the degree to which daily life is affected is marked on the horizontal line with the numerical values between 0 and 10. A score of 0 on the scale indicates that daily life is "not affected at all" by dysmenorrhea, while a score of 10 indicates that it is "completely affected".

    Time frame: 4 weeks

Secondary outcomes

  1. Pain Beliefs Scale (BPS)

    It was developed by Edwards and colleagues in 1992. It has an 8-item Organic Beliefs subtest (items 1, 2, 3, 5, 7, 8, 10, 11) and a 4-item Psychological Beliefs subtest (items 4, 6, 9, 12). When the scale is applied, the person is asked to mark the most appropriate option for themselves from 6 options ranging from "never" to "always". Scoring varies between 1 and 6 for each item. The total score for each subtest is calculated by adding the scores from the items in the relevant subtest and dividing them by the number of items in the relevant subtest, and three score types (organic beliefs subscale, psychological beliefs subscale, and total score) are obtained.

    Time frame: 4 weeks

  2. McGill Pain Scale Short Form (MSS-SF)

    The McGill Pain Scale Short Form consists of three sections. Section One: This section contains 15 descriptive word groups. 11 of these evaluate the sensory and 4 evaluate the perceptual dimensions of pain. These descriptive words are rated on an intensity scale between 0 and 3 (0=none, 1=mild, 2=moderate, 3=extreme). In the first section of the scale, a total of 3 pain scores are obtained: sensory pain score, perceptual pain score, and total pain score. Section Two: The second section of the form contains five word groups ranging from "mild pain" to "unbearable pain" to determine the severity of the patient's pain. Section Three: In the third section, the patient's current pain intensity is evaluated using a visual comparison scale.

    Time frame: 4 weeks

07

Study locations

1 site
  • Uskudar University, Faculty of Health Sciences
    Istanbul, 34000, Turkey (Türkiye)
08

References and documents

Publications

  • Zimney K, Van Bogaert W, Louw A. The Biology of Chronic Pain and Its Implications for Pain Neuroscience Education: State of the Art. J Clin Med. 2023 Jun 21;12(13):4199. doi: 10.3390/jcm12134199. PubMed 37445234 ↗
  • O'Connor M, Sillevis R, Erickson MR. Pain Neuroscience Education Delivered by a Student Physical Therapist for a Patient with Persistent Musculoskeletal Pain. Am J Case Rep. 2021 Aug 16;22:e932212. doi: 10.12659/AJCR.932212. PubMed 34398869 ↗
  • Louw A, Farrell K, Choffin B, Foster B, Lunde G, Snodgrass M, Sweet R, Weitzel M, Wilder R, Puentedura EJ. Immediate effect of pain neuroscience education for recent onset low back pain: an exploratory single arm trial. J Man Manip Ther. 2019 Dec;27(5):267-276. doi: 10.1080/10669817.2019.1624006. Epub 2019 Jun 4. PubMed 31161919 ↗
  • Sillevis R, Trincado G, Shamus E. The immediate effect of a single session of pain neuroscience education on pain and the autonomic nervous system in subjects with persistent pain, a pilot study. PeerJ. 2021 May 31;9:e11543. doi: 10.7717/peerj.11543. eCollection 2021. PubMed 34131526 ↗
  • Inkaya C, Coban O. Effectiveness of pain neuroscience education in women with dysmenorrhea: controlled clinical trial. BMC Womens Health. 2026 May 21;26(1):374. doi: 10.1186/s12905-026-04530-y. PubMed 42169005 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2024 to primary completion in Jan 2025, 3 months.

Of 606 non-industry interventional studies with no phase under Agnosia, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's 3 months is below that.

Counting every sponsor, half of 615 studies reached it within 12 months; a quarter within 5 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 9, 2024
First posted
Dec 13, 2024
StartActual
Oct 1, 2024
Primary completionActual
Jan 31, 2025
CompletionActual
Feb 1, 2025
Last update
Feb 17, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06732778
Lead sponsor
Uskudar University
Responsible party
osman coban (Asst. Professor, Uskudar University) — Principal investigator
First posted
Dec 13, 2024
Start date
Oct 1, 2024
Primary completion
Jan 31, 2025
Completion
Feb 1, 2025
Last update
Feb 17, 2025

Study contacts

osman coban, Asst Prof.
study director · Uskudar University
cigdem inkaya, PT
principal investigator · Uskudar University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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