Pain ManagementNCT06732778
Effectiveness of Pain Neuroscience Education in Women With Menstrual Pain
A study testing Pain Neuroscience Education (PNE) in people with Pain Management and Dysmenorrhea (Disorder), run by Uskudar University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain Management, Dysmenorrhea (Disorder)
- What is being tested?
- Pain Neuroscience Education (PNE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Uskudar University, Faculty of Health Sciences
Istanbul, 34000
About this study
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.
- Conditions
- Pain Management, Dysmenorrhea (Disorder)
- Being tested
- Pain Neuroscience Education (PNE), Control Group (CG)
- Keywords
- dysmenorrhea, pain, quality of life, pain neuroscience education
- Medical subject headings
- Agnosia, Dysmenorrhea, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Neuroscience Education (PNE)Other
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
Control Group (CG)Other
The control group will not receive any training or practice.
| Study group | Role | What they receive |
|---|---|---|
| Pain neuroscience education group (PNE) | Experimental | The cases in this group will be given online PNE training one week before menstruation. Receives: Other: Pain Neuroscience Education (PNE) |
| Control Group (CG) | Other | No training or application will be given to the control group Receives: Other: Control Group (CG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 4 weeks
Secondary outcomes (2)
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.
Measured: 4 weeks
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start1 Oct 2024
- Primary completion31 Jan 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled Trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, osman coban, Uskudar University
- Investigators
- osman coban, Asst Prof., Study director, Uskudar Universitycigdem inkaya, PT, Principal investigator, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732778
- Sponsor's protocol ID
- Uskudaruniversity5
- Status last verified
- Feb 2025
- First submitted
- 9 Dec 2024
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 37445234O'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 34398869Louw 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 31161919Sillevis 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 34131526Inkaya 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pain Neuroscience Education in Women With Menstrual Pain
- ClinicalTrials.gov ID
- NCT06732778
- Acronym / sponsor ID
- Uskudaruniversity5
- Conditions
- Pain Management, Dysmenorrhea (Disorder)
- Keywords
- dysmenorrhea, pain, quality of life, pain neuroscience education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Pain neuroscience education group (PNE) | Experimental | Other: Pain Neuroscience Education (PNE)The cases in this group will be given online PNE training one week before menstruation. |
| Control Group (CG) | Other | Other: Control Group (CG)No training or application will be given to the control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain 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 | Other | Pain neuroscience education group (PNE) |
| Control Group (CG)The control group will not receive any training or practice. | Other | Control Group (CG) |
Primary outcome
Scale for Assessing the Impact of Dysmenorrhea on Daily Life (SAIDDL)
Time frame: 4 weeks
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".
2 secondary outcomes
Pain Beliefs Scale (BPS)
Time frame: 4 weeks
McGill Pain Scale Short Form (MSS-SF)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Results publication: PubMed 37445234Zimney 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.
- Results publication: PubMed 34398869O'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.
- Results publication: PubMed 31161919Louw 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.
- Results publication: PubMed 34131526Sillevis 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.
- Derived from this study: PubMed 42169005Inkaya 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.
- Individual participant dataSharing planned: No
Related trials for Pain Management
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
osman coban, Asst Prof. study director
Uskudar University
cigdem inkaya, PT principal investigator
Uskudar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Neuroscience Education (PNE) in people with Pain Management and Dysmenorrhea (Disorder), run by Uskudar University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scale for Assessing the Impact of Dysmenorrhea on Daily Life (SAIDDL) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06732778, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.