Clinical trial NCT06732778: Effectiveness of Pain Neuroscience Education in Women With Menstrual Pain
Official title: Effectiveness of Pain Neuroscience Education in Women With Menstrual Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Management
Dysmenorrhea (Disorder)
Keywords: dysmenorrhea
pain
quality of life
pain neuroscience education
Lead sponsor: Uskudar University
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled Trial
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Scale for Assessing the Impact of Dysmenorrhea on Daily Life (SAIDDL)
timeFrame: 4 weeks
Secondary outcomes:
measure: Pain Beliefs Scale (BPS)
timeFrame: 4 weeks
measure: McGill Pain Scale Short Form (MSS-SF)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Uskudar University, Faculty of Health Sciences
Study officials:
affiliation: Uskudar University
name: osman coban, Asst Prof.
role: STUDY_DIRECTOR
affiliation: Uskudar University
name: cigdem inkaya, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.