Pain Neuroscience Education and Biomedical Pain Education in Primary Dysmenorrhea

NCT06040866 | Completed

• 1 other identifier: KA-22038
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Dysmenorrhea

Outcome Measures

Primary Outcomes (1)

• Severity of menstrual pain

  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 Outcomes (7)

• Menstrual stress level

  Change in level of menstrual stress from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)

• Somatosensory function status

  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

  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

  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

  Change in level of anxiety/depressive symptom from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)

Study Arms (2)

Pain neuroscience education

EXPERIMENTAL

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.

Other: Exercise training; Other: Pain neuroscience education

Biomedical pain education

ACTIVE COMPARATOR

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.

Other: Exercise training; Other: Biomedical pain education

Interventions

Exercise training OTHER

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.

Biomedical pain education; Pain neuroscience education

Pain neuroscience education OTHER

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.

Pain neuroscience education

Biomedical pain education OTHER

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.

Biomedical pain education

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being diagnosed with PD by a gynecologist based on the Primary Dysmenorrhea Consensus Guidelines,
• Nulligravid,
• Not having any known disease,
• Regular menstrual cycle (28±7 days),
• Severity of menstrual pain ≥ 4 cm according to VAS in the last 6 months and during the last menstruation,
• years and over,
• Volunteer healthy female individuals who consented to participate in the study, willing to be randomized, will be included.

You may not qualify if:

• 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
• Taking antidepressants, anxiolytics or oral contraceptives,
• Receiving alternative treatment in the last year,
• Individuals using an intrauterine contraceptive device will not be included.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Büşra Nur Erol

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (14)

• Ponce-Fuentes F, Cuyul-Vasquez I, Bustos-Medina L, Fuentes J. Effects of pain neuroscience education and rehabilitation following arthroscopic rotator cuff repair. A randomized clinical trial. Physiother Theory Pract. 2023 Sep 2;39(9):1861-1870. doi: 10.1080/09593985.2022.2061394. Epub 2022 Apr 12.

  PMID: 35412432 BACKGROUND

• Li X, Hao X, Liu JH, Huang JP. Efficacy of non-pharmacological interventions for primary dysmenorrhoea: a systematic review and Bayesian network meta-analysis. BMJ Evid Based Med. 2024 May 22;29(3):162-170. doi: 10.1136/bmjebm-2023-112434.

  PMID: 38242565 BACKGROUND

• Matthewman G, Lee A, Kaur JG, Daley AJ. Physical activity for primary dysmenorrhea: a systematic review and meta-analysis of randomized controlled trials. Am J Obstet Gynecol. 2018 Sep;219(3):255.e1-255.e20. doi: 10.1016/j.ajog.2018.04.001. Epub 2018 Apr 7.

  PMID: 29630882 BACKGROUND

• Wickstrom K, Edelstam G. Minimal clinically important difference for pain on the VAS scale and the relation to quality of life in women with endometriosis. Sex Reprod Healthc. 2017 Oct;13:35-40. doi: 10.1016/j.srhc.2017.05.004. Epub 2017 May 25.

  PMID: 28844356 BACKGROUND

• Moos RH. The development of a menstrual distress questionnaire. Psychosom Med. 1968 Nov-Dec;30(6):853-67. doi: 10.1097/00006842-196811000-00006. No abstract available.

  PMID: 5749738 BACKGROUND

• Mayer TG, Neblett R, Cohen H, Howard KJ, Choi YH, Williams MJ, Perez Y, Gatchel RJ. The development and psychometric validation of the central sensitization inventory. Pain Pract. 2012 Apr;12(4):276-85. doi: 10.1111/j.1533-2500.2011.00493.x. Epub 2011 Sep 27.

  PMID: 21951710 BACKGROUND

• Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.

  PMID: 7726811 BACKGROUND

• Edwards LC, Pearce SA, Turner-Stokes L, Jones A. The Pain Beliefs Questionnaire: an investigation of beliefs in the causes and consequences of pain. Pain. 1992 Dec;51(3):267-272. doi: 10.1016/0304-3959(92)90209-T.

  PMID: 1491853 BACKGROUND

• The World Health Organization Quality of Life Assessment (WHOQOL): development and general psychometric properties. Soc Sci Med. 1998 Jun;46(12):1569-85. doi: 10.1016/s0277-9536(98)00009-4.

  PMID: 9672396 BACKGROUND

• Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989 Dec;10(4):407-15. doi: 10.1016/0197-2456(89)90005-6.

  PMID: 2691207 BACKGROUND

• Suren M, Okan I, Gokbakan AM, Kaya Z, Erkorkmaz U, Arici S, Karaman S, Kahveci M. Factors associated with the pain catastrophizing scale and validation in a sample of the Turkish population. Turk J Med Sci. 2014;44(1):104-8. doi: 10.3906/sag-1206-67.

  PMID: 25558568 BACKGROUND

• Duzce Keles E, Birtane M, Ekuklu G, Kilincer C, Caliyurt O, Tastekin N, Is EE, Ketenci A, Neblett R. Validity and reliability of the Turkish version of the central sensitization inventory. Arch Rheumatol. 2021 Oct 18;36(4):518-526. doi: 10.46497/ArchRheumatol.2022.8665. eCollection 2021 Dec.

  PMID: 35382371 BACKGROUND

• Haldeman S. North American Spine Society: failure of the pathology model to predict back pain. Spine (Phila Pa 1976). 1990 Jul;15(7):718-24. No abstract available.

  PMID: 2145646 BACKGROUND

• Nijs J, Paul van Wilgen C, Van Oosterwijck J, van Ittersum M, Meeus M. How to explain central sensitization to patients with 'unexplained' chronic musculoskeletal pain: practice guidelines. Man Ther. 2011 Oct;16(5):413-8. doi: 10.1016/j.math.2011.04.005. Epub 2011 May 31.

  PMID: 21632273 BACKGROUND

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Serap Özgül, Prof.

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: This study was designed as a parallel group randomized clinical trial. In this study, individuals were planned to be randomly assigned to either Pain Neuroscience Education combined with exercise training or Biomedical Pain Education combined with exercise training groups.

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 18, 2023
• Study Start: October 9, 2023
• Primary Completion: November 8, 2024
• Study Completion: November 8, 2024
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)