Clinical trial NCT06233786 - References

Primary Dysmenorrhea — The Effectivenes of Non-invasive Neuromodulation in Adult Women With Primary Dysmenorrhea, Through the TENS Stimulation at Different Times of Mentrual Cycle in Each Group

Citation(s)

•   Abaraogu UO, Igwe SE, Tabansi-Ochiogu CS, Duru DO
  A Systematic Review and Meta-Analysis of the Efficacy of Manipulative Therapy in Women with Primary Dysmenorrhea. Explore (NY). 2017 Nov-Dec;13(6):386-392. doi: 10.1016/j.explore.2017.08.001. Epub 2017 Au
•   Abreu-Sanchez A, Ruiz-Castillo J, Onieva-Zafra MD, Parra-Fernandez ML, Fernandez-Martinez E
  Interference and Impact of Dysmenorrhea on the Life of Spanish Nursing Students. Int J Environ Res Public Health. 2020 Sep 5;17(18):6473. doi: 10.3390/ijerph17186
•   Abubakar U, Zulkarnain AI, Samri F, Hisham SR, Alias A, Ishak M, Sugiman H, Ghozali T
  Use of complementary and alternative therapies for the treatment of dysmenorrhea among undergraduate pharmacy students in Malaysia: a cross sectional study. BMC Complem
•   ACOG Committee Opinion No
  760: Dysmenorrhea and Endometriosis in the Adolescent. Obstet Gynecol. 2018 Dec;132(6):e249-e258. doi: 10.1097/AOG.0000000000002978.
•   Akin MD, Weingand KW, Hengehold DA, Goodale MB, Hinkle RT, Smith RP
  Continuous low-level topical heat in the treatment of dysmenorrhea. Obstet Gynecol. 2001 Mar;97(3):343-9. doi: 10.1016/s0029-7844(00)01163-7.
•   Apay SE, Arslan S, Akpinar RB, Celebioglu A
  Effect of aromatherapy massage on dysmenorrhea in Turkish students. Pain Manag Nurs. 2012 Dec;13(4):236-40. doi: 10.1016/j.pmn.2010.04.002. Epub 2010 Sep 15.
•   Armour M, Ee CC, Naidoo D, Ayati Z, Chalmers KJ, Steel KA, de Manincor MJ, Delshad E
  Exercise for dysmenorrhoea. Cochrane Database Syst Rev. 2019 Sep 20;9(9):CD004142. doi: 10.1002/14651858.CD004142.pub4.
•   Armour M, Smith CA, Steel KA, Macmillan F
  The effectiveness of self-care and lifestyle interventions in primary dysmenorrhea: a systematic review and meta-analysis. BMC Complement Altern Med. 2019 Jan 17;19(1):22. doi: 10.1186/s12906-019-2433-8.
•   Azima S, Bakhshayesh HR, Kaviani M, Abbasnia K, Sayadi M
  Comparison of the Effect of Massage Therapy and Isometric Exercises on Primary Dysmenorrhea: A Randomized Controlled Clinical Trial. J Pediatr Adolesc Gynecol. 2015 Dec;28(6):486-91. doi: 10.1016/j
•   Bai HY, Bai HY, Yang ZQ
  Effect of transcutaneous electrical nerve stimulation therapy for the treatment of primary dysmenorrheal. Medicine (Baltimore). 2017 Sep;96(36):e7959. doi: 10.1097/MD.0000000000007959.
•   Bajaj P, Bajaj P, Madsen H, Arendt-Nielsen L
  A comparison of modality-specific somatosensory changes during menstruation in dysmenorrheic and nondysmenorrheic women. Clin J Pain. 2002 May-Jun;18(3):180-90. doi: 10.1097/00002508-200205000-00007.
•   Beck SL, Schwartz AL, Towsley G, Dudley W, Barsevick A
  Psychometric evaluation of the Pittsburgh Sleep Quality Index in cancer patients. J Pain Symptom Manage. 2004 Feb;27(2):140-8. doi: 10.1016/j.jpainsymman.2003.12.002.
•   Bergeron-Vezina K, Leonard G
  On "what makes transcutaneous electrical nerve stimulation work?..." Sluka KA, Bjordal JM, Marchand S, Rakel BA. Phys Ther. 2013;93:1397-1402. Phys Ther. 2013 Oct;93(10):1426-7. doi: 10.2522/ptj.2013.93.10.1426. No abstract a
•   Bisset LM, Evans K, Tuttle N
  Reliability of 2 protocols for assessing pressure pain threshold in healthy young adults. J Manipulative Physiol Ther. 2015 May;38(4):282-7. doi: 10.1016/j.jmpt.2015.03.001. Epub 2015 Apr 27.
•   Bjelland I, Dahl AA, Haug TT, Neckelmann D
  The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.
•   Budgell BS, Sovak G, Soave D
  TENS augments blood flow in somatotopically linked spinal cord segments and mitigates compressive ischemia. Spinal Cord. 2014 Oct;52(10):744-8. doi: 10.1038/sc.2014.120. Epub 2014 Jul 22.
•   Burnett M, Lemyre M
  No. 345-Primary Dysmenorrhea Consensus Guideline. J Obstet Gynaecol Can. 2017 Jul;39(7):585-595. doi: 10.1016/j.jogc.2016.12.023.
•   Campbell MA, McGrath PJ
  Use of medication by adolescents for the management of menstrual discomfort. Arch Pediatr Adolesc Med. 1997 Sep;151(9):905-13. doi: 10.1001/archpedi.1997.02170460043007.
•   Chen CX, Shieh C, Draucker CB, Carpenter JS
  Reasons women do not seek health care for dysmenorrhea. J Clin Nurs. 2018 Jan;27(1-2):e301-e308. doi: 10.1111/jocn.13946. Epub 2017 Sep 7.
•   Chesterton LS, Sim J, Wright CC, Foster NE
  Interrater reliability of algometry in measuring pressure pain thresholds in healthy humans, using multiple raters. Clin J Pain. 2007 Nov-Dec;23(9):760-6. doi: 10.1097/AJP.0b013e318154b6ae.
•   Classification of chronic pain
  Descriptions of chronic pain syndromes and definitions of pain terms. Prepared by the International Association for the Study of Pain, Subcommittee on Taxonomy. Pain Suppl. 1986;3:S1-226. No abstract available.
•   Cleland JA, Childs JD, Whitman JM
  Psychometric properties of the Neck Disability Index and Numeric Pain Rating Scale in patients with mechanical neck pain. Arch Phys Med Rehabil. 2008 Jan;89(1):69-74. doi: 10.1016/j.apmr.2007.08.126.
•   Coco AS
  Primary dysmenorrhea. Am Fam Physician. 1999 Aug;60(2):489-96.
•   Dawood MY, Ramos J
  Transcutaneous electrical nerve stimulation (TENS) for the treatment of primary dysmenorrhea: a randomized crossover comparison with placebo TENS and ibuprofen. Obstet Gynecol. 1990 Apr;75(4):656-60.
•   Dawood MY
  Dysmenorrhoea and prostaglandins: pharmacological and therapeutic considerations. Drugs. 1981 Jul;22(1):42-56. doi: 10.2165/00003495-198122010-00003.
•   Dawood MY
  Nonsteroidal anti-inflammatory drugs and changing attitudes toward dysmenorrhea. Am J Med. 1988 May 20;84(5A):23-9. doi: 10.1016/0002-9343(88)90473-1.
•   Dawood MY
  Primary dysmenorrhea: advances in pathogenesis and management. Obstet Gynecol. 2006 Aug;108(2):428-41. doi: 10.1097/01.AOG.0000230214.26638.0c.
•   Di Girolamo G, Sanchez AJ, De Los Santos AR, Gonzalez CD
  Is acetaminophen, and its combination with pamabrom, an effective therapeutic option in primary dysmenorrhoea? Expert Opin Pharmacother. 2004 Mar;5(3):561-70. doi: 10.1517/14656566.5.3.561.
•   Dmitrovic R, Kunselman AR, Legro RS
  Continuous compared with cyclic oral contraceptives for the treatment of primary dysmenorrhea: a randomized controlled trial. Obstet Gynecol. 2012 Jun;119(6):1143-50. doi: 10.1097/AOG.0b013e318257217a.
•   Dogan H, Eroglu S, Akbayrak T
  The effect of kinesio taping and lifestyle changes on pain, body awareness and quality of life in primary dysmenorrhea. Complement Ther Clin Pract. 2020 May;39:101120. doi: 10.1016/j.ctcp.2020.101120. Epub 2020 Feb 22.
•   Edelman A, Micks E, Gallo MF, Jensen JT, Grimes DA
  Continuous or extended cycle vs. cyclic use of combined hormonal contraceptives for contraception. Cochrane Database Syst Rev. 2014 Jul 29;2014(7):CD004695. doi: 10.1002/14651858.CD004695.pub3.
•   Elboim-Gabyzon M, Kalichman L
  Transcutaneous Electrical Nerve Stimulation (TENS) for Primary Dysmenorrhea: An Overview. Int J Womens Health. 2020 Jan 8;12:1-10. doi: 10.2147/IJWH.S220523. eCollection 2020.
•   Ferries-Rowe E, Corey E, Archer JS
  Primary Dysmenorrhea: Diagnosis and Therapy. Obstet Gynecol. 2020 Nov;136(5):1047-1058. doi: 10.1097/AOG.0000000000004096.
•   Fischer AA
  Pressure algometry over normal muscles. Standard values, validity and reproducibility of pressure threshold. Pain. 1987 Jul;30(1):115-126. doi: 10.1016/0304-3959(87)90089-3.
•   Gandek B, Ware JE, Aaronson NK, Apolone G, Bjorner JB, Brazier JE, Bullinger M, Kaasa S, Leplege A, Prieto L, Sullivan M
  Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. Interna
•   Gaubeca-Gilarranz A, Fernandez-de-Las-Penas C, Medina-Torres JR, Seoane-Ruiz JM, Company-Palones A, Cleland JA, Arias-Buria JL
  Effectiveness of dry needling of rectus abdominis trigger points for the treatment of primary dysmenorrhoea: a randomised paral
•   Hampson E
  A brief guide to the menstrual cycle and oral contraceptive use for researchers in behavioral endocrinology. Horm Behav. 2020 Mar;119:104655. doi: 10.1016/j.yhbeh.2019.104655. Epub 2019 Dec 23.
•   Harlow SD, Park M
  A longitudinal study of risk factors for the occurrence, duration and severity of menstrual cramps in a cohort of college women. Br J Obstet Gynaecol. 1996 Nov;103(11):1134-42. doi: 10.1111/j.1471-0528.1996.tb09597.x. Erratum In: Br J O
•   Hawker GA, Mian S, Kendzerska T, French M
  Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale
•   Hu Z, Tang L, Chen L, Kaminga AC, Xu H
  Prevalence and Risk Factors Associated with Primary Dysmenorrhea among Chinese Female University Students: A Cross-sectional Study. J Pediatr Adolesc Gynecol. 2020 Feb;33(1):15-22. doi: 10.1016/j.jpag.2019.09.004. E
•   Iacovides S, Avidon I, Baker FC
  What we know about primary dysmenorrhea today: a critical review. Hum Reprod Update. 2015 Nov-Dec;21(6):762-78. doi: 10.1093/humupd/dmv039. Epub 2015 Sep 7.
•   Jaleel G, Shaphe MA, Khan AR, Malhotra D, Khan H, Parveen S, Qasheesh M, Beg RA, Chahal A, Ahmad F, Ahmad MF
  Effect of Exercises on Central and Endocrine System for Pain Modulation in Primary Dysmenorrhea. J Lifestyle Med. 2022 Jan 31;12(1):15-25. doi: 1
•   Karout S, Soubra L, Rahme D, Karout L, Khojah HMJ, Itani R
  Prevalence, risk factors, and management practices of primary dysmenorrhea among young females. BMC Womens Health. 2021 Nov 8;21(1):392. doi: 10.1186/s12905-021-01532-w.
•   Lauretti GR, Oliveira R, Parada F, Mattos AL
  The New Portable Transcutaneous Electrical Nerve Stimulation Device Was Efficacious in the Control of Primary Dysmenorrhea Cramp Pain. Neuromodulation. 2015 Aug;18(6):522-6; discussion 522-7. doi: 10.1111/ner.
•   Lazaro C, Caseras X, Whizar-Lugo VM, Wenk R, Baldioceda F, Bernal R, Ovalle A, Torrubia R, Banos JE
  Psychometric properties of a Spanish version of the McGill Pain Questionnaire in several Spanish-speaking countries. Clin J Pain. 2001 Dec;17(4):365-74. d
•   Lee MS, Lee HW, Khalil M, Lim HS, Lim HJ
  Aromatherapy for Managing Pain in Primary Dysmenorrhea: A Systematic Review of Randomized Placebo-Controlled Trials. J Clin Med. 2018 Nov 10;7(11):434. doi: 10.3390/jcm7110434.
•   Lewers D, Clelland JA, Jackson JR, Varner RE, Bergman J
  Transcutaneous electrical nerve stimulation in the relief of primary dysmenorrhea. Phys Ther. 1989 Jan;69(1):3-9. doi: 10.1093/ptj/69.1.3.
•   Lopez-Liria R, Torres-Alamo L, Vega-Ramirez FA, Garcia-Luengo AV, Aguilar-Parra JM, Trigueros-Ramos R, Rocamora-Perez P
  Efficacy of Physiotherapy Treatment in Primary Dysmenorrhea: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2
•   Machado AFP, Perracini MR, Rampazo EP, Driusso P, Liebano RE
  Effects of thermotherapy and transcutaneous electrical nerve stimulation on patients with primary dysmenorrhea: A randomized, placebo-controlled, double-blind clinical trial. Complement Ther Me
•   Masedo AI, Esteve R
  Some empirical evidence regarding the validity of the Spanish version of the McGill Pain Questionnaire (MPQ-SV). Pain. 2000 Apr;85(3):451-456. doi: 10.1016/S0304-3959(99)00300-0.
•   Maybin JA, Critchley HO
  Menstrual physiology: implications for endometrial pathology and beyond. Hum Reprod Update. 2015 Nov-Dec;21(6):748-61. doi: 10.1093/humupd/dmv038. Epub 2015 Aug 7.
•   Mayer DJ, Hayes RL
  Stimulation-produced analgesia: development of tolerance and cross-tolerance to morphine. Science. 1975 May 30;188(4191):941-3. doi: 10.1126/science.1094537.
•   Melzack R, Wall PD
  Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. doi: 10.1126/science.150.3699.971. No abstract available.
•   Melzack R
  The McGill Pain Questionnaire: major properties and scoring methods. Pain. 1975 Sep;1(3):277-299. doi: 10.1016/0304-3959(75)90044-5.
•   Messing K, Saurel-Cubizolles MJ, Bourgine M, Kaminski M
  Factors associated with dysmenorrhea among workers in French poultry slaughterhouses and canneries. J Occup Med. 1993 May;35(5):493-500.
•   Mihm M, Gangooly S, Muttukrishna S
  The normal menstrual cycle in women. Anim Reprod Sci. 2011 Apr;124(3-4):229-36. doi: 10.1016/j.anireprosci.2010.08.030. Epub 2010 Sep 3.
•   Milsom I, Hedner N, Mannheimer C
  A comparative study of the effect of high-intensity transcutaneous nerve stimulation and oral naproxen on intrauterine pressure and menstrual pain in patients with primary dysmenorrhea. Am J Obstet Gynecol. 1994 Jan;170(1
•   Monteagudo Piqueras O, Hernando Arizaleta L, Palomar Rodriguez JA
  [Population based norms of the Spanish version of the SF-12V2 for Murcia (Spain)]. Gac Sanit. 2011 Jan-Feb;25(1):50-61. doi: 10.1016/j.gaceta.2010.09.001. Epub 2010 Oct 25. Spanish.
•   Montero P, Bernis C, Fernandez V, Castro S
  Influence of body mass index and slimming habits on menstrual pain and cycle irregularity. J Biosoc Sci. 1996 Jul;28(3):315-23. doi: 10.1017/s0021932000022380.
•   Morris JL, Rohay J, Chasens ER
  Sex Differences in the Psychometric Properties of the Pittsburgh Sleep Quality Index. J Womens Health (Larchmt). 2018 Mar;27(3):278-282. doi: 10.1089/jwh.2017.6447. Epub 2017 Nov 20.
•   Nie H, Arendt-Nielsen L, Andersen H, Graven-Nielsen T
  Temporal summation of pain evoked by mechanical stimulation in deep and superficial tissue. J Pain. 2005 Jun;6(6):348-55. doi: 10.1016/j.jpain.2005.01.352.
•   Ortiz MI, Cortes-Marquez SK, Romero-Quezada LC, Murguia-Canovas G, Jaramillo-Diaz AP
  Effect of a physiotherapy program in women with primary dysmenorrhea. Eur J Obstet Gynecol Reprod Biol. 2015 Nov;194:24-9. doi: 10.1016/j.ejogrb.2015.08.008. Epub 2015 A
•   Osayande AS, Mehulic S
  Diagnosis and initial management of dysmenorrhea. Am Fam Physician. 2014 Mar 1;89(5):341-6.
•   Parazzini F, Tozzi L, Mezzopane R, Luchini L, Marchini M, Fedele L
  Cigarette smoking, alcohol consumption, and risk of primary dysmenorrhea. Epidemiology. 1994 Jul;5(4):469-72. doi: 10.1097/00001648-199407000-00016.
•   Parra-Fernandez ML, Onieva-Zafra MD, Abreu-Sanchez A, Ramos-Pichardo JD, Iglesias-Lopez MT, Fernandez-Martinez E
  Management of Primary Dysmenorrhea among University Students in the South of Spain and Family Influence. Int J Environ Res Public Health. 202
•   Petrovic P, Kalso E, Petersson KM, Ingvar M
  Placebo and opioid analgesia-- imaging a shared neuronal network. Science. 2002 Mar 1;295(5560):1737-40. doi: 10.1126/science.1067176. Epub 2002 Feb 7.
•   PICKLES VR
  Myometrial responses to the menstrual plain muscle stimulant. J Endocrinol. 1959 Nov;19:150-7. doi: 10.1677/joe.0.0190150. No abstract available.
•   Proctor M, Farquhar C
  Diagnosis and management of dysmenorrhoea. BMJ. 2006 May 13;332(7550):1134-8. doi: 10.1136/bmj.332.7550.1134. No abstract available.
•   Proctor ML, Smith CA, Farquhar CM, Stones RW
  Transcutaneous electrical nerve stimulation and acupuncture for primary dysmenorrhoea. Cochrane Database Syst Rev. 2002;2002(1):CD002123. doi: 10.1002/14651858.CD002123.
•   Ramos-Pichardo JD, Ortega-Galan AM, Iglesias-Lopez MT, Abreu-Sanchez A, Fernandez-Martinez E
  Why Do Some Spanish Nursing Students with Menstrual Pain Fail to Consult Healthcare Professionals? Int J Environ Res Public Health. 2020 Nov 5;17(21):8173. doi:
•   Reading AE
  The internal structure of the McGill pain questionnaire in dysmenorrhoea patients. Pain. 1979 Dec;7(3):353-358. doi: 10.1016/0304-3959(79)90091-5.
•   Reed BG, Carr BR
  The Normal Menstrual Cycle and the Control of Ovulation. 2018 Aug 5. In: Feingold KR, Anawalt B, Blackman MR, Boyce A, Chrousos G, Corpas E, de Herder WW, Dhatariya K, Dungan K, Hofland J, Kalra S, Kaltsas G, Kapoor N, Koch C, Kopp P, Ko
•   Rodrigues JC, Avila MA, Driusso P
  Transcutaneous electrical nerve stimulation for women with primary dysmenorrhea: Study protocol for a randomized controlled clinical trial with economic evaluation. PLoS One. 2021 May 20;16(5):e0250111. doi: 10.1371/jour
•   Ruoff G, Lema M
  Strategies in pain management: new and potential indications for COX-2 specific inhibitors. J Pain Symptom Manage. 2003 Feb;25(2 Suppl):S21-31. doi: 10.1016/s0885-3924(02)00628-0.
•   Sharghi M, Mansurkhani SM, Larky DA, Kooti W, Niksefat M, Firoozbakht M, Behzadifar M, Azami M, Servatyari K, Jouybari L
  An update and systematic review on the treatment of primary dysmenorrhea. JBRA Assist Reprod. 2019 Jan 31;23(1):51-57. doi: 10.5935/1
•   Smith CA, Armour M, Zhu X, Li X, Lu ZY, Song J
  Acupuncture for dysmenorrhoea. Cochrane Database Syst Rev. 2016 Apr 18;4(4):CD007854. doi: 10.1002/14651858.CD007854.pub3.
•   Sundell G, Milsom I, Andersch B
  Factors influencing the prevalence and severity of dysmenorrhoea in young women. Br J Obstet Gynaecol. 1990 Jul;97(7):588-94. doi: 10.1111/j.1471-0528.1990.tb02545.x.
•   Thorbert G, Alm P, Owman C, Sjoberg NO, Sporrong B
  Regional changes in structural and functional integrity of myometrial adrenergic nerves in pregnant guinea-pig, and their relationship to the localization of the conceptus. Acta Physiol Scand. 1978 Jun;1
•   Treede RD
  Gain control mechanisms in the nociceptive system. Pain. 2016 Jun;157(6):1199-1204. doi: 10.1097/j.pain.0000000000000499.
•   Tsonis O, Gkrozou F, Barmpalia Z, Makopoulou A, Siafaka V
  Integrating Lifestyle Focused Approaches into the Management of Primary Dysmenorrhea: Impact on Quality of Life. Int J Womens Health. 2021 Mar 17;13:327-336. doi: 10.2147/IJWH.S264023. eCollection
•   Vance CG, Dailey DL, Rakel BA, Sluka KA
  Using TENS for pain control: the state of the evidence. Pain Manag. 2014 May;4(3):197-209. doi: 10.2217/pmt.14.13.
•   Vilagut G, Valderas JM, Ferrer M, Garin O, Lopez-Garcia E, Alonso J
  [Interpretation of SF-36 and SF-12 questionnaires in Spain: physical and mental components]. Med Clin (Barc). 2008 May 24;130(19):726-35. doi: 10.1157/13121076. Spanish.
•   Wang SF, Lee JP, Hwa HL
  Effect of transcutaneous electrical nerve stimulation on primary dysmenorrhea. Neuromodulation. 2009 Oct;12(4):302-9. doi: 10.1111/j.1525-1403.2009.00226.x. Epub 2009 Aug 20.
•   Weissman AM, Hartz AJ, Hansen MD, Johnson SR
  The natural history of primary dysmenorrhoea: a longitudinal study. BJOG. 2004 Apr;111(4):345-52. doi: 10.1111/j.1471-0528.2004.00090.x.
•   Yokozuka M, Nagai M, Katsura R, Kenmyo K
  Analgesia by Sacral Surface Electrical Stimulation for Primary Dysmenorrhoea. J Rehabil Med Clin Commun. 2020 Feb 27;3:1000027. doi: 10.2340/20030711-1000027. eCollection 2020.

Effectiveness of Non-invasive Neuromodulation in Primary Dysmenhorrea: A Randomized Clinical Trial

Details for clinical trial NCT06233786