Transvaginal Photobiomodulation for the Treatment of Chronic Pelvic Pain: A Pilot Study

Ralph Zipper, Brian Pryor, Georgine Lamvu, Ralph Zipper, Brian Pryor, Georgine Lamvu

Abstract

Background: Chronic pelvic pain (CPP) is a common and debilitating condition that affects millions of U.S. women. Most treatments are ineffective and innovative new therapies are desperately needed. Large, controlled studies show that photobiomodulation (PBM) can reduce pain in patients with other chronic pain conditions, such as low back pain, neck pain, and fibromyalgia. The objective of this pilot study was to determine if transvaginal PBM (TV-PBM) can reduce pain in women with CPP. Methods: We conducted a before and after, observational, pilot study. Patients completed the Short Form-McGill Pain Questionnaire (SF-MPQ) at baseline, 1 week, 3 months, and 6 months after nine treatments of TV-PBM. Clinicians completed the Clinical Global Impression Scale (CGI) assessing patient illness severity at the same time. Wilcoxon rank-sum t-tests and effect size using Cohen's d coefficient (low effect size if d < 0.2, medium if 0.2 < d > 8, and high if d > 0.8) was used to measure degree of pain improvement, which was also considered clinically significant if pain reduction was >30%. Results: Thirteen women completed 9 treatments, and 10 women were successfully followed to 6 months. At baseline, the mean SF-MPQ score was 19.7 (standard deviation [SD] ± 5.9). Compared with baseline, 60% improved; the mean SF-MPQ score decreased to 10.0 (SD ±7.5, p = 0.004, d = 1.6) at 1 week after treatment, to 9.7 (SD ±7.9, p = 0.005, d = 1.7) at 3 months, and 8.2 (SD ±8.1, p = 0.002, d = 1.9) at 6 months. Conclusion: Transvaginal PBM provided significant and sustained pain relief to women with CPP up to 6 months. Further controlled studies are needed to confirm these findings, however, in this initial pilot, TV-PBM shows promise.

Keywords: chronic pelvic pain; low-level laser therapy; photobiomodulation.

Conflict of interest statement

R.Z. is chief executive officer of SoLá Pelvic Therapy. B.P. is employed by DJO global and he is also a shareholder and board member of SoLá Pelvic Therapy. G.L. is a consulting Chief Scientific Officer for SoLá Pelvic Therapy.

© Ralph Zipper et al., 2021; Published by Mary Ann Liebert, Inc.

Figures

FIG. 1.
FIG. 1.
Photobiomodulation device with transvaginal probe.
FIG. 2.
FIG. 2.
Percent of patients in each severity of illness category on the Clinical Global Impression (CGI) scale before and after treatment. CGI, Clinical Global Impression scale.
FIG. 3.
FIG. 3.
Mean severity of illness scores on the Clinical Global Impression scale before and after treatment.
FIG. 4.
FIG. 4.
Changes in global improvement scores from pre- to post-treatment.
FIG. 5.
FIG. 5.
Mean therapeutic effect scores (efficacy) comparing baseline to after treatment.
FIG. 6.
FIG. 6.
Change in SF-MPQ Mean Score for Each Pain Descriptor Across Time. SF-MPQ, Short Form-McGill Pain Questionnaire.

References

    1. Mathias SD, Kuppermann M, Liberman RF, Lipschutz RC, Steege JF. Chronic pelvic pain: Prevalence, health-related quality of life, and economic correlates. Obstet Gynecol 1996;87:321–327.
    1. Latthe P, Latthe M, Say L, Gulmezoglu M, Khan KS. WHO systematic review of prevalence of chronic pelvic pain: A neglected reproductive health morbidity. BMC Public Health 2006;6:177.
    1. American College of Obstetricians, Gynecologists' Committee on Practice Bulletins—Gynecology. Chronic Pelvic Pain: ACOG Practice Bulletin, Number 218. Obstet Gynecol 2020;135:e98–e109.
    1. Pain IAftSo. Classification of Chronic Pain, Second Edition (Revised). Available at: . Published 2020. Accessed April 7, 2021.
    1. Allaire C, Williams C, Bodmer-Roy S, et al. . Chronic pelvic pain in an interdisciplinary setting: 1-year prospective cohort. Am J Obstet Gynecol 2018;218:114..e1–114.e12.
    1. Lamvu G, Williams R, Zolnoun D, et al. . Long-term outcomes after surgical and nonsurgical management of chronic pelvic pain: One year after evaluation in a pelvic pain specialty clinic. Am J Obstet Gynecol 2006;195:591–598; discussion 598–600.
    1. Lamvu G, Carrillo J, Ouyang C, Rapkin A. Chronic pelvic pain in women: A review. JAMA 2021;325:2381–2391.
    1. Veasley C, Clare D, Clauw DJ, et al. Impact of Chronic Overlapping Pain Conditions on Public Health and the Urgent Need for Safe and Effective Treatment- 2015 Analysis and Policy Recommendations. Chronic Pain Research Alliance, 2020. Available at: . Published 2015. Accessed November 17, 2021.
    1. Zondervan KT, Yudkin PL, Vessey MP, et al. . Chronic pelvic pain in the community—Symptoms, investigations, and diagnoses. Am J Obstet Gynecol 2001;184:1149–1155.
    1. Fitzgerald CM, Neville CE, Mallinson T, Badillo SA, Hynes CK, Tu FF. Pelvic floor muscle examination in female chronic pelvic pain. J Reprod Med 2011;56:117–122.
    1. Mieritz RM, Thorhauge K, Forman A, Mieritz HB, Hartvigsen J, Christensen HW. Musculoskeletal dysfunctions in patients with chronic pelvic pain: A preliminary descriptive survey. J Manipulative Physiol Ther 2016;39:616–622.
    1. Sedighimehr N, Manshadi FD, Shokouhi N, Baghban AA. Pelvic musculoskeletal dysfunctions in women with and without chronic pelvic pain. J Bodyw Mov Ther 2018;22:92–96.
    1. Rodriguez MA, Afari N, Buchwald DS; National Institute of Diabetes and Digestive and Kidney Diseases Working Group on Urological Chronic Pelvic Pain. Evidence for overlap between urological and nonurological unexplained clinical conditions. J Urol 2009;182:2123–2131.
    1. Tirlapur SA, Kuhrt K, Chaliha C, Ball E, Meads C, Khan KS. The ‘evil twin syndrome’ in chronic pelvic pain: A systematic review of prevalence studies of bladder pain syndrome and endometriosis. Int J Surg 2013;11:233–237.
    1. Zondervan KT, Yudkin PL, Vessey MP, et al. . The community prevalence of chronic pelvic pain in women and associated illness behaviour. Br J Gen Pract 2001;51:541–547.
    1. Berlanda N, Vercellini P, Fedele L. The outcomes of repeat surgery for recurrent symptomatic endometriosis. Curr Opin Obstet Gynecol 2010;22:320–325.
    1. Flyckt R, Kim S, Falcone T. Surgical management of endometriosis in patients with chronic pelvic pain. Semin Reprod Med 2017;35:54–64.
    1. Hartmann KE, Ma C, Lamvu GM, Langenberg PW, Steege JF, Kjerulff KH. Quality of life and sexual function after hysterectomy in women with preoperative pain and depression. Obstet Gynecol 2004;104:701–709.
    1. Fuentes-Marquez P, Cabrera-Martos I, Valenza MC. Physiotherapy interventions for patients with chronic pelvic pain: A systematic review of the literature. Physiother Theory Pract 2019;35:1131–1138.
    1. Yunker A, Sathe NA, Reynolds WS, Likis FE, Andrews J. Systematic review of therapies for noncyclic chronic pelvic pain in women. Obstet Gynecol Surv 2012;67:417–425.
    1. Cotler HB, Chow RT, Hamblin MR, Carroll J. The use of low level laser therapy (LLLT) for musculoskeletal pain. MOJ Orthop Rheumatol 2015;2:00068.
    1. Clijsen R, Brunner A, Barbero M, Clarys P, Taeymans J. Effects of low-level laser therapy on pain in patients with musculoskeletal disorders: A systematic review and meta-analysis. Eur J Phys Rehabil Med 2017;53:603–610.
    1. Glazov G, Yelland M, Emery J. Low-level laser therapy for chronic non-specific low back pain: A meta-analysis of randomised controlled trials. Acupunct Med 2016;34:328–341.
    1. Yeh SW, Hong CH, Shih MC, Tam KW, Huang YH, Kuan YC. Low-level laser therapy for fibromyalgia: A systematic review and meta-analysis. Pain Physician 2019;22:241–254.
    1. Young S, Bolton P, Dyson M, Harvey W, Diamantopoulos C. Macrophage responsiveness to light therapy. Lasers Surg Med 1989;9:497–505.
    1. Anders JR, T, Moges H, Ilev I, Waynant R, Longo L. Light Interaction With Human Central Nervous System Progenitor Cells. NAALT conference proceedings; Tucson, Arizona, 2007.
    1. Gigo-Benato D, Russo TL, Tanaka EH, Assis L, Salvini TF, Parizotto NA. Effects of 660 and 780 nm low-level laser therapy on neuromuscular recovery after crush injury in rat sciatic nerve. Lasers Surg Med 2010;42:673–682.
    1. Rochkind S, Leider-Trejo L, Nissan M, Shamir MH, Kharenko O, Alon M. Efficacy of 780-nm laser phototherapy on peripheral nerve regeneration after neurotube reconstruction procedure (double-blind randomized study). Photomed Laser Surg 2007;25:137–143.
    1. Rochkind S, Drory V, Alon M, Nissan M, Ouaknine GE. Laser phototherapy (780 nm), a new modality in treatment of long-term incomplete peripheral nerve injury: A randomized double-blind placebo-controlled study. Photomed Laser Surg 2007;25:436–442.
    1. Litecure L, ed. Litecure LCT-1000 User Manual. Newark, DE: Litecure, LLC, 19702.
    1. Pendergrass PB, Belovicz MW, Reeves CA. Surface area of the human vagina as measured from vinyl polysiloxane casts. Gynecol Obstet Invest 2003;55:110–113.
    1. Tan JS, Lukacz ES, Menefee SA, Luber KM, Albo ME, Nager CW. Determinants of vaginal length. Am J Obstet Gynecol 2006;195:1846–1850.
    1. Melzack R. The short-form McGill Pain Questionnaire. Pain 1987;30:191–197.
    1. Busner J, Targum SD. The Clinical Global Improvement Scale: Applying a research tool in clinical practice. Psychiatry 2007;4:28–37.
    1. Todd KH. Clinical versus statistical significance in the assessment of pain relief. Ann Emerg Med 1996;27:439–441.
    1. Younger J, McCue R, Mackey S. Pain outcomes: A brief review of instruments and techniques. Curr Pain Headache Rep 2009;13:39–43.
    1. Zipper R, Pryor B. Evaluation of a novel deep tissue transvaginal near-infrared laser and applicator in an ovine model. Lasers Med Sci 2021.

Source: PubMed

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

3
Se inscrever