Mindful Movement for Pelvic Pain

NCT05899088 | Unknown

• 2 other identifiers: 19798737141745
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Female chronic pelvic pain (CPP) is defined as the sensation of pain arising from the lower urinary tract, bowel, muscles, nerves, and gynecologic organs within the pelvis. It can also include menstrual pain and pain with intercourse, when these adversely affects a patient's well-being. Chronic pelvic pain is often associated with negative cognitive, behavioral, sexual and emotional consequences, which can include physical deconditioning, pain catastrophizing (magnifying the threat of pain), kinesiophobia (fear of movement), and depression. CPP has been estimated to affect between 5.7%-26.6% of women.Treatments for chronic pelvic pain are limited, and the use of centrally acting pain medications such as opioids is common. There is increasing awareness of the risks of these medications, including dependence, addiction, and over-dose related death. Therefore, it is critical to look for safe alternatives to manage chronic pelvic pain. Exercise has been targeted as a treatment strategy for chronic pain conditions, improving both pain intensity and physical function. Studies have demonstrated that yoga, Zumba®, and treadmill walking can improve menstrual related pain and quality of life. Mindfulness is the non-judgmental acceptance and investigation of present experience, including body sensations, internal mental states, thoughts, emotions, impulses, and memories to reduce suffering or distress and to increase well-being. Prior research by our group has demonstrated efficacy of mindfulness meditation in reducing pain and improving quality of life in women with chronic pelvic pain. Mindful movement is putting attention into what the body is feeling as it moves. It involves paying attention movement that feels good as well as to early warning signs that an exercise may be too intense or may cause a pain flare. This study is a 12-week program of gentle aerobic exercise and stretching for patients with CPP that applies mindful movement practices. Patients will be randomized to weekly classes versus the routine recommendations for exercise. We will measure pain reduction, improvement in quality of life, and reduction in pain catastrophizing and kinesiophobia.

Conditions

Pelvic Pain; Endometriosis

Keywords

Chronic Pelvic Pain, Kinesiophobia, Mindful movement, Endometriosis

Outcome Measures

Primary Outcomes (3)

• Change in Pelvic Pain Level

  To determine if mindful movement can reduce pain in a patient with CPP

  12 weeks

• Impact on Quality of Life

  To determine if mindful movement can improve quality of life in patients with CPP

  12 weeks

• Change in Kinesiophobia and Pain Catastrophizing

  To determine if mindful movement can reduce kinesiophobia and pain catastrophizing in patients with CPP

  12 weeks

Study Arms (2)

Control Arm

NO INTERVENTION

Patients follow-up as normal with physician. Recommended by physician to engage in physical activity 4x/w. No other intervention or follow-up.

Study Arm

EXPERIMENTAL

Patients engage in weekly exercise program as recommended by the study. Researchers follow up weekly with patient to assess progress. Complete surveys at beginning and end.

Other: Mindful Movement

Interventions

Mindful Movement OTHER

Mindful Movement Program with Researcher Follow-up

Study Arm

Eligibility Criteria

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

You may qualify if:

• Must receive care in the Pelvic Pain Program at the Women's Medicine Collaborative at Lifespan
• Aged 18 or over
• Able to ambulate independently
• Not exercising regularly: defined by less than 30 minutes of aerobic exercise per week in the past 3 months.
• Able to speak and understand conversational English. Written materials will be available in English and Spanish.

You may not qualify if:

• Under age 18
• Currently pregnant or up to 6 weeks postpartum
• Medical conditions for which exercise is contraindicated
• Major surgery within the past 12 weeks or planned within the next 12 weeks

Sponsors & Collaborators

• The Miriam Hospital: lead
• Rhode Island Foundation: collaborator

Related Publications (24)

• Chronic Pelvic Pain: ACOG Practice Bulletin, Number 218. Obstet Gynecol. 2020 Mar;135(3):e98-e109. doi: 10.1097/AOG.0000000000003716.

  PMID: 32080051 BACKGROUND

• American College of Obstetricians and Gynecologists. Revitalize. Gyencology data definitions (version 1.0). Washington, DC: American College of Obstetricians and Gynecologists: 2018. Available at : Httph://www.acog.org/-/media/Departments/patient-safety-and-quality-improvement/revit alize-Gynecology-Definitions-V2.pdf. Retrieved 5/2/2021

  BACKGROUND

• Ahangari A. Prevalence of chronic pelvic pain among women: an updated review. Pain Physician. 2014 Mar-Apr;17(2):E141-7.

  PMID: 24658485 BACKGROUND

• Simoens S, Dunselman G, Dirksen C, Hummelshoj L, Bokor A, Brandes I, Brodszky V, Canis M, Colombo GL, DeLeire T, Falcone T, Graham B, Halis G, Horne A, Kanj O, Kjer JJ, Kristensen J, Lebovic D, Mueller M, Vigano P, Wullschleger M, D'Hooghe T. The burden of endometriosis: costs and quality of life of women with endometriosis and treated in referral centres. Hum Reprod. 2012 May;27(5):1292-9. doi: 10.1093/humrep/des073. Epub 2012 Mar 14.

  PMID: 22422778 BACKGROUND

• Steege JF, Siedhoff MT. Chronic pelvic pain. Obstet Gynecol. 2014 Sep;124(3):616-629. doi: 10.1097/AOG.0000000000000417.

  PMID: 25162265 BACKGROUND

• As-Sanie S, Soliman AM, Evans K, Erpelding N, Lanier RK, Katz NP. Short-acting and Long-acting Opioids Utilization among Women Diagnosed with Endometriosis in the United States: A Population-based Claims Study. J Minim Invasive Gynecol. 2021 Feb;28(2):297-306.e2. doi: 10.1016/j.jmig.2020.05.029. Epub 2020 Jun 9.

  PMID: 32531340 BACKGROUND

• Rosenberg JM, Bilka BM, Wilson SM, Spevak C. Opioid Therapy for Chronic Pain: Overview of the 2017 US Department of Veterans Affairs and US Department of Defense Clinical Practice Guideline. Pain Med. 2018 May 1;19(5):928-941. doi: 10.1093/pm/pnx203.

  PMID: 29025128 BACKGROUND

• Geneen LJ, Moore RA, Clarke C, Martin D, Colvin LA, Smith BH. Physical activity and exercise for chronic pain in adults: an overview of Cochrane Reviews. Cochrane Database Syst Rev. 2017 Apr 24;4(4):CD011279. doi: 10.1002/14651858.CD011279.pub3.

  PMID: 28436583 BACKGROUND

• Rakhshaee Z. Effect of three yoga poses (cobra, cat and fish poses) in women with primary dysmenorrhea: a randomized clinical trial. J Pediatr Adolesc Gynecol. 2011 Aug;24(4):192-6. doi: 10.1016/j.jpag.2011.01.059. Epub 2011 Apr 21.

  PMID: 21514190 BACKGROUND

• Yang NY, Kim SD. Effects of a Yoga Program on Menstrual Cramps and Menstrual Distress in Undergraduate Students with Primary Dysmenorrhea: A Single-Blind, Randomized Controlled Trial. J Altern Complement Med. 2016 Sep;22(9):732-8. doi: 10.1089/acm.2016.0058. Epub 2016 Jun 17.

  PMID: 27315239 BACKGROUND

• Yonglitthipagon P, Muansiangsai S, Wongkhumngern W, Donpunha W, Chanavirut R, Siritaratiwat W, Mato L, Eungpinichpong W, Janyacharoen T. Effect of yoga on the menstrual pain, physical fitness, and quality of life of young women with primary dysmenorrhea. J Bodyw Mov Ther. 2017 Oct;21(4):840-846. doi: 10.1016/j.jbmt.2017.01.014. Epub 2017 Feb 7.

  PMID: 29037637 BACKGROUND

• Heidarimoghadam R, Abdolmaleki E, Kazemi F, Masoumi SZ, Khodakarami B, Mohammadi Y. The Effect of Exercise Plan Based on FITT Protocol on Primary Dysmenorrhea in Medical Students: A Clinical Trial Study. J Res Health Sci. 2019 Aug 24;19(3):e00456.

  PMID: 31586377 BACKGROUND

• Kannan P, Chapple CM, Miller D, Claydon-Mueller L, Baxter GD. Effectiveness of a treadmill-based aerobic exercise intervention on pain, daily functioning, and quality of life in women with primary dysmenorrhea: A randomized controlled trial. Contemp Clin Trials. 2019 Jun;81:80-86. doi: 10.1016/j.cct.2019.05.004. Epub 2019 May 7.

  PMID: 31071464 BACKGROUND

• Samy A, Zaki SS, Metwally AA, Mahmoud DSE, Elzahaby IM, Amin AH, Eissa AI, Abbas AM, Hussein AH, Talaat B, Ali AS. The Effect of Zumba Exercise on Reducing Menstrual Pain in Young Women with Primary Dysmenorrhea: A Randomized Controlled Trial. J Pediatr Adolesc Gynecol. 2019 Oct;32(5):541-545. doi: 10.1016/j.jpag.2019.06.001. Epub 2019 Jun 11.

  PMID: 31195099 BACKGROUND

• Luque-Suarez A, Martinez-Calderon J, Falla D. Role of kinesiophobia on pain, disability and quality of life in people suffering from chronic musculoskeletal pain: a systematic review. Br J Sports Med. 2019 May;53(9):554-559. doi: 10.1136/bjsports-2017-098673. Epub 2018 Apr 17.

  PMID: 29666064 BACKGROUND

• Clark Donat L, Reynolds J, Friedman L, Bublitz M, Flynn E, Fox SD. (2020) October. The Effect of a Brief Mindfulness Meditation Based Intervention on Women with Chronic Pelvic Pain. Poster presentation. 23rdAnnual Scientific Meeting on Pelvic Pain; Virtual.

  BACKGROUND

• Kabat-Zinn J (2013). Full Catastrophe Living: Using the Wisdom of Your Body and Mind to Face Stress, Pain, and Illness. New York: Bantam Dell. ISBN 978-0345539724.

  BACKGROUND

• Crane-Okada R, Kiger H, Anderson NL, Carroll-Johnson RM, Sugerman F, Shapiro SL, Wyman-McGinty W. Participant perceptions of a mindful movement program for older women with breast cancer: focus group results. Cancer Nurs. 2012 May-Jun;35(3):E1-10. doi: 10.1097/NCC.0b013e31822539c5.

  PMID: 21897212 BACKGROUND

• Chan RR, Larson JL. Meditation Interventions for Chronic Disease Populations: A Systematic Review. J Holist Nurs. 2015 Dec;33(4):351-65. doi: 10.1177/0898010115570363. Epub 2015 Mar 2.

  PMID: 25731777 BACKGROUND

• Fox SD, Flynn E, Allen RH. Mindfulness meditation for women with chronic pelvic pain: a pilot study. J Reprod Med. 2011 Mar-Apr;56(3-4):158-62.

  PMID: 21542535 BACKGROUND

• Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.

  PMID: 9626712 BACKGROUND

• Miller R, Kori S, Todd D. The Tampa Scale, The Clinical Journal of Pain: March 1991; 7(1):51

  BACKGROUND

• Sullivan, M. J. L., Bishop, S. R., & Pivik, J. (1995). The Pain Catastrophizing Scale: Development and validation. Psychological Assessment 1995;7(4):524-32.

  BACKGROUND

• Safikhani S, Gries KS, Trudeau JJ, Reasner D, Rudell K, Coons SJ, Bush EN, Hanlon J, Abraham L, Vernon M. Response scale selection in adult pain measures: results from a literature review. J Patient Rep Outcomes. 2018 Sep 6;2:40. doi: 10.1186/s41687-018-0053-6. eCollection 2017.

  PMID: 30238085 BACKGROUND

MeSH Terms

Conditions

Pelvic Pain; Endometriosis; Kinesiophobia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Phobic Disorders; Anxiety Disorders; Mental Disorders

Central Study Contacts

Lindsay Clark Donat, MD, FACOG

CONTACT

(401) 606-3000; lindsay.clarkdonat@lifespan.org

Sonja G Kapadia, BA

CONTACT

(804) 980-6124; sonja_kapadia@brown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Rolling admission of participants. Each participant completes 12 weeks of intervention with weekly follow-up if in treatment arm. No follow-up in control arm.

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 12, 2023
• Study Start: June 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: June 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share