Pelvic floor muscle contraction-plus-relaxation versus relaxation-only with mindfulness for women with endometriosis-associated pelvic pain: A randomised controlled feasibility study

Introduction:

Methods:

Conclusion: Trail Registration:

Methods Trial design Participants Recruitment and consent Interventions | CERT item | Detailed description | |---|---| | 1: Exercise equipment | During the face-to-face intervention sessions, both groups used a single-patient intravaginal sensor connected to a sEMG biofeedback unit. A sEMG biofeedback unit was used to guide participants in performing either the PFMC + R or PFMR exercise protocol. The unit had two preset programmes: one for PFMC + R and another specifically for PFMR. | | A per vaginam examination was performed prior to inserting an intra-vaginal sensor to ensure the sensor would be comfortable for the participants and to assess tenderness of the obturator internus and levator ani muscles, which are commonly observed in women with pelvic pain and a diagnosis of endometriosis.25 At home, participants were instructed to use either a mirror or digital vaginal self-palpation as a form of biofeedback to ensure that they were performing the correct PFMC + R or PFMR. | | | 2: Qualifications | One physiotherapist (PhD student with training in PFMC + R, PFMR, and mindfulness) provided the PFMC + R and PFMR programmes using a standardised protocol. | | 3: Individual or group | Participants in both groups received individual education and instruction regarding PFMC + R, PFMR and mindfulness. | | 4: Supervision | Participants in both groups were asked to attend two–four face-to-face sessions over a period of 8 weeks of supervised PFMC + R or PFMR (weeks 1, 2, 5 and 8). Participants had the choice to attend the other sessions (weeks 2 and 5) via telehealth or face-to-face. The physiotherapist emailed each participant a Zoom link to attend the remotely delivered consultations. Zoom meetings were scheduled for supervised mindfulness, PFMC + R and PFMR in weeks 3, 4, 6 and 7. | | 5: Adherence | Adherence to the PFM protocol was monitored through exercise diaries completed by the participants. Participants were asked to keep a diary and to record their PFMC + R or PFMR repetitions and mindfulness throughout the 8 weeks. The diary was reviewed weekly by the physiotherapist. | | 6: Motivation | To encourage adherence to the PFMC + R or PFMR programme, the Capability, Opportunity and Motivation behaviour (COM-B) framework was used by the physiotherapist.26 The COM-B is an overarching framework of behavioural systems that identifies appropriate targets for enhancing adherence in practice through three interacting factors: | | (1) Capability: in the first intervention session, the physiotherapist explained the possible benefit of performing PFMC + R or PFMR, and how to perform these exercises to ensure that the participant understood the PFM exercise protocol and to increase participant confidence to perform PFMC + R or PFMR. In addition, participants were provided with a home exercise sheet that includes instructions, PFMC + R or PFMR figures, and positions. | | | (2) Opportunity27: In the weekly sessions, the physiotherapist checked the exercise diary and discussed any barriers to and enablers for performing the PFMC + R or PFMR. | | | (3) Motivation: In the weekly sessions, the physiotherapist provided feedback to enhance motivation and adherence and to encourage positive thoughts and feelings about PFMC + R or PFMR | | | 7: Progression decision rules and 8: exercise description | A standardised protocol was used for all participants in both groups. The PFM protocol for each group was progressed gradually through the addition of repetitions and alterations in exercise and relaxation positions (supine, sitting and standing; Appendix 1). The progression was based on a set time-based programme (each participant did the same thing at the same time-point). However, if a participant reported pain or difficulty performing the PFMC + R or PFMR, the progression was then tailored based on individual rate of progression, pelvic pain, and response to pelvic pain and the exercises. In the face-to-face sessions, biofeedback and intra-vaginal sEMG sensor were used by both groups. | | 9: Home programme | All participants received an email containing a link to the home-based mindfulness intervention and a document detailing PFMC + R or PFMR that used the same parameters and progression as the supervised sessions. In addition, a hard copy of PFMC + R or PFMR protocol was provided to the participants. Both groups were asked to perform both mindfulness and the PFM protocol at home for the same period of time. In addition, all participants were encouraged to complete the mindfulness and PFM exercise diary. | | 10: Non-exercise components | The first session included education about PFM anatomy and function and pelvic pain education including pelvic pain mechanisms, factors influencing pelvic pain, and the involvement of PFM in pelvic pain. | | 11: Adverse events | The PFM protocol was considered to be low risk. An adverse event is defined as any unfavourable sign or symptom that occurs after a participant receives treatment, and this AE may or may not related to the treatment.28 Any AE that occurred during the intervention was documented by the physiotherapist during or following the intervention sessions. Any AE reported by participants was evaluated and recorded by the research team. The severity of AE was rated based on the common terminology criteria for AE version 5.0,28 which was adapted for the study: | | Grade 1: Asymptomatic or mild AE, which is easily tolerated by the participant, causes minimal discomfort and does not interfere with normal activities. | | | Grade 2: Moderate or minimal AE, which is sufficiently discomforting to interfere with normal everyday activities. | | | Grade 3: Severe or medically significant AE but not immediately life-threatening. An AE which prevents normal everyday activities. Hospitalisation or prolongation of hospitalisation indicated. | | | Grade 4: Life-threatening consequences; urgent intervention indicated. | | | Grade 5: Death related to AE. | | | 12: Setting | Participants were asked to attend two to four face-to-face sessions; the remainder by telehealth, and to perform daily home exercise for 8 weeks. Participants had the choice to attend the middle sessions (weeks 2 and 5) via telehealth or face-to-face. Face-to-face intervention sessions were undertaken in a private clinical room at Monash University. | | 13: Intervention description | Appendix 1. Supplementary data provides details regarding the intervention description | | 14, 15 and 16: Tailoring, starting level, and programme fidelity | Participants in both groups received standardised sets of PFM exercise or relaxation. However, if a participant reported pain or discomfort during the PFMC + R or PFMR, the number of PFMC + R or PFMR repetitions, MVC intensity and duration were modified for the participant. For example, the participant may be advised to reduce the number of PFMC + R or PFMR repetitions or for PFMC = R participants, to contract their PFM within pain-free range. | Outcomes Feasibility outcomes Outcomes of pelvic pain and related symptoms Pelvic floor muscle morphometry outcomes Sample size Randomisation Statistical method

Flow of participants through the study Participant chracteristics | Variables | All participants (n = 45) | PFMC + R group (n = 23) | PFMR group (n = 22) | |---|---|---|---| | Age (years), mean ± SD | 31.22 ± 6.50 | 32.21 ± 7.20 | 30.45 ± 6.48 | | Body mass index (kg/m2), mean ± SD | 22.48 ± 2.80 | 22.43 ± 2.90 | 22.50 ± 2.36 | | Region of birth | ||| | Australia | 34 (75%) | 17 (73%) | 17 (77%) | | Asia | 4 (8%) | 1 (4%) | 3 (13%) | | Europe | 5 (11%) | 4 (17%) | 1 (4%) | | Other | 2 (4%) | 1 (4%) | 1 (4%) | | Current employment status | ||| | Employee | 36 (80%) | 19 (82%) | 17 (77%) | | Studying | 3 (6%) | 1 (4%) | 2 (9%) | | Unemployed | 2 (4%) | 2 (8%) | 0 | | Unable to work because of chronic pelvic pain | 2 (4%) | 1 (4%) | 1 (4%) | | Other | 2 (4%) | 0 | 2 (9%) | | Current relationship status | ||| | Married/De facto | 24 (53%) | 13(56%) | 11 (50%) | | In a relationship but not living with partner | 13 (28%) | 6(26%) | 7 (31%) | | Single | 6 (13%) | 2 (8%) | 4 (18%) | | Divorced/separated | 1 (2%) | 1 (4%) | 0 | | Other | 1 (2%) | 1 (4%) | 0 | | Highest education level attained | ||| | Bachelor’s degree | 21 (46%) | 11 (47%) | 10 (40%) | | Postgraduate degree | 10 (22%) | 5 (21%) | 5 (22%) | | High school or less | 9 (20%) | 5 (21%) | 4 (18%) | | Other | 5 (11%) | 1 (4%) | 4 (18%) | | Recruitment source | ||| | - Hospital clinics | 32 (71%) | 17 (74%) | 15 (68%) | | - Social media | 13 (29%) | 6 (26%) | 7 (31%) | | Stage of endometriosis lesions (rASRM) | ||| | Stage I (Minimal) | 9 (20%) | 2 (8%) | 7 (31%) | | Stage II (Mild) | 6 (13%) | 1 (4%) | 5 (22%) | | Stage III (Moderate) | 9 (20%) | 5 (21%) | 4 (18%) | | Stage IV (Severe) | 15 (33%) | 13 (56%) | 2 (9%) | | Unknown (participants recruited via social media; stage data unavailable) | 6 (13%) | 2 (8%) | 4 (18%) | | Site of endometriosis lesions | ||| | Enzian A (vagina, rectovaginal septum) | 24 (55%) | 14 (60%) | 11 (50%) | | Enzian B (sacrouterine ligaments, cardinal ligaments, pelvic sidewall) | 33 (73%) | 18 (78%) | 15 (68%) | | Enzian C (rectum) | 14 (31%) | 11 (21%) | 3 (13%) | | Enzian FA (adenomyosis) | 7 (15%) | 5 (21%) | 2 (9%) | | Enzian FB (bladder) | 5 (11%) | 2 (8%) | 3 (13%) | | Enzian FU (ureters) | 1 (2%) | 1 (4%) | 0 | | Enzian FO (other locations) | 2 (9%) | 1 (4%) | 1 (4%) | | Unknown (participants recruited via social media; Enzian classification data unavailable) | 10 (22%) | 4 (17%) | 6 (27%) | | Pelvic floor pain on palpation | ||| | Presence of LA muscle tenderness | 26 (57%) | 20 (86%) | 6 (27%) | | LA pain intensity (NRS 0–10), mean ± SD: | ||| | Right | 1.17 ± 1.42 | 1.87 ± 1.32 | 0.56 ± 1.20 | | Left | 0.80 ± 1.21 | 1.27 ± 1.40 | 0.34 ± 0.90 | | Pelvic floor pain on palpation | ||| | Presence of OI muscle tenderness | 11 (24%) | 8 (36%) | 3 (13%) | | OI pain intensity (NRS 0–10), mean ± SD: | ||| | Right | 0.29 ± 0.60 | 0.32 ± 0.71 | 0.11 ± 0.41 | | Left | 0.48 ± 0.91 | 0.67 ± 0.90 | 0.39 ± 0.92 | | Surgery for endometriosis during the intervention phase of the trial | 3 (6%) | 1 (4%) | 2 (9%) | Study feasibility | Outcomes | PFMC + R group (n = 23)a | PFMR group (n = 22)a | |---|---|---| | Retention rate | 20/23 (86%) | 14/22 (63%)b | | Recruitment rate | 45/95 (47%) | | | Dropout rate | 2/23 (8%) | 5/22 (22%) | | Adherence rate to the PFM exercise protocol | 70% | 71%c | | High adherence rate (>70%) | 14/23 (60%) | 9/22 (40%) | | Low adherence rate (70%) | 15/23 (65%) | 9/22 (40%) | | Low adherence rate (<70%) | 6/23 (26%) | 6/22 (27%) | | Attendance rate | || | Attended all 8 sessions | 20/23 (86%) | 14/22 (63%) | | 2 sessions | 14/23 (61%) | 10/22 (45%) | | Adverse events associated with PFM exercise | 4/23 (17%) | 2/22 (9%) | | Pelvic pain and abdominal pain within 48 h of an internal ultrasound examination. | 1/23 (4%) | 0 | | Pelvic pain and abdominal pain during menstrual cycle. | 2/23 (8%) | 0 | | Pelvic pain and abdominal pain within a week of endometriosis surgery. | 1/23 (4%) | 2/22 (9%) | | Intervention acceptability | || | Acceptable | 19/23 (82%) | 14/22 (63%) | | Neutral | 2 /23 (8%) | 2/22 (9%) | | Unacceptable | 0 | 1/22 (4%) | | Intervention satisfaction | || | Satisfied | 19/23 (82%) | 13/22 (59%) | | Neutral | 2/23 (8%) | 3/22 (13%) | | Dissatisfied | 0 | 1/22 (4%) | Acceptability and satisfaction of the intervention components Outcomes of pelvic pain and related symptoms | Dependent variables | PFMC + R group (n = 23) | PFMR group (n = 22) | Post-intervention between-group mean differencef | Adjusted analysis controlling for endometriosis severity | |||| |---|---|---|---|---|---|---|---|---| | Baseline | Post-interventiona | Baseline | Post-interventionb | Mean (95% CI) | p-Value | β (95% CI) | p-Value | | | Pelvic pain intensity (NRS) | 5.71 ± 3.12 | 2.19 ± 2.40a | 7.01 ± 2.70 | 5.01 ± 2.62b | −2.80 (−4.22, −1.45) | <0.001 | 0.34 (0.58, 3.71) | 0.043 | | Dysmenorrhoea intensity (NRS) | 7.53 ± 1.94 | 4.41 ± 2.62a | 7.92 ± 2.21 | 5.71 ± 2.71b | −1.30 (−2.64, 0.17) | 0.130 | 0.20 (−0.84, 2.91) | 0.266 | | Dyspareunia intensity (NRS) | 4.92 ± 2.93 | 1.22 ± 1.83a | 6.10 ± 2.92 | 3.63 ± 2.52b | −2.43 (−3.90, −1.03) | <0.001 | 0.33 (0.06, 3.72) | 0.041 | | Dyschezia intensity (NRS) | 5.64 ± 2.91 | 1.35 ± 2.43a | 3.82 ± 3.47 | 1.40 ± 2.11b | −0.11 (−1.49, 1.18) | 0.215 | 0.04 (−1.42, 1.89) | 0.781 | | Dysuria intensity (NRS) | 2.22 ± 3.21 | 0.30 ± 1.13a | 2.11 ± 2.84 | 0.50 ± 1.50b | −0.24 (−0.95, 0.55) | 0.531 | 0.01 (−0.10, 1.12) | 0.970 | | McGill Pain Questionnaire score (SF-MPQ) | |||||||| | Sensory pain | 18.92 ± 6.91 | 8.21 ± 6.41a | 21.30 ± 5.52 | 13.12 ± 5.33b | −4.91 (−8.31, −1.39) | 0.020 | 0.20 (−1.99, 7.53) | 0.243 | | Affective pain | 6.65 ± 3.67 | 2.82 ± 2.63a | 8.02 ± 2.50 | 3.32 ± 3.42b | −0.42 (−2.22, 1.31) | 0.971 | −0.12 (−3.19, 1.62) | 0.502 | | Pain Catastrophising Scale (PCS) | 38.91 ± 14.62 | 25.62 ± 12.54 | 45.74 ± 11.90 | 34.80 ± 11.42b | −9.22 (−12.40, −0.79) | 0.021 | 0.22 (−2.35, 13.70) | 0.164 | | Pain Anxiety Symptoms Scale (PASS) | 51.41 ± 24.73 | 26.24 ± 18.91a | 60.55 ± 18.72 | 45.76 ± 18.86b | −19.4 (−30.80, −8.11) | <0.001 | 0.29 (−0.91, 26.7) | 0.063 | | Pain Self-Efficacy Questionnaire (PSEQ) | 26.22 ± 12.61 | 37.23 ± 14.90a | 23.49 ± 10.90 | 30.70 ± 11.51b | 6.22 (−1.61, 14.02) | 0.148 | −0.08 (−10.91, 6.42) | 0.605 | | Pelvic pain related interference, n (%): | |||||||| | Work or school | |||||||| | No | 6 (26) | 21 (91)a | 0 | 6 (27)b | 1.0 (reference) | <0.001 | 1.0 (reference) | 0.030 | | Yes | 17 (73) | 2 (8)a | 22 (100) | 16 (72)b | 0.31e (0.16, 5.95) | 0.13e (0.20, 0.80) | || | Sexual intercourse | |||||||| | No | 5 (21%) | 15 (65%)a | 5 (22%) | 13 (59%)b | 1.0 (reference) | 0.305 | 1.0 (reference) | 0.879 | | Yes | 18 (78%) | 8 (34%)a | 17(77%) | 9 (40%)b | 1.13e (0.26, 4.84) | 0.88e (0.18, 4.10) | || | ARA at rest (◦) | 116.11 ± 12.62 | 121.34 ± 12.33c | 117.51 ± 10.80 | 117.61 ± 8.42d | 3.61 (2.52, 9.48) | <0.001 | −0.18 (−8.81, −0.35) | 0.040 | | ARA on MVC (◦) | 108.82 ± 13.51 | 109.91 ± 13.24c | 108.32 ± 8.80 | 104.40 ± 6.71d | 5.42 (0.14, 11.13) | <0.001 | −0.16 (−8.32, 1.01) | 0.124 | | LH-AP mid-sagittal at rest (cm) | 3.70 ± 0.72 | 4.19 ± 0.80c | 3.51 ± 0.51 | 3.86 ± 0.42d | 0.22 (−0.12, 0.63) | 0.850 | 0.04 (−0.10, 0.35) | 0.655 | | LH-AP mid-sagittal on MVC (cm) | 3.30 ± 0.80 | 3.49 ± 0.82c | 3.22 ± 0.51 | 2.90 ± 0.51d | 0.31 (0.17, 0.78) | 0.030 | −0.08 (−0.39, 0.18) | 0.483 | | LH-AP axial plane at rest (cm) | 4.62 ± 0.8 | 4.99 ± 0.70c | 4.51 ± 0.32 | 4.64 ± 0.32d | 0.34 (0.14, 0.63) | <0.001 | −0.21 (−0.40, −0.08) | <0.001 | | LH-AP axial plane on MVC (cm) | 4.20 ± 0.62 | 4.07 ± 0.81c | 4.22 ± 1.64 | 3.89 ± 0.42d | 0.23 (−0.12, 0.63) | 0.160 | −0.06 (−0.36, 0.19) | 0.563 | | LHA at rest (cm2) | 12.91 ± 2.13 | 13.67 ± 1.63c | 12.31 ± 1.82 | 13.33 ± 1.40d | 0.34 (−0.54, 1.16) | 0.817 | −0.08 (−0.85, 0.33) | 0.372 | | LHA on MVC (cm2) | 10.84 ± 2.12 | 10.98 ± 2.00c | 10.60 ± 2.14 | 10.19 ± 1.91d | 0.70 (−0.34, 1.75) | 0.073 | −0.16 (−1.56, 0.24) | 0.148 | Pelvic floor muscle morphometry outcomes

Conclusion Acknowledgments Ethical considerations and consent to participate Consent for publication Declaration of conflicting interests Funding ORCID iDs Data availability statement

Supplementary Material Please find the following supplemental material available below. For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with. For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article. Cite Cite Cite Download to reference manager If you have citation software installed, you can download citation data to the citation manager of your choice Information, rights and permissions Information Published In

Data availability statement Authors Metrics and citations Metrics Journals metrics This article was published in Journal of Endometriosis and Pelvic Pain Disorders. View All Journal MetricsPublication usage* Total views and downloads: 1318 *Publication usage tracking started in December 2016 Publications citing this one Receive email alerts when this publication is cited Web of Science: 0 view articles Opens in new tab Crossref: There are no citing articles to show. Figures and tables Figures & Media Tables View Options View options PDF/EPUB View PDF/EPUBAccess options If you have access to journal content via a personal subscription, university, library, employer or society, select from the options below: loading institutional access options Alternatively, view purchase options below: Purchase 24 hour online access to view and download content. Access journal content via a DeepDyve subscription or find out more about this option.