Group-based multimodal physical therapy in women with chronic pelvic pain: A randomized controlled trial

Nygaard AS, Rydningen M, Stedenfeldt M, et al. Group‐based multimodal physical therapy in women with chronic pelvic pain: A randomized controlled trial. Acta Obstetricia Et Gynecologica Scandinavica. 2020;99(10):1320-1329. doi:10.1111/aogs.13896

Link to Original Article: https://obgyn.onlinelibrary.wiley.com/doi/10.1111/aogs.13896

Key Points

1. Chronic pelvic pain (CPP) in women is a complex condition with a prevalence of 6%-27%, impacting various aspects of their health and lifestyle.

2. Physical therapy focusing on body awareness and cognitive techniques has been highlighted as a promising therapy for CPP.

3. A group-based multimodal physical therapy program was developed to compare with primary-care physical therapy for women with CPP.

4. The group-based multimodal physical therapy showed a smaller than expected difference in reducing mean pelvic pain intensity after 12 months compared to primary-care physical therapy.

5. The intervention group showed additional improvements in respiratory patterns and pain-related fear of movements.

6. The results suggest a need to refine the multimodal intervention and to investigate predictors for different treatment approaches for women with CPP.

Introduction

The introduction of the paper discusses chronic pelvic pain (CPP) in women as a complex condition with a prevalence of 6%-27% worldwide. CPP is defined as chronic or persistent pain in the pelvic area and can have various negative consequences. Women with CPP report poorer overall health, higher number of surgeries, and more incidences of abuse. Altered movement patterns and pain-related fear of movements are observed. The paper emphasizes the importance of a biopsychosocial approach for treatment, including physical therapy and active patient participation. While positive results have been seen with physical therapy, evidence is limited, and more research is needed, especially in group-based physical therapy. The study aims to compare a group-based multimodal physical therapy program with primary-care physical therapy in women with CPP, with the primary hypothesis being that the intervention group will show greater reduction in mean pain intensity after 12 months.

Methods

The study was a parallel group randomized controlled trial with an allocation ratio of 1:1, conducted at the Pelvic Floor Center at the University Hospital of North Norway. Participants were recruited from the outpatient clinic after assessment by medical specialists based on specific eligibility and exclusion criteria. Inclusion criteria included Norwegian speaking women between 20 to 65 years old with CPP and motivated to participate in a group session. Exclusion criteria included signs of malignancy or pregnancy that require special medical attention, prior use of drugs, diagnosis of severe psychiatric disorder, previous treatment of CPP with physical therapy, intra-abdominal or pelvic surgery in the last 6 months, and treatment with botulinum toxin in the pelvic area in the last 4 months.

The intervention, based on the biopsychosocial model, combined body awareness therapy, patient education, and cognitive approaches of "acceptance and commitment therapy" in a group setting, with a pre-planned schedule of sessions of an initial 10 day session followed by 2 day session at 3, 6, and 12 months post the initial session. The goal of the intervention was to reduce pain and improve daily function by challenging avoidance habits and providing new positive body experiences. The comparator group received referral to a physical therapist in primary health care with expertise in women's health, with therapists providing treatment based on their competence and in consultation with the woman, and the deductibles of the physical therapy treatment were refunded.

The research compared the effectiveness of group-based multimodal physical therapy in a hospital setting with primary-care physical therapy for reducing mean pelvic pain intensity in women with chronic pelvic pain. The study used semi-structured interviews to collect demographic information, medical history, and treatment details. The primary outcome measure was the change in mean pain intensity from baseline to 12 months using the Numeric Pain Rating Scale (NPRS) with 0 indicating no pain and 10 indicating worst pain. Various secondary outcome measures were also assessed, including movement patterns with Standardized Mensendieck Test, pain-related fear of physical movement using Tamp Scale for Kinesiophobia, health-related quality of life using EQ5D-5L, symptoms of anxiety and depression using Hopkins Symptom Checklist-25, somatic and psychological health complaints, urinary incontinence, anal incontinence, obstructed defecation, and sexual function.

Statistical analyses

The study's sample size calculation was based on the results of a previous RCT on women with CPP. The effect size was estimated as "1", with a significance level of 0.05, 90% power, and a 30% estimated dropout rate, indicating a need for 33 women in each group. Descriptive statistics were used to present data, and missing data on sub-items of secondary outcome measures were addressed by using averages of available responses. The statistical analyses followed an intention-to-treat approach. For continuous data, independent samples t-test or Mann-Whitney U test was used for primary analyses, with sensitivity analysis performed using a linear regression model adjusted for the baseline value. The statistical analyses were conducted using IBM SPSS Statistics. The study adhered to the principles of the Declaration of Helsinki, providing written and oral information to participants and obtaining signed informed consent forms. The study was approved by the Regional Committee.

Results

The study involved 62 women assigned to intervention (n=30) and comparator (n=32) groups. Data collection was completed in January 2017, with 26 and 25 women available for 12-month analyses from the intervention and comparator groups, respectively. The majority of women in the intervention group attended all the sessions. The median number of physical therapy consultations in the comparator group was 14. For the primary outcome, the group-difference in change was -1.2 (P = .027). Nineteen women in the intervention group reported improvement, whereas 17 women in the comparator group reported improvement. No adverse effects were registered. Statistically significant differences were found in respiratory patterns and pain-related fear of movements. Sixteen women from both groups reported being sexually active before and after treatment. The intervention group showed a greater improvement in pain-related fear of movements compared to the comparator group. There were no differences in the total scores for incontinence or obstructed defecation between the groups.

Discussion

This study compared a group-based treatment for women with chronic pelvic pain (CPP) with primary-care physical therapy. The intervention group showed significant improvements in pelvic pain intensity, respiratory patterns, and pain-related fear of movement. However, there were no significant differences in other aspects such as health-related quality of life, anxiety, depression, sexual function, incontinence, and defecation. The study's strengths included its randomized controlled trial (RCT) design and validated outcome measures, but limitations included the lack of blinding, potential selection bias, and a relatively small sample size. The study suggested a need for refining the intervention and selection criteria, as well as investigating predictors for different treatment approaches. The findings indicated that the long duration of treatment is important for achieving lasting changes, and future studies could consider additional follow-up periods. The study emphasized the challenges of selecting appropriate outcome measures for CPP and the need for more research to refine the multimodal intervention and tailor treatment for different subgroups of women with CPP. Additionally, the study highlighted the importance of including symptom-specific measures for health-related quality of life in future research.

Conclusion

Although the participants who participated in group-based multimodal physical therapy reported a greater decrease in pain compared to the comparative group who received a standard physical therapy care, a statistically significant difference between the two groups is not found and the researchers cannot conclude that a group-based intervention is better than standard physical therapy care for women with CPP.