Pelvic floor physical therapy in patients with chronic anal fissure: a randomized controlled trial
Van Reijn-Baggen DA, Elzevier HW, Putter H, Pelger RCM, Han-Geurts IJM. Pelvic floor physical therapy in patients with chronic anal fissure: a randomized controlled trial. Techniques in Coloproctology. 2022;26(7):571-582. doi:10.1007/s10151-022-02618-9Link to Original Article: https://pubmed.ncbi.nlm.nih.gov/35511322/
Key Points
- Chronic anal fissure is a common and painful condition, often associated with pelvic floor dysfunction.
- Pelvic floor physical therapy (PFPT) including electromyographic biofeedback is effective in improving muscle tone, healing of the fissure, pain, and pelvic floor function in patients with chronic anal fissure and pelvic floor dysfunction.
- PFPT significantly reduces resting muscle tone of the pelvic floor and the external anal sphincter, leading to improved symptoms and outcomes.
- PFPT also decreases dyssynergia and increased pelvic floor muscle tone, which are contributing factors to delayed healing and pain in patients with chronic anal fissure.
- PFPT is a safe and cost-effective treatment option, with no reported negative side effects or complications.
- PFPT should be recommended as an adjuvant treatment for patients with chronic anal fissure and pelvic floor dysfunction, in addition to regular conservative treatment.
- The study had a prospective randomized controlled trial design and included a real-world population of patients with chronic anal fissure.
- The findings provide strong evidence supporting the effectiveness of PFPT in the treatment of chronic anal fissure and pelvic floor dysfunction.
- Further research and study are needed to explore the long-term effects and optimal duration of PFPT for chronic anal fissure.
Introduction
Chronic anal fissure (CAF) is a common proctological problem that causes significant morbidity and affects quality of life. The exact cause of CAF is still debated, but mucosal damage from passing hard or liquid stools can lead to an overreaction of the external anal sphincter and increased resting pressure, resulting in spasm and reduced blood flow. Dysfunctional defecation, characterized by an inability to relax or contract the pelvic floor muscles properly, is also believed to contribute to delayed healing and pain in CAF patients. Initial treatment involves conservative management with fiber and laxatives, followed by ointments and botulinum toxin injections if necessary. However, these treatments have limitations, including recurrence and potential incontinence risk. Pelvic floor physical therapy (PFPT), including biofeedback therapy, has shown effectiveness in treating increased muscle tone and dyssynergia but has not been investigated in CAF patients. The authors hypothesize that PFPT, along with conservative management, will improve pelvic floor muscle function, pain, fissure healing, and patient satisfaction in those with CAF and pelvic floor dysfunction.
Methods
Study design
The study described is a single-center, parallel, randomized controlled trial aimed at investigating the effectiveness of pelvic floor physical therapy (PFPT) with surface electromyographic biofeedback (EMG) in patients with chronic atrial fibrillation (CAF) and pelvic floor dysfunction. The trial's design was intended to detect a difference in PFPT outcomes at the first follow-up. The study included consecutive patients with CAF and pelvic floor dysfunction who met the eligibility criteria. These patients were randomly assigned to either an intervention group receiving 8 weeks of PFPT with EMG-biofeedback or a control group receiving postponed PFPT. Each participant provided written informed consent before their assignment to the intervention or control group. The purpose of this study is to compare the efficacy of PFPT with EMG-biofeedback to no PFPT in patients with CAF and pelvic floor dysfunction.
Baseline and follow-up
The baseline and follow-up appointments in this study consisted of clinical examinations to assess the healing of anal fissures. Anal sphincter pressure, pelvic floor muscle tone and function were measured through digital rectal examinations. Pelvic floor dysfunction was defined as the presence of dyssynergia and/or increased pelvic floor muscle tone. EMG measurements were also taken to assess pelvic floor muscle tone. Dyssynergia was detected through digital rectal examination and a balloon expulsion test. This test assessed the patient's ability to expel an artificial stool during simulated defecation. Patients also completed self-administered questionnaires to assess pain intensity during defecation and to evaluate the impact of proctologic complaints on their daily life.
Participants
The study recruited men and women aged 18 years or older with chronic anal fissures (CAF) and pelvic floor dysfunction. Participants were recruited from the Proctos Clinic in the Netherlands between December 2018 and July 2021. CAF was defined as a longitudinal ulcer with symptoms lasting longer than 6 weeks or recurrent fissures. All participants had previously tried conservative treatments such as fiber, laxatives, and ointments for at least 6 weeks with instructions on how to use them correctly, but had not experienced success. Participants needed to have a sufficient understanding of the Dutch language and the ability to complete online questionnaires. Those who could not undergo a digital rectal examination were excluded from the study, as were individuals with abscesses or fistulas, Crohn's disease or ulcerative colitis, prior rectal radiation, or who were pregnant.
Interventions
The intervention in this study involved a pelvic floor physical therapy (PFPT) program consisting of five face-to-face appointments over eight consecutive weeks. The treatment protocol included intrarectal myofascial techniques such as stretching the puborectalis muscle and myofascial release on trigger points in the pelvic floor. Patients were also taught how to contract and relax the pelvic floor muscles and incorporate these exercises into their daily lives. EMG-biofeedback with an intraanal probe was used to increase awareness and monitor pelvic floor function. Patients with pelvic floor dyssynergia learned how to relax the pelvic floor during straining, and neuromuscular electrical stimulation was used if they were unable to contract or relax the muscles. A home exercise program was provided, which included stretching exercises, pelvic floor muscle exercises, breathing exercises, and thermotherapy with heat blankets or sitz baths. Patients in the control group did not receive additional treatment. Data on adverse events were collected.
Outcome Measures
Sample size
The sample size for this study was determined based on the primary outcome, the pelvic floor tone during EMG-registration. Previous research showed a mean tone of 1.75 μV at rest with a standard deviation of 1.75. To detect a difference of 1.0 between the treatment and control groups, a slightly conservative standard deviation of 1.8 was used. It was concluded that a minimum of 70 patients in each treatment arm were needed to detect the desired difference. This sample size provided a power of over 90% to detect a moderate effect size at a 5% alpha level.
Randomization
In this study, patients were randomly assigned to either the PFPT treatment group or the control group that received postponed PFPT. The randomization was done using a computer-generated system called Castor EDC, with allocation ratios of 1:1 and block sizes of 4, 6, and 8. A unique record number was generated for each patient, and the allocation was disclosed. The principal investigator had a decoding list with randomization numbers and patient identification numbers but did not have access to the randomization sequence. Only the coordinating surgeon and principal investigator had access to the key to the code. The principal investigator informed the patients about their group allocation and follow-up appointments. This randomization process ensured that the assignment to either group was unbiased and allowed for a fair comparison between the two groups in terms of the effectiveness of the PFPT treatment.
Statistical analysis
The Statistical Analysis section of this research paper provides an overview of the methods used to analyze the data. The authors utilized the Statistical Packages for Social Sciences (SPSS) software to conduct the analysis. Descriptive methods were employed to assess data quality, treatment group homogeneity, and important endpoints. Normality of the data was determined using histograms. The results were presented using mean and standard deviation for normal numeric variables, median and range for non-normal variables, and frequency and percentages for categorical variables. To compare variables within groups, paired t-tests, Wilcoxon signed-rank tests, and McNemar tests were used for continuous and categorical variables respectively. For comparisons between groups, repeated-measure analysis of variance was used with treatment, time, and their interaction as fixed effects and random patient effects. Independent samples t-tests, Mann-Whitney U tests, and chi-square tests were employed for comparisons at each time point. Significance was set at p<0.05. Multiple imputation was not necessary as missing data were less than 5%. Interim analysis was not performed in this study.
Results
Between December 2018 and July 2021, a total of 155 patients with CAF were deemed eligible for the study. Out of these, 140 patients were randomized into either the PFPT group (n = 70) or the control group (n = 70). The baseline characteristics of the two groups were similar. However, one patient from the PFPT group and two patients from the control group decided to withdraw from the study after randomization. Additionally, during the course of the study, four patients were lost to follow-up at the 8-week mark, with one patient from the PFPT group and three from the control group. At 20 weeks after inclusion, a total of eight patients were lost to follow-up, with four from each group. Further details can be observed in the accompanying table and figure.
Primary outcome
The research paper investigated the effectiveness of pelvic floor physical therapy (PFPT) on reducing pelvic floor muscle tone and tone of the external anal sphincter (EAS) in women with pelvic floor dysfunction. The study found that the PFPT group had significantly reduced pelvic floor muscle tone and EAS tone compared to the control group. At the first follow-up (8 weeks), the difference in pelvic floor muscle tone between the PFPT group and control group was -1.88 µV, but at 20 weeks, when both groups had received PFPT, no significant difference was observed. The PFPT group also had a significant decrease in resting tone of the pelvic floor and EAS at post-treatment and 20-week follow-up, while the control group showed no significant decrease at first follow-up but did show a significant decrease at 20-week follow-up. These findings suggest that PFPT is effective in reducing pelvic floor muscle and EAS tone in women with pelvic floor dysfunction.
Pain
The study compared the effectiveness of pelvic floor physical therapy (PFPT) to a control group in reducing pain. It was found that the PFPT group had a significantly greater reduction in pain scores on the Visual Analog Scale (VAS) compared to the control group at 8 weeks from baseline. However, at the 20-week follow-up, there was no significant difference in pain scores between the two groups. Both groups showed significant reduction in pain scores at 8 weeks and at the 20-week follow-up compared to baseline. The study suggests that PFPT may be effective in reducing pain in the short term but not in the long term. Further investigation is needed to understand the optimal duration and frequency of PFPT to maintain pain reduction.
Pelvic floor function
The study found that pelvic floor physical therapy (PFPT) was effective in reducing dyssynergia, a condition where there is an inability to coordinate pelvic floor muscle contractions during defecation. Before treatment, 67.1% of the PFPT group and 78.6% of the control group showed dyssynergia. After eight weeks of intervention, the percentage decreased to 25.7% in the PFPT group compared to 64.3% in the control group (p < 0.001). However, at the 20-week follow-up, when both groups received treatment, the difference in dyssynergia was no longer significant between the groups (p = 0.964). Additionally, there was no significant difference in dyssynergia measured with the balloon expulsion test between the PFPT group and the control group after 20 weeks of treatment (p = 0.566). Regarding increased pelvic floor muscle tone, the study showed that PFPT was effective in reducing it. Before treatment, 87.1% of the PFPT group and 81.4% of the control group had increased muscle tone. After eight weeks of intervention, the percentage decreased to 28.6% in the PFPT group compared to 77.1% in the control group (p < 0.05). However, there was no significant difference in increased muscle tone between the two groups at the 20-week follow-up (p = 0.750).
Patient-related outcome measurement
The research study compared the effectiveness of pelvic floor physical therapy (PFPT) with a control group in reducing complaints related to pelvic floor dysfunction. The results showed that the PFPT group had significantly greater reduction in complaints at 8 weeks compared to the control group. The mean estimated difference between groups at 8 weeks was -1.56, indicating a greater improvement in the PFPT group. However, at 20 weeks, there was no significant difference in complaints between the two groups. Both the PFPT group and the control group showed a decrease in complaints from pre-treatment to post-treatment at 8 weeks. These improvements were maintained in both groups at the 20-week follow-up. In conclusion, PFPT was more effective than the control group in reducing complaints at 8 weeks, but there was no significant difference between the two groups at 20 weeks.
Discussion
This study aimed to evaluate the effectiveness of EMG-biofeedback-assisted pelvic floor physical therapy (PFPT) for chronic anal fissure (CAF). The randomized controlled trial found that PFPT resulted in a significant decrease in pelvic floor muscle tone, improvement in healing of the fissure, pelvic floor function, pain reduction, and complaint reduction compared to the control group. EMG-biofeedback was proven to be an effective modality for PFPT. The study also found that patients with CAF had higher levels of pelvic floor muscle tone, tenderness, and dyssynergia. PFPT, including biofeedback, was effective in relieving dyssynergia. The results showed that anterior fissures were associated with low anal sphincter pressure, while posterior fissures were associated with high anal sphincter pressure. The study highlighted the importance of comprehensive evaluation and treatment of alterations in the pelvic floor and associated structures. The Proctoprom questionnaire was used to assess the patient's perspective, and patients in both the PFPT and control groups showed improvement over time. The study concluded that PFPT is an effective, safe, and low-cost treatment option for CAF and pelvic floor dysfunction. However, there were limitations in the study design and potential for bias.
Opportunities for Future Research
1. Investigate the long-term effects of pelvic floor physical therapy (PFPT) in patients with chronic anal fissure and pelvic floor dysfunction, including an assessment of sustained improvement in muscle tone, healing of the fissure, pain reduction, and pelvic floor function.
2. Explore the optimal duration and frequency of PFPT sessions for maximum effectiveness in treating chronic anal fissure and pelvic floor dysfunction.
3. Assess the impact of PFPT on quality of life measures, including psychological well-being and overall patient satisfaction.
4. Investigate the cost-effectiveness of PFPT as adjuvant treatment alongside regular conservative treatment for chronic anal fissure.
5. Examine the efficacy of PFPT in specific patient populations, such as those with anterior anal fissures or a history of vaginal delivery.
6. Compare the outcomes of PFPT with other treatment modalities, such as ointments, botulinum toxin injections, and surgical interventions, to determine the most effective approach for managing chronic anal fissure and pelvic floor dysfunction.
