Efficacy of Electrogalvanic Stimulation in Treatment of Levator Ani Syndrome Revisited

The Levator ani syndrome, also known as anismus, levator spasm, puborectalis syndrome, chronic proctalgia, pyriformis syndrome and pelvic tension myalgia [1,2], produces chronic anal pain which is often debilitating and characteristically referred to as constant and/ or frequent dull anorectal pain. Tenderness to palpation of the levator ani can be elicited in all patients. The pathophysiology of levator ani syndrome is poorly understood but the pain is a direct result of levator ani muscle spasm without an underlying organic disease.


Keywords: Anismus; Electrogalvanic stimulation; Muscle spasm Background
The Levator ani syndrome, also known as anismus, levator spasm, puborectalis syndrome, chronic proctalgia, pyriformis syndrome and pelvic tension myalgia [1,2], produces chronic anal pain which is often debilitating and characteristically referred to as constant and/ or frequent dull anorectal pain. Tenderness to palpation of the levator ani can be elicited in all patients. The pathophysiology of levator ani syndrome is poorly understood but the pain is a direct result of levator ani muscle spasm without an underlying organic disease.

Objectives
We review our experience using EGS in the treatment of levator ani syndrome.

Methods
A retrospective chart review was conducted in 25 patients treated with EGS for levator ani syndrome from July 2004 to August 2008. All patients who underwent EGS in a single center were included for review. The study was done under an Institutional Review Board approval.
Patients' clinical histories were taken to ensure they did not have a pacemaker, as this is a contraindication for EGS. Patients were then educated about the procedure and placed in the left lateral decubitus position. Digital rectal examination was performed prior to each session to assess the point of worst tenderness. The dispersive pad was placed under the patient's left thigh and an intra-anal probe was inserted. Both initial and final sessions. Empty cells meant that the information was not available in the patient's chart, and results for patients 08, 09 and 12 were not reported using the Visual Analog Scale, therefore data was reported the same way it was collected in the medical needs.
Both Multiple Linear Regression and Logistic Regression show the same results that The EGS treatment results were influenced by the number of sessions and the previous treatment prior the EGS. In addition, a greater number of sessions can help the EGS treatment to decrease the pain score remarkably; however, the more previous treatment affect the results adversely. Both of the two approaches indicate that a patient is more likely to be treated successfully by the EGS treatment with a greater number of sessions. But a patient is not more likely to be treated successfully by the EGS after other prior treatments.
Scatter plots were used to indicate whether there are linear relationship between the continuous predictor variables and the outcome variable. Figure 3 shows that there is a linear relationship between number of sessions and treatment success. However, there is no clear cut linear relationship between the time withthe diagnosis and treatment success.

Discussion
Early in the 1980's, high voltage electrogalvanic stimulation for the treatment of the levator ani syndrome started to be utilized. In 1982, Sohn et al published a series of 80 patients treated successfully with EGS, with total relief of pain in 69% of the patients [6].
Nicosia and Abcarian in 1985 showed that electrogalvanic stimulation provided total relief of pain symptoms in eighty percent of a cohort of 45 patients with only two patients reporting no benefit [13].
were connected to the EGXtra® Model EGS4000 (Cen-Med Enterprise Inc., East Brunswick, NJ) ( Figure 1). The pulse per second dial was turned up to 100. Voltage was adjusted based on patient tolerance but ranged from 100-330 volts and was delivered at a frequency of 100 pulses per sec (pps). The treatments began with 30 minute sessions. The length of sessions was gradually increased from 30 to 45 min. Each session started with minimum voltage (generally around 150 volts), and slowly increased to the patient's maximum tolerance. During the increments of voltage, patients were asked about their tolerance, so they that the voltage could be appropriately adjusted. The intensity was kept at this level for half of the session and, then gradually decreased from 100-330 volts to 10-100 volts. Lastly, the dispersive pad site is checked for any signs of burns. Multiple linear regression and logistical regression analysis was performed using NORM software.

Results
A total of 22 patients were treated. The majority were males (72%). The mean age was 56 years old (range 30-86). The mean duration of symptoms was 60 months (range 3-240). 41 percent of patients had additional anorectal pathology (anal fissure, anal fistula and hemorrhoids). Over 60% of patients were taking muscle relaxants and/ or analgesics. Fifty-nine percent of patients had previous treatments, including biofeedback (32%), botox injection (14%) and epidural injection (14%). The mean number of EGS sessions was 7.5 (range 2-15). The average duration of each session was 29 minutes for the initial visit and 46 minutes for the concluding visit. The intensity was 70% at initial visit, and 88% by the last treatment (330 volts=100%). Patients' assessment of results at the last session is shown in Figure 2. Complete relief or significant improvement in 8 (36%); moderate improvement in 2 (9%); slight improvement in 7 (32%); and no improvement or worsening of pain in 5 (23%). The mean follow up was 11 months (range 0.4-38). There were no complications associated with the EGS. Table 1 summarizes our patient population based on gender, time with the diagnosis (months), previous treatments before undergoing EGS, number of EGS sessions and the outcomes after the last session. In the "Results" column we assessed the outcomes according to the Visual Analog Scale for pain reported by the patients in the chart during the     . Most articles stress that the diagnosis of levator ani syndrome requires that organic causes of anorectal pain be excluded [15]. In 1987, a study of twenty-eight patients showed success of 50% after eight treatments. The authors noted that patients with irritable bowel syndrome (IBS) or previous anorectal surgery were least likely to benefit from EGS [16].
Drossman et al. reported that the prevalence of symptoms compatible with levator ani syndrome in the general population was 6.6% and that more than 50% of this of patients were 30-60 years old. Women were noticeably more affected than men (7.4% vs. 5.7%) [2]. However, these results were contrary to our patient population where men predominated (72.3%).
Diagnosis of levator ani syndrome is one of exclusion and many patients are refractory to treatment. Patients describe the pain as a vague, dull ache, fullness pressure sensation high in the rectum that often gets worse with sitting. On physical examination, overly spastic levator ani muscles can be felt; tenderness to palpation of pelvic floor muscles represents a cardinal symptom and prominent finding. For unknown reasons, the tenderness is frequently asymmetric, affecting mostly the left side [3]. The pathophysiology remains unknown. Patients with levator ani syndrome are often troubled with psychological co-morbidities associated with chronic anal pain which may result in social isolation. In a study by Ger et al., one fourth of patients had coexisting psychiatric conditions most commonly anxiety and depression [3]. It is uncertain if the association between chronic pelvic pain and psychosocial distress in multiple domains represents an underlying cause or a consequence of pain [1][2][3][4][5]. Electro-physiologic testing suggests increased anal pressures which may reflect increased external and/or internal anal sphincter tone [1]. Noninvasive treatment options for levator ani syndrome include sitz baths, biofeedback, analgesics and muscle relaxants while more invasive options include digital message, botox injection, steroid and epidural injections, and electrogalvanic stimulation (EGS) [17].
Hull and colleagues in 1993 reported forty-three percent of patients had at least partial relief of symptoms with a mean follow-up of more than two years [18].
Most treatments provide temporary relief and often require multiple visits [19]. Billingham et al. confirmed this in a study of twenty patients with levator ani syndrome treated with EGS. Sixty percent of their patients had immediate pain relief, one-third of which eventually had recurrent pain [20]. Few recent trials have looked at the efficacy of EGS in the treatment of levator ani syndrome. We hypothesize that EGS is still a viable adjunct in the management of this troubling disorder and an effective treatment for levator ani syndrome. In 2003 women with pelvic pain from levator spasm were treated with vaginal EGS by gynecologists and more than half of them had long-lasting relief of 6 months or more [21]. Our data support results similar to the above mentioned studies, with 45% of patients showing benefit from EGS.

Conclusion
Electrogalvanic stimulation for the treatment of LAS seems to have similar success rate for more than three decades. The vast majority of publications have reported the utility and superiority of EGS to other therapeutic modalities. Therefore, it is safe to conclude that EGS is an effective treatment option in a selected group of patients with levator ani syndrome offering moderate or complete symptomatic relief in 45% of patients with essentially no risk. Analysis of our data confirms that the more EGS sessions performed yields more successful symptom relief based on visual analog pain scales. The results also showed that patients who had other treatments prior to EGS benefited less from it. Due to the safety profile and moderate efficacy, EGS should be considered as a treatment option for levator ani syndrome.