Biofeedback for Intractable Rectal Pain O u t c o m e and Predictors of Success Robert Gilliland, M.B., F.R.C.S., J. Steve Heymen, M.S., Donato F. Altomare, M.D., Dawn Vickers, R.N., Steven D. Wexner, M.D. From the Department of Colorectal Surgery, Cleveland Clinic Florida, Fort Lauderdale, Florida PURPOSE: A number of modalities have been used for the treatment of intractable rectal pain, with varying degrees of success. Electromyography (EMG)-based biofeedback therapy has been used in the treatment of this condition during the past six years. MATERIALS AND METHODS: Medical records of 86 patients w h o completed at least one session of biofeedback for rectal pain between February 1989 and August 1995 were retrospectively reviewed. All sessions were one-hour outpatient encounters with a trained biofeedback therapist. There were 31 male and 55 female patients with a median age of 68 (range, 12-96) years. Surgery (19.8 percent) or stress (15.1 percent) were frequently cited as precipitating factors for the development of rectal pain. Eleven patients completed only one session of biofeedback and were excluded from further analysis. Of the remaining patients, 28 complained of concomitant constipation. Assessment of the benefit of therapy was based on the patients' subjective reports of the level of symptoms, aided by a linear analog scale. RESULTS: Twenty six patients (34.7 percent) reported an improvement in symptoms. Outcome was not influenced by patients' ages (P = 0.63), duration of symptoms (P = 1.0), or a prior history of surgery (P = O.14). Alleviation of symptoms was not significantly related to the presence of paradoxical puborectalis contraction demonstrated on either EMG (P = 1) or dcfecography (P = 0.12). Importantly, outcome was significantly improved in patients who completed the treatment schedule compared with those who self-discharged (P < 0.001). CONCLUSIONS: Although idiopathic rectal pain is difficult to treat, EMG-based biofeedback can produce alleviation of symptoms. However, success depends on patients' willingness to pursue a frill course of therapy. [Key words: Rectal pain; Levator syndrome; Paradoxical puborectalis contraction; Biofeedback]

mittent p a i n a n d d i s c o m f o r t in the rectal or p e r i n e a l area, o f t e n a g g r a v a t e d b y sitting or b y the n e e d to e v a c u a t e . This d i s c o m f o r t m a y b e c o m e m o r e p r o tracted, a n d patients c o m p l a i n o f p e r s i s t e n t t e n e s mus. 5 Levator s p a s m is m o r e c o m m o n in w o m e n , a n d p h y s i c a l findings m a y i n c l u d e t e n d e r n e s s o n p a l p a tion o f the l e v a t o r muscles, m o r e f r e q u e n t l y o n the left side. 4-7 T h e r e m a y b e a n o t i c e a b l e i n c r e a s e in t h e m u s c l e t o n e o f the p u b o r e c t a l i s sling. Proctalgia f u g a x is c h a r a c t e r i z e d b y s u d d e n , stabb i n g p a i n in the p e r i r e c t a l a r e a o f t e n w a k e n i n g the p a t i e n t f r o m sleep.* Clinical f i n d i n g s a r e similar to t h o s e features s e e n in levator spasm. C o c c y d y n i a is t h e t e r m g i v e n to p a i n l o c a l i z e d in the c o c c y g e a l area, often r e p r o d u c e d b y e x t e r n a l o r t r a n s a n a l m a n i p u l a tion o f the coccyx. 6 D e s p i t e t h e s e e x a c t definitions, in p r a c t i c e t h e s e s y n d r o m e s are rarely t h e result o f a n a t o m i c a l l y d e f i n e d a b n o r m a l i t i e s a n d are s e l d o m definitely d i a g n o s e d b y a test o r c o m b i n a t i o n of tests. F o r simplification, t h e s e d i s o r d e r s c a n all b e c o n s i d e r e d u n d e r the g l o b a l d i a g n o s i s o f c h r o n i c i d i o p a t h i c rectal pain. Etiology o f c h r o n i c i d i o p a t h i c rectal p a i n r e m a i n s u n k n o w n . T h i e l e 4 b e l i e v e d t h a t a s s o c i a t e d a n a l inf e c t i o n r e s u l t e d in r e f l e x s p a s m o f t h e l e v a t o r a n i muscles. Others have noted an association among obstructed defecation, paradoxical puborectalis contraction, a n d i d i o p a t h i c pain. 2' 9

Gilliland R, Heymen JS, Altomare DF, Vickers D, Wexner SD. Biofeedback for intractable rectal pain: outcome and predictors of success. Dis Colon Rectum 1997;40:190-196.

C o n s e r v a t i v e t r e a t m e n t i n c l u d i n g m u s c l e relaxants, 6 l e v a t o r m u s c l e m a s s a g e , < 7 o r p e r i n e a l -

h r o n i c i d i o p a t h i c rectal p a i n is a p o o r l y u n d e r s t o o d d i s o r d e r that has b e e n c a t e g o r i z e d b y s o m e a u t h o r s into t h r e e o v e r l a p p i n g s y n d r o m e s . ~' 2 Levator ani s y n d r o m e o r l e v a t o r s p a s m h a s b e e n reco g n i z e d for m a n y y e a r s as b e i n g r e s p o n s i b l e for rectal pain.3, 4 T h e s y n d r o m e is c h a r a c t e r i z e d b y b r i e f inter-

C

s t r e n g t h e n i n g e x e r c i s e s 6 m a y result in alleviation o f s y m p t o m s . I n d e e d , G r a n t et al. 7 r e p o r t e d relief o f s y m p t o m s in 68 p e r c e n t o f p a t i e n t s f o l l o w i n g t h r e e or f e w e r m a s s a g e treatments. 7 N o n s t e r o i d a l anti-inflamm a t o r y d r u g s a n d s e d a t i v e s h a v e also b e e n u s e d w i t h s o m e benefit. 7 A number of treatment modalities have been de-

Supported in part by a grant from the Eleanor Naylor Dana Trust. Dr. Gilliland is a visiting surgeon from the Department of Surgery, Queen's University of Belfast, Northern Ireland. Dr. Altomare is a visiting surgeon from the Istituto di Ctinica Chirurgica, Universita Degli Studi di Bari, Bari, Italy. Address reprint requests to Dr. Wexner: Department of Colorectal Surgery, Cleveland Clinic Florida, 3000 West Cypress Creek Road, Fort Lauderdale, Florida. 33309.

v e l o p e d for c a s e s r e s i s t a n t to t h e s e c o n s e r v a t i v e measures. These therapies include electrogalvanic stimulation,5, ~0-~2 s t e r o i d c a u d a l b l o c k , ~3 a n d biofeedback.2, 9 D u r i n g the p a s t six years, electrom y o g r a p h i c ( E M G ) - b a s e d b i o f e e d b a c k t h e r a p y has 190

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BIOFEEDBACK FOR RECTALPAIN

been used in the treatment of patients with intractable rectal pain. The aim of this study was to review our experience with this modality and to identify factors that might be predictive of success.

MATERIALS A N D M E T H O D S Medical records of all patients w h o completed at least one session of biofeedback therapy for the treatment of rectal pain between February 1989 and August 1995 were retrospectively reviewed. All patients had been referred by either staff colorectal surgeons or gastroenterologists, and all had had organic disease excluded by physical examination and by barium enema, anoscopy, flexible sigmoidoscopy or colonoscopy, and other radiologic investigations as clinically indicated. In addition, anorectal physiologic investigations included anorectal manometry with elicitation of the rectoanal inhibitory reflex, cinedefecography, pudendal nerve terminal motor latency assessment, external anal sphincter electromyography, colonic transit study in patients with associated constipation, and, after 1990, endoanal ultrasonography. These tests were performed as previously described. 14-16 Standard normal values for the various parameters measured are shown in Table 1.17 Paradoxical contraction of the puborectalis is defined as a paradoxical increase in puborectalis muscular activity during needle EMG or the inability to achieve prompt and complete evacuation of the barium paste during cinedefecography, with lack of a measurable increase in the anorectal angle between rest and attempted evacuation. 18 Biofeedback training was performed in sessions that lasted one hour and

Table 1.

Normal Values for Anorectal Physiology Tests (Cleveland Clinic Florida) Mean resting pressure Mean squeeze pressure High-pressure zone length (cm) Female Male Sensory threshold Maximum capacity Rectoanal inhibitory reflex Pudendal nerve terminal motor latency Perineal descent (cm) Fixed Dynamic

40-70 mmHg 1.5-2.5 times mean resting pressure 2.0-3,0 2.5-3.5 10-30 ml 100-300 ml Present <2.2 ms

<3 <3

191

were conducted by a certified biofeedback therapist. Electrical activity of the external anal sphincter and puborectalis muscles was detected using a 12-mm diameter, 45-mm long PerryMeterTM anal EMG sensor EPS-21 (PerryMeter Systems, Stratford, PA). This probe was connected to an Orion 8600 (Self Regulation Systems, Redmond, WA) computer on which the tracing was displayed for biofeedback. Training patients to sense the activity of their pelvic musculature began with a detailed explanation of the anatomy and physiology of evacuation. EMG-based biofeedback was then used to enable the patient to discriminate among three events--rest, squeeze, and push. After insertion of the anal sensor, patients dressed and sessions were conducted with patients seated on a standard chair. Patients were taught squeeze-relax (Kegel) exercises, which they were encouraged to practice at home. In addition to the tenserelax strategy, patients were asked to push slightly as ff to evacuate, but with much less pressure. This exercise capitalizes on the body's natural reflex of pelvic floor relaxation with pushing. Along with EMGbased biofeedback, the therapist attempted to shift the patient's focus away from a preoccupation with pain and bowel habits. Stress management techniques such as diaphragmatic breathing and Jacobson's progressive muscle relaxation technique with biofeedback 19 and cognitive-behavioral psychotherapy techniques were used. All patients were encouraged to perform daily physical exercise. These abovelisted techniques and instructions were directed to all patients. In addition, advice on adoption of proper posture for defecation and reducing d e p e n d e n c e on laxatives, suppositories, enemas, and digitation was presented during these sessions to those with concomitant constipation. Assessments of patients' responses to biofeedback therapy were based mainly on the patients' subjective impressions of their symptoms, supplemented by the use of a linear analog scale. Outcome was divided into three subjective categories--complete resolution, partial improvement, and no improvement. Patients continued to be scheduled for biofeedback sessions until they experienced complete or partial resolution of their symptoms or, alternatively, until no further improvement was apparent after ten sessions. In addition, a number of patients discharged themselves. Statistical analysis by Fisher's exact test was performed using InStat T M V2.02 software (GraphPad Software, San Diego, CA), with statistical significance being attached to any P < 0.05.

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GILLILAND E T A L RESULTS

Eighty-six patients attended at least one session of biofeedback for rectal pain, including 30 (34.9 percent) w h o had concomitant constipation. There were 55 female patients w h o had a median age of 71 (12-96) years, and 31 male patients w h o had a median age of 64 (19-82) years. Median duration of symptoms was three years (3 months-lifelong). Nine patients, all of w h o m had concomitant constipation, gave a lifelong history. Fifty seven (66.3 percent) patients had had a previous operation, of which hemorrhoidectomy and hysterectomy were the most c o m m o n reasons (Table 2). Twenty-seven patients (31.4 percent) had undergone two or more prior procedures. Thirty-two patients (37.2 percent) attributed the start of their symptoms to a particular precipitating event. A surgical procedure was the most frequently cited event (Table 3). Thirteen patients attributed their symptoms to stress, of w h o m three patients identified a specific stressor (bereavement (1), motor vehicle accident (1), and stopping smoking (1). Two patients attributed the c o m m e n c e m e n t of their symptoms to a direct perineal injury. Nine patients had previously had treatment for rectal pain (electrogalvanic stimulation (8), steroid Table 2. Previous Surgical Procedures in Patients with Rectal Pain* Hemorrhoidectomy 21 Hysterectomy 19 Cholecystectomy 8 Appendectomy 6 Anal dilation 6 Laminectomy 5 Segmental colectomy 5 Transurethral resection of prostate 4 Ovarian cystectomy 4 Coccygectomy 3 Total abdominal colectomy 2 Vagotomy 2 Gastrectomy 2 Sphincterotomy 2 Fissurectomy 2 Rectocoele repair 2 Bladder repair 2 Delorme's 1 Sphincter repair 1 Rectopexy 1 Nephrectomy 1 Open prostatectomy 1 Total hip replacement 1 Enterocoele repair 1 * Patients may have had more than one procedure.

Dis Colon Rectum, February 1997

Table 3. Surgical Procedures Credited with Precipitating Rectal Pain Hemorrhoidectomy Hysterectomy Laminectomy Total abdominal colectomy Cholecystectomy Gastrectomy Sphincterotomy Fissurectomy Rectocele repair Total hip replacement Transurethral resection of prostate

3 3 3 1 1 1 1 1 1 1 1

caudal block (1)), of w h o m six had had some relief for a limited time. Majority (82.6 percent) of patients discharged themselves before completion of treatment protocol to the satisfaction of the therapist. Eleven patients attended for only one session and were excluded from further analysis. The remaining 75 patients were divided between those who had rectal pain alone (n = 47; 62.7 percent) and those with concomitant constipation (n = 28; 37.3 percent). There were significant differences between these groups with regard to their bowel habits. Patients w h o complained of rectal pain alone had a median of six (0-14) spontaneous bowel movements per week, with only 23.4 percent of patients having no spontaneous bowel movements. Patients with constipation in conjunction with rectal pain had a median of zero spontaneous bowel movements per week, with 82.1 percent of patients having no spontaneous bowel movements ( P < 0.0001). Majority (72.3 percent) of patients with rectal pain did not use cathartics (median, never; range, never-daily), whereas most (89.3 percent) patients with concomitant constipation required cathartics (median, 3 days/ week; range, never-daily; P < 0.0001). Outcome was not significantly different between the two groups, with improvement noted in 17 (36.2 percent) patients with rectal pain alone (complete resolution (4), partial improvement (13)) and in 9 (32.1 percent) patients with concomitant constipation (complete resolution (6), partial improvement (3); P = 0.81). No morbidity or pain was associated with biofeedback therapy in any patient. In neither group was improvement significantly related to patients' ages (rectal pain: --<65 years, 28.6 percent; >65 years, 42.3 percent; P = 0.38; rectal pain and constipation: -<65 years, 36.4 percent; >65 years, 29.4 percent; P = 1), duration of their symptoms

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BIOFEEDBACK FOR RECTALPAIN

(rectal pain. --<5 years, 33.3 percent; > 5 years, 50 percent; P = 0.46; rectal pain and constipation: -<5 years, 27.3 percent; > 5 years, 37.5 percent; P = 0.69), or a prior history of surgery (rectal pain with prior surgery, 14.9 percent; no surgery, 21.3 percent; P = 0.24; rectal pain and constipation with prior surgery, 17.9 percent; without surgery, 14.3 percent; P = 0.41). Similarly, gender did not influence the outcome of patients with rectal pain and concomitant constipation (male, 16.7 percent; female, 36.4 percent; P = 0.63); however, male patients with isolated rectal pain had a higher rate of improvement than did their female counterparts (male, 52.2 percent; female, 20.8 percent; P - - 0.04). Although success of treatment was not related to the number of sessions attended (Table 4), improvement was significantly higher in individuals w h o completed the treatment schedule compared with those w h o discharged themselves. Thirty-nine patients with rectal pain alone discharged themselves following a median of 5 sessions (range, 2-18), and seven were discharged by the therapist after a median of 11 sessions (range, 6-17). Improvement was obtained by 85.7 percent of those who completed the protocol compared with 28.2 percent w h o prematurely discontinued treatment ( P < 0.01). Similarly, in those individuals with associated constipation, improvement was obtained by 62.5 percent of patients w h o persisted with treatment (median, 10 sessions; range, 5-15) compared with only 15.8 percent w h o discharged themselves (median, 5 sessions; range, 2-17; P < 0.05). There was no correlation between any manometric parameter and outcome of biofeedback for patients with combined rectal pain and constipation. How-

Table 4. Outcome Compared with Number of Sessions Attended Rectal Pain No, of Sessions

2-4 5-7 >7

Rectal Pain with Associated Constipation

Improved

Failed

Improved

Failed

6 5 6

13 13 4

4 2 3

5 8 6

Rectal pain 2 - 4 sessions vs. > 4 sessions, P Rectal pain 2-7 sessions vs. > 7 sessions, P Rectal pain with associated constipation 2-4 vs. > 4 sessions, P = 0.41. Rectal pain with associated constipation 2-7 vs. > 7 sessions, P = 1.00.

= 0.76. = 0.14. sessions sessions

193

ever, patients with isolated rectal pain w h o had a low mean or maximum squeeze pressure did significantly worse than patients in w h o m these parameters were within normal limits (Table 5). In neither group was outcome related to paradoxical puborectalis contraction as demonstrated by needle EMG or cinedefecography. Furthermore, neither prolongation of pudendal nerve terminal motor latencies nor an increase in the extent of fixed or dynamic perineal descent influenced the outcome in either group of patients (Table 6). Insufficient patients with significant intussusception (n = 4) or rectocele (n = 6) were available to make statistical analysis meaningful. Nineteen patients (rectal pain (14); rectal pain and constipation (5)) were referred for further treatment including electrogalvanic stimulation (n = 10), steroid caudal block (n = 3), injection of Clostridium botul i n u m neurotoxin (n = 2), further biofeedback (n = 2), and stress management (n = 1). In addition, four patients underwent surgery in other institutions (hemorrhoidectomy (1), anterior resection (1), coccygectomy (1), colostomy (1)). The specific surgical indications are unknown, although rectal pain was the chief clinical complaint of each of the four patients.

DISCUSSION Biofeedback is a process w h e r e b y information on patients' bodily functions are displayed to individuals so they may alter their responses to alleviate symptoms. These techniques have been used in the treatment of a number of conditions including irritable bowel syndrome, 2~ tension headache, 2a and hypertension. = Considerable experience has been gained in treating disorders of the pelvic floor, including fecal incontinence 23-25 and obstructed defecation, 18, 26-32 but there is little k n o w n about the use of this modality in the treatment of chronic intractable rectal pain. Mechanism of action of biofeedback in the treatment of rectal pain remains obscure. In patients with a functional disturbance such as paradoxical puborectalis contraction or anal hypertonia, Kegel exercises may improve symptoms by inducing muscle fatigue and, thereby, interrupting the spastic cycle in much the same way as electrogalvanic stimulationY Alternatively, biofeedback makes pelvic floor relaxation apparent to the patients and allows their perception of this relaxation to improve. With training, patients are able to reproduce this relaxation. In individuals with no demonstrable physiologic disorder, this ratio-

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GILLILAND ET AL

Dis Colon Rectum, February 1997

Table 5. Outcome Compared with Manometric Parameters

Rectal Pain with Associated Constipation

Rectal Pain Improved

Failed

P

Improved

Failed

P

2 8

6 15

1.0

6 3

12 3

0.63

1 9

14 7

<0.01

8 1

9 6

0.19

7 3

5 16

<0.05

1 8

3 12

0.62

7 3

14 7

1.0

7 2

8 7

0.39

1 8

6 15

0.39

4 5

7 8

1.0

2 8

8 14

0.44

4 5

7 8

1.0

Mean resting pressure >70 -<70 Mean squeeze pressure Low Normal Maximum squeeze pressure (mmHg) >120 -<120 High-pressure zone length (cm) <4 ->4 Sensory threshold (ml) >30 -<30 Maximum capacity (ml) > 150 -<150

Table 6. Outcome Compared with Neurophysiologic and Cinedefecographic Parameters

Rectal Pain with Associated Constipation

Rectal Pain

Pudendal nerve terminal motor latencies (ms) <2.2 ->2.2 Needle electromyography Normal Paradox Cinedefecography Normal Paradox Perineal descent Normal Increased

Improved

Failed

P

Improved

Failed

P

5 4

17 6

0.41

3 5

8 6

0.66

4 5

15 7

0.25

7 2

9 6

0.66

5 5

8 14

0.70

4 3

3 14

0.13

5 5

8 14

0.70

0 7

7 9

0.06

nale is less convincing. In these patients, the beneficial effect obtained may be attributable to a psychotherapeutic effect, either as a placebo or by an undetermined mechanism. The success rate of biofeedback experienced by our patients was low compared with success rates quoted for other modalities. Several factors may account for this finding. First, some investigators w h o report high success rates with electrogalvanic stimulation used this modality as a primary treatment, 5' 11 whereas all patients in our study had failed to im-

prove with conservative methods before commencing biofeedback. Furthermore, population demographics are not well defined in several of these studies. Two tertiary referral centers have reported that electrogalvanic stimulation has produced some improvement in only 40 percent of patients, 34' 35 with only 19 percent having complete resolution. Furthermore, although biofeedback had no associated morbidity, almost 25 percent of patients reported discomfort from electrogalvanic stimulation. Second, the geographic position of our facility and the high proportion of tertiary

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BIOFEEDBACK FOR RECTAL PAIN

referrals meant that our treatment population was older and had suffered from their s y m p t o m s for considerably longer than patients in other series. Third, w e have s h o w n in a previous study that m a n y of the patients in our population w h o suffer from rectal pain have increased levels of somatization as determined by the Minnesota Multiphasic Personality Inventory assessment, 36 making this a difficult patient group to treat. Indeed, the success rate of other modalities including electrogalvanic stimulation and steroid caudal block in our population is less than 30 percent, similar to rates reported from other tertiary referral centers.34, 35 These observations m a y explain the low success rate seen with biofeedback, which remains the most effective modality in our patients. Physiologic testing was of n o benefit in identifying those patients w h o would benefit from biofeedback treatment. Furthermore, w e have previously d e m o n strated the lack of usefulness of physiologic testing in identifying the cause of rectal pain. 9 Both of these findings suggest that physiologic testing should be a b a n d o n e d in the routine assessment of patients with rectal pain. However, in practice it b e c o m e s impossible to implement this advice. Despite the fact that w e have previously demonstrated the futility of anorectal physiologic testing in patients with rectal pain, patients continue to be referred to our center and others for such testing. The reason for this perpetuation is frustration on the part of both the referring physician and the patient. As with other chronic pain disorders, m a n y patients are willing to try the test, despite a very low probability of success, each patient hoping to be the one in w h o m testing reveals a previously undiagnosed, treatable problem. The high attrition rate during therapy is perhaps attestation to the abnormal psychologic functioning found in m a n y of these patients and their frustration in not having found a specific, treatable entity.

CONCLUSIONS Biofeedback resulted in some alleviation of symptoms in only 34.7 percent of patients overall. H o w ever, 73.3 percent of patients w h o finished the prescribed treatment course improved. Thus, patients' willingness to comply with treatment protocols was the most significant predictor of success. More than 70 percent of those patients willing to s p e n d time to alleviate their s y m p t o m s improved, this success being achieved without any associated morbidity. The possibility that this small cohort of patients m a y be a

195

self-selected group w h o s e s y m p t o m s would resolve with any treatment modality cannot be ignored. This highlights the n e e d for a prospective, randomized trial of the three major modalities that m a y help resolve this conjecture.

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