Distension of painful structures in the treatment for chronic pelvic pain in women

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1 Acta Obstetricia et Gynecologica. 2006; 85: 599 /603 ORIGINAL ARTICLE Distension of painful structures in the treatment for chronic pelvic pain in women J. HEYMAN 1,J. ÖHRVIK 2 & J. LEPPERT 2 1 Primary Health Care Centre, Kolbäck, and 2 Centre for Clinical Research, Uppsala University, Central Hospital, Västerås, Sweden Abstract Background. There is a lack of established treatment for chronic pelvic pain (CPP), defined as acyclic pain of at least six months duration. We decided to study the pain-alleviating effects of stretching on defined structures in women with CPP and the treatment s impact on quality of life variables. Design of study. An open, randomized study. Setting. Primary Health Care Centre, Kolbäck, Sweden. Methods. Fifty women, median age 33 years (range 19 /54), complaining of CPP for a median duration of 25.5 months (range 6/264) were randomly assigned to either a treatment or a control group. A short questionnaire containing 17 questions was administered before randomization and two to three weeks after a second treatment of distension of pelvic structures. Visual analog scales were used for questions concerning intensity of pain and quality of life. Five-point scales were used for questions dealing with duration and frequency of pain. Results. Intensity, frequency and duration of pelvic pain, painful intercourse, lower back pain, sleep disturbance, sleep quality, mental fatigue, depression, mood and anger improved significantly more in the treatment group than in the control group. Treatment proved more effective than counseling as reflected by self-rating scales: pain intensity (OR 18.37, 95% CI 3.39/99.64) and pain during intercourse (OR 8.59, 95% CI 1.57 /46.68). Conclusion. In this open, randomized study, distension of painful pelvic structures in women with CPP resulted in significant relief of pain and improvement in quality of life measures. Key words: Chronic pelvic pain, randomized study, quality of life, women, manual therapy Introduction Chronic pelvic pain (CPP) in women is defined as acyclic pain of at least a six-month duration (1/5). The pain in CPP is typically dull, with diffuse aching throughout the lower abdomen or localized either uni- or bilaterally at the iliac fossa. The pain often increases pre- and paramenstrually. Upon rectal palpation, the findings in CPP consist of tenderness of the following structures: the musculature of the pelvic floor and possibly the coccygeal vertebrae and/ or the sacrotuberous/spinal ligaments. No clear underlying cause of CPP has been demonstrated; however, the etiology is considered multifactorial (1/6). Numerous methods of treatment have been proposed, including hormonal therapy (7), surgical intervention (8), psychotherapy (9), multidisciplinary management (4/6,10,11), and manual therapy (12/16). In a recent Cochrane review, nine randomized studies were identified. Only five of those where of good methodological standard (17). Two non-randomized studies have shown alleviation of pain in such conditions as coccygodynia and levator syndrome after dorsal stretching of pelvic floor structures (12,13). In order to evaluate the effects of dorsal stretching of defined pelvic structures in women with CPP in relation to pain and quality of life variables, we performed an open, randomized study. Methods Participants Fifty women with CPP, after standard examination by a gynecologist including ultrasound, were randomized to the treatment and the control group. Correspondence: Jerzy Leppert, Centre for Clinical Research, Uppsala University, Central Hospital, Västerås, Sweden. jerzy.leppert@ltv.se (Received 27 May 2005; accepted 18 November 2005) ISSN print/issn online # 2006 Taylor & Francis DOI: /

2 600 J. Heyman et al. Two women in the treatment group were withdrawn after the first treatment because they suffered from generalized pain, i.e. fibromyalgia. An additional woman in the treatment group was excluded because of pregnancy. Two women in the control group reported disappointment at not receiving treatment right away as the reason for withdrawal. The third woman moved to an unknown location. Background characteristics are presented in Table I. Inclusion criteria The main criterion was pelvic pain in fertile women /19 years of age with a duration of at least six months, with continuous or intermittent pain at least two days a week as a rule. Moreover, the patient should experience pain from approximately 5 s of firm, moderately hard pressure against the musculature of the pelvic floor and, in addition, possibly against the coccyx and sacrotuberous/spinal ligaments, unilaterally or bilaterally. Examination for this purpose was carried out either vaginally or rectally. Exclusion criteria Exclusion criteria included known diseases of abdomen, pelvis, or lumbar spine (e.g. inflammatory bowel disease, severe endometriosis, severe back pain, and abdominal tumor). Further reasons for exclusion included pregnancy, sexually transmitted disease, severe mental illness or substance abuse and previous treatment with distension for painful structures in the pelvic floor. Study procedures The physician (JH) repeated examination of the pelvic floor. The participants were given verbal and Table I. Basal characteristics of the study groups n/25 Median (range) n/25 Median (range) 31 (19/54) 36 (20/51) Age (years) 36 (6/264) 21 (6/156) Duration of CPP (months) Number (%) Number (%) CPP due to parturition 9 (36) 8 (32) and/or pregnancy CPP due to accident 3 (12) 0 Regular intercourse 16 (64) 20 (80) Satisfied with their sex life 15 (60) 15 (60) Reported sexual abuse 0 2 (8) written information. Randomization, by drawing an envelope, to either treatment or control group was performed in blocks of four, i.e. the number of patients in each group was balanced after each fourth patient (Figure 1). The participants in the treatment group underwent distension of the pelvic floor while the participants in the control group were given casual care (counseling). Every woman was given an explanation for the pain (i.e. tension in the pelvic floor). The human ethics committee at Uppsala University approved the study. The questionnaire consisted of: / dichotomous questions regarding background variables, / visual analog scale (VAS) to assess the pain severity and the quality of life, / a five-point scale (duration of pain episodes from never any pain to constant pain and frequency of pain episodes from never any pain to daily pain ). These variables were dichotomized into a few days or constant pain as yes, and a couple of days each week or daily as yes, respectively. / One question concerned duration of symptoms. The treatment was performed by the same physician according to the following procedure. The patient lay in a prone position and the physician placed his index finger deep in the patient s rectum and previously identified painful structures were treated as follows in the given order: At a point two fingerwidths lateral of the sacrum, the physician used his index finger to exert strong pressure against the sacrotuberous/spinal ligaments for 15 s to elicit pain. Thereafter, the musculature of the pelvic floor and the joint between the coccyx and sacrum were concurrently forcefully distended dorsally for 60 s using the index finger. This procedure was repeated after 2/3 weeks. Statistics The main efficacy variable, intensity of pelvic pain, was assessed using a VAS. The Wilcoxon Mann/Whitney rank sum test was used to test for possible differences between the treatment and control group. In order to detect a standardized difference in the relative change from baseline of size 1 between the treatment group and control with 80% power using a two-tailed test with a 5% significance level, approximately 20 patients in each group were needed. We therefore included 50 women (25 in each group) to compensate for eventual dropouts.

3 Treatment procedure for chronic pelvic pain in women 601 Women who fulfil the criteria for the CPP study Written + verbal information RANDOMISATION n = 50 3 dropouts n = 25 Treatment n = 25 Repeated treatment after 2-4 weeks Counselling, casual care 3 dropouts Follow-up after 2-3 weeks n = 22 Follow-up after 2-3 weeks Reduced pain Persistent pain Figure 1. Study procedure (flowchart). Randomization to the treatment and control group was performed in blocks of four. The Wilcoxon Mann /Whitney rank sum test and the Wilcoxon signed rank test were used for comparisons between and within treatment and control group, respectively, for all variables measured on a VAS. The variables measured on the VASs were also dichotomized, with a decrease from baseline of 13 mm or more being considered as an improvement (18). These dichotomized variables were analyzed using logistic regression with treatment serving as the independent factor. The results of these analyses are presented as odd ratios (OR) together with corresponding 95% confidence intervals. Finally, for questions with ordered alternatives, the Wilcoxon Mann /Whitney rank sum test was performed. Results After randomization, the duration of CPP was longer in the treatment group, while the control group had somewhat more pronounced pain during intercourse. Otherwise, the two groups were comparable (Table I and II). Comparisons within each group (Table II) The treatment group improved significantly on the following variables: intensity, frequency, and duration of pelvic pain, painful intercourse, lower back pain, sleep disturbance, sleep quality, mental fatigue, mood, depression, and anger. The treatment group did not become worse on any of the variables used in this study. In contrast, the control group did not improve in any variable, but became worse with respect to sleep disturbance and mental fatigue. Comparisons between the groups (Table II) Treatment was found to be significantly better than counseling as reflected by the self-rating scales: pain intensity (OR 18.37, 95% CI 3.39 /99.64), pain during intercourse (OR 8.59, 95% CI 1.57 /46.7); and almost significantly for lower back pain (OR 3.1, 95% CI 0.88 /11.04). When comparing the treatment and control group, the following variables were found to be significantly decreased in favor of the treatment group: pelvic pain (intensity, frequency, and duration), painful intercourse, sleep disturbance,

4 602 J. Heyman et al. Table II. Differences within and between control and treatment group, in studying variables measured before and after treatment using visual analogue scale (VAS). Figures in the table express following values 0 (no complaints) to 100 (worst complaints). Variable Before After p-value Difference Before After p-value Difference p -value Diff treatment/diff control Intensity of pelvic pain 649/22 299/ /31 719/17 719/ /0.89/ Painful intercourse 469/37 279/ /38 689/31 689/ /0.139/ Low back pain 599/37 389/ /39 529/31 579/ /59/ Sleep disturbance 349/32 289/ /21 419/31 539/ /119/ Quality of sleep 439/35 329/ /23 489/31 529/ /4.09/ Mental fatigue 429/28 319/ /27 369/31 519/ /15.29/ Depression 409/23 299/ /18 449/23 439/ / Mood 479/23 389/ /22 489/21 509/ /2.19/ Anger 409/27 309/ /23 369/29 429/ /5.99/ sleep quality, depression, mood, anger, and mental fatigue. Follow-up of the control group All women in the control group were offered treatment in connection with the follow-up. Despite unchanged pain, five of the women declined the treatment. These women reported that they were satisfied with having obtained an explanation for their problems. The other 17 women received treatment on one occasion. None of them wanted repeated treatment, and they were assessed four to six weeks later for a change in their pain status. Four women reported being pain-free, three were almost free of pain, four reported slight or moderate pain alleviation and two experienced no change in their pain status. Four women could not be reached for a new follow-up. Discussion The most important finding of this study was that distension of painful pelvic structures resulted in a significant improvement in pelvic pain (intensity, frequency, and duration), painful intercourse, sleep disturbance, sleep quality, mental fatigue, depression, mood, and anger. The control group, who did not receive the distension treatment but was otherwise managed in the same way, showed unchanged or worse results for all variables investigated. These results were obtained in women with protracted suffering and with marked detrimental effects in their quality of life. The differences were found both at the group and at the individual level. The improvements were of clinical and psychological importance. Treatment consisted of a simple and inexpensive procedure, performed twice within a 2/3-week period. The only observed side effect of the treatment was mild temporary increased local pain, which resulted in two dropouts. Previous studies show that both concurrent psychological and somatic problems are overrepresented in women with CPP as compared with healthy individuals: sleep disturbances, depressed mood, having been abused earlier in life, dyspareunia, pain in the sacrogluteal region, urethritis-like symptoms, and irritable bowel (1 /6,19). In this respect, patients with CPP do not differ substantially from patients with other chronic pain conditions (20). Some authors assert that CPP is caused only by psychological factors (21,22), while Savidge and Slade did not find scientific support for this idea (20). On the other hand, Johnson and Laube claim that psychological problems can be the result of pain (2). This is supported by Sternback and Timmermans, who found that patients reporting abnormal values on a standardized psychiatric measurement returned almost to normal values after their chronic pain disappeared (23). Some authors pointed out that making a diagnosis, an explanation for the pain, could be of great psychological significance to the patient (10,24). Other authors assert that endometriosis and pelvic adhesions are considered to be common somatic causes of CPP. Those findings have not been shown to be more common in CPP than in pain-free controls (5,25,26). Another common intervention for CPP is hysterectomy. Randomized studies showing positive effects of hysterectomy in CPP are lacking (5). Nevertheless, around 70,000 hysterectomies are performed yearly in the USA for the indication of CPP, and of these, it is calculated that 70 women die as a result of the operation (27).

5 Treatment procedure for chronic pelvic pain in women 603 In the Cochrane review authors found that significant pain reduction was observed only in therapy with progestogen, and with counseling supported by ultrasound. Furthermore, a multidisciplinary approach was beneficial for daily activity but not for pain, and adhesiolysis did not show any favorable effect (17). We identified several weaknesses in the study. The follow-up time was short, only four to six weeks after the first treatment. It should be noted, however, that the study was not initially designed with the intention to study long-term effects of the treatment. Still, in a pilot study we performed before this randomized study, very good pain relief in 28 of 32 women was reported five months after a single treatment. Another weakness in the present study is that the same physician carried out all procedures. On the other hand, an advantage with such an approach is that the treatment and control groups were treated in the same way. In order to increase study power, the treatment procedure should be blinded. Unfortunately, we couldn t find a way to blind the painful distension of pelvic structures. According to the ethic committee s decision, we had to inform the patients that the treatment procedure was painful. Conclusion Distension of painful pelvic structures in women with CPP resulted in a dramatic reduction in pain and a marked improvement in quality of life. In the control group, which received the same care and explanation of CPP, we did not observe any pain reduction or an enhancement in quality of life. This simple and inexpensive treatment procedure may be introduced to gynecologists and general practitioners with the aim of reducing pain and improving quality of life in women with CPP. 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