CHICAGO (EGMN)–Results of a second randomized trial confirm that significantly more women with interstitial cystitis respond to myofascial physical therapy than traditional massage therapy.

Among 81 women with interstitial cystitis and moderate to severe pain or urgency, global response assessment (GRA) rates at 12 weeks were 59% with myofascial physical therapy versus 26% with global massage therapy consisting of full-body Western massage.

This is the second positive randomized controlled trial for a disorder in desperate need of new treatment options, Rhonda Kotarinos, a physical therapist in Oakbrook Terrace, Illinois, said at the annual meeting of the International Pelvic Pain Society.

There is no cure for interstitial cystitis (IC), also referred to as painful bladder syndrome. Treatments include eliminating dietary triggers and reproductive organ triggers, anesthetic instillations, physical therapy, and use of pain medications such as opioids, nonsteroidal anti-inflammatory agents, and tricyclic antidepressants.

The prevalence of IC also varies greatly. A widely cited study reports that 1.1% of 1,218 women presenting for a routine primary care office visit had IC based on the O’Leary-Sant Interstitial Cystitis Symptom and Problem Index, while 12.6% had IC based on responses to the PUF (Pelvic Pain and Urgency/Frequency Patient Symptom Scale) questionnaire. The authors concluded that “the true prevalence of IC in women may be somewhere between these two extremes,” (J. Urol. 2005;174:2231-4).

The feasibility of myofascial physical therapy (MPT) was evaluated by the same group of researchers in a pilot trial involving 44 men and women with urologic chronic pelvic pain syndrome, including IC. As in the current study, MPT consisted of connective tissue manipulation to all body wall tissues in the abdominal wall, thighs, back, and buttocks that clinically were found to contain connective tissue abnormalities or painful myofascial trigger points. Myofascial manipulation focused on trigger points and restrictive bands.

Patients also were assigned to 10 1-hour sessions of MPT or global massage therapy (GMT), and asked to rate their overall symptoms using the 7-point global response assessment (GRA), with 1 being “markedly worse” and 7 being “markedly improved.”

GRA rates were significantly higher at 57% with MPT vs. 21% with massage therapy (J. Urol. 2009;182:570-80). Subgroup analyses revealed a striking difference in the response to standard massage therapy between the all-male patients with chronic pelvic pain syndrome (CPPS) and women with IC (40% vs. 7%), suggesting that patients with CPPS or men respond differently to massage therapy.

The pilot study was the first and only positive trial in 10 years of research in urologic CPPS funded by the U.S. National Institute of Diabetes and Digestive and Kidney Diseases, Ms. Kotarinos said.

The current trial was conducted at 11 centers in the United States and Canada, and included 81 women with IC for less than 3 years who had moderate to severe pelvic pain (95%) or moderate to severe urgency (93%). Their mean age was 43 years; 84% were white, 5% were black, and ethnicity for the remaining 11% was not provided.

The secondary end points did not confirm the primary results, Ms. Kotarinos said. The MPT arm had greater mean changes in symptom scores than did the GMT arm on the Interstitial Cystitis Symptom Index (-3.2 vs. -2.2), Interstitial Cystitis Problem Index (-3.6 vs. -2.4), Likert Pain scale (-2.2 vs. -1.5), and Likert Urge Scale (-2.1 vs. -1.4), but the differences did not reach statistical significance.

In all, 85% of patients in both arms completed therapy, which was well tolerated, she said. This is important as myofascial PT can be painful or seen as unduly invasive. Adverse events of any kind were reported in 64% of the MPT group and 60% of the GMT group, and serious adverse events in 15% vs. 14%, respectively. Serious adverse events among MPT patients included four cases of pain and one case each of dehydration, vomiting, and other genitourinary symptoms.

Ms. Kotarinos pointed out that the study included a small group of highly select patients, and that blinding was ineffective, as nearly all patients correctly guessed their treatment arm.

She suggests that future research is warranted to investigate the lack of response in secondary outcomes and to define the role of MPT in the broader IC population, the optimal patient selection criteria, and optimal treatment parameters.

The study was funded by the U.S. National Institute of Diabetes and Digestive and Kidney Diseases. Ms. Kotarinos disclosed no conflicts of interest.

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芝加哥(EGMN)­——两项随机对照试验的结果证实，对于间质性膀胱炎(IC)女性患者，采用肌筋膜物理治疗的有效率显著高于传统按摩治疗。

首项研究在美国和加拿大的11家医学中心进行，共纳入81例罹患IC时间＜3年的女性患者，患者普遍存在中、重度的骨盆疼痛(95%)或尿急(93%)。患者平均年龄为43岁，其中84%是白种人，5%是黑种人，余下11%患者的种族组成不详。患者被安排随机接受肌筋膜物理治疗(MPT)或全身按摩治疗(GMT，以全身西式按摩为主)，MPT治疗的定义是对全身各处体壁组织进行结缔组织推拿，具体部位包括腹壁、大腿、背部和臀部，其治疗重点是存在结缔组织异常(如限制性结节)或肌筋膜激痛点的部位。研究的主要终点是治疗总有效率(GRA)评分，次要终点是由4种量表评分组成的联合终点。