22 Japanese Journal of Comprehensive Rehabilitation Science (2013) Original Article The effectiveness of patches containing Loxoprofen Sodium Hydrate (LX-P) in the conservative therapy of muscular back pain – Clinical results using the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) Toyoko Asami, MD, PhD,1 Naoya Yamanouchi, MD,1 Akihiko Asami, MD, PhD,2 Hisato Tanaka, MD,3 PhD, Norihiko Nogami, MD, PhD4 1Department of Rehabilitation Medicine, Saga University Hospital, Saga, Japan. 2Saga Social Insurance Hospital, Saga, Japan. 3Tanaka Hospital (Anju Medical Corporation), Saga, Japan. 4Wakakusu Ryoikuen, Tosu, Saga, Japan. ABSTRACT life disability. The rate of effectiveness of LX-P against Asami T, Yamanouchi N, Asami A, Tanaka H, Nogami pain-related disabilities in the fourth week was 62.2%. N. The effectiveness of patches containing Loxoprofen Conclusion: LX-P showed satisfactory analgesic Sodium Hydrate (LX-P) in the conservative therapy of effect and QOL improvement. We believe it is effective muscular back pain - Clinical results using the Japanese for clinical practice. Orthopaedic Association Back Pain Evaluation Keywords: loxoprofen sodium, JOABPEQ, VAS, Questionnaire (JOABPEQ). Jpn J Compr Rehabil Sci QOL, muscular back pain 2013; 4: 22-29. Objectives: We investigated the analgesic effect, Introduction degree of patient satisfaction, and QOL improvement provided by patches containing loxoprofen sodium According to the Ministry of Health, Labour and hydrate (LX-P) using a questionnaire based on the Welfare’s Comprehensive Survey of Living Conditions evaluation criteria of the Japanese Orthopaedic (several surveys conducted in fiscal 2004, 2007, 2010), Association Back Pain Evaluation Questionnaire pain in the locomotive organs, including “lower back (JOABPEQ). pain,” “stiff shoulders,” and “joint pain,” is one of the Methods: In this study of 53 patients (18 men, 35 most common subjective symptoms reported. These women) with muscular back pain, LX-P 100mg was surveys also revealed that approximately 30% of those applied once per day for four weeks. Patients provided with Certification of Needed Long-Term Care (under subjective feedback by answering a questionnaire. the Japanese health insurance system) report the Results: After one week of LX-P application, Visual reason they require nursing care as “joint pain” or Analogue Scale (VAS) scores were significantly lower “bone fracture/falling down” [1-3]. In addition, since and in the fourth week over 50% of the patients who health care and nursing care costs are rising every had switched from other NSAIDs reported improved year, medical professionals now need to create satisfaction over the drug previously used. The treatment evaluation standards that are convincing to JOABPEQ Severity of Illness Index (for all patients) third parties and provide medical care that is based on was significantly higher after one week for pain- scientific grounds and these standards. related disability and lower back functional disorder, In the past the Japan Orthopaedic Association’s and was significantly higher after two weeks for daily lower back pain treatment evaluation score (JOA score) was commonly used in Japan. However, the Correspondence: Toyoko Asami, MD, PhD JOA score had several problems, including the fact Department of Rehabilitation Medicine, Saga University that, compared to international evaluation criteria, it Hospital, 5-1-1 Nabeshima, Saga City, Saga 849-8501, did not include patient assessments regarding pain, Japan numbness, and general health condition, and the E-mail: [email protected] validity of the evaluation categories as well as the Accepted: March 14, 2013 points assigned to each were never verified. Thus, the This study was conducted without any conflict of interest Japan Orthopaedic Association Back Pain Evaluation and received no research funding. Jpn J Compr Rehabil Sci Vol 4, 2013 CW6_A3342D02.indd 22 2013/04/08 9:11:23 Asami T et al.: The effectiveness of topical adhesive agents with Non-Steroidal Anti-inflammatory Drugs (NSAIDs) as evaluated using JOABPEQ 23 Questionnaire (JOABPEQ) was released in 2007 as a 2. Those with a history of sensitivity to any of the method of evaluation specific to patients suffering ingredients of LX-P from lower back pain. 3. Those who were pregnant, nursing, may have been JOABPEQ is a new, patient-based evaluation pregnant, or those trying to get pregnant during the criterion that overcomes the problems associated with testing period the JOA score. It includes in its evaluation categories 4. Those with a history of drug sensitivity to loxoprofen pain, bodily functions, activities, and psychosocial 5. Those from whom written consent could not be elements and is considered an effective criterion obtained whose reliability and validity have been verified. 6. Those determined by their attending physicians as In general, muscular back pain is managed through unsuitable for this study for any other reason the use of non-steroidal anti-inflammatory drugs (NSAIDs), but in many cases long-term treatment is 2. Methods necessary and transdermal patches, which are less The study was conducted after providing the likely to cause gastrointestinal problems than oral subjects with a detailed explanation of the outline of drugs, are commonly used. Loxoprofen sodium the study and obtaining their consent to participate in hydrate (LX) is known to have strong anti- the study of their own free will. inflammatory, analgesic, and antipyretic effects when In principle, the subjects were administered LX-P administered orally, and studies have shown that PAP 100mg (one application per day) for a period of four (hydrogel patch) containing loxoprofen (LX-A) has weeks. The subjects were asked to fill in questionnaires the same degree of efficacy and safety as oral drugs before the first administration and again in the first, [4-6]. In addition, patches containing loxoprofen (LX- second, and fourth weeks. We did not have any P) have been approved on the basis that they have particular standard regarding their use of other been confirmed to be the bioequivalent of LX-A and NSAIDs prior to the first administration of LX-P. have been shown in animal experiments to have During the study period, we prohibited the subjects excellent anti-inflammatory and analgesic actions [7]. from using other NSAIDs or beginning any new type In this study of patients with muscular back pain, of physiotherapy. However, we allowed them to we investigated the analgesic effect and degree of continue using steroids, muscle relaxants, and other satisfaction, and assessed QOL using a questionnaire analgesics and anti-inflammatory drugs that they had that incorporated JOABPEQ evaluation categories. been using before the start of the study. We also surveyed (using patient questionnaires) and investigated the clinical effectiveness of LX-P. 3. Evaluation We evaluated the effect on QOL and the analgesic Methods effect using the JOABPEQ Severity of Illness Score (five categories: pain-related disability, functional 1. Subjects disorder of the lumbar vertebrae, walking disorder, The subjects were inpatients and outpatients treated daily life disability, psychological disability) based on between August 2008 and March 2012 at Saga the length of time LX-P was affixed to the skin and the University Hospital and related facilities within Saga administration of LX-P (Table. 1). We also assessed Prefecture who were 20 years of age or older, suffered the degree of satisfaction reported by patients who from muscular back pain, and were prescribed LX-P. were switched from another NSAID tape. The length Those who met any of the exclusion criteria listed of time LX-P was affixed, the analgesic effect, the below were not included. The back pain suffered by subjects’ degree of satisfaction, and the improvement the subjects in this study was myofascial low back in QOL were assessed using the criteria below. pain, commonly referred to as “lower back pain.” Statistical processing was done using the paired t-test Back pain is defined in the 10th edition of the and the Wilcoxon signed-rank test, and statistical International Statistical Classification of Diseases and significance was set atp <0.05. Related Health Problems (ICD-10), published by the 1) Length of time LX-P was affixed World Health Organization (WHO), as pain anywhere The average length of time (score) LX-P was affixed from the back to the lumbar region. It is diagnosed was calculated for the first, second, and fourth weeks. when the patient presents spontaneous pain, kinesalgia, The length of time corresponding to this average score and pain on palpation in the back or lumbar region was set as the length of time LX-P was affixed. when not accompanied by neurologic manifestations 2) Analgesic effect and when the cause cannot be attributed to any clearly The analgesic effect was assessed by observing definable organic injury. changes in the Visual Analogue Scale (VAS) score. 3) Degree of satisfaction Exclusion Criteria The degree of satisfaction with having switched to 1. Those suffering from bronchial asthma (due to the LX-P was assessed using a 5-step assessment scale risk that their condition may worsen) (large improvement, slight improvement, not sure, not Jpn J Compr Rehabil Sci Vol 4, 2013 CW6_A3342D02.indd 23 2013/04/08 9:11:23 24 Asami T et al.: The effectiveness of topical adhesive agents with Non-Steroidal Anti-inflammatory Drugs (NSAIDs) as evaluated using JOABPEQ Table 1. JOABPEQ evaluation.