Low Back Pain
Conditions
Interventions
Patients in celecoxib group are administrated celecoxib 100 mg twice per day for 12 weeks
Patients in loxoprofen group are administrated loxoprofen 60 mg three times per day for 12 weeks
Sponsors
Department of Orthopaedic Surgery, Showa University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Inpatient/outpatient status: Both 2) Disease, severity: Patients diagnosed as a low back pain by the investigators, the main site of low back pain locating lower than the twelfth dorsal vertebra, nd pain assessment of >40 mm (using the VAS) by the patients 3) Duration of disease: The current low back pain persisting for at least 3 months 4) Duration of treatment: Any 5) Sleep disorder: PSQI score >6 6) Patients for whom written Informed Consent has been obtained from the patient personally in this study prior to study initiation.
Exclusion criteria
Exclusion criteria: 1) Patients with low back pain associated with neurogenic or neurological signs and symptoms and evident neurogenic symptoms in the area from the buttocks to legs. 2) Patients for whom NSAID therapy is determined to be not suitable by the investigators due to a history of psychiatric disorder, such as depression, or uncontrollable chronic disease. 3) Patients who are scheduled to receive surgical therapy during the study period. 4) Patients who underwent surgery for the treatment of low back pain during the past 6 months. 5) Patients with a history of rheumatoid arthritis, seronegative spondyloarthropathy,metastasis of tumor, etc., Paget's disease, fibromyalgia, spinal or intervertebral disc tumor or infection, or other disease causing generalized pain. 6) Patients with low back pain caused by trauma within 6 months before study enrollment. 7) Patients with low back pain attributable to visceral disease. 8) Patients who received adrenocortical hormone by oral,intramuscular,epidural or perineural administration within 4 weeks before the treatment initiation. 9) Patients with a history of hypersensitivity to the ingredients of celecoxib, sulfonamide or loxoprofen sodium. 10) Patients with a current or past history of aspirin-induced asthma. 11) Patients with peptic and/or gastroduodental ulcers less than 90 days before randomization. 12) Patients with serious liver disorder, renal impairment or cardiac dysfunction. 13) Patients in the perioperative period of coronary artery bypass revascularization. 14) Women at the end of pregnancy. 15) Patients with diseases that strongly affect sleep such as depression, schizophrenia, bipolar disorder, Parkinson's disease, sleep apnoea syndrome,restless legs syndrome, urological diseases with nocturia,and skin diseases with itching. 16) Patients who participated in other clinical studies within the last 3 months. 17) Other patients considered unsuited for the study by their doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation on the improvement effect on the quality of sleep using the Pittsburgh Sleep Quality Index(PSQI) after 12-week study treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Evaluation on the long-acting effect of the pain relief using the Visual Analog scale (VAS) 2) Evaluation on the effect of the pain relief using VAS 3) Improvement effect on low back pain-specific QOL using the Roland-Morris Disability Questionnaire (RDQ) 4) Evaluation on overall improvement 5) Evaluation on intention for treatment continuation (questionnaire to patients) 6) Evaluation on the incidence of gastrointestinal adverse drug reactions (questionnaire to patients) 7) Evaluation of sleep quality using sleep electroencephalogram as a parameter 8) Evaluation on the improvement effect on the quality of sleep using the PSQI. (day 28 and day 56 after treatment) 9) Evaluation on the improvement effect on the quality of sleep using the Medical Outcomes Study Sleep Scale (MOS-SS) 10) The % of Patients Requesting Rescue Medication. 11) The % of patient with PSQI score more than 6 point | — |
Countries
Japan
Outcome results
None listed