The effect of NSAIDs on sleep quality in chronic low back pain patients with sleep disorder (A randomized, open-label, parallel-group comparison study)

Not Applicable

• Conditions: ow Back Pain

• Registration Number: JPRN-UMIN000009333
• Lead Sponsor: Department of Orthopaedic Surgery, Showa University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified