UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009333
Receipt number R000010959
Scientific Title The effect of NSAIDs on sleep quality in chronic low back pain patients with sleep disorder (A randomized, open-label, parallel-group comparison study)
Date of disclosure of the study information 2012/11/15
Last modified on 2014/06/18 16:31:39

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Basic information

Public title

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

Acronym

The effect of NSAIDs on sleep quality in chronic low back pain patients with sleep disorder

Scientific Title

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

Scientific Title:Acronym

The effect of NSAIDs on sleep quality in chronic low back pain patients with sleep disorder

Region

Japan


Condition

Condition

Low Back Pain

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to perform an exploratory examination of the improvement effect on sleep disorder at 12 weeks after treatment in chronic low back pain patients with sleep disorder, in comparison between a group of celecoxib and a group of loxoprofen sodium.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Evaluation on the improvement effect on the quality of sleep using the Pittsburgh Sleep Quality Index(PSQI) after 12-week study treatment

Key secondary outcomes

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


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients in celecoxib group are administrated celecoxib 100 mg twice per day for 12 weeks

Interventions/Control_2

Patients in loxoprofen group are administrated loxoprofen 60 mg three times per day for 12 weeks

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key 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.

Key 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.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Katsunori Inagaki

Organization

Showa University School of
Medicine

Division name

Department of Orthopaedic Surgery

Zip code


Address

1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Showa University School of

Division name

Department of Orthopaedic Surgery

Zip code


Address

1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666

TEL


Homepage URL


Email



Sponsor or person

Institute

Department of Orthopaedic Surgery, Showa University School of
Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Orthopaedic Surgery, Showa University School of
Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2012 Year 11 Month 15 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2012 Year 09 Month 10 Day

Date of IRB


Anticipated trial start date

2013 Year 01 Month 15 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 11 Month 14 Day

Last modified on

2014 Year 06 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010959


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name