UMIN-CTR Clinical Trial

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

Low Back Pain

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Orthopaedic Surgery, Showa University School of
Medicine

Institute

Department

Personal name

Organization

Department of Orthopaedic Surgery, Showa University School of
Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

11

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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