Efficacy and cost-effectiveness analysis of oral diclofenac sodium 3 days, 7 days for conventional radiofrequency denervation in the treatment of chronic facet joint pain: double-blinded randomised controlled trial

ISRCTN	ISRCTN68542008
DOI	https://doi.org/10.1186/ISRCTN68542008
Secondary identifying numbers	N/A

Submission date: 23/08/2008
Registration date: 12/09/2008
Last edited: 09/05/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ma Ke
Scientific

Department of Anaesthesiology and Pain Centre
Shanghai Sixth People's Hospital
Shanghai Jiao Tong University
600 Yi-Shan Road
Shanghai
200233
China

Study information

Study design	Prospective, double-blinded, randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	1. Diclofenac sodium can decrease the pain degree, and improve the patient's satisfaction after conventional radiofrequency denervation 2. Compared to 7 days dosage, 3 days diclofenac sodium therapeusis has the same efficacy and better cost-effectiveness for the treatment of pain after conventional radiofrequency denervation
Ethics approval(s)	Ethics Committee of Shanghai Sixth People's Hospital, Shanghai Jiaotong University. Date of approval: 20/08/2008
Health condition(s) or problem(s) studied	Chronic low back facet joints pain
Intervention	Arm 1: Placebo 3 times daily (tid) for 7 days Arm 2: Diclofenac sodium 25 mg tid for 3 days and placebo tid for following 4 days Arm 3: Diclofenac sodium 25 mg tid for 7 days Total duration of treatment: 7 days Total duration of follow-up: 60 days
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Diclofenac sodium
Primary outcome measure	1. Pain, measured by a visual analogue scale (VAS) at baseline, Day 7, 14, 30, 60 2. Oswestry Disability Index (ODI) at baseline, Day 30 and 60 3. Cost-effectiveness analysis at 60 days
Secondary outcome measures	1. Overall patients' satisfaction, measured by Patients' Satisfaction Score (3: excellent; 2: good; 1: moderate; 0: bad) at Day 60 2. Number needed to treat (NNT) to obtain one patient with good or complete pain relief at Day 60 3. Dosage of rescue drug. Duration of follow-up: 60 days after radiofrequency denervation. 4. Presence, frequency and duration of adverse effects at Day 7, 14, 30, 60
Overall study start date	03/09/2008
Completion date	30/03/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	66
Key inclusion criteria	1. Both males and females, age greater than 18 years 2. Duration of facet joints pain more than 6 months 3. Oswestry disability index 20%+ 4. Unresponsiveness to traditional conservative treatments such as bed rest, medication, physical therapy, trigger point injection and epidural block
Key exclusion criteria	1. Prior radiofrequency treatment 2. Coagulation disturbances 3. Allergies to local anaesthetic 4. Malignancy 5. Mental handicap or psychiatric condition precluding adequate communication, language problems 7. Unstable medical or psychiatric condition 8. Pregnancy 9. No effect of diagnostic blockades (one or two) 10. Gastrointestinal tract ulcer 11. Radicular syndrome 12. Indication for low back surgery
Date of first enrolment	03/09/2008
Date of final enrolment	30/03/2009

Locations

Countries of recruitment

China

Study participating centre

Department of Anaesthesiology and Pain Centre

Shanghai
200233
China

Sponsor information

Shanghai Sixth People's Hospital (China)
Hospital/treatment centre

Department of Anaesthesiology and Pain Centre
Shanghai Sixth People's Hospital
Shanghai JiaoTong University
600 Yi-Shan Road
Shanghai
200233
China

"ROR"	https://ror.org/049zrh188

Funders

Funder type

Hospital/treatment centre

Shanghai Sixth People's Hospital Clinical Research Fund (China)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2011		Yes	No