Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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
Ethics Committee of Shanghai Sixth People's Hospital, Shanghai Jiaotong University. Date of approval: 20/08/2008
Study design
Prospective, double-blinded, randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
03/09/2008
Overall trial end date
30/03/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
66
Participant 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
Recruitment start date
03/09/2008
Recruitment end date
30/03/2009
Locations
Countries of recruitment
China
Trial participating centre
Department of Anaesthesiology and Pain Centre
Shanghai
200233
China
Funders
Funder type
Hospital/treatment centre
Funder name
Shanghai Sixth People's Hospital Clinical Research Fund (China)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21040436
Publication citations
-
Results
Ma K, Yiqun M, Wu T, Wang W, Liu X, Huang X, Wang Y, Efficacy of diclofenac sodium in pain relief after conventional radiofrequency denervation for chronic facet joint pain: a double-blind randomized controlled trial., Pain Med, 2011, 12, 1, 27-35, doi: 10.1111/j.1526-4637.2010.00978.x.