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 |
| Protocol serial number | N/A |
| Sponsor | Shanghai Sixth People's Hospital (China) |
| Funder | Shanghai Sixth People's Hospital Clinical Research Fund (China) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
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
| Primary study design | Interventional |
|---|---|
| Study design | Prospective, double-blinded, randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Diclofenac sodium |
| Primary outcome measure(s) |
1. Pain, measured by a visual analogue scale (VAS) at baseline, Day 7, 14, 30, 60 |
| Key secondary outcome measure(s) |
1. Overall patients' satisfaction, measured by Patients' Satisfaction Score (3: excellent; 2: good; 1: moderate; 0: bad) at Day 60 |
| Completion date | 30/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
200233
China
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
