Chronic low back facet joints pain Signs and Symptoms Other joint disorders, not elsewhere classified
Conditions
Interventions
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 treatm
Sponsors
Shanghai Sixth People's Hospital (China)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
China
Outcome results
None listed