Condition category
Signs and Symptoms
Date applied
23/08/2008
Date assigned
12/09/2008
Last edited
09/05/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ma Ke

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

Shanghai Sixth People's Hospital (China)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21040436

Publication citations

  1. 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.

Additional files

Editorial Notes