The efficacy of pulsed radiofrequency on chronic shoulder pain

ISRCTN	ISRCTN67524289
DOI	https://doi.org/10.1186/ISRCTN67524289
Secondary identifying numbers	N/A

Submission date: 20/11/2012
Registration date: 22/03/2013
Last edited: 21/10/2016

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
There are many treatments for chronic (long-term) shoulder pain, including physiotherapy, painkillers and corticosteroid (hormone) injections. However, there is limited evidence of their effectiveness. Often surgery is not an option for patients who have multiple other illnesses or are unwilling to undergo surgery. Pulsed radiofrequency is a new method for treating shoulder pain. It involves using a needle to apply an electrical field to the nerve which may be responsible for transmitting pain signals to the brain. The aim of this study is to assess the effectiveness of pulsed radiofrequency for chronic shoulder pain.

Who can participate?
Patients aged over 20 with chronic shoulder pain

What does the study involve?
Participants are randomly allocated to one of two groups. One group receives an injection of local anesthetic and undergoes PRF treatment for 3 minutes (two cycles). The other group receives an injection of local anesthetic. Shoulder pain and range of motion are assessed in both groups at the start of the study and after 1 week, 3 months and 6 months.

What are the possible benefits and risks of participating?
Participants may benefit from pain relief for a couple of months. The possible risks include subcutaneous hematoma (bruise), infection, pain during treatment, and allergy.

Where is the study run from?
E-Da Hospital (Taiwan)

When is the study starting and how long is it expected to run for?
January 2011 to December 2012

Who is funding the study?
I-Shou University (Taiwan)

Who is the main contact?
Dr Po-Chou Liliang
ed100172@edah.org.tw

Contact information

Dr Po-Chou Liliang
Scientific

I-Shou University
No 1 Yi-Da Rd
Yan-chau District
Kaohsiung
824
Taiwan

Phone	+886 (0)7 6150011
Email	ed100172@edah.org.tw

Study information

Study design	Randomised single-blind single-centre placebo-controlled cross-over study
Primary study design	Interventional
Secondary study design	Randomised cross over trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet [Chinese]
Scientific title	Pulsed radiofrequency lesioning for painful shoulder: a prospective, randomized, single-blinded study
Study objectives	The efficacy of pulsed radiofrequency lesioning on suprascapular nerve is better than placebo group (lidocaine injection only) in patients with chronic shoulder pain.
Ethics approval(s)	E-Da Hospital, January 2011, ref: EMRP37098N
Health condition(s) or problem(s) studied	Chronic shoulder pain
Intervention	Each patient is placed in a prone position, and the skin overlying the peration area was prepared and draped. A standard radiofrequency lesion generator (Neurotherm JK 25T) was used for the whole procedure. The suprascapular notch was identified under C-arm fluoroscopy at an angle slightly oblique to the treated side and angled cephalo-caudal. After sterile preparation and administration of local anesthesia, a 22-gauge 10-mm radiofrequency (RF) needle was inserted and advanced toward the suprascapular notch PRF treatment: The operator turns on the PRF for 3 min (2 cycles). The placebo group, after the location and same needle insertion, receive an injection of xylocaine (also could provide pain relief), but without connecting the machine to the RF needle.
Intervention type	Procedure/Surgery
Primary outcome measure	Pain, measured using Visual Analogue Scale (VAS) at baseline, at 1 week, 3 months and 6 months
Secondary outcome measures	1. Range of Motion (ROM): ROM at flexion, extension, abduction, external rotation and internal rotation (active and passive) 2. Shoulder Pain and Disability Index (SPADI) Measured at baseline, 1 week, 3 months, and 6 months
Overall study start date	01/01/2011
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	40
Key inclusion criteria	1. Adult patients (aged over 20 years) 2. Have chronic shoulder pain for 3 months, including osteoarthritis of glenohumeral, acromioclavicular joints, adhesive capsulitis, rotator cuff impingement
Key exclusion criteria	1. Inflammatory arthritis (rheumatoid arthritis, ankylosing spondylitis, etc.) 2. Active synovitis in the joints 3. Advanced osteoarthritis 4. Referred pain in the shoulder 5. Neurological impairment 6. Bleeding problems 7. Major depression
Date of first enrolment	01/01/2011
Date of final enrolment	31/12/2012

Locations

Countries of recruitment

Taiwan

Study participating centre

I-Shou University

Kaohsiung
824
Taiwan

Sponsor information

I-Shou University (Taiwan)
University/education

No 8 Yi-Da Rd
Yan-Chau DIstrict
Kaohsiung
824
Taiwan

Phone	+886 (0)7 6151100
Email	ed100146@edah.org.tw
Website	http://www.isu.edu.tw/en1/index.htm
"ROR"	https://ror.org/04d7e4m76

Funders

Funder type

University/education

E-Da University (Taiwan) ref: ISU 100-04-11

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

Editorial Notes

21/10/2016: Plain English summary added.