Condition category
Signs and Symptoms
Date applied
20/11/2012
Date assigned
22/03/2013
Last edited
21/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Po-Chou Liliang

ORCID ID

Contact details

I-Shou University
No 1 Yi-Da Rd
Yan-chau District
Kaohsiung
824
Taiwan
+886 (0)7 6150011
ed100172@edah.org.tw

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Pulsed radiofrequency lesioning for painful shoulder: a prospective, randomized, single-blinded study

Acronym

Study hypothesis

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

E-Da Hospital, January 2011, ref: EMRP37098N

Study design

Randomised single-blind single-centre placebo-controlled cross-over study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet [Chinese]

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/01/2011

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant 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

Recruitment start date

01/01/2011

Recruitment end date

31/12/2012

Locations

Countries of recruitment

Taiwan

Trial participating centre

I-Shou University
Kaohsiung
824
Taiwan

Sponsor information

Organisation

I-Shou University (Taiwan)

Sponsor details

No 8 Yi-Da Rd
Yan-Chau DIstrict
Kaohsiung
824
Taiwan
+886 (0)7 6151100
ed100146@edah.org.tw

Sponsor type

University/education

Website

http://www.isu.edu.tw/en1/index.htm

Funders

Funder type

University/education

Funder name

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

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

Publication citations

Additional files

Editorial Notes

21/10/2016: Plain English summary added.