Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202106521751797 Date of Approval: 23/06/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Pulsed radiofrequency of suprascapular nerve versus radiofrequency ablation of articular branches of the shoulder for Chronic shoulder pain: a randomized controlled study
Official scientific title Pulsed radiofrequency of suprascapular nerve versus radiofrequency ablation of articular branches of the shoulder for chronic shoulder pain: a randomized controlled study
Brief summary describing the background and objectives of the trial Chronic shoulder pain is common in the community that may cause an important functional disability. Rotator cuff disease, shoulder impingement syndrome, adhesive capsulitis, tendinitis and degenerative disease may cause chronic shoulder pain, which can negatively affect upper extremity joint function and life quality by limiting the range of motion of the joint [1]. The treatment of shoulder pain requires an all-around approach, including noninvasive methods (nonsteroidal anti-inflammatory drugs, physical therapy and rehabilitation), minimally invasive methods (intraarticular steroid injections and suprascapular nerve procedures) and surgical procedures [2]. The suprascapular nerve (SSN) provides 70% of the sensory innervation of the shoulder joint; therefore, SSN procedures (selective nerve blocks, steroid injections and radiofrequency applications) have been reported to be effective in the treatment of acute and chronic shoulder pain [3, 4]. Although rapid pain control can be provided with a SSN block, its short duration of action limits its use in treatment [5]. Longer pain control can be achieved with a neurolysis or neurectomy, but these methods may cause irreversible paralysis in the supraspinatus and infraspinatus muscles [1]. The technique of radiofrequency reduces transmission of pain signals. RF can be pulsed or continuous [6]. In continuous thermal radiofrequency (CTRF) treatment, a portion of nerve tissue is heated by the application of current with an oscillating frequency of 500,000 Hz via an electrode up to a temperature of 85 °C. The use of the small thermocouple electrodes allows temperature monitoring and nerve confirmation with motor and sensory stimulation, thus affording selective nerve lesion with minimal risk. The beneficial outcome from such treatments is reported as being 50% pain relief at least for 6 months up to 24 months [7-9]. Thermal RF produces Wallerian degeneration in all nerve fibers, physical disruption of the basal laminae and focal disruption of the perineurium, resulting in delayed axonal regeneration. At a given probe temperature, lesion size may be plotted against exposure time, giving an early linear curve before a steady-state plateau is reached at approximate 60 seconds [10]. Pulsed mode radiofrequency (PRF) lesioning is a nonneurolytic lesioning method for pain relief and can relieve pain without evidence of neural damage [1, 11-13]. It has gained a great popularity among pain physicians in the treatment of chronic shoulder pain due to its long duration of action and the lack of any damage to the targeted and surrounding tissue, thereby reducing the risk of neural damage and neuritis [14].This study will be conducted to compare between the outcomes of pulsed radiofrequency of suprascapular nerve and radiofrequency ablation of articular branches of the shoulder for intractable shoulder pain. Our hypothesis is that pulsed radiofrequency of suprascapular nerve will be more effective in controlling chronic shoulder pain than radiofrequency ablation of articular branches of the shoulder.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Injury, Occupational Diseases, Poisoning,Musculoskeletal Diseases,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/07/2021
Actual trial start date 15/07/2021
Anticipated date of last follow up 15/07/2022
Actual Last follow-up date 15/07/2022
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Pulsed radiofrequency of suprascapular nerve include cases who will be subjected to pulsed radiofrequency procedure. Regular follow up visits will be scheduled for all cases at 1,3 and 6 months after intervention. Pulsed radiofrequency technique The PRF therapy of the SSN will be performed under operating room conditions while the patient is monitored in a sitting position with ultrasound guidance. An ultrasound-guided 22 G 5-mm active-tip 100-mm radiofrequency needle (SC-K; Top Neuropole, Tokyo, Japan) will be pushed forward to the floor of the supraspinous fossa using an in-plane approach. Sensorial stimulation will be given at 50 Hz for 1 ms with a wide pulse. The PRF treatment will be applied for 3 cycles at 42 °C, 45 V, 2 Hz, and 20 ms, with a wide wave for 120 s (NeuroTherm, Middleton, MA, USA). This will be done after obtaining maximal 0.4 V paresthesia in the area of the suprascapular nerve innervation of the shoulder and after monitoring the shoulder abduction and/or external rotation response to the motor stimulus applied at 2 Hz for 1 ms and at least 1 volt 45 Active-Treatment of Control Group
Experimental Group Thermal radiofrequency of articular branches of the shoulder Regular follow up visits will be scheduled for all cases at 1,3 and 6 months after intervention. Thermal continuous radiofrequency procedure After identification of the suprascapular notch, a 50-mm insulated electrode with a 5-mm tip will be inserted percutaneously and directed to the suprascapular notch. Proximity to the SSN will be confirmed with sensory stimulation at 100 Hz and motor stimulation at 2 Hz, with stimulatory thresholds of < 0.5 V and 1 V, respectively. The latter will cause visible contraction of the supraspinatus and infraspinatus muscles. Once localized, 5 ml of 2% lignocaine will be injected and a radiofrequency thermocoagulation lesion from a Neurotherm radiofrequency lesion generator (model JK25T; Neurotherm Inc., Wilmington, MA, USA) will be delivered at 70 °C for 60 seconds. After completion of the lesion, 4 ml of 0.5% bupivicaine with 60 mg of depomedrone will be injected to reduce post-thermal discomfort 45
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Age > 18 years. • Diagnosed with at least one of the following; adhesive capsulitis, rotator cuff syndrome, shoulder impingement syndrome or shoulder osteoarthritis. • Intractable shoulder pain for more than 3 months. • Failure of conservative therapies, including oral analgesics, intra-articular corticosteroid injections, and physical therapy. • Visual analogue scale ≥ 4 or Shoulder Pain and Disability Index (SPADI) > 60. • Age < 18 years. • Chronic pain due to other diseases rather than the previously mentioned. • Abnormal coagulation profile. • Malignancy. • Uncontrolled systemic comorbidities like uncontrolled diabetes. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/04/2021 Mansoura Faculty of Medicine Institutional Research Board
Ethics Committee Address
Street address City Postal code Country
2 El-Gomhouria Street, Mansoura 35516, Egypt. Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain improvement during 6 months after the procedure at 1,3 and 6 months after intervention.
Secondary Outcome Functional improvement. Procedure related complications. Total analgesic consumption. at 1,3 and 6 months after intervention.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University Hospital 2 El-Gomhouria Street, Mansoura 35516, Egypt. Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ibrahim Abdelbaser 2 El-Gomhouria Street Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ibrahim Abdelbaser 2 El-Gomhouria Street Mansoura 35516 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Ibrahim Ibrahim Abd Elbaser 2 El-Gomhouria Street Mansoura 35516 Egypt
Elsayed Elemam 2 El-Gomhouria Street Mansoura 35516 Egypt
Khaled Elbahrawy 2 El-Gomhouria Street Mansoura 35661 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ibrahim Abdelbaser ibrahimbaser2010@yahoo.com +201004976825 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Assist professor of anesthesia Mansoura University
Role Name Email Phone Street address
Public Enquiries Elsayed Elemam sayedemam0606@gmail.com +201008765995 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Assist professor of of Anesthesia and Surgical Intensive Care at Mansoura University
Role Name Email Phone Street address
Scientific Enquiries Nabil Mageed nabil_abderaouf@yahoo.com 01001538648 2-Elgomhorria street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Professor of anesthesia and surgical Intensive care at faculty of medicine Mansoura university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will provide individual participant data and share it through the PubMed indexed journal Informed Consent Form,Study Protocol Beginning 6 months and ending 12 months following article publication We will provide individual participant data and share it through the PubMed indexed journal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information