Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06527014
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-21
Brief Title:
Pulsed Radiofrequency to the Suprascapular Nerve
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of the Effectiveness of Pulsed Radiofrequency pRF to the Suprascapular Nerve Versus Conventional Physical Therapy Program in Chronic Shoulder Pain
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Regardless of the etiology chronic shoulder pain is a distressing condition that affects daily life and is among the first common reasons for musculoskeletal system problems when admitting to clinics Pulsed radiofrequency pRF treatment to the suprascapular nerve SSN is a promising interventional procedure that is thought to be effective in case of chronic shoulder pain However conventional physical therapy program is preferred more often and found more applicable The aim of current study is to compare the effectiveness of two treatment procedures
Detailed Description:
This study carried out in 27 chronic shoulder pain patients aged between 18-75 years in Ankara Bilkent City Hospital Physical Medicine and Rehabilitation Hospital Total of 25 patients who had 3 months shoulder pain and pain more than 4 according to the numerical rating scale NRS completed the study Twenty-seven patients randomized into two groups 21 patients underwent pRF of Suprascapular nerve SSN in Group 1 16 patients received 10 sessions conventional physical therapy CPT program One patient did not come to follow-ups after SSN pRF procedure other patient did not complete the 10 session CPT program
Approval for the study was granted by the 2nd Ethics Committee of Ankara Bilkent City Hospital Protocol number E2-23-3799 The study was conducted in line with the Helsinki Declaration All patients signed informed consent prior to participation
Inclusion criteria were 1 shoulder pain lasts more than 3 months 2 Shoulder pain more than 4 according to NRS 3 no passive range of motion limitation 4 unilateral chronic shoulder pain 5 INR 12 in blood samples
Exclusion criteria were 1 Adhesive capsulitis that cause passive range of motion in shoulder joint 2 History of intra-articular joint injection or physical therapy at the last 6 months 3 History of fracture trauma or surgery 4 Accompanying rheumatologic disease or other inflammatory arthritis involved shoulder joint 5 Local infection sepsis malignancy or pregnancy 6 Uncontrolled diabetes or other co-morbidities that worsens general condition 7 History of allergy to the materials used in treatment 8 Mental disorders that lead incooperation
After the informed consent patients divided into 2 groups with closed envelope method by the staff who is not participated in the study Group 1 underwent SSN pRF and Group 2 received 10 sessions of CPT program including hotpack therapeatic ultrasound as a deep heater and transcutaneous electrical nerve stimulation TENS All patients were thought shoulder exercises such as pendulum exercises and isometric exercises around shoulder muscles to be performed individually until the 1st month follow-up
Approval for the study was granted by the 2nd Ethics Committee of Ankara Bilkent City Hospital Protocol number E2-23-3799 The study was conducted in line with the Helsinki Declaration All patients signed informed consent prior to participation
Inclusion criteria were 1 shoulder pain lasts more than 3 months 2 Shoulder pain more than 4 according to NRS 3 no passive range of motion limitation 4 unilateral chronic shoulder pain 5 INR 12 in blood samples
Exclusion criteria were 1 Adhesive capsulitis that cause passive range of motion in shoulder joint 2 History of intra-articular joint injection or physical therapy at the last 6 months 3 History of fracture trauma or surgery 4 Accompanying rheumatologic disease or other inflammatory arthritis involved shoulder joint 5 Local infection sepsis malignancy or pregnancy 6 Uncontrolled diabetes or other co-morbidities that worsens general condition 7 History of allergy to the materials used in treatment 8 Mental disorders that lead incooperation
After the informed consent patients divided into 2 groups with closed envelope method by the staff who is not participated in the study Group 1 underwent SSN pRF and Group 2 received 10 sessions of CPT program including hotpack therapeatic ultrasound as a deep heater and transcutaneous electrical nerve stimulation TENS All patients were thought shoulder exercises such as pendulum exercises and isometric exercises around shoulder muscles to be performed individually until the 1st month follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None