Pain Managment in Chronic Shoulder Pain

Addition of Pulsed Radiofrequency to Suprascapular Nerve Block With Glenohumeral Steroid Injection in Patients With Chronic Shoulder Pain

The purpose of this study is to evaluate the effect of adding pulsed radiofrequency (PRF) modality to suprascapular nerve injection with ultrasound glenohumeral steroid in chronic shoulder pain patients focusing on both changes in pain and function scores

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain Management
• Intervention / Treatment: Other: the effect of adding pulsed radiofrequency (PRF) modality to suprascapular nerve injection with ultrasound glenohumeral steroid in chronic shoulder pain patients

Detailed Description

Shoulder pain is the second most prevalent musculoskeletal condition in adults which is frequently treated poorly and results in chronic pain .

The use of steroid injection has been demonstrated to be superior to conventional therapies, particularly non-steroidal anti-inflammatory drugs. Its impact is transient (4-6 weeks) and occasionally may not be clinically sufficient .

An alternate analgesic injection for the pain management of numerous shoulder diseases is the suprascapular nerve block (SSN) .

Although pulse radiofrequency analgesia typically lasts for a much longer period than nerve blocking, it has become increasingly popular to apply pulse radiofrequency to peripheral nerves.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nahla yahia, Msc; Phone Number: 00201000312825; Email: nahla.yahya@med.asu.edu.eg
• Study Contact Backup: Name: Azza youssef, lecturer; Phone Number: 01003574518; Email: azzalotfy@med.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11566
    • Recruiting
    • Faculty of Medicine Ain Shams University
    • Contact: Amr M Abdelfatah, Professor; Phone Number: 01001034225; Email: dramr2001@gmail.com
    • Contact: Azza M Lotfy, Lecturer; Phone Number: 01003574518; Email: Azzalotfy@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged from 21-60 years.
• Patients with American Society of Anesthesiologists (ASA) physical status I and II.
• Chronic shoulder pain (>3 months) and will undergo interventional treatment due to inadequate response to conservative treatments.

Exclusion Criteria:

• Refusal of procedure or participation in the study by patients.
• History of shoulder surgery, another intervention history between 3 months before and 1 year after the intervention applied.
• Patients with chronic pain syndrome due to other shoulder pathology (fibromyalgia, cervical discopathy, brachial plexus injury).
• Uncontrolled diabetes mellitus patients with glycated hemoglobin (HbA1C) levels of more than 7%.
• Patients with known history of allergy to the study drugs.
• Infection at site of injection.
• Cognitive or psychiatric illness that will lead to inability to cooperate, speak, or provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Suprasacapular nerve block; Patients will receive ultrasound guided intra articular Gleno-humeral steroid injection of Diprofos® (betamethasone 14 mg/ 2ml) and ultrasound guided suprascapular nerve block US SSN with 10mL of 0.25% preservative-free bupivacaine	Other: the effect of adding pulsed radiofrequency (PRF) modality to suprascapular nerve injection with ultrasound glenohumeral steroid in chronic shoulder pain patients; Suprascapular nerve block group: Patients will receive ultrasound guided intra articular Gleno-humeral steroid injection of Diprofos® (betamethasone 14 mg/ 2ml) and ultrasound guided suprascapular nerve block US SSN with 10mL of 0.25% preservative-free bupivacaine Pulsed radiofrequency group: Patients will receive ultrasound guided intra articular Gleno-humeral steroid injection of Diprofos® (betamethasone 14 mg/ 2ml) and ultrasound guided suprascapular nerve block US SSN with 10mL of 0.25% preservative-free bupivacaine with application of pulse PRF at 42 Celsius of suprascapular nerve for 480 seconds.
Active Comparator: Pulsed Radiofrequency group; Patients will receive ultrasound guided intra articular Gleno-humeral steroid injection of Diprofos® (betamethasone 14 mg/ 2ml) and ultrasound guided suprascapular nerve block US SSN with 10mL of 0.25% preservative-free bupivacaine with application of pulse PRF at 42 Celsius of suprascapular nerve for 480 seconds.	Other: the effect of adding pulsed radiofrequency (PRF) modality to suprascapular nerve injection with ultrasound glenohumeral steroid in chronic shoulder pain patients; Suprascapular nerve block group: Patients will receive ultrasound guided intra articular Gleno-humeral steroid injection of Diprofos® (betamethasone 14 mg/ 2ml) and ultrasound guided suprascapular nerve block US SSN with 10mL of 0.25% preservative-free bupivacaine Pulsed radiofrequency group: Patients will receive ultrasound guided intra articular Gleno-humeral steroid injection of Diprofos® (betamethasone 14 mg/ 2ml) and ultrasound guided suprascapular nerve block US SSN with 10mL of 0.25% preservative-free bupivacaine with application of pulse PRF at 42 Celsius of suprascapular nerve for 480 seconds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of Shoulder Pain and Disability Index (SPADI) questionnaire in both groups after the intervention	The Shoulder Pain and Disability Index (SPADI) a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities, overall total scores range from 0 to 130 with a percentage score of 0 indicating less shoulder disability and 100 indicating more shoulder dysfunction	15th day, 1st month, 3rd month and 6th month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical pain rating scale (NRS).physiological parameter	patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.	15th day, 1st month, 3rd month and 6th month
Duration of pain relief physiological parameter	when the effect of the intervention will be lost after the intervention	15th day, 1st month, 3rd month and 6th month
Active range of motion (AROM).physiological parameter	will be measured using a geniometer.	15th day, 1st month, 3rd month and 6th month

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Amr Abdelfatah, proffessor, AinShams University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: October 14, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): October 30, 2023

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Shoulder pain; Pulsed radiofrequency; Suprascapular nerve block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Chronic Pain; Shoulder Pain
• Other Study ID Numbers: FMASU MD128/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: summary results
• IPD Sharing Time Frame: one year after publication
• IPD Sharing Access Criteria: internet search by keywords
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No