Pain Managment in Chronic Shoulder Pain

Not Applicable

Recruiting

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

• Registration Number: NCT06106490
• Lead Sponsor: Ain Shams University

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-10-14
• Study First Submitted QC: 2023-10-27
• Study First Posted: 2023-10-30
• Study Start: 2023-11-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-10-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Suprasacapular nerve block	the effect of adding pulsed radiofrequency (PRF) modality to suprascapular nerve injection with ultrasound glenohumeral steroid in chronic shoulder pain patients	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	the effect of adding pulsed radiofrequency (PRF) modality to suprascapular nerve injection with ultrasound glenohumeral steroid in chronic shoulder pain patients	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.

Primary Outcome Measures

Name	Time	Method
change of Shoulder Pain and Disability Index (SPADI) questionnaire in both groups after the intervention	15th day, 1st month, 3rd month and 6th month	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

Secondary Outcome Measures

Name	Time	Method
Active range of motion (AROM).physiological parameter	15th day, 1st month, 3rd month and 6th month	will be measured using a geniometer.
Duration of pain relief physiological parameter	15th day, 1st month, 3rd month and 6th month	when the effect of the intervention will be lost after the intervention
Numerical pain rating scale (NRS).physiological parameter	15th day, 1st month, 3rd month and 6th month	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'.

Trial Locations

Locations (1)

Faculty of medicine Ain Shams University; 🇪🇬 Cairo, Egypt