Pain Managment in Chronic Shoulder Pain

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Pain Management

Intervention / Treatment
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* Other: the effect of adding pulsed radiofrequency (PRF) modality to suprascapular nerve injection with ultrasound glenohumeral steroid in chronic shoulder pain patients


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Suprasacapular nerve block<br>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<br>* 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.<br>|
| Active Comparator: Pulsed Radiofrequency group<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shoulder pain, Suprascapular nerve block, Pulsed radiofrequency