Clinical trial NCT06106490: Pain Managment in Chronic Shoulder Pain
Official title: Addition of Pulsed Radiofrequency to Suprascapular Nerve Block With Glenohumeral Steroid Injection in Patients With Chronic Shoulder Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain Management
Keywords: Shoulder pain
Suprascapular nerve block
Pulsed radiofrequency
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: change of Shoulder Pain and Disability Index (SPADI) questionnaire in both groups after the intervention
timeFrame: 15th day, 1st month, 3rd month and 6th month
Secondary outcomes:
measure: Numerical pain rating scale (NRS).physiological parameter
timeFrame: 15th day, 1st month, 3rd month and 6th month
measure: Duration of pain relief physiological parameter
timeFrame: 15th day, 1st month, 3rd month and 6th month
measure: Active range of motion (AROM).physiological parameter
timeFrame: 15th day, 1st month, 3rd month and 6th month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine Ain Shams University
Study officials:
affiliation: Ainshams University
name: Amr Abdelfatah, proffessor
role: STUDY_DIRECTOR
References: