Pain Managment in Chronic Shoulder Pain

NCT06106490 | Recruiting

• 1 other identifier: FMASU MD128/2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Pain Management

Keywords

Shoulder pain; Suprascapular nerve block; Pulsed radiofrequency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Numerical pain rating scale (NRS).physiological parameter

  15th day, 1st month, 3rd month and 6th month

• Duration of pain relief physiological parameter

  15th day, 1st month, 3rd month and 6th month

• Active range of motion (AROM).physiological parameter

  15th day, 1st month, 3rd month and 6th month

Study Arms (2)

Suprasacapular nerve block

ACTIVE COMPARATOR

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

Pulsed Radiofrequency group

ACTIVE COMPARATOR

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

Interventions

the effect of adding pulsed radiofrequency (PRF) modality to suprascapular nerve injection with ultrasound glenohumeral steroid in chronic shoulder pain patients OTHER

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.

Pulsed Radiofrequency group; Suprasacapular nerve block

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of medicine Ain Shams University

Cairo, 11566, Egypt

RECRUITING

MeSH Terms

Conditions

Shoulder Pain

Interventions

Prolactin-Releasing Hormone

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Amr Abdelfatah, proffessor

  Ainshams University

  STUDY DIRECTOR

Central Study Contacts

Nahla yahia, Msc

CONTACT

00201000312825; nahla.yahya@med.asu.edu.eg

Azza youssef, lecturer

CONTACT

01003574518; azzalotfy@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer of anesthesia

Study Record Dates

• First Submitted: October 14, 2023
• First Posted: October 30, 2023
• Study Start: November 1, 2023
• Primary Completion: October 30, 2024
• Study Completion: November 30, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: one year after publication
• Access Criteria: internet search by keywords

Locations

EG (1)