Pain Managment in Chronic Shoulder Pain

Sponsor
Ain Shams University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06106490
Collaborator
(none)
60
2
13

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: the effect of adding pulsed radiofrequency (PRF) modality to suprascapular nerve injection with ultrasound glenohumeral steroid in chronic shoulder pain patients
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Addition of Pulsed Radiofrequency to Suprascapular Nerve Block With Glenohumeral Steroid Injection in Patients With Chronic Shoulder Pain
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Oct 30, 2024
Anticipated Study Completion Date :
Nov 30, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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'.

  2. 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

  3. Active range of motion (AROM).physiological parameter [15th day, 1st month, 3rd month and 6th month]

    will be measured using a geniometer.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ain Shams University

Investigators

  • Study Director: Amr Abdelfatah, proffessor, Ainshams University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nahla yahia, assistant lecturer of anesthesia, Ain Shams University
ClinicalTrials.gov Identifier:
NCT06106490
Other Study ID Numbers:
  • FMASU MD128/2023
First Posted:
Oct 30, 2023
Last Update Posted:
Oct 30, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nahla yahia, assistant lecturer of anesthesia, Ain Shams University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 30, 2023