Assessing the Effectiveness of BFA as a Non-pharmacologic Pain Management Intervention: A Randomised Sham Controlled Study

Assessing the Effectiveness of BFA as a Non-pharmacologic Pain Management Intervention: A Randomised Sham Controlled Study in Participants Who Hospitalized in Department of Internal Medicine

This is a randomized sham controlled study that will include patients hospitalized in the internal medicine department and the orthopedics department at Bnei Zion Hospital presenting with pain from various sources with an NRS level equal to or above 4.

Study Overview

• Status: Recruiting
• Conditions: Assessing the Effectiveness of BFA as a Non-pharmacologic Pain Management Intervention: A Randomised Sham Controlled Study
• Intervention / Treatment: Other: accupunture

Detailed Description

All patients will complete pain assessment according NSR and ESAS after treatment ( SHAM or BFA) one hour before and every 24 hours until discharge.

If there was no sufficient improvement in pain within 24 hours (decrease of 1.5 points or more in NRS) - additional acupuncture will be performed in the contralateral ear and repeated assessments as above.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julia Sterlin; Phone Number: 0528976129; Email: JULIA.STERLIN@GMAIL.COM
• Study Contact Backup: Name: Shira Ginsberg, MD; Email: shiragins@gmail.com

Study Locations

• Israel
  • Haifa, Israel
    • Recruiting
    • BnaiZion MC
    • Contact: Julia Sterlin; Phone Number: 97258976129; Email: JULIA.STERLIN@GMAIL.COM
    • Contact: Shira Ginsberg, MD; Phone Number: 97258976129; Email: shiragins@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

-1.Pain of skeletal muscle origin (Musculoskeletal MSK)/rheumatological/orthopedic syndromes 2.Visual Analog Score (VAS) grade 4 or higher before receiving the treatment.

3.Eligible to participate in the study according to the assessment of the investigator

Exclusion Criteria:

1. Pain syndromes of non-muscular bony/rheumatological/orthopedic origin
2. Planned an MRI next week
3. An infectious process in the ear planned for acupuncture or a history of sensitivity to metal
4. have any participant condition that ' according to the Investigator ' could interfere with the conduct of the trial -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: sham controlled arm	Other: accupunture; BFA
Active Comparator: battlefield acupunture	Other: accupunture; BFA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
efficacy of BFA	Evaluating the analgesic efficacy of BFA in addition to the standard treatment for pain - Standard of care (SOC) to reduce pain in patients hospitalized in the internal and orthopedic department who experience pain of moderate intensity and above compared to SHAM BFA.	two years

Collaborators and Investigators

• Sponsor: Bnai Zion Medical Center
• Investigators: Principal Investigator: shira ginsberg, MD, BnaiZion MC

Study record dates

Study Major Dates

• Study Start (Estimated): July 23, 2023
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): January 10, 2026

Study Registration Dates

• First Submitted: July 23, 2023
• First Submitted That Met QC Criteria: July 23, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 23, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 062-23 BNZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No