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

Sponsor

Bnai Zion Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05969353

Collaborator

(none)

200

Enrollment

Location

Arms

29.6

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Assessing the Effectiveness of BFA as a Non-pharmacologic Pain Management Intervention: A Randomised Sham Controlled Study	Other: accupunture	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Jul 23, 2023

Anticipated Primary Completion Date :

Dec 30, 2025

Anticipated Study Completion Date :

Jan 10, 2026

Arms and Interventions

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

Arm

Intervention/Treatment

Sham Comparator: sham controlled arm

Other: accupunture

BFA

Active Comparator: battlefield acupunture

Other: accupunture

BFA

Outcome Measures

Primary Outcome Measures

efficacy of BFA [two years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BnaiZion MC	Haifa		Israel

Sponsors and Collaborators

Bnai Zion Medical Center

Investigators

Principal Investigator: shira ginsberg, MD, BnaiZion MC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

shira.ginsberg, MD, Bnai Zion Medical Center

ClinicalTrials.gov Identifier:

NCT05969353

Other Study ID Numbers:

062-23 BNZ

First Posted:

Aug 1, 2023

Last Update Posted:

Aug 1, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 1, 2023