Assessing the Effectiveness of BFA as a Non-pharmacologic Pain Management Intervention: A Randomised Sham Controlled StudyNCT05969353
Assessing the Effectiveness of BFA as a Non-pharmacologic Pain Management Intervention: A Randomised Sham Controlled Study
A study testing accupunture in people with Assessing the Effectiveness of BFA as a Non-pharmacologic Pain Management Intervention: A Randomised Sham Controlled Study, run by Bnai Zion Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Assessing the Effectiveness of BFA as a Non-pharmacologic Pain Management Intervention: A Randomised Sham Controlled Study
- What is being tested?
- accupunture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 23 Jul 2023to 10 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -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
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country.
Shira Ginsberg, MD contact
Israel1 site, 1 recruiting
- Recruiting
BnaiZion MC
Haifa
Julia Sterlin, 97258976129, JULIA.STERLIN@GMAIL.COM
Shira Ginsberg, MD, 97258976129, shiragins@gmail.com
About this study
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
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.
Read the 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.
- Being tested
- accupunture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
accupuntureOther
BFA
| Study group | Role | What they receive |
|---|---|---|
| sham controlled arm | Sham comparator | Not described Receives: Other: accupunture |
| battlefield acupunture | Active comparator | Not described Receives: Other: accupunture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start23 Jul 2023 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion10 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assessing the Effectiveness of BFA as a Non-pharmacologic Pain Management Intervention: A Randomised Sham Controlled StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, shira.ginsberg, Bnai Zion Medical Center
- Investigators
- shira ginsberg, MD, Principal investigator, BnaiZion MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969353
- Sponsor's protocol ID
- 062-23 BNZ
- Status last verified
- Jul 2023
- First submitted
- 23 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05969353
- Acronym / sponsor ID
- 062-23 BNZ
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- 23 Jul 2023 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 10 Jan 2026 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sham controlled arm | Sham comparator | Other: accupunture |
| battlefield acupunture | Active comparator | Other: accupunture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- -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
Key exclusion criteria (4 listed)
- 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 -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| accupuntureBFA | Other | battlefield acupunture, sham controlled arm |
Primary outcome
efficacy of BFA
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shira Ginsberg, MD contact
shira ginsberg, MD principal investigator
BnaiZion MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing accupunture in people with Assessing the Effectiveness of BFA as a Non-pharmacologic Pain Management Intervention: A Randomised Sham Controlled Study, run by Bnai Zion Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julia Sterlin (0528976129, JULIA.STERLIN@GMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of BFA (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.