Pain SyndromeNCT02508519
Study of Zonal and Balance Acupuncture Pain Relief Effect
A study testing Acupuncture in people with Pain Syndrome, run by Bogomolets National Medical University.
Trial summary
The aim of the study is to investigate how effective is zonal acupuncture method compared to balance method to obtain a short coming pain relief effect, which takes place several minutes after needle insertion. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain Syndrome
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Jul 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- post traumatic pain syndrome
- vertebrogenic pain syndrome
Who cannot join
- oncological diseases
- narcotic dependency
- psychiatric disorders
About this study
The aim of the study is to investigate how effective is zonal acupuncture method compared to balance method to obtain a short coming pain relief effect, which takes place several minutes after needle insertion.
Read the detailed description
Main purpose of the study is to estimate the efficiency of the zonal acupuncture method compared to control group and the balance acupuncture method.
This study includes random completion of 3 groups of participants : zonal acupuncture, control group, balance acupuncture approximately 20 participants each.
The zonal acupuncture group will receive a treatment according to a zonal method and a pain level will be estimated by the investigator according to a visual analog pain scale (VAS) before and 10 minutes and 15 minutes after the beginning of the treatment and the change of the pain level will be recorded. If possible the pain level will be measured again approximately 24 hours after the treatment and the change of the pain level will be again recorded.
The control group will provide only the estimation of the the pain level according to a visual analog pain scale (VAS) but receive no acupuncture treatment. Then if possible the pain level will be measured again approximately 24 hours after the first measurement and the change of the pain level will be recorded for a control group too.
The balance acupuncture group will receive a treatment according to a balance method, and a pain level will be estimated according to a visual analog pain scale (VAS) before and 10 minutes and 15 minutes after the beginning of the treatment and the change of the pain level will be recorded. If possible the pain level will be measured again approximately 24 hours after the treatment and the change of the pain level will be again recorded.
These measurements are primary outcome of the experiment. Provided statistically consistent they will be treated to extract method efficiency estimation.
The participants from all tree groups may receive drug analgesia at some recorded moment of time before the procedure, however the investigators want to investigate the effect of acupuncture analgesia at the time when no other analgesia effect is present, so the investigators can exclude possible interference.
- Conditions
- Pain Syndrome
- Being tested
- Acupuncture
- Medical subject headings
- Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
An acupuncture needle insertion according to zonal or balance method.
| Study group | Role | What they receive |
|---|---|---|
| Zonal | Experimental | The zonal acupuncture group will receive a treatment according to a zonal method and a pain level will be estimated by the investigator according to a visual analog pain scale (VAS) before and 10 minutes and 15 minutes after the beginning of the treatment and the change of the pain level will be recorded. If possible the pain level will be measured again approximately 24 hours after the treatment and the change of the pain level will be again recorded. Receives: Procedure: Acupuncture |
| Balance | Experimental | The balance acupuncture group will receive a treatment according to a balance method, and a pain level will be estimated according to a visual analog pain scale (VAS) before and 10 minutes and 15 minutes after the beginning of the treatment and the change of the pain level will be recorded. If possible the pain level will be measured again approximately 24 hours after the treatment and the change of the pain level will be again recorded. Receives: Procedure: Acupuncture |
| Control | No intervention | The control group will provide only the estimation of the the pain level according to a visual analog pain scale (VAS) but receive no acupuncture treatment. Then if possible the pain level will be measured again approximately 24 hours after the first measurement and the change of the pain level will be recorded. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the Pain level on the VAS scale
Pain level is measured according to VAS scale before and 10 minutes and 15 minutes after the beginning of the treatment and the change of the pail level is recorded. If possible the pain level will be measured again approximately 24 hours after the treatment and the change of the pain level will be again recorded.
Measured: 10 minutes, 15 minutes, 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bogomolets National Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Golovchanskyi Oleksandr, Bogomolets National Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02508519
- Sponsor's protocol ID
- no grant number
- Status last verified
- Aug 2015
- First submitted
- 21 Jul 2015
- Last updated
- 17 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Zonal and Balance Acupuncture Pain Relief Effect
- ClinicalTrials.gov ID
- NCT02508519
- Acronym / sponsor ID
- no grant number
- Conditions
- Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Bogomolets National Medical UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2017 (estimated)
- First posted
- 27 Jul 2015 (estimated)
- 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.
The aim of the study is to investigate how effective is zonal acupuncture method compared to balance method to obtain a short coming pain relief effect, which takes place several minutes after needle insertion.
Detailed description
Main purpose of the study is to estimate the efficiency of the zonal acupuncture method compared to control group and the balance acupuncture method.
This study includes random completion of 3 groups of participants : zonal acupuncture, control group, balance acupuncture approximately 20 participants each.
The zonal acupuncture group will receive a treatment according to a zonal method and a pain level will be estimated by the investigator according to a visual analog pain scale (VAS) before and 10 minutes and 15 minutes after the beginning of the treatment and the change of the pain level will be recorded. If possible the pain level will be measured again approximately 24 hours after the treatment and the change of the pain level will be again recorded.
The control group will provide only the estimation of the the pain level according to a visual analog pain scale (VAS) but receive no acupuncture treatment. Then if possible the pain level will be measured again approximately 24 hours after the first measurement and the change of the pain level will be recorded for a control group too.
The balance acupuncture group will receive a treatment according to a balance method, and a pain level will be estimated according to a visual analog pain scale (VAS) before and 10 minutes and 15 minutes after the beginning of the treatment and the change of the pain level will be recorded. If possible the pain level will be measured again approximately 24 hours after the treatment and the change of the pain level will be again recorded.
These measurements are primary outcome of the experiment. Provided statistically consistent they will be treated to extract method efficiency estimation.
The participants from all tree groups may receive drug analgesia at some recorded moment of time before the procedure, however the investigators want to investigate the effect of acupuncture analgesia at the time when no other analgesia effect is present, so the investigators can exclude possible interference.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Zonal | Experimental | Procedure: AcupunctureThe zonal acupuncture group will receive a treatment according to a zonal method and a pain level will be estimated by the investigator according to a visual analog pain scale (VAS) before and 10 minutes and 15 minutes after the beginning of the treatment and the change of the pain level will be recorded. If possible the pain level will be measured again approximately 24 hours after the treatment and the change of the pain level will be again recorded. |
| Balance | Experimental | Procedure: AcupunctureThe balance acupuncture group will receive a treatment according to a balance method, and a pain level will be estimated according to a visual analog pain scale (VAS) before and 10 minutes and 15 minutes after the beginning of the treatment and the change of the pain level will be recorded. If possible the pain level will be measured again approximately 24 hours after the treatment and the change of the pain level will be again recorded. |
| Control | No intervention | –The control group will provide only the estimation of the the pain level according to a visual analog pain scale (VAS) but receive no acupuncture treatment. Then if possible the pain level will be measured again approximately 24 hours after the first measurement and the change of the pain level will be recorded. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- post traumatic pain syndrome
- vertebrogenic pain syndrome
Key exclusion criteria (3 listed)
- oncological diseases
- narcotic dependency
- psychiatric disorders
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 |
|---|---|---|
| AcupunctureAn acupuncture needle insertion according to zonal or balance method. | Procedure or surgery | Balance, Zonal |
Primary outcome
Change of the Pain level on the VAS scale
Time frame: 10 minutes, 15 minutes, 24 hours.
Pain level is measured according to VAS scale before and 10 minutes and 15 minutes after the beginning of the treatment and the change of the pail level is recorded. If possible the pain level will be measured again approximately 24 hours after the treatment and the change of the pain level will be again recorded.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Pain Syndrome, run by Bogomolets National Medical University.
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 3 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 17 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the Pain level on the VAS scale (time frame: 10 minutes, 15 minutes, 24 hours.). 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 17 Aug 2015.