Study of Zonal and Balance Acupuncture Pain Relief Effect

NCT ID: NCT02508519

Last Updated: 2015-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Brief Summary

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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

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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

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Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Zonal

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.

Group Type EXPERIMENTAL

Acupuncture

Intervention Type PROCEDURE

An acupuncture needle insertion according to zonal or balance method.

Balance

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.

Group Type EXPERIMENTAL

Acupuncture

Intervention Type PROCEDURE

An acupuncture needle insertion according to zonal or balance method.

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acupuncture

An acupuncture needle insertion according to zonal or balance method.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* post traumatic pain syndrome
* vertebrogenic pain syndrome

Exclusion Criteria

* oncological diseases
* narcotic dependency
* psychiatric disorders
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bogomolets National Medical University

OTHER

Sponsor Role lead

Responsible Party

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Golovchanskyi Oleksandr

M.D., Ph.D., Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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no grant number

Identifier Type: -

Identifier Source: org_study_id

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