NCT02508519

Brief 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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 27, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Last Updated

August 17, 2015

Status Verified

August 1, 2015

Enrollment Period

2 years

First QC Date

July 21, 2015

Last Update Submit

August 14, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 minutes, 15 minutes, 24 hours.

Study Arms (3)

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.

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.

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.

Interventions

AcupuncturePROCEDURE

An acupuncture needle insertion according to zonal or balance method.

BalanceZonal

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • post traumatic pain syndrome
  • vertebrogenic pain syndrome

You may not qualify if:

  • oncological diseases
  • narcotic dependency
  • psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Somatoform Disorders

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D., Lecturer

Study Record Dates

First Submitted

July 21, 2015

First Posted

July 27, 2015

Study Start

July 1, 2015

Primary Completion

July 1, 2017

Last Updated

August 17, 2015

Record last verified: 2015-08