Study of Zonal and Balance Acupuncture Pain Relief Effect

Pain Syndrome Clinical Trial

Official title:

Study of Zonal and Balance Acupuncture Pain Relief Effect

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02508519
• Other study ID #: no grant number
• Status: Enrolling by invitation
• Phase: N/A
• First received: July 21, 2015
• Last updated: August 14, 2015
• Start date: July 2015

Study information

• Verified date: August 2015
• Source: Bogomolets National Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ukraine: Ministry of Health
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• post traumatic pain syndrome

• vertebrogenic pain syndrome

Exclusion Criteria:

• oncological diseases

• narcotic dependency

• psychiatric disorders

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain Syndrome

Intervention

Procedure:
• Acupuncture
An acupuncture needle insertion according to zonal or balance method.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bogomolets National Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No