Study of Zonal and Balance Acupuncture Pain Relief Effect
Study Overview
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- post traumatic pain syndrome
- vertebrogenic pain syndrome
Exclusion Criteria:
- oncological diseases
- narcotic dependency
- psychiatric disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
An acupuncture needle insertion according to zonal or balance method.
|
|
Experimental: 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.
|
An acupuncture needle insertion according to zonal or balance method.
|
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
10 minutes, 15 minutes, 24 hours.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- No grant number (Other Grant/Funding Number: The Swedish Society of Spinal Surgeons)
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