- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01483885
Comparison of the Analgesic Effects of Acupuncture and Modulated Electroanalgesia in Cold Induced Pain
November 29, 2011 updated by: Fuad Ahmad Hazime, Universidade Federal do Piauí
Comparison of the Analgesic Effects of Acupuncture and Modulated Electroanalgesia in Cold Induced Pain.
Physiotherapy offers a range of therapeutic modalities for pain management including Transcutaneous Electrical Nerve Stimulation (TENS), Interferential current (IC) and Acupuncture.
The objective of this study was to investigate the hypoalgesic effect of TENS, CI and Acupuncture in a cold-induced pain model.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
82
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Piauí
-
Parnaíba, Piauí, Brazil, 64202-020
- Fuad Ahmad Hazime
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy subjects
Exclusion Criteria:
- Subjects with no history of any kind of disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: TENS 4Hz
|
Tens at 4Hz and 100 Hz will be delivered using TENS stimulator (Ibramed/Neurodyn-São Paulo, Brazil)
|
|
EXPERIMENTAL: Interferential Current 4Hz
|
Interferential Current (IC) at 4Hz and 100 Hz will be delivered using IC stimulator (Ibramed/Neurodyn-São Paulo, Brazil)
|
|
PLACEBO_COMPARATOR: TENS
|
Tens at 4Hz and 100 Hz will be delivered using TENS stimulator (Ibramed/Neurodyn-São Paulo, Brazil)
|
|
PLACEBO_COMPARATOR: Interferential Current
|
Interferential Current (IC) at 4Hz and 100 Hz will be delivered using IC stimulator (Ibramed/Neurodyn-São Paulo, Brazil)
|
|
EXPERIMENTAL: Manual Acupuncture
|
Manual acupuncture will be delivered with sterile needles for each subject in the acupoint TA5 and CS6 localized in the dominant forearm.
|
|
EXPERIMENTAL: TENS 100 Hz
|
Tens at 4Hz and 100 Hz will be delivered using TENS stimulator (Ibramed/Neurodyn-São Paulo, Brazil)
|
|
EXPERIMENTAL: Interferential Current 100Hz
|
Interferential Current (IC) at 4Hz and 100 Hz will be delivered using IC stimulator (Ibramed/Neurodyn-São Paulo, Brazil)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cold Pain threshold
Time Frame: 24 hours
|
Cold pain threshold is recorded as the time from immersing the hand in the cold water to pain using a digital timer.
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Tolerance threshold
Time Frame: 24 hours
|
Cold Tolerance threshodl is recorded as the time from immersing the hand in the cold water to maximal pain tolerance using a digital timer.
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (ACTUAL)
August 1, 2011
Study Completion (ACTUAL)
October 1, 2011
Study Registration Dates
First Submitted
November 23, 2011
First Submitted That Met QC Criteria
November 29, 2011
First Posted (ESTIMATE)
December 2, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
December 2, 2011
Last Update Submitted That Met QC Criteria
November 29, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- 0208.0.045.000-11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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