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Comparison of the Analgesic Effects of Acupuncture and Modulated Electroanalgesia in Cold Induced Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fuad Ahmad Hazime, Universidade Federal do Piauí
ClinicalTrials.gov Identifier:
NCT01483885
First received: November 23, 2011
Last updated: November 29, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Cold Exposure
 Device: Transcutaneous Electric Nerve Stimulation
Device: Interferential Current
Procedure: Manual Acupuncture
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of the Analgesic Effects of Acupuncture and Modulated Electroanalgesia in Cold Induced Pain.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universidade Federal do Piauí:

Primary Outcome Measures:
  • Cold Pain threshold [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Cold pain threshold is recorded as the time from immersing the hand in the cold water to pain using a digital timer.


Secondary Outcome Measures:
  • Pain Tolerance threshold [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Cold Tolerance threshodl is recorded as the time from immersing the hand in the cold water to maximal pain tolerance using a digital timer.


Enrollment: 82
Study Start Date: July 2011
Study Completion Date: October 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TENS 4Hz Device: Transcutaneous Electric Nerve Stimulation
Tens at 4Hz and 100 Hz will be delivered using TENS stimulator (Ibramed/Neurodyn-São Paulo, Brazil)
Experimental: Interferential Current 4Hz Device: Interferential Current
Interferential Current (IC) at 4Hz and 100 Hz will be delivered using IC stimulator (Ibramed/Neurodyn-São Paulo, Brazil)
Placebo Comparator: TENS Device: Transcutaneous Electric Nerve Stimulation
Tens at 4Hz and 100 Hz will be delivered using TENS stimulator (Ibramed/Neurodyn-São Paulo, Brazil)
Placebo Comparator: Interferential Current Device: Interferential Current
Interferential Current (IC) at 4Hz and 100 Hz will be delivered using IC stimulator (Ibramed/Neurodyn-São Paulo, Brazil)
Experimental: Manual Acupuncture Procedure: 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 Device: Transcutaneous Electric Nerve Stimulation
Tens at 4Hz and 100 Hz will be delivered using TENS stimulator (Ibramed/Neurodyn-São Paulo, Brazil)
Experimental: Interferential Current 100Hz Device: Interferential Current
Interferential Current (IC) at 4Hz and 100 Hz will be delivered using IC stimulator (Ibramed/Neurodyn-São Paulo, Brazil)

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects

Exclusion Criteria:

  • Subjects with no history of any kind of disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01483885

Locations
Brazil
Fuad Ahmad Hazime
Parnaíba, Piauí, Brazil, 64202-020
Sponsors and Collaborators
Universidade Federal do Piauí
  More Information

No publications provided

Responsible Party: Fuad Ahmad Hazime, Assistant Professor at School of Physiotherapy, Universidade Federal do Piauí
ClinicalTrials.gov Identifier: NCT01483885     History of Changes
Other Study ID Numbers: 0208.0.045.000-11
Study First Received: November 23, 2011
Last Updated: November 29, 2011
Health Authority: Brazil: Ethics Committee

Additional relevant MeSH terms:
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 13, 2013