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

Cold Exposure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01483885
• Other study ID #: 0208.0.045.000-11
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 23, 2011
• Last updated: November 29, 2011
• Start date: July 2011
• Est. completion date: October 2011

Study information

• Verified date: November 2011
• Source: Universidade Federal do Piauí
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: October 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy subjects

Exclusion Criteria:

• Subjects with no history of any kind of disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cold Exposure

Intervention

Device:
• Transcutaneous Electric Nerve Stimulation
Tens at 4Hz and 100 Hz will be delivered using TENS stimulator (Ibramed/Neurodyn-São Paulo, Brazil)
• Interferential Current
Interferential Current (IC) at 4Hz and 100 Hz will be delivered using IC stimulator (Ibramed/Neurodyn-São Paulo, Brazil)

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.

Locations

Country	Name	City	State
Brazil	Fuad Ahmad Hazime	Parnaíba	Piauí

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Piauí

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cold Pain threshold	Cold pain threshold is recorded as the time from immersing the hand in the cold water to pain using a digital timer.	24 hours	No
Secondary	Pain Tolerance threshold	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	No