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

• Sponsor: Universidade Federal do Piauí (Other)
• Overall Status: Completed
• CT.gov ID: NCT01483885
• Collaborator: (none)
• Enrollment: 82
• Location: 1
• Arms: 7
• Duration (Months): 3
• Patients Per Site Per Month: 27.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cold Exposure	Device: Transcutaneous Electric Nerve Stimulation; Device: Interferential Current; Procedure: Manual Acupuncture	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Comparison of the Analgesic Effects of Acupuncture and Modulated Electroanalgesia in Cold Induced Pain.
• Study Start Date: Jul 1, 2011
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

1. Cold Pain threshold [24 hours]

   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

1. Pain Tolerance threshold [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy subjects

Exclusion Criteria:

• Subjects with no history of any kind of disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fuad Ahmad Hazime	Parnaíba	Piauí	Brazil	64202-020

Sponsors and Collaborators

• Universidade Federal do Piauí

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fuad Ahmad Hazime, Assistant Professor at School of Physiotherapy, Universidade Federal do Piauí
• ClinicalTrials.gov Identifier: NCT01483885
• Other Study ID Numbers: 0208.0.045.000-11
• First Posted: Dec 2, 2011
• Last Update Posted: Dec 2, 2011
• Last Verified: Nov 1, 2011

Study Results

No Results Posted as of Dec 2, 2011