NCT01483885

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 2, 2011

Completed
Last Updated

December 2, 2011

Status Verified

November 1, 2011

Enrollment Period

1 month

First QC Date

November 23, 2011

Last Update Submit

November 29, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Pain Tolerance threshold

    24 hours

Study Arms (7)

TENS 4Hz

EXPERIMENTAL
Device: Transcutaneous Electric Nerve Stimulation

Interferential Current 4Hz

EXPERIMENTAL
Device: Interferential Current

TENS

PLACEBO COMPARATOR
Device: Transcutaneous Electric Nerve Stimulation

Interferential Current

PLACEBO COMPARATOR
Device: Interferential Current

Manual Acupuncture

EXPERIMENTAL
Procedure: Manual Acupuncture

TENS 100 Hz

EXPERIMENTAL
Device: Transcutaneous Electric Nerve Stimulation

Interferential Current 100Hz

EXPERIMENTAL
Device: Interferential Current

Interventions

Tens at 4Hz and 100 Hz will be delivered using TENS stimulator (Ibramed/Neurodyn-São Paulo, Brazil)

TENSTENS 100 HzTENS 4Hz

Interferential Current (IC) at 4Hz and 100 Hz will be delivered using IC stimulator (Ibramed/Neurodyn-São Paulo, Brazil)

Interferential CurrentInterferential Current 100HzInterferential Current 4Hz

Manual acupuncture will be delivered with sterile needles for each subject in the acupoint TA5 and CS6 localized in the dominant forearm.

Manual Acupuncture

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects

You may not qualify if:

  • Subjects with no history of any kind of disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuad Ahmad Hazime

Parnaíba, Piauí, 64202-020, Brazil

Location

MeSH Terms

Interventions

Transcutaneous Electric Nerve StimulationElectric Stimulation Therapy

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor at School of Physiotherapy

Study Record Dates

First Submitted

November 23, 2011

First Posted

December 2, 2011

Study Start

July 1, 2011

Primary Completion

August 1, 2011

Study Completion

October 1, 2011

Last Updated

December 2, 2011

Record last verified: 2011-11

Locations