NCT02322489

Brief Summary

15 participants will be included in the present study. They will attend two groups of three sessions (i.e. sessions 1-2-3 and sessions 4-5-6) spaced by 3 months:

  • session 1 and 4 (performed a few days before the experimental session): session for participants to get familiarized with the test battery.
  • session 2 and 5: experimental session (the test battery followed by the provocative task, the test battery, the one-hour "treatment" and the test battery again).
  • session 3 and 6 (performed 2 days later): the test battery. The test battery included flexibility, functional, pressure pain threshold tests. The provocative task was an isokinetic eccentric task for knee flexors and extensors. The treatment was either a microcurrent therapy or a placebo microcurrent therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

December 6, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 23, 2014

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 9, 2015

Status Verified

June 1, 2015

Enrollment Period

4 months

First QC Date

December 6, 2014

Last Update Submit

June 8, 2015

Conditions

Keywords

microcurentpainflexibility

Outcome Measures

Primary Outcomes (1)

  • Intensity of pain (Visual analogue scale)

    baseline, post-provocative task, post-treatment, 48h follow-up, following days until pain disappears

Secondary Outcomes (4)

  • Flexibility of quadriceps and hamstrings muscles

    baseline, post-provocative task, post-treatment, 48h follow-up

  • Functional test (Unilateral counter-movement jump)

    baseline, post-provocative task, post-treatment, 48h follow-up

  • Pain sensibility threshold (Determined by using a dolorimeter)

    baseline, post-provocative task, post-treatment, 48h follow-up

  • Isometric strength (Maximal voluntary contraction of knee flexor and extensor muscles)

    baseline, post-provocative task, post-treatment, 48h follow-up

Study Arms (2)

Sham microcurrent therapy

SHAM COMPARATOR

The participant is lying on an examination table for one hour; several electrodes are placed over the muscles involved in the provocative task. The microcurrent therapy is then started but it lasts only for 5 seconds.

Device: Sham microcurrent therapy

Microcurrent Group

EXPERIMENTAL

The participant is lying on an examination table for one hour; several electrodes are placed over the muscles involved in the provocative task. The microcurrent therapy is then started.

Device: Microcurrent Therapy

Interventions

Several electrodes are placed over the muscles involved in the provocative task. The microcurrent therapy is then started and lasts for one hour.

Microcurrent Group

Several electrodes are placed over the muscles involved in the provocative task. The microcurrent therapy is then started but lasts only for five seconds.

Sham microcurrent therapy

Eligibility Criteria

Age18 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Asymptomatic subjects

You may not qualify if:

  • practice of sports \>3h per week
  • present pain in the lower limbs
  • history of thigh muscle injuries
  • recent injury (last 3 months) of the lower limbs
  • recent (last 3 months) plyometric exercises or lower limbs strengthening program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liege University Hospital Center

Liège, Liege, 4000, Belgium

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christophe Demoulin, PhD

    University of Liege

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Main investigator

Study Record Dates

First Submitted

December 6, 2014

First Posted

December 23, 2014

Study Start

January 1, 2015

Primary Completion

May 1, 2015

Study Completion

June 1, 2015

Last Updated

June 9, 2015

Record last verified: 2015-06

Locations