NCT02391376

Brief Summary

The purpose of this study is to compare the effects generated by the application of three different packs on the flexibility of the lower back of sedentary students. Method: Three sessions of 15 minutes of superficial heat through a hot pack (moist heat pack-MHP, seed pack-SP or gel pack-GP) were applied on the lower back. Pack and lower back temperatures and erythema were registered every 5 minutes. Schober test was performed before first session and after the third session.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 3, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
Last Updated

March 18, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

March 3, 2015

Last Update Submit

March 12, 2015

Conditions

Keywords

superficial heathot packthermotherapyphysiotherapySchober Test

Outcome Measures

Primary Outcomes (1)

  • Change of lower back flexibility (Schober test)

    Schober test

    Before first session (day 1) and after the third session (day 3-final day).

Secondary Outcomes (2)

  • Change of pack and lower back temperatures

    every 5 minutes during each one of the three 15 minutes sessions

  • Change of lower back erythema

    every 5 minutes during each one of the three 15 minutes sessions

Study Arms (3)

moist heat pack group

EXPERIMENTAL

Three sessions of 15 minutes of superficial heat through a moist heat pack on the lower back of healthy subjects

Other: moist heat pack; ;

seed pack group

EXPERIMENTAL

Three sessions of 15 minutes of superficial heat through a seed pack on the lower back of healthy subjects

Other: seed pack

gel pack group

EXPERIMENTAL

Three sessions of 15 minutes of superficial heat through a gel pack on the lower back of healthy subjects

Other: gel pack

Interventions

Three sessions of 15 minutes of superficial heat through a moist heat pack-MHP applied on the lower back.

moist heat pack group

Three sessions of 15 minutes of superficial heat through a seed pack-SP applied on the lower back.

seed pack group

Three sessions of 15 minutes of superficial heat through a gel pack-GP applied on the lower back.

gel pack group

Eligibility Criteria

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

You may qualify if:

  • sedentary subjects (physical activity performed less than 3 times-week)

You may not qualify if:

  • recent scars or wounds in the lower back region,
  • history of peripheral vascular diseases,
  • impaired sensitivity,
  • body mass index above 25 kg/m2,
  • fat index above 14% according to Faulkner's formula.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hyperthermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeat Stress DisordersWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT; MSc.

Study Record Dates

First Submitted

March 3, 2015

First Posted

March 18, 2015

Study Start

March 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2014

Last Updated

March 18, 2015

Record last verified: 2015-03