Heat Transfer by Three Types of Packs and Its Implication on the Flexibility of the Lower Back

March 12, 2015 updated by: Gabriel Nasri Marzuca Nassr, Universidad Católica del Maule

Heat Transfer by Three Types of Packs and Its Implication on the Flexibility of the Lower Back: a Randomized, Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A different type of hot pack was applied in the lower back of each subject: moist heat pack (MHP) , seed pack (SP) or gel pack (GP) as directed by each manufacturer and in accordance with clinical practice for 15 minutes for 3 consecutive days. On day one, prior to the application of the pack, the initial evaluation of flexibility of the lumbar spine of each subject was recorded using Schober test. On day 3, after the application of each pack, the final evaluation of the flexibility of the lower back was performed using the same test. During the sessions, the temperature of the corporal area, the temperature of the pack and the pigmentation change of the corporal area were assessed every 5 minutes through a photographic record.The method used to assess the flexibility was the Schober Test. In order to perform the evaluation, the patient was placed in standing position with its bare feet slightly apart; two points were marked on the skin, one above the spinous apophysis S1 and another point, 10 cm above that mark. The patient performed a maximal trunk flexion without flexing the knees and the increase of the distance between the two marks was recorded. After this evaluation, the packs were applied on the lower back, wrapped in two layers of towels in order to avoid skin injuries by the heat. The temperature of the lower back and of each type of pack was recorded at minutes 0 (baseline measurement), 5, 10 and 15. Temperature was measured through a digital pyrometer at a set distance of 50 cm and it was held perpendicular to patient skin and the pack. The photographic record of the lower back of each subject, before and after each session of superficial thermotherapy, was recorded using a digital camera . The camera was placed perpendicular to the lower back, at a distance of 50 cm. The brightness of the photograph was taken into account so as not to affect the later analysis of the erythema. The erythema analysis of the lower back was performed with the freeware Picture Color Analyzer (Shizuoka, Japan; http://www.isao.com). The software measures the red color intensity of each pixel (attributing a value between 1 and 255) within the chosen area. The average red color value obtained in arbitrary units is the result of the following formula: Average red color = total red color value / (255 X number of pixels in the area).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: moist heat pack group
Three sessions of 15 minutes of superficial heat through a moist heat pack on the lower back of healthy subjects
Other: moist heat pack; ;
Three sessions of 15 minutes of superficial heat through a moist heat pack-MHP applied on the lower back.
Experimental: seed pack group
Three sessions of 15 minutes of superficial heat through a seed pack on the lower back of healthy subjects
Other: seed pack
Three sessions of 15 minutes of superficial heat through a seed pack-SP applied on the lower back.
Experimental: gel pack group
Three sessions of 15 minutes of superficial heat through a gel pack on the lower back of healthy subjects
Other: gel pack
Three sessions of 15 minutes of superficial heat through a gel pack-GP applied on the lower back.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of lower back flexibility (Schober test)
Time Frame: Before first session (day 1) and after the third session (day 3-final day).
Schober test
Before first session (day 1) and after the third session (day 3-final day).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change of pack and lower back temperatures
Time Frame: every 5 minutes during each one of the three 15 minutes sessions
every 5 minutes during each one of the three 15 minutes sessions
Change of lower back erythema
Time Frame: every 5 minutes during each one of the three 15 minutes sessions
every 5 minutes during each one of the three 15 minutes sessions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Católica del Maule

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TUCM/1261/B326e/2013

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