Orthopedic Manual Therapy vs Foam Roller on Flexibility, Joint Range of Motion, rm and Vertical Jump

October 27, 2022 updated by: Agustín Aibar Almazán, University of Jaén

Effects of Finding-oriented Orthopedic Manual Therapy Combined With Foam Roller on Lower Limb Flexibility and Muscular Power in Colombian University Athletes: a Randomized Controlled Clinical Trial

Orthopedic Manual Therapy (OMT) is one of the branches of physiotherapy that has less evidence about its action and efficacy, but those who have had the opportunity to apply or receive it know its great benefits. Currently, worldwide, the approach given to physiotherapy goes hand in hand with the guidelines of the TMO, but in Colombia it is not seen in the same way. The objective of this TFM is to compare the effects of Finding-Oriented Orthopedic Manual Therapy combined with Foam Roller versus the effects of Foam Roller alone, specifically in terms of muscle power and lower limb flexibility in Colombian athletes. For this, a randomized controlled clinical trial will be carried out with two groups that will undergo different interventions. To measure the variables, the CMJ jump protocol will be used with the Optogait and the Wells or sit and reach test.

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

This research corresponds to an experimental study, a blind randomized controlled clinical trial, where a total of 87 people, men and women, of legal age, university athletes of collective disciplines, distributed in 2 groups will be evaluated: the experimental group will receive therapy with foam roller and with manual therapy guided by findings-oriented (n = 44) for 8 weeks, while the control (n = 43) will only receive the foam roller treatment. The variables will be measured with equipment and protocols validated in both groups. Evaluations will be made at the beginning of the intervention and immediately after the end of this period, all the data being unified in an Excel, assigning a code to each individual to maintain the privacy of the participants. As independent variables, sociodemographic data will be taken, as a result variable, the Maximum Repetition (RM) will be obtained following the protocol of a maximum repetition, the range of joint mobility using the goniometer pro app on an iPhone XR, flexibility with the Sit & Reach in V and the vertical jump measured with OptoGait. All variables will be measured pre and post intervention. As a result, manual therapy is expected to generate greater effects on the sports performance of university athletes in collective disciplines. Based on statistical processes, the data will be processed and it will be evaluated whether or not there are significant differences within and between groups.

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.
87

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Pereira, Colombia
        • Andina Area University Foundation

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Over 18 years of age.
  • Be active in any of the joint sports programs of the Fundación Universitaria del Área Andina headquarters Pereira - Colombia.
  • Voluntarily accept participation in the study.
  • Sign the consent informed.

Exclusion Criteria:

  • Have a lower limb injury that may affect flexibility or muscle power.
  • Refuse to participate in the study.
  • Be under 18 years of age.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

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: Experimental group
The experimental group (EG) after taking initial measurements and signing their informed consent will be subjected to an 8-week intervention plan with 2 sessions per week where they will receive 1 MTOH and 1 Foam roller on discontinuous days. MTOH consists of first evaluating the structures that have restrictions, whether soft tissues or joints, to later be treated with a specific manual technique. For this, evaluation methods based on Kaltenborn are used when it comes to joints and Pilat when focusing on soft tissues. Interventions will not exceed 20 minutes per subject. For the foam roller, subjects will perform slides on the instrument using their body weight on the following muscles: quadriceps, hamstrings, gastrocnemius, and tensor fascia lata, for 60 seconds with 3 repetitions for each. Each repetition will have a rest period of 30 seconds, this will be done on both lower limbs.
Other: Finding-oriented orthopedic manual therapy treatment combined with foam roller
Blind randomized controlled clinical trial, where a total of 87 people, men and women, of legal age, university athletes of collective disciplines will be evaluated. The experimental group will receive foam roller therapy and manual therapy guided by findings (n = 44) for 8 weeks.
Active Comparator: Control group
After taking measurements, they will perform 2 foam roller sessions per week following the same indications expressed in the experimental group.
Other: Foam roller treatment
Subjects will perform slides on the instrument using their body weight on the following muscles: quadriceps, hamstrings, gastrocnemius, and tensor fascia lata, for 60 seconds with 3 repetitions for each. Each repetition will have a rest period of 30 seconds, this will be done on both lower limbs.

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
Flexibility
Time Frame: Up to twelve weeks
The sit and reach or Wells test is a test commonly used to measure the flexibility of the hamstring muscles and the posterior muscles in general (Mayorga-Vega et al., 2014). This test will be carried out following the guidelines of the American College of Sports Medicine (American College of Sport Medicine [ACSM], 2000). This test consists of placing the person evaluated sitting on the floor in front of a box with their feet resting on it without any type of footwear, keeping their knees fully extended, on the box there is a plate with a tape measure on which the person evaluated must place their hands, later they will perform a maximum trunk flexion trying to cover the greatest possible distance with their upper limbs without altering the rest of the position, if the person cannot reach the plate, the missing distance will be measured to be able to contact it and it will be presented as a negative value.
Up to twelve weeks
Joint range of motion
Time Frame: Up to twelve weeks
The goniometer pro application available for iphone will be used. This tool has been previously tested and validated in the Latino population (Barboza et al., 2020). For this, the mobile device will be located with a system of straps that will ensure the position of the equipment on the segment to generate the displacement, once the individual is located in the starting position, the initial point will be selected in the application to then carry out the movement. The mobile device will then measure the displacement and give a measurement in degrees (°) that will be recorded.
Up to twelve weeks
Muscular Power
Time Frame: Up to twelve weeks
The Optogate will be used, following the CMJ jump test, in which the subject stands in the middle of the instrument's optical led strips, adopts a position of knee and hip flexion where the knee joint forms an angle of 90 °, to ensure that it will be done in this way, it will be measured with a manual goniometer and a rope will be placed to give the subject a stimulus when he is in the correct position. In addition, you must place your hands on the waist and execute the jump in a single movement, fluid and without interruptions, before taking the measurements the subject will be allowed to become familiar with the test, in the first session. On measurement days, 3 jumps will be allowed and the one with the highest score will be considered valid.
Up to twelve weeks
Muscle strength
Time Frame: Up to twelve weeks
Strength will be measured through the 1RM test, validated in different populations, regardless of gender or age (Grgic, Lazinica, Schoenfeld, & Pedisic, 2020). For the calculation of 1RM, the subjects will first receive an adaptation session, where they will get used to the gesture with low load so that after 2 days they can perform the real test. The actual test will consist of a warm-up with low resistance performing 10 repetitions of the exercise, then the load will be progressively increased until failure occurs, regardless of the verbal reinforcement given. A repetition will be considered successful when the subject performs the full range of motion without significant fasciculations or compensatory movements. The RM will be determined in 5 attempts for all subjects, all following the guidelines of the National Strength and Conditioning Association (Baechele & Earle, 2008).
Up to twelve weeks

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.
University of Jaén

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 (Actual)

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 28, 2022

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.
June 10, 2022

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.
June 17, 2022

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).
April 20, 2022

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.
April 25, 2022

First Posted (Actual)

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.
April 26, 2022

Study Record Updates

Last Update Posted (Actual)

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.
October 31, 2022

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.
October 27, 2022

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.
October 1, 2022

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.
  • "University of Jaén"

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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