NCT05347303

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

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

Study Start

First participant enrolled

March 28, 2022

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2022

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2022

Completed
Last Updated

October 31, 2022

Status Verified

October 1, 2022

Enrollment Period

2 months

First QC Date

April 20, 2022

Last Update Submit

October 27, 2022

Conditions

Keywords

Orthopedic Manual TherapyFoam rollerStrength

Outcome Measures

Primary Outcomes (4)

  • Flexibility

    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

    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

    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

    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

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

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.

Experimental group

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.

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andina Area University Foundation

Pereira, Colombia

Location

Related Publications (1)

  • Afanador-Restrepo DF, Rodriguez-Lopez C, Rivas-Campo Y, Baena-Marin M, Castellote-Caballero Y, Quesada-Ortiz R, Osuna-Perez MC, Carcelen-Fraile MDC, Aibar-Almazan A. Effects of Myofascial Release Using Finding-Oriented Manual Therapy Combined with Foam Roller on Physical Performance in University Athletes. A Randomized Controlled Study. Int J Environ Res Public Health. 2023 Jan 12;20(2):1364. doi: 10.3390/ijerph20021364.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Epidat randomization will be used to assign the groups. This assignment will be hidden, so the therapists will not be aware of which group each subject belongs to. Random assignment will be done by an investigator who will have no influence on the measurements or statistical analysis. The analysis will be carried out by another researcher who will remain unrelated to the measurements and the intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 20, 2022

First Posted

April 26, 2022

Study Start

March 28, 2022

Primary Completion

June 10, 2022

Study Completion

June 17, 2022

Last Updated

October 31, 2022

Record last verified: 2022-10

Locations