AthletesNCT05347303
Orthopedic Manual Therapy vs Foam Roller on Flexibility, Joint Range of Motion, rm and Vertical Jump
A study testing Finding-oriented orthopedic manual therapy treatment combined with foam roller and Foam roller treatment in people with Athletes, run by University of Jaén at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Athletes
- What is being tested?
- Finding-oriented orthopedic manual therapy treatment combined with foam roller and Foam roller treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteColombia
- Study dates
- 28 Mar 2022to 17 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Have a lower limb injury that may affect flexibility or muscle power.
- Refuse to participate in the study.
- Be under 18 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Athletes
- Being tested
- Finding-oriented orthopedic manual therapy treatment combined with foam roller, Foam roller treatment
- Keywords
- Orthopedic Manual Therapy, Foam roller, Strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finding-oriented orthopedic manual therapy treatment combined with foam rollerOther
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.
Foam roller treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Foam roller treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Up to twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start28 Mar 2022
- Primary completion10 Jun 2022
- Study completion17 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AthletesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agustín Aibar Almazán, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347303
- Sponsor's protocol ID
- "University of Jaén"
- Status last verified
- Oct 2022
- First submitted
- 20 Apr 2022
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36674120
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05347303
- Acronym / sponsor ID
- "University of Jaén"
- Conditions
- Athletes
- Keywords
- Orthopedic Manual Therapy, Foam roller, Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 17 Jun 2022 (actual)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Finding-oriented orthopedic manual therapy treatment combined with foam rollerThe 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. |
| Control group | Active comparator | Other: Foam roller treatmentAfter taking measurements, they will perform 2 foam roller sessions per week following the same indications expressed in the experimental group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Have a lower limb injury that may affect flexibility or muscle power.
- Refuse to participate in the study.
- Be under 18 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Finding-oriented orthopedic manual therapy treatment combined with foam rollerBlind 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. | Other | Experimental group |
| Foam roller treatmentSubjects 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 | Control group |
Primary outcome
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.
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.
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
- Derived from this study: PubMed 36674120Afanador-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Finding-oriented orthopedic manual therapy treatment combined with foam roller and Foam roller treatment in people with Athletes, run by University of Jaén at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flexibility (time frame: Up to twelve weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05347303, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2022.