HealthyNCT06357611
Combination of Two Osteopathic Techniques for the Hamstring's Stretching Capacity in Basketball Female Players
A study testing Simulated technique, Muscle energy technique and 4th ventricle technique and muscular energy technique in people with Healthy, run by Natália Maria Oliveira Campelo at 1 site in Portugal.
Trial summary
It is known that there are studies that prove the effectiveness of muscle energy techniques and the fourth ventricle technique separately, however, information is scarce regarding the combination of the two and their effectiveness in the population. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Simulated technique, Muscle energy technique and 4th ventricle technique and muscular energy technique
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 sitePortugal
- Study dates
- Sep 2024to Dec 2024
- 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 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Over 18 years old
- Female
- Playing federated basketball
- Signature of informed consent documents
Who cannot join
- Surgical intervention/trauma in the areas of activity (cervical-cranial and lower limb)
- Exposure to medicinal therapy
- Participants with hypertension
- Participants at risk of cerebral hemorrhage (e.g. aneurysm)
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Escola Superior de Saúde do Porto
Porto, 4200-072
Natália Campelo, +35122 206 1000, nmc@ess.ipp.pt
Natália MO Campelo
About this study
Official title: Effect of the Muscular Energy Technique With the 4th Ventricle Technique on the Range of Motion of the Hamstring Muscles in Female Basketball Players: RCT
It is known that there are studies that prove the effectiveness of muscle energy techniques and the fourth ventricle technique separately, however, information is scarce regarding the combination of the two and their effectiveness in the population. The aim of this randomized controlled study is to compare the immediate effects of the techniques compared to the muscle energy technique alone in female basketball players.
Read the detailed description
The muscular energy technique (MET) is a manual therapy technique that uses isometric contractions with the aim of increasing the extensibility of the muscle group, as well as promoting lymphatic and venous circulation. The fourth ventricle technique (CV-four) plays an amplifying role in the movement of tissues and fluids, restoring the flexibility of the autonomous response. For the MET, the researcher adopted a position homolateral to the dominant limb, contacting the lower limb with the caudal hand in the region of the malleoli. He then helped the participant to perform the movement, which consisted of flexion of the hip and extension of the knee passively until the motor barrier was reached, after which she was instructed to perform an isometric contraction of the hamstring. A total of three contractions of seven seconds with an interval of two to three seconds were requested, using approximately twenty per cent of their maximum force, and gaining a new motor barrier between each series, for a total of three series. For the CV-four technique, the researcher adopted a seated position and laterally contacted the scaly portion of the occiput, bringing it closer to the posterior convexity of the occiput, bringing the skull into extension, changing the compression movement with decompression, until three minutes had elapsed. At all stages of the session, the participant was positioned in the supine position, with the upper limbs alongside the body and the neck in a neutral position. All the participants in the study underwent an initial and final assessment protocol to determine their range of motion (ROM).
- Conditions
- Healthy
- Being tested
- Simulated technique, Muscle energy technique, 4th ventricle technique and muscular energy technique
- Keywords
- Fourth ventricle technique, Muscle energy technique, Range of motion, Hamstring Muscles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulated techniqueOther
The participant was in a supine position, with her upper limbs at her sides and her neck in a neutral position.
The researcher sat in a cephalic position, making contact with the participant's shoulders, without any movement, until 5 minutes had elapsed.
Muscle energy techniqueOther
The participant was in a supine position, with her upper limbs alongside her body and her neck in a neutral position.
The researcher adopted a position homolateral to the dominant limb, contacting the lower limb with the caudal hand in the region of the malleoli. He then helped the participant to perform the movement, which consisted of flexing the hip and extending the knee passively until the motor barrier was reached, and instructed her to perform an isometric contraction of the hamstrings. She was asked to perform three 7-second contractions with a 2 to 3-second interval, using approximately 20% of her maximum strength, gaining a new motor barrier between each set, for a total of three sets.
4th ventricle technique and muscular energy techniqueOther
The participant was in a supine position, with her upper limbs alongside her body and her neck in a neutral position.
For CV-4, the researcher contacted the squamous portion of the occiput laterally, bringing it close to the posterior convexity of the occiput, bringing the skull into extension, changing the compression movement with decompression, until 3 minutes had elapsed.
For the MET, the researcher adopted a position homolateral to the dominant limb, contacting the lower limb with the caudal hand in the region of the malleoli. She then helped the participant to perform the movement, which consisted of flexing the hip and extending the knee passively to the motor barrier, having been instructed to perform an isometric contraction of the hamstring. A total of 3 7-second contractions with a 2-3 second interval were requested, using approximately 20% of her maximum strength, and with a new motor barrier being gained between each series, for a total of 3 series.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | After completing an individual questionnaire and giving informed consent, a placebo technique was performed, consisting only of contact in the area of the participant's shoulders. Receives: Other: Simulated technique |
| Experimental group MET | Experimental | After completing an individual questionnaire and giving informed consent, the muscle energy technique was performed on the dominant hamstring muscle. Receives: Other: Muscle energy technique |
| Experimental group CV-4 and MET | Experimental | After completing an individual questionnaire and giving informed consent, the 4th ventricle technique (CV-4) was performed, followed by the muscle energy technique on the dominant hamstring muscle. Receives: Other: 4th ventricle technique and muscular energy technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Altered range of motion of the hamstring muscles.
The universal goniometer is a tool used to assess joint ROM.
Measured: 10 minutes after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study startSep 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In order to allocate each participant to an intervention group, each voluntary participation questionnaire was assigned a number. Subsequently, all the numbers of the participants in the sample were randomly distributed among the 3 groups by the principal investigator.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Natália Maria Oliveira Campelo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Natália Maria Oliveira Campelo, Escola Superior de Tecnologia da Saúde do Porto
- Investigators
- Natália MO Campelo, PhD, Principal investigator, Escola Superior de Saúde do Politecnico do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357611
- Sponsor's protocol ID
- OST1_015
- Status last verified
- Apr 2024
- First submitted
- 5 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Balasubramaniam, A., Gandhi V, M., Purushothaman, V. K. (2022). Myofascial Release Theraphy versus Muscle Energy Technique on Hamstring Flexibility in Physical Inactive students - A randomized controlled trial. Universal Journal of Public Health, 299-303.
Barroso, G. C., & Thiele, E. S. (2011, Junho 28). Lesão Muscular nos Atletas.
Bonorino, D. S. (2017). Efeitos da técnica CV-4 para o tratamento da enxaqueca.
Chaitow, L. (2013). Muscle Energy Techniques.
Chaitow, L. (2023). Muscle Energy Techniques (Fifth Edition ed.). Elsevier.
DeLucia, R. (2016). Farmacologia Integrada: Uso Racional de Medicamentos.
DeStefano, L. (2011). Principales of Manual Medicine. Wolters Kluwer.
E. de Gray, L., & Seth, B. (2020). Drugs used to treat joint and muscle disease.
Favareto, R. M. (2019). Influência da manipulação osteopática craniana, sobre o sistema nervoso autônomo mensurado pela neurometria funcional em pacientes com fibromialgia. Revista Científica de Neurometria, 5.
Fryer, G., Fleischmann, M., & Vaughan, B. (2021). Use of muscle energy technique amongst a nationally representative sample of Australian Osteopaths. International Journal of Osteopathic Medicine, 5.
Jakel A, von Hauenschild P. Therapeutic effects of cranial osteopathic manipulative medicine: a systematic review. J Am Osteopath Assoc. 2011 Dec;111(12):685-93.
PubMed 22182954Kang YH, Ha WB, Geum JH, Woo H, Han YH, Park SH, Lee JH. Effect of Muscle Energy Technique on Hamstring Flexibility: Systematic Review and Meta-Analysis. Healthcare (Basel). 2023 Apr 11;11(8):1089. doi: 10.3390/healthcare11081089.
PubMed 37107922Laurino, C., Murer, F., & Iglesias, R. (2018, Julho 19). Tratamento cirurgico das lesões dos músculos isquiotibiais da coxa.
Liem, T. (2004). Cranial Osteopathy: principles and practice. Elsevier.
Nicholas, A. N. (2016). Atlas of Osteopathic Techniques (3 ed.). Wolters Kluwer Editora.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Muscular Energy Technique With the 4th Ventricle Technique on the Range of Motion of the Hamstring Muscles in Female Basketball Players: RCT
- ClinicalTrials.gov ID
- NCT06357611
- Acronym / sponsor ID
- OST1_015
- Conditions
- Healthy
- Keywords
- Fourth ventricle technique, Muscle energy technique, Range of motion, Hamstring Muscles
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Natália Maria Oliveira CampeloUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 10 Apr 2024 (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.
It is known that there are studies that prove the effectiveness of muscle energy techniques and the fourth ventricle technique separately, however, information is scarce regarding the combination of the two and their effectiveness in the population. The aim of this randomized controlled study is to compare the immediate effects of the techniques compared to the muscle energy technique alone in female basketball players.
Detailed description
The muscular energy technique (MET) is a manual therapy technique that uses isometric contractions with the aim of increasing the extensibility of the muscle group, as well as promoting lymphatic and venous circulation. The fourth ventricle technique (CV-four) plays an amplifying role in the movement of tissues and fluids, restoring the flexibility of the autonomous response. For the MET, the researcher adopted a position homolateral to the dominant limb, contacting the lower limb with the caudal hand in the region of the malleoli. He then helped the participant to perform the movement, which consisted of flexion of the hip and extension of the knee passively until the motor barrier was reached, after which she was instructed to perform an isometric contraction of the hamstring. A total of three contractions of seven seconds with an interval of two to three seconds were requested, using approximately twenty per cent of their maximum force, and gaining a new motor barrier between each series, for a total of three series. For the CV-four technique, the researcher adopted a seated position and laterally contacted the scaly portion of the occiput, bringing it closer to the posterior convexity of the occiput, bringing the skull into extension, changing the compression movement with decompression, until three minutes had elapsed. At all stages of the session, the participant was positioned in the supine position, with the upper limbs alongside the body and the neck in a neutral position. All the participants in the study underwent an initial and final assessment protocol to determine their range of motion (ROM).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- In order to allocate each participant to an intervention group, each voluntary participation questionnaire was assigned a number. Subsequently, all the numbers of the participants in the sample were randomly distributed among the 3 groups by the principal investigator.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Other: Simulated techniqueAfter completing an individual questionnaire and giving informed consent, a placebo technique was performed, consisting only of contact in the area of the participant's shoulders. |
| Experimental group MET | Experimental | Other: Muscle energy techniqueAfter completing an individual questionnaire and giving informed consent, the muscle energy technique was performed on the dominant hamstring muscle. |
| Experimental group CV-4 and MET | Experimental | Other: 4th ventricle technique and muscular energy techniqueAfter completing an individual questionnaire and giving informed consent, the 4th ventricle technique (CV-4) was performed, followed by the muscle energy technique on the dominant hamstring muscle. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Over 18 years old
- Female
- Playing federated basketball
- Signature of informed consent documents
Key exclusion criteria (4 listed)
- Surgical intervention/trauma in the areas of activity (cervical-cranial and lower limb)
- Exposure to medicinal therapy
- Participants with hypertension
- Participants at risk of cerebral hemorrhage (e.g. aneurysm)
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 |
|---|---|---|
| Simulated techniqueThe participant was in a supine position, with her upper limbs at her sides and her neck in a neutral position. The researcher sat in a cephalic position, making contact with the participant's shoulders, without any movement, until 5 minutes had elapsed. | Other | Control Group |
| Muscle energy techniqueThe participant was in a supine position, with her upper limbs alongside her body and her neck in a neutral position. The researcher adopted a position homolateral to the dominant limb, contacting the lower limb with the caudal hand in the region of the malleoli. He then helped the participant to perform the movement, which consisted of flexing the hip and extending the knee passively until the motor barrier was reached, and instructed her to perform an isometric contraction of the hamstrings. She was asked to perform three 7-second contractions with a 2 to 3-second interval, using approximately 20% of her maximum strength, gaining a new motor barrier between each set, for a total of three sets. | Other | Experimental group MET |
| 4th ventricle technique and muscular energy techniqueThe participant was in a supine position, with her upper limbs alongside her body and her neck in a neutral position. For CV-4, the researcher contacted the squamous portion of the occiput laterally, bringing it close to the posterior convexity of the occiput, bringing the skull into extension, changing the compression movement with decompression, until 3 minutes had elapsed. For the MET, the researcher adopted a position homolateral to the dominant limb, contacting the lower limb with the caudal hand in the region of the malleoli. She then helped the participant to perform the movement, which consisted of flexing the hip and extending the knee passively to the motor barrier, having been instructed to perform an isometric contraction of the hamstring. A total of 3 7-second contractions with a 2-3 second interval were requested, using approximately 20% of her maximum strength, and with a new motor barrier being gained between each series, for a total of 3 series. | Other | Experimental group CV-4 and MET |
Primary outcome
Altered range of motion of the hamstring muscles.
Time frame: 10 minutes after intervention.
The universal goniometer is a tool used to assess joint ROM.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- BackgroundBalasubramaniam, A., Gandhi V, M., Purushothaman, V. K. (2022). Myofascial Release Theraphy versus Muscle Energy Technique on Hamstring Flexibility in Physical Inactive students - A randomized controlled trial. Universal Journal of Public Health, 299-303.
- BackgroundBarroso, G. C., & Thiele, E. S. (2011, Junho 28). Lesão Muscular nos Atletas.
- BackgroundBonorino, D. S. (2017). Efeitos da técnica CV-4 para o tratamento da enxaqueca.
- BackgroundChaitow, L. (2013). Muscle Energy Techniques.
- BackgroundChaitow, L. (2023). Muscle Energy Techniques (Fifth Edition ed.). Elsevier.
- BackgroundDeLucia, R. (2016). Farmacologia Integrada: Uso Racional de Medicamentos.
- BackgroundDeStefano, L. (2011). Principales of Manual Medicine. Wolters Kluwer.
- BackgroundE. de Gray, L., & Seth, B. (2020). Drugs used to treat joint and muscle disease.
- BackgroundFavareto, R. M. (2019). Influência da manipulação osteopática craniana, sobre o sistema nervoso autônomo mensurado pela neurometria funcional em pacientes com fibromialgia. Revista Científica de Neurometria, 5.
- BackgroundFryer, G., Fleischmann, M., & Vaughan, B. (2021). Use of muscle energy technique amongst a nationally representative sample of Australian Osteopaths. International Journal of Osteopathic Medicine, 5.
- Background: PubMed 22182954Jakel A, von Hauenschild P. Therapeutic effects of cranial osteopathic manipulative medicine: a systematic review. J Am Osteopath Assoc. 2011 Dec;111(12):685-93.
- Background: PubMed 37107922Kang YH, Ha WB, Geum JH, Woo H, Han YH, Park SH, Lee JH. Effect of Muscle Energy Technique on Hamstring Flexibility: Systematic Review and Meta-Analysis. Healthcare (Basel). 2023 Apr 11;11(8):1089. doi: 10.3390/healthcare11081089.
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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.
Natália MO Campelo, PhD principal investigator
Escola Superior de Saúde do Politecnico do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulated technique, Muscle energy technique and 4th ventricle technique and muscular energy technique in people with Healthy, run by Natália Maria Oliveira Campelo at 1 site in Portugal.
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 4 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: status not confirmed, as of the sponsor's last update on 30 Apr 2024. 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 Portugal. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natália MO Campelo, PhD (+35122 206 1000, nmc@ess.ipp.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Altered range of motion of the hamstring muscles. (time frame: 10 minutes after intervention.). 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 NCT06357611, which also lists 19 linked publications.
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 30 Apr 2024.