PainNCT04512651
The Thrust Technique of Tibiotarsal Joint on the Symptomatology of Pain at Classical Ballet Dancers
A study testing Tibiotarsal Thrust Manipulation and Simulation Tibiotarsal Thrust Manipulation in people with Pain and Osteopathia, run by Universidade Estadual do PiauÍ at 1 site in Brazil.
Trial summary
Classical ballet is a type of high performance dance that requires great effort and extreme joint positions by its dancers, not to mention a precise control of the ankle joint when on pointe position. Read more about this study
- Who is it for?
- Ages 15 to 15 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Osteopathia, Ankle Injuries
- What is being tested?
- Tibiotarsal Thrust Manipulation and Simulation Tibiotarsal Thrust Manipulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Jun 2017to 1 Oct 2017
- 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 15 to 15 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Classical ballet dancers with a minimum period of 02 years of practice and who presented pain complaints in the ankle during ballet training, pain at palpation in the anterior and posterior tibiotalar joint of the ankle and dysfunction in compression of the tibiotarsal joint.
Who cannot join
- Classical ballet dancers with joint hypermobility, painful symptomatology without tibiotarsal compression of the dysfunction and participants who suffered some injury during the survey period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Thrust Technique of Tibiotarsal Joint on the Symptomatology of Pain at Classical Ballet Dancers
Classical ballet is a type of high performance dance that requires great effort and extreme joint positions by its dancers, not to mention a precise control of the ankle joint when on pointe position. Ballet dancers excessively dorsiflex, and especially plantar flex the ankle, which predisposes anterior displacement of the talus, possibly causing mobility restrictions of the tibiotarsal articulation and making it difficult and painful to move the ankle while dancing. The Thrust technique of tibiotarsal joint is a manipulation that aim to improve mobility and articular function through a high-speed and short-range movement. The purpose of the study is to verify the effect of the Thrust technique of tibiotarsal joint on the pain symptomatology in classical ballet dancers. Ballerinas included in the study presented pain in the ankle when dancing classical ballet, tenderness to palpation in the anterior and posterior tibiotarsal articulation, and dysfunction after compression of the tibiotarsal articulation. The sample consisted of 20 ballerinas, out of which 10 were subjected to manipulation (IG) and 10 formed the control group (CG). Algic symptomatology in classical ballet dance was assessed after some practice with the Visual Analogue Scale (VAS). After that, an algometer was used to quantify the threshold of pain in the anterior and posterior ankle joint that presented restrictions in mobility. The Tug technique was performed in the tibiotarsal articulation in the IG, and in the CG it was simulated. The threshold of pain in the anterior and posterior tibiotalar joint was measured again immediately after the intervention or simulation. The ballerinas were reassessed using algometry and the Visual Analogue Scale (VAS) one week after the manipulation.
Read the detailed description
This is a randomized clinical trial of quantitative character, realized in a classical ballet school in Teresina, Piauí, Brazil, from June to October 2017. The present research was approved by the Ethics and Research Committee of State University of Piauí. The participants or their guardians signed the Term of Free and Informed Consent in accordance with Resolution 466/12 of the National Health Council (CNS).
The Random randomization in two groups (n=10, each) happens through drawing lots, with the intervention group (GI) submitted to the thrust technique of the tibiotarsal joint for decoaptation of this joint, and the control group (GC), to its simulation.
The instruments used to data collect from the study were: (1) Visual Analog Scale (VAS), a scale that quantifies the intensity of pain through punctuated values, at one extreme of 0, indicating "no pain", to 10, pointing an "maximum pain" 19; (2) Digital algometer (Wagner Instuments®) with a capacity of ten kilograms-force (kgf) and compression deformation of 10 cm, to evaluate the threshold of painful pressure; (3) Questionnaire, developed by the researchers, relating to personal and anthropometric data and related to the ballet practice.
The data collection was carried out in an evaluation room at the ballet school, after the dancers had participated of the classical dance, by a research assistant that was blind to conditions for treatment. The evaluation of the dysfunction in compression of tibiotarsis and the osteopathic manipulation were performed by an experienced osteopath and familiarized with the technique.
To determine the presence of tibiotarsal compression dysfunction in dancers who presented pain during dancing and on palpation at the anterior and posterior tibiotalar joint, the tibiotarsal coaptation and decoaptation test was performed20 (Figure 01): the participants were positioned in dorsal decubitus, already the osteopath, with the internal hand slipped the pinky finger on the medial edge of the foot to the talus neck, the other fingers on the dorsum of the foot and the thumbs on the sole of the foot, the ankle of the dancer was kept in slight inversion and plantar flexion, the therapist flexed his knees, until his forearms stay in the same level as the lower limbs of the participant. Shortly after tractioned and related the joint to perceive if there articulation mobility, or if the joint was fixed.
The VAS was used to weighting (evaluate) the effects on pre and post-test of the osteopathic manipulation, and the algometer checked quantitatively. The points measured by this instrument were the anterior and posterior tibiotalar joint. Before the evaluation, the dancers were submitted to familiarity with the equipment in the triceps surae, in which they were orientated to inform when the pressure would become a painful sensation. In the assessment, the algometer was positioned perpendicularly at the aforementioned points (Figure 01).
The GI dancers, submitted to tibiotarsal thrust manipulation (Figure 02), were positioned in dorsal decubitus position with the heel outside the stretcher. The osteopath positioned in a lateral feint, inflected knees and forearms in the same plane as the participant's leg. With the internal hand slipped the pinky finger on the medial edge of the foot to the talus neck, the other fingers on the dorsum of the foot and the thumbs controlling the first metatarsus. The position of the talus in relation to the tibia was corrected, initially by placing the foot in eversion and then in dorsal flexion. The osteopath left the body weight behind, causing a traction in the joint. The thrust consisted of a impulse of high speed and low amplitude impulse in a caudal direction, closing the elbows20. The technique was performed until the obtainment (achieved) the joint noise only in the restricted foot, and only one service was performed. After one week, a reassessment of the painful sensation after the dance was performed.
For the CG was performed the simulation of the technique, with the participants and the osteopath positioned in the same way as the IG, however there was no reproduction of joint noise.
- Conditions
- Pain, Osteopathia, Ankle Injuries
- Being tested
- Tibiotarsal Thrust Manipulation, Simulation Tibiotarsal Thrust Manipulation
- Keywords
- Osteopathy, Thrust, Classical Ballet, Pain
- Medical subject headings
- Pain, Bone Diseases, Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tibiotarsal Thrust ManipulationOther
The dancers were positioned in dorsal decubitus position with the heel outside the stretcher. The osteopath positioned in a lateral feint, inflected knees and forearms in the same plane as the participant's leg. With the internal hand slipped the pinky finger on the medial edge of the foot to the talus neck, the other fingers on the dorsum of the foot and the thumbs controlling the first metatarsus. The position of the talus in relation to the tibia was corrected, initially by placing the foot in eversion and then in dorsal flexion. The osteopath left the body weight behind, causing a traction in the joint. The thrust consisted of a impulse of high speed and low amplitude impulse in a caudal direction, closing the elbows20. The technique was performed until the obtainment (achieved) the joint noise only in the restricted foot, and only one service was performed. After one week, a reassessment of the painful sensation after the dance was performed.
Simulation Tibiotarsal Thrust ManipulationOther
Simulation of the technique Tibiotarsal Thrust Manipulation, with the participants and the osteopath positioned in the same way as the IG, however there was no reproduction of joint noise.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (IG) | Experimental | The GI dancers, submitted to tibiotarsal thrust manipulation Receives: Other: Tibiotarsal Thrust Manipulation |
| Control Group (CG) | Sham comparator | For the CG was performed the simulation of the technique, with the participants and the osteopath positioned in the same way as the IG, however there was no reproduction of joint noise. Receives: Other: Simulation Tibiotarsal Thrust Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
A scale that quantifies the intensity of pain through punctuated values, at one extreme of 0, indicating "no pain", to 10, pointing an "maximum pain"
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start10 Jun 2017
- Primary completion1 Oct 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Model description
- This is a randomized clinical trial of quantitative character.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual do PiauÍ
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laiana Sepúlveda de Andrade Mesquita, Universidade Estadual do PiauÍ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512651
- Sponsor's protocol ID
- 2.064.502
- Status last verified
- Aug 2020
- First submitted
- 8 Aug 2020
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Thrust Technique of Tibiotarsal Joint on the Symptomatology of Pain at Classical Ballet Dancers
- ClinicalTrials.gov ID
- NCT04512651
- Acronym / sponsor ID
- 2.064.502
- Conditions
- Pain, Osteopathia, Ankle Injuries
- Keywords
- Osteopathy, Thrust, Classical Ballet, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidade Estadual do PiauÍUniversity, hospital or other
- Study start
- 10 Jun 2017 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 13 Aug 2020 (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.
Classical ballet is a type of high performance dance that requires great effort and extreme joint positions by its dancers, not to mention a precise control of the ankle joint when on pointe position. Ballet dancers excessively dorsiflex, and especially plantar flex the ankle, which predisposes anterior displacement of the talus, possibly causing mobility restrictions of the tibiotarsal articulation and making it difficult and painful to move the ankle while dancing. The Thrust technique of tibiotarsal joint is a manipulation that aim to improve mobility and articular function through a high-speed and short-range movement. The purpose of the study is to verify the effect of the Thrust technique of tibiotarsal joint on the pain symptomatology in classical ballet dancers. Ballerinas included in the study presented pain in the ankle when dancing classical ballet, tenderness to palpation in the anterior and posterior tibiotarsal articulation, and dysfunction after compression of the tibiotarsal articulation. The sample consisted of 20 ballerinas, out of which 10 were subjected to manipulation (IG) and 10 formed the control group (CG). Algic symptomatology in classical ballet dance was assessed after some practice with the Visual Analogue Scale (VAS). After that, an algometer was used to quantify the threshold of pain in the anterior and posterior ankle joint that presented restrictions in mobility. The Tug technique was performed in the tibiotarsal articulation in the IG, and in the CG it was simulated. The threshold of pain in the anterior and posterior tibiotalar joint was measured again immediately after the intervention or simulation. The ballerinas were reassessed using algometry and the Visual Analogue Scale (VAS) one week after the manipulation.
Detailed description
This is a randomized clinical trial of quantitative character, realized in a classical ballet school in Teresina, Piauí, Brazil, from June to October 2017. The present research was approved by the Ethics and Research Committee of State University of Piauí. The participants or their guardians signed the Term of Free and Informed Consent in accordance with Resolution 466/12 of the National Health Council (CNS).
The Random randomization in two groups (n=10, each) happens through drawing lots, with the intervention group (GI) submitted to the thrust technique of the tibiotarsal joint for decoaptation of this joint, and the control group (GC), to its simulation.
The instruments used to data collect from the study were: (1) Visual Analog Scale (VAS), a scale that quantifies the intensity of pain through punctuated values, at one extreme of 0, indicating "no pain", to 10, pointing an "maximum pain" 19; (2) Digital algometer (Wagner Instuments®) with a capacity of ten kilograms-force (kgf) and compression deformation of 10 cm, to evaluate the threshold of painful pressure; (3) Questionnaire, developed by the researchers, relating to personal and anthropometric data and related to the ballet practice.
The data collection was carried out in an evaluation room at the ballet school, after the dancers had participated of the classical dance, by a research assistant that was blind to conditions for treatment. The evaluation of the dysfunction in compression of tibiotarsis and the osteopathic manipulation were performed by an experienced osteopath and familiarized with the technique.
To determine the presence of tibiotarsal compression dysfunction in dancers who presented pain during dancing and on palpation at the anterior and posterior tibiotalar joint, the tibiotarsal coaptation and decoaptation test was performed20 (Figure 01): the participants were positioned in dorsal decubitus, already the osteopath, with the internal hand slipped the pinky finger on the medial edge of the foot to the talus neck, the other fingers on the dorsum of the foot and the thumbs on the sole of the foot, the ankle of the dancer was kept in slight inversion and plantar flexion, the therapist flexed his knees, until his forearms stay in the same level as the lower limbs of the participant. Shortly after tractioned and related the joint to perceive if there articulation mobility, or if the joint was fixed.
The VAS was used to weighting (evaluate) the effects on pre and post-test of the osteopathic manipulation, and the algometer checked quantitatively. The points measured by this instrument were the anterior and posterior tibiotalar joint. Before the evaluation, the dancers were submitted to familiarity with the equipment in the triceps surae, in which they were orientated to inform when the pressure would become a painful sensation. In the assessment, the algometer was positioned perpendicularly at the aforementioned points (Figure 01).
The GI dancers, submitted to tibiotarsal thrust manipulation (Figure 02), were positioned in dorsal decubitus position with the heel outside the stretcher. The osteopath positioned in a lateral feint, inflected knees and forearms in the same plane as the participant's leg. With the internal hand slipped the pinky finger on the medial edge of the foot to the talus neck, the other fingers on the dorsum of the foot and the thumbs controlling the first metatarsus. The position of the talus in relation to the tibia was corrected, initially by placing the foot in eversion and then in dorsal flexion. The osteopath left the body weight behind, causing a traction in the joint. The thrust consisted of a impulse of high speed and low amplitude impulse in a caudal direction, closing the elbows20. The technique was performed until the obtainment (achieved) the joint noise only in the restricted foot, and only one service was performed. After one week, a reassessment of the painful sensation after the dance was performed.
For the CG was performed the simulation of the technique, with the participants and the osteopath positioned in the same way as the IG, however there was no reproduction of joint noise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized clinical trial of quantitative character.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (IG) | Experimental | Other: Tibiotarsal Thrust ManipulationThe GI dancers, submitted to tibiotarsal thrust manipulation |
| Control Group (CG) | Sham comparator | Other: Simulation Tibiotarsal Thrust ManipulationFor the CG was performed the simulation of the technique, with the participants and the osteopath positioned in the same way as the IG, however there was no reproduction of joint noise. |
Who may qualify
- Ages
- 15 to 15 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Classical ballet dancers with a minimum period of 02 years of practice and who presented pain complaints in the ankle during ballet training, pain at palpation in the anterior and posterior tibiotalar joint of the ankle and dysfunction in compression of the tibiotarsal joint.
Key exclusion criteria (1 listed)
- Classical ballet dancers with joint hypermobility, painful symptomatology without tibiotarsal compression of the dysfunction and participants who suffered some injury during the survey period.
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 |
|---|---|---|
| Tibiotarsal Thrust ManipulationThe dancers were positioned in dorsal decubitus position with the heel outside the stretcher. The osteopath positioned in a lateral feint, inflected knees and forearms in the same plane as the participant's leg. With the internal hand slipped the pinky finger on the medial edge of the foot to the talus neck, the other fingers on the dorsum of the foot and the thumbs controlling the first metatarsus. The position of the talus in relation to the tibia was corrected, initially by placing the foot in eversion and then in dorsal flexion. The osteopath left the body weight behind, causing a traction in the joint. The thrust consisted of a impulse of high speed and low amplitude impulse in a caudal direction, closing the elbows20. The technique was performed until the obtainment (achieved) the joint noise only in the restricted foot, and only one service was performed. After one week, a reassessment of the painful sensation after the dance was performed. | Other | Intervention Group (IG) |
| Simulation Tibiotarsal Thrust ManipulationSimulation of the technique Tibiotarsal Thrust Manipulation, with the participants and the osteopath positioned in the same way as the IG, however there was no reproduction of joint noise. | Other | Control Group (CG) |
Primary outcome
Visual Analog Scale
Time frame: One week
A scale that quantifies the intensity of pain through punctuated values, at one extreme of 0, indicating "no pain", to 10, pointing an "maximum pain"
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 13 Aug 2020.
- Individual participant dataSharing planned: No
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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 Tibiotarsal Thrust Manipulation and Simulation Tibiotarsal Thrust Manipulation in people with Pain and Osteopathia, run by Universidade Estadual do PiauÍ at 1 site in Brazil.
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 1 inclusion and 1 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 13 Aug 2020. 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 Brazil. 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?
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?
Visual Analog Scale (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2020.