ManipulationNCT05583760
Stabilometric and Baropodometric Evaluation After Osteopathic Scaphoid Tug Manipulation
A study testing Experimental: Osteopathic manipulation TUG for scaphoid bone in people with Manipulation and Osteopathic, run by Cardenal Herrera University at 1 site in Spain.
Trial summary
This is a clinical, longitudinal, prospective and randomised study in which the subject will be assessed by stabilometric and baropodometric techniques on two occasions (before being subjected to the scaphoid tug manipulation for the experimental group or placebo technique in the case of the control group). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Manipulation, Osteopathic
- What is being tested?
- Experimental: Osteopathic manipulation TUG for scaphoid bone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 18 Oct 2022to 7 Feb 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with right scaphoid external rotation dysfunction
Who cannot join
- Suffering from disorders that alter balance (tension headaches, vertigo, migraines...).
- Deformities, orthopaedic injuries or sequelae in the limbs or spine that may alter postural statics (valgus-varus, lower limb operations, lower limb dysmetries, scoliosis, etc.).
- Pathologies or sequelae related to the postural sensors or disorders in the same:
- Uncorrected visual defects.
- Vestibular disorders.
- Uncorrected stomatological disorders.
Show all 12Show fewer
- Sensory alterations in the foot sensor (Hypoaesthesia, Morton's neuroma, tarsal canal syndrome, etc.).
- Cutaneous alterations that influence the foot pick-up (papillomas, plantar warts, ingrown toenails, etc.).
- Ingestion of medication that alters the perception of stability.
- Having any contraindication to the scaphoid tug technique.
- Having carried out intense physical activity immediately prior to the study.
- Having received osteopathic treatment in the last month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stabilometric and Baropodometric Evaluation of Osteopathic Scaphoid Tug Manipulation
This is a clinical, longitudinal, prospective and randomised study in which the subject will be assessed by stabilometric and baropodometric techniques on two occasions (before being subjected to the scaphoid tug manipulation for the experimental group or placebo technique in the case of the control group).
- Conditions
- Manipulation, Osteopathic
- Being tested
- Experimental: Osteopathic manipulation TUG for scaphoid bone, Sham group: Sham osteopathic manipulation TUG for scaphoid bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Osteopathic manipulation TUG for scaphoid boneProcedure or surgery
The sequence of execution of the scaphoid TUG technique shall be applied as follows. Patient in the supine position. The inner hand of the intervener makes contact with the pisiform through the hypothenar eminence and ulnar border of the hand over the scaphoid tubercle, the outer hand reinforces the contact. The thumbs are directed to the sole of the patient's foot. The parameters are sought by bringing the sole of the foot into eversion, thus bringing the scaphoid into internal rotation (the direction of correction). In order to reduce the slack, the operator drops his body weight backwards while increasing the internal rotation parameter of the scaphoid. The manipulation is performed by associating a rapid traction movement with an increase of the correction parameter towards the internal rotation of the scaphoid.
Sham group: Sham osteopathic manipulation TUG for scaphoid boneProcedure or surgery
The intervention will be performed in the same way as the intervention group, without actually performing the TUG manipulation on the scaphoid bone, only placing it in tension.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Osteopathic manipulation TUG for scaphoid bone | Experimental | Not described Receives: Procedure: Experimental: Osteopathic manipulation TUG for scaphoid bone |
| Sham group: Sham osteopathic manipulation TUG for scaphoid bone | Sham comparator | Not described Receives: Procedure: Sham group: Sham osteopathic manipulation TUG for scaphoid bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
stabilometric measurements: oscillation about the X-axis
(mm)
Measured: five minutes post-intervention
stabilometric measurements: oscillation about the Y-axis
(mm)
Measured: five minutes post-intervention
stabilometric measurements: area of the ellipse
(cm2)
Measured: five minutes post-intervention
static baropodometric measurements: scan Foot bearing area
(cm2)
Measured: five minutes post-intervention
static baropodometric measurements: scan percentage of body load supported by each foot
Measured: five minutes post-intervention
static baropodometric measurements: scan point of maximum plantar pressure
(kg/cm2)
Measured: five minutes post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start18 Oct 2022
- Primary completion18 Oct 2022
- Study completion7 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ManipulationStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SERGIO MONTERO NAVARRO, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583760
- Sponsor's protocol ID
- CEEI22/322
- Status last verified
- Feb 2023
- First submitted
- 10 Oct 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Latash ML, Krishnamoorthy V, Scholz JP, Zatsiorsky VM. Postural synergies and their development. Neural Plast. 2005;12(2-3):119-30; discussion 263-72. doi: 10.1155/NP.2005.119.
PubMed 16097480Zhang Y, Kiemel T, Jeka J. The influence of sensory information on two-component coordination during quiet stance. Gait Posture. 2007 Jul;26(2):263-71. doi: 10.1016/j.gaitpost.2006.09.007. Epub 2006 Oct 13.
PubMed 17046262Myklebust JB, Prieto T, Myklebust B. Evaluation of nonlinear dynamics in postural steadiness time series. Ann Biomed Eng. 1995 Nov-Dec;23(6):711-9. doi: 10.1007/BF02584470.
PubMed 8572421Hessert MJ, Vyas M, Leach J, Hu K, Lipsitz LA, Novak V. Foot pressure distribution during walking in young and old adults. BMC Geriatr. 2005 May 19;5:8. doi: 10.1186/1471-2318-5-8.
PubMed 15943881Van Buskirk RL. Nociceptive reflexes and the somatic dysfunction: a model. J Am Osteopath Assoc. 1990 Sep;90(9):792-4, 797-809.
PubMed 2211195
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stabilometric and Baropodometric Evaluation of Osteopathic Scaphoid Tug Manipulation
- ClinicalTrials.gov ID
- NCT05583760
- Acronym / sponsor ID
- CEEI22/322
- Conditions
- Manipulation, Osteopathic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 18 Oct 2022 (actual)
- Study completion
- 7 Feb 2023 (actual)
- First posted
- 18 Oct 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.
This is a clinical, longitudinal, prospective and randomised study in which the subject will be assessed by stabilometric and baropodometric techniques on two occasions (before being subjected to the scaphoid tug manipulation for the experimental group or placebo technique in the case of the control group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Osteopathic manipulation TUG for scaphoid bone | Experimental | Procedure: Experimental: Osteopathic manipulation TUG for scaphoid bone |
| Sham group: Sham osteopathic manipulation TUG for scaphoid bone | Sham comparator | Procedure: Sham group: Sham osteopathic manipulation TUG for scaphoid bone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with right scaphoid external rotation dysfunction
Key exclusion criteria (12 listed)
- Suffering from disorders that alter balance (tension headaches, vertigo, migraines...).
- Deformities, orthopaedic injuries or sequelae in the limbs or spine that may alter postural statics (valgus-varus, lower limb operations, lower limb dysmetries, scoliosis, etc.).
- Pathologies or sequelae related to the postural sensors or disorders in the same:
- Having any contraindication to the scaphoid tug technique.
- Having carried out intense physical activity immediately prior to the study.
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 |
|---|---|---|
| Experimental: Osteopathic manipulation TUG for scaphoid boneThe sequence of execution of the scaphoid TUG technique shall be applied as follows. Patient in the supine position. The inner hand of the intervener makes contact with the pisiform through the hypothenar eminence and ulnar border of the hand over the scaphoid tubercle, the outer hand reinforces the contact. The thumbs are directed to the sole of the patient's foot. The parameters are sought by bringing the sole of the foot into eversion, thus bringing the scaphoid into internal rotation (the direction of correction). In order to reduce the slack, the operator drops his body weight backwards while increasing the internal rotation parameter of the scaphoid. The manipulation is performed by associating a rapid traction movement with an increase of the correction parameter towards the internal rotation of the scaphoid. | Procedure or surgery | Experimental: Osteopathic manipulation TUG for scaphoid bone |
| Sham group: Sham osteopathic manipulation TUG for scaphoid boneThe intervention will be performed in the same way as the intervention group, without actually performing the TUG manipulation on the scaphoid bone, only placing it in tension. | Procedure or surgery | Sham group: Sham osteopathic manipulation TUG for scaphoid bone |
Primary outcome
stabilometric measurements: oscillation about the X-axis
Time frame: five minutes post-intervention
(mm)
stabilometric measurements: oscillation about the Y-axis
Time frame: five minutes post-intervention
(mm)
stabilometric measurements: area of the ellipse
Time frame: five minutes post-intervention
(cm2)
static baropodometric measurements: scan Foot bearing area
Time frame: five minutes post-intervention
(cm2)
static baropodometric measurements: scan percentage of body load supported by each foot
Time frame: five minutes post-intervention
static baropodometric measurements: scan point of maximum plantar pressure
Time frame: five minutes post-intervention
(kg/cm2)
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 8 Feb 2023.
- Background: PubMed 16097480Latash ML, Krishnamoorthy V, Scholz JP, Zatsiorsky VM. Postural synergies and their development. Neural Plast. 2005;12(2-3):119-30; discussion 263-72. doi: 10.1155/NP.2005.119.
- Background: PubMed 17046262Zhang Y, Kiemel T, Jeka J. The influence of sensory information on two-component coordination during quiet stance. Gait Posture. 2007 Jul;26(2):263-71. doi: 10.1016/j.gaitpost.2006.09.007. Epub 2006 Oct 13.
- Background: PubMed 8572421Myklebust JB, Prieto T, Myklebust B. Evaluation of nonlinear dynamics in postural steadiness time series. Ann Biomed Eng. 1995 Nov-Dec;23(6):711-9. doi: 10.1007/BF02584470.
- Background: PubMed 15943881Hessert MJ, Vyas M, Leach J, Hu K, Lipsitz LA, Novak V. Foot pressure distribution during walking in young and old adults. BMC Geriatr. 2005 May 19;5:8. doi: 10.1186/1471-2318-5-8.
- Background: PubMed 2211195Van Buskirk RL. Nociceptive reflexes and the somatic dysfunction: a model. J Am Osteopath Assoc. 1990 Sep;90(9):792-4, 797-809.
- The University CEU-Cardenal Herrera is th first private university inthe Valencian Community. It belongs to the Foundation San Pablo - CEU andis the leading educational organization in Spain with three Universities all overSpainLink provided by the sponsor.
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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 Experimental: Osteopathic manipulation TUG for scaphoid bone in people with Manipulation and Osteopathic, run by Cardenal Herrera University at 1 site in Spain.
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 12 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 8 Feb 2023. 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 Spain. 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?
stabilometric measurements: oscillation about the X-axis (time frame: five minutes post-intervention). The study lists 6 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 NCT05583760, which also lists 5 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 8 Feb 2023.