Sacroiliac DisorderNCT04337528
Osteopathic Thrust and Muscle-energy Manipulations on Sacroiliac Joint Dysfunction
A study testing Osteopathic manipulation type thrust and Osteopathic manipulation type muscle-energy in people with Sacroiliac Disorder, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
This study assesses the effect of manipulative techniques of thrust and muscle-energy over the sacroiliac joint on plantar foot support, weight distribution in the lower limbs and balance in amateur runners with sacroiliac dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sacroiliac Disorder
- What is being tested?
- Osteopathic manipulation type thrust and Osteopathic manipulation type muscle-energy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 7 Jan 2020to 30 Jun 2021
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Amateur runners who perform between 10-30 km per week) and present a sacroiliac joint dysfunction.
Who cannot join
- Low back pain
- Vertebral bone pathology
- Radicular neurological condition
- Fracture or recent surgical intervention in the lumbosacral or pelvic region
- Anatomical short leg with a difference greater than 0.5 cm
- Pregnant
- Fear of manipulation technique
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
UCAM Research Center for High Performance Sport
Guadalupe, Murcia, 30107
Linda H Chung, PhD, 968 278 611, lhchung@ucam.edu
About this study
Official title: Biomechanical Effects of Osteopathic Thrust and Muscle-energy Manipulations in Sacroiliac Joint Dysfunction of Athletes or Runners
This study assesses the effect of manipulative techniques of thrust and muscle-energy over the sacroiliac joint on plantar foot support, weight distribution in the lower limbs and balance in amateur runners with sacroiliac dysfunction. participants will be randomly assigned to one of 3 manipulations (i.e., intervention): thrust, muscle-energy or placebo.
Read the detailed description
The thrust manipulation applies a high velocity and intensity push in a specified direction to correct the position or movement of the sacroiliac joint.
The muscle-energy technique consists of the therapist correcting the sacroiliac joint while the participant is applying active resistance.
For the placebo manipulation, participants will receive a false manipulation over the affected joint, without producing movement at the sacroiliac joint.
- Conditions
- Sacroiliac Disorder
- Being tested
- Osteopathic manipulation type thrust, Osteopathic manipulation type muscle-energy, Placebo technique
- Keywords
- osteopathy, baropodometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic manipulation type thrustOther
The osteopathic manipulation type thrust is applied to solve the sacroiliac joint dysfunction. This technique applies a high velocity and intensity push in a specified direction to correct the dysfunction produced by a not correct position or movement of one joint.
Osteopathic manipulation type muscle-energyOther
The muscle-energy manipulation is applied to solve the sacroiliac joint dysfunction. This technique applies a movement with an intermittent resistance in a specified direction to correct the position or movement of one joint. The therapist applies the movement in the correct direction since he feels a limitation of movement. When he feels the limitation he requests to the participant pushing in the contrary direction without movement. After five or seven seconds the participant finishes the contraction and the therapist continues the correct movement since he feels once again the limitation, and he request to the participant contraction another five or seven seconds. The therapist request to the participant only three times, when he finish the three contraction and the therapy applies the last movement to correct direction the intervention finishes.
Placebo techniqueOther
The therapist simulates a false technique. The therapist applies movement in the sacroiliac joint without dysfunction, he applies movement since ninety degrees of pelvic flexion, and he wait sixty seconds. Whit this placebo technique the sacroiliac joint with the dysfunction is not altered.
| Study group | Role | What they receive |
|---|---|---|
| Thrust Group | Experimental | Participant will receive the thrust technique manipulation of the affected sacroiliac joint. Receives: Other: Osteopathic manipulation type muscle-energy; Other: Placebo technique |
| Muscle-energy group | Active comparator | Participant will receive the muscle-energy technique manipulation of the affected sacroiliac joint. Receives: Other: Osteopathic manipulation type thrust; Other: Placebo technique |
| Placebo Group | Placebo comparator | Participant will receive a placebo manipulation of the affected sacroiliac joint. Receives: Other: Osteopathic manipulation type thrust; Other: Osteopathic manipulation type muscle-energy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight Distribution
The baropodometry platform will be used to measure the distribution of weight (%) between legs.
Measured: throughout study completion, an average of 1 month
Center of Gravity Displacement
The baropodometry platform will measure the distance traveled (mm in x- and y-axis)
Measured: throughout study completion, an average of 1 month
Center of Pressure Displacement
The baropodometry platform will measure the distance traveled (mm in x- and y-axis)
Measured: throughout study completion, an average of 1 month
Change in Plantar support
The baropodometry platform will measure the distribution of weight (%) across the foot (i.e., forefoot and rearfoot)
Measured: throughout study completion, an average of 1 month
Foot Plantar Pressure
The baropodometry platform will measure the points of pressure across the foot with the aid of colorimetry (N/cm2)
Measured: throughout study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start7 Jan 2020
- Primary completion30 Mar 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac DisorderStudies 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
- Group 1: Thrust technique Group 2: Muscle-energy technique Group 3: Placebo
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda H. Chung, Universidad Católica San Antonio de Murcia
- Investigators
- Linda H Chung, PhD, Principal investigator, UCAM Research Center for High Performance Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04337528
- Sponsor's protocol ID
- CE031911
- Status last verified
- Nov 2020
- First submitted
- 18 Feb 2020
- Last updated
- 13 Nov 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 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical Effects of Osteopathic Thrust and Muscle-energy Manipulations in Sacroiliac Joint Dysfunction of Athletes or Runners
- ClinicalTrials.gov ID
- NCT04337528
- Acronym / sponsor ID
- CE031911
- Conditions
- Sacroiliac Disorder
- Keywords
- osteopathy, baropodometry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 7 Apr 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.
This study assesses the effect of manipulative techniques of thrust and muscle-energy over the sacroiliac joint on plantar foot support, weight distribution in the lower limbs and balance in amateur runners with sacroiliac dysfunction. participants will be randomly assigned to one of 3 manipulations (i.e., intervention): thrust, muscle-energy or placebo.
Detailed description
The thrust manipulation applies a high velocity and intensity push in a specified direction to correct the position or movement of the sacroiliac joint.
The muscle-energy technique consists of the therapist correcting the sacroiliac joint while the participant is applying active resistance.
For the placebo manipulation, participants will receive a false manipulation over the affected joint, without producing movement at the sacroiliac joint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Group 1: Thrust technique Group 2: Muscle-energy technique Group 3: Placebo
| Arm | Type | Receives |
|---|---|---|
| Thrust Group | Experimental | Other: Osteopathic manipulation type muscle-energy, Other: Placebo techniqueParticipant will receive the thrust technique manipulation of the affected sacroiliac joint. |
| Muscle-energy group | Active comparator | Other: Osteopathic manipulation type thrust, Other: Placebo techniqueParticipant will receive the muscle-energy technique manipulation of the affected sacroiliac joint. |
| Placebo Group | Placebo comparator | Other: Osteopathic manipulation type thrust, Other: Osteopathic manipulation type muscle-energyParticipant will receive a placebo manipulation of the affected sacroiliac joint. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Amateur runners who perform between 10-30 km per week) and present a sacroiliac joint dysfunction.
Key exclusion criteria (7 listed)
- Low back pain
- Vertebral bone pathology
- Radicular neurological condition
- Fracture or recent surgical intervention in the lumbosacral or pelvic region
- Anatomical short leg with a difference greater than 0.5 cm
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 |
|---|---|---|
| Osteopathic manipulation type thrustThe osteopathic manipulation type thrust is applied to solve the sacroiliac joint dysfunction. This technique applies a high velocity and intensity push in a specified direction to correct the dysfunction produced by a not correct position or movement of one joint. | Other | Muscle-energy group, Placebo Group |
| Osteopathic manipulation type muscle-energyThe muscle-energy manipulation is applied to solve the sacroiliac joint dysfunction. This technique applies a movement with an intermittent resistance in a specified direction to correct the position or movement of one joint. The therapist applies the movement in the correct direction since he feels a limitation of movement. When he feels the limitation he requests to the participant pushing in the contrary direction without movement. After five or seven seconds the participant finishes the contraction and the therapist continues the correct movement since he feels once again the limitation, and he request to the participant contraction another five or seven seconds. The therapist request to the participant only three times, when he finish the three contraction and the therapy applies the last movement to correct direction the intervention finishes. | Other | Placebo Group, Thrust Group |
| Placebo techniqueThe therapist simulates a false technique. The therapist applies movement in the sacroiliac joint without dysfunction, he applies movement since ninety degrees of pelvic flexion, and he wait sixty seconds. Whit this placebo technique the sacroiliac joint with the dysfunction is not altered. | Other | Muscle-energy group, Thrust Group |
Primary outcome
Change in Weight Distribution
Time frame: throughout study completion, an average of 1 month
The baropodometry platform will be used to measure the distribution of weight (%) between legs.
Center of Gravity Displacement
Time frame: throughout study completion, an average of 1 month
The baropodometry platform will measure the distance traveled (mm in x- and y-axis)
Center of Pressure Displacement
Time frame: throughout study completion, an average of 1 month
The baropodometry platform will measure the distance traveled (mm in x- and y-axis)
Change in Plantar support
Time frame: throughout study completion, an average of 1 month
The baropodometry platform will measure the distribution of weight (%) across the foot (i.e., forefoot and rearfoot)
Foot Plantar Pressure
Time frame: throughout study completion, an average of 1 month
The baropodometry platform will measure the points of pressure across the foot with the aid of colorimetry (N/cm2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 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.
Linda H Chung, PhD principal investigator
UCAM Research Center for High Performance Sport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic manipulation type thrust and Osteopathic manipulation type muscle-energy in people with Sacroiliac Disorder, run by Universidad Católica San Antonio de Murcia 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 7 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 13 Nov 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linda H Chung, PhD (+34 968 278 611, lhchung@ucam.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Weight Distribution (time frame: throughout study completion, an average of 1 month). The study lists 5 primary outcomes in all. 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 Nov 2020.