- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04337528
Osteopathic Thrust and Muscle-energy Manipulations on Sacroiliac Joint Dysfunction
Biomechanical Effects of Osteopathic Thrust and Muscle-energy Manipulations in Sacroiliac Joint Dysfunction of Athletes or Runners
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Linda H Chung, PhD
- Phone Number: +34 968 278 611
- Email: lhchung@ucam.edu
Study Locations
-
-
Murcia
-
Guadalupe, Murcia, Spain, 30107
- Recruiting
- UCAM Research Center for High Performance Sport
-
Contact:
- Linda H Chung, PhD
- Phone Number: 968 278 611
- Email: lhchung@ucam.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Amateur runners who perform between 10-30 km per week) and present a sacroiliac joint dysfunction.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Thrust Group
Participant will receive the thrust technique manipulation of the affected sacroiliac joint.
|
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.
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.
|
Active Comparator: Muscle-energy group
Participant will receive the muscle-energy technique manipulation of the affected sacroiliac joint.
|
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.
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.
|
Placebo Comparator: Placebo Group
Participant will receive a placebo manipulation of the affected sacroiliac joint.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
throughout study completion, an average of 1 month
|
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)
|
throughout study completion, an average of 1 month
|
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)
|
throughout study completion, an average of 1 month
|
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)
|
throughout study completion, an average of 1 month
|
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)
|
throughout study completion, an average of 1 month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Linda H Chung, PhD, UCAM Research Center for High Performance Sport
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CE031911
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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