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Osteopathic Thrust and Muscle-energy Manipulations on Sacroiliac Joint Dysfunction

Primary Purpose

Sacroiliac Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Osteopathic manipulation type thrust
Osteopathic manipulation type muscle-energy
Placebo technique
Sponsored by
Universidad Católica San Antonio de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sacroiliac Disorder focused on measuring osteopathy, baropodometry

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UCAM Research Center for High Performance SportRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Thrust Group

Muscle-energy group

Placebo Group

Arm Description

Participant will receive the thrust technique manipulation of the affected sacroiliac joint.

Participant will receive the muscle-energy technique manipulation of the affected sacroiliac joint.

Participant will receive a placebo manipulation of the affected sacroiliac joint.

Outcomes

Primary Outcome Measures

Change in Weight Distribution
The baropodometry platform will be used to measure the distribution of weight (%) between legs.
Center of Gravity Displacement
The baropodometry platform will measure the distance traveled (mm in x- and y-axis)
Center of Pressure Displacement
The baropodometry platform will measure the distance traveled (mm in x- and y-axis)
Change in Plantar support
The baropodometry platform will measure the distribution of weight (%) across the foot (i.e., forefoot and rearfoot)
Foot Plantar Pressure
The baropodometry platform will measure the points of pressure across the foot with the aid of colorimetry (N/cm2)

Secondary Outcome Measures

Full Information

First Posted
February 18, 2020
Last Updated
November 11, 2020
Sponsor
Universidad Católica San Antonio de Murcia
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1. Study Identification

Unique Protocol Identification Number
NCT04337528
Brief Title
Osteopathic Thrust and Muscle-energy Manipulations on Sacroiliac Joint Dysfunction
Official Title
Biomechanical Effects of Osteopathic Thrust and Muscle-energy Manipulations in Sacroiliac Joint Dysfunction of Athletes or Runners
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 7, 2020 (Actual)
Primary Completion Date
March 30, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Católica San Antonio de Murcia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sacroiliac Disorder
Keywords
osteopathy, baropodometry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group 1: Thrust technique Group 2: Muscle-energy technique Group 3: Placebo
Masking
ParticipantOutcomes Assessor
Masking Description
Participants and the assessor of pre-post-biomechanical measurements will be blinded to which manipulation the participant has been assigned to. The manipulation intervention will be performed by a separate physical therapist who is not involved with the biomechanical measurements.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thrust Group
Arm Type
Experimental
Arm Description
Participant will receive the thrust technique manipulation of the affected sacroiliac joint.
Arm Title
Muscle-energy group
Arm Type
Active Comparator
Arm Description
Participant will receive the muscle-energy technique manipulation of the affected sacroiliac joint.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Participant will receive a placebo manipulation of the affected sacroiliac joint.
Intervention Type
Other
Intervention Name(s)
Osteopathic manipulation type thrust
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Osteopathic manipulation type muscle-energy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Weight Distribution
Description
The baropodometry platform will be used to measure the distribution of weight (%) between legs.
Time Frame
throughout study completion, an average of 1 month
Title
Center of Gravity Displacement
Description
The baropodometry platform will measure the distance traveled (mm in x- and y-axis)
Time Frame
throughout study completion, an average of 1 month
Title
Center of Pressure Displacement
Description
The baropodometry platform will measure the distance traveled (mm in x- and y-axis)
Time Frame
throughout study completion, an average of 1 month
Title
Change in Plantar support
Description
The baropodometry platform will measure the distribution of weight (%) across the foot (i.e., forefoot and rearfoot)
Time Frame
throughout study completion, an average of 1 month
Title
Foot Plantar Pressure
Description
The baropodometry platform will measure the points of pressure across the foot with the aid of colorimetry (N/cm2)
Time Frame
throughout study completion, an average of 1 month

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linda H Chung, PhD
Phone
+34 968 278 611
Email
lhchung@ucam.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda H Chung, PhD
Organizational Affiliation
UCAM Research Center for High Performance Sport
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCAM Research Center for High Performance Sport
City
Guadalupe
State/Province
Murcia
ZIP/Postal Code
30107
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda H Chung, PhD
Phone
968 278 611
Email
lhchung@ucam.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Osteopathic Thrust and Muscle-energy Manipulations on Sacroiliac Joint Dysfunction

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