Back to resultsManual Therapy for the Treatment of Athletic Pubalgia
Primary Purpose
Osteitis Pubis
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
High force hip Lateral distraction
Placebo force hip lateral distraction
Sponsored by
About this trial
This is an interventional treatment trial for Osteitis Pubis
Eligibility Criteria
Inclusion Criteria: Athletes diagnosed with osteitis pubis stage 1 with at least 3 months of evolution. Internal rotation ROM limited. Positive provocation pain tests. Exclusion Criteria: Pain due to intraarticular hip pathology. Hip pain due to inflamatory diseases. Previous surgical interventions in hip, pelvis or lumbar spine. MRI results or provocation pain tests inconcluyent.
Sites / Locations
- Silvia Lahuerta MartínRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Lateral distraction group
Placebo distraction group
Arm Description
High force lateral distraction of affected hip.
Placebo lateral traction of affected hip.
Outcomes
Primary Outcome Measures
Actual PAIN
actual pain reported by the patient using visual analog scale (VAS) from 0 to 10, in which higher scores are worse.
Actual PAIN
actual pain reported by the patient using visual analog scale (VAS)from 0 to 10, in which higher scores are worse.
Actual PAIN
actual pain reported by the patient using visual analog scale (VAS) from 0 to 10, in which higher scores are worse.
Last week PAIN
past week pain reported by the patient using visual analog scale (VAS) from 0 to 10, in which higher scores are worse.
Last week PAIN
past week pain reported by the patient using visual analog scale (VAS) from 0 to 10, in which higher scores are worse.
Last week PAIN
past week pain reported by the patient using visual analog scale (VAS) from 0 to 10, in which higher scores are worse.
Secondary Outcome Measures
Range of Movement (ROM)
Hip ROM as described by Pua et al. (2008)
Range of Movement (ROM)
Hip ROM as described by Pua et al. (2008)
Range of Movement (ROM)
Hip ROM as described by Pua et al. (2008)
Global Rating of Change
Subjective impression as described in GROC scale by Jaeschke, Singer & Guyat (1989)
Global Rating of Change
Subjective impression as described in GROC scale by Jaeschke, Singer & Guyat (1989)
Group of treatment assignment
Question about which group of treatment was the patient assigned in.
Group of treatment assignment
Question about which group of treatment was the patient assigned in.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05712486
Brief Title
Manual Therapy for the Treatment of Athletic Pubalgia
Official Title
Effects on Pain Anda Range of Motion of High Force Lateral Distraction Mobilization of the Hip in Athletes With Hip-related Groin Pain. A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valladolid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Athletic osteitis pubis is a high prevalent pathology among athletes, especially in those who make quick change of direction of the movement, like runners or footballers. Despite the fact that there is evidence about conservative treatments, there is a lack of evidence about manual therapy (MT) techniques applied in isolation and its consequences in pain and range of movement. The investigators decided to conduct a randomized controlled trial to compare the effects of a MT technique with placebo technique.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteitis Pubis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Double- blind
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lateral distraction group
Arm Type
Experimental
Arm Description
High force lateral distraction of affected hip.
Arm Title
Placebo distraction group
Arm Type
Sham Comparator
Arm Description
Placebo lateral traction of affected hip.
Intervention Type
Other
Intervention Name(s)
High force hip Lateral distraction
Intervention Description
Hip lateral distraction in adjusted position of maximun flexion and internal rotation, with neutral position of abduction/adduction applying high force of distraction.
Intervention Type
Other
Intervention Name(s)
Placebo force hip lateral distraction
Intervention Description
Hip lateral distraction in adjusted position of maximun flexion and internal rotation, with neutral position of abduction/adduction applying placebo force of distraction.
Primary Outcome Measure Information:
Title
Actual PAIN
Description
actual pain reported by the patient using visual analog scale (VAS) from 0 to 10, in which higher scores are worse.
Time Frame
Baseline
Title
Actual PAIN
Description
actual pain reported by the patient using visual analog scale (VAS)from 0 to 10, in which higher scores are worse.
Time Frame
after to two weeks of treatment
Title
Actual PAIN
Description
actual pain reported by the patient using visual analog scale (VAS) from 0 to 10, in which higher scores are worse.
Time Frame
3 months follow-up
Title
Last week PAIN
Description
past week pain reported by the patient using visual analog scale (VAS) from 0 to 10, in which higher scores are worse.
Time Frame
Baseline
Title
Last week PAIN
Description
past week pain reported by the patient using visual analog scale (VAS) from 0 to 10, in which higher scores are worse.
Time Frame
after to two weeks of treatment
Title
Last week PAIN
Description
past week pain reported by the patient using visual analog scale (VAS) from 0 to 10, in which higher scores are worse.
Time Frame
3 months follow-up
Secondary Outcome Measure Information:
Title
Range of Movement (ROM)
Description
Hip ROM as described by Pua et al. (2008)
Time Frame
Baseline
Title
Range of Movement (ROM)
Description
Hip ROM as described by Pua et al. (2008)
Time Frame
after to two weeks of treatment
Title
Range of Movement (ROM)
Description
Hip ROM as described by Pua et al. (2008)
Time Frame
3 months follow-up
Title
Global Rating of Change
Description
Subjective impression as described in GROC scale by Jaeschke, Singer & Guyat (1989)
Time Frame
after to two weeks of treatment
Title
Global Rating of Change
Description
Subjective impression as described in GROC scale by Jaeschke, Singer & Guyat (1989)
Time Frame
3 months follow-up
Title
Group of treatment assignment
Description
Question about which group of treatment was the patient assigned in.
Time Frame
after to two weeks of treatment
Title
Group of treatment assignment
Description
Question about which group of treatment was the patient assigned in.
Time Frame
3 months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Athletes diagnosed with osteitis pubis stage 1 with at least 3 months of evolution.
Internal rotation ROM limited.
Positive provocation pain tests.
Exclusion Criteria:
Pain due to intraarticular hip pathology.
Hip pain due to inflamatory diseases.
Previous surgical interventions in hip, pelvis or lumbar spine.
MRI results or provocation pain tests inconcluyent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Silvia Lahuerta Martín
Phone
+34 620431438
Email
silvia.lahuerta@uva.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Lahuerta Martín
Organizational Affiliation
University of Valladolid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Silvia Lahuerta Martín
City
Soria
Country
Spain
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Manual Therapy for the Treatment of Athletic Pubalgia
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