Manual Therapy for the Treatment of Athletic Pubalgia
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 Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Silvia Lahuerta Martín
- Phone Number: +34 620431438
- Email: silvia.lahuerta@uva.es
Study Locations
-
-
-
Soria, Spain
- Silvia Lahuerta Martín
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Lateral distraction group
High force lateral distraction of affected hip.
|
Hip lateral distraction in adjusted position of maximun flexion and internal rotation, with neutral position of abduction/adduction applying high force of distraction.
|
|
Sham Comparator: Placebo distraction group
Placebo lateral traction of affected hip.
|
Hip lateral distraction in adjusted position of maximun flexion and internal rotation, with neutral position of abduction/adduction applying placebo force of distraction.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Actual PAIN
Time Frame: Baseline
|
actual pain reported by the patient using visual analog scale (VAS) from 0 to 10, in which higher scores are worse.
|
Baseline
|
|
Actual PAIN
Time Frame: after to two weeks of treatment
|
actual pain reported by the patient using visual analog scale (VAS)from 0 to 10, in which higher scores are worse.
|
after to two weeks of treatment
|
|
Last week PAIN
Time Frame: Baseline
|
past week pain reported by the patient using visual analog scale (VAS) from 0 to 10, in which higher scores are worse.
|
Baseline
|
|
Last week PAIN
Time Frame: after to two weeks of treatment
|
past week pain reported by the patient using visual analog scale (VAS) from 0 to 10, in which higher scores are worse.
|
after to two weeks of treatment
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional capacity
Time Frame: Baseline
|
Evaluated with a patient reported outcome questionnaire called Copenhagen Hip and Groin Outcome score (HAGOS) which assesses pain, symptoms, physical function in daily living, physical function in sport and recreation, participation in physical activities and hip and groin -related quality of life.
For each item answer range from "never" to "always".
|
Baseline
|
|
Range of Movement (ROM)
Time Frame: Baseline
|
Hip ROM as described by Pua et al. (2008)
|
Baseline
|
|
Range of Movement (ROM)
Time Frame: after to two weeks of treatment
|
Hip ROM as described by Pua et al. (2008)
|
after to two weeks of treatment
|
|
Global Rating of Change
Time Frame: after to two weeks of treatment
|
Subjective impression as described in GROC scale by Jaeschke, Singer & Guyat (1989)
|
after to two weeks of treatment
|
|
Group of treatment assignment
Time Frame: after to two weeks of treatment
|
Question about which group of treatment was the patient assigned in.
|
after to two weeks of treatment
|
|
Pain in sport activities
Time Frame: Baseline
|
Appearance time of pain during activities
|
Baseline
|
|
Pain in sport activities
Time Frame: After two weeks of treatment
|
Appearance time of pain during activities
|
After two weeks of treatment
|
|
Pain intensity in pain provocation tests: Single adductor, squeeze and bilateral adductor tests
Time Frame: Baseline
|
Appearance of pain during or after the execution of Single adductor, squeeze and bilateral adductor tests.
If pain appears it will be reported by the patient using visual analog scale (VAS) from 0 to 10, in which higher scores are worse.
|
Baseline
|
|
Pain intensity in pain provocation tests: Single adductor, squeeze and bilateral adductor tests
Time Frame: After two weeks of treatment
|
Appearance of pain during or after the execution of Single adductor, squeeze and bilateral adductor tests.
If pain appears it will be reported by the patient using visual analog scale (VAS) from 0 to 10, in which higher scores are worse.
|
After two weeks of treatment
|
|
Muscle function
Time Frame: Baseline
|
Velocity (m/s), force (N) and power (W) evaluated for internal and external hip rotators with a rotary axis flywheel-encoder system.
|
Baseline
|
|
Muscle function
Time Frame: After two weeks of treatment
|
Velocity (m/s), force (N) and power (W) evaluated for internal and external hip rotators with a rotary axis flywheel-encoder system.
|
After two weeks of treatment
|
|
Functional capacity
Time Frame: After two weeks of treatment
|
Evaluated with a patient reported outcome questionnaire called Copenhagen Hip and Groin Outcome score (HAGOS) which assesses pain, symptoms, physical function in daily living, physical function in sport and recreation, participation in physical activities and hip and groin -related quality of life.
For each item answer range from "never" to "always".
|
After two weeks of treatment
|
|
Treatment credibility and expectancy
Time Frame: Day 1, before treatment
|
Evaluated with Credibility and expectancy Questionaire (CEQ) in which the patient answer question related to the expectations of the intervention.
Higher values mean better expectations on the therapy.
|
Day 1, before treatment
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Silvia Lahuerta Martín, University of Valladolid
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- CASVE-NM-22-623
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
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