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.

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.

Study Overview

• Status: Recruiting
• Conditions: Osteitis Pubis
• Intervention / Treatment: Other: High force hip Lateral distraction; Other: Placebo force hip lateral distraction

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Silvia Lahuerta Martín; Phone Number: +34 620431438; Email: silvia.lahuerta@uva.es

Study Locations

• Spain
  • Soria, Spain
    • Recruiting
    • Silvia Lahuerta Martín

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lateral distraction group; High force lateral distraction of affected hip.	Other: High force hip Lateral distraction; 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.	Other: Placebo force hip lateral distraction; 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

Outcome Measure	Measure Description	Time Frame
Actual PAIN	actual pain reported by the patient using visual analog scale (VAS) from 0 to 10, in which higher scores are worse.	Baseline
Actual PAIN	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
Actual PAIN	actual pain reported by the patient using visual analog scale (VAS) from 0 to 10, in which higher scores are worse.	3 months follow-up
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.	Baseline
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.	after to two weeks of treatment
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.	3 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of Movement (ROM)	Hip ROM as described by Pua et al. (2008)	Baseline
Range of Movement (ROM)	Hip ROM as described by Pua et al. (2008)	after to two weeks of treatment
Range of Movement (ROM)	Hip ROM as described by Pua et al. (2008)	3 months follow-up
Global Rating of Change	Subjective impression as described in GROC scale by Jaeschke, Singer & Guyat (1989)	after to two weeks of treatment
Global Rating of Change	Subjective impression as described in GROC scale by Jaeschke, Singer & Guyat (1989)	3 months follow-up
Group of treatment assignment	Question about which group of treatment was the patient assigned in.	after to two weeks of treatment
Group of treatment assignment	Question about which group of treatment was the patient assigned in.	3 months follow-up

Collaborators and Investigators

• Sponsor: University of Valladolid
• Investigators: Principal Investigator: Silvia Lahuerta Martín, University of Valladolid

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: January 16, 2023
• First Submitted That Met QC Criteria: January 25, 2023
• First Posted (Actual): February 3, 2023

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Osteitis
• Other Study ID Numbers: CASVE-NM-22-623

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No