Effects of Manual Therapy in Strenght, Pain and Functional Capacity for Sport Related Groin Pain

Effects on Pain, Strength and Functional Capacity of High Force Distraction of the Hip in Athletes With Osteitis Pubis.

Athletic osteitis pubis is a pathologic entity that can cause functional impairment. Scientific evidence have noticed that athletes experiment pain and a decrease on strength. Moreover, this symptomathology can affect daily life and functionality. There is no scientific evidence about the influence of manual therapy (MT) as a single treatment to improve this condition. The investigators decided to conduct a randomized controlled trial to compare the effects of a MT technique with placebo technique.

Study Overview

• Status: Withdrawn
• Conditions: Athletic Pubalgia; Osteitis Pubis
• Intervention / Treatment: Other: High force lateral distraction; Other: Placebo distraction group

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Soria, Spain, 42004
    • 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: High force lateral distraction group; High force lateral distraction of the hip in maximun adjusted position.	Other: High force lateral distraction; High force lateral distraction on the affected hip.
Sham Comparator: Placebo distraction group; Placebo lateral distraction of the affected hip in maximun adjusted position.	Other: Placebo distraction group; Placebo lateral distraction on the affected hip.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Strength	Strength evaluate for internal and external hip rotators with a conical pulley.	Baseline
Strength	Strength evaluate for internal and external hip rotators with a conical pulley.	Through study completion, an average of two weeks
Strength	Strength evaluate for internal and external hip rotators with a conical pulley.	3 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain in sports activities	Appearance time of pain during activities	Baseline
Pain in sports activities	Appearance time of pain during activities	Through study completion, an average of two weeks
Pain in sports activities	Appearance time of pain during activities	3 months follow-up
Pain intensity during/after pain provocation tests: Single adductor, squeeze and bilateral adductor tests	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 after pain provocation tests: Single adductor, squeeze and bilateral adductor tests	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.	Through study completion, an average of two weeks
Pain intensity after pain provocation tests: Single adductor, squeeze and bilateral adductor tests	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.	3 months follow-up
Functional capacity	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
Functional capacity	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".	Through study completion, an average of two weeks
Functional capacity	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".	3 months follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment expectancy and credibility	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.	Through study completion, an average of two weeks
Treatment expectancy and credibility	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.	3 months follow-up

Collaborators and Investigators

• Sponsor: University of Valladolid
• Investigators: Principal Investigator: Silvia Lahuerta Martín, University of Valladolid; Study Director: Luis Ceballos Laita, University of Valladolid; Study Director: Sandra Jiménez del Barrio, University of Valladolid; Study Director: Maria Teresa Mingo Gómez, University of Valladolid

Publications and helpful links

General Publications

• Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.
• Verrall GM, Slavotinek JP, Barnes PG, Fon GT. Description of pain provocation tests used for the diagnosis of sports-related chronic groin pain: relationship of tests to defined clinical (pain and tenderness) and MRI (pubic bone marrow oedema) criteria. Scand J Med Sci Sports. 2005 Feb;15(1):36-42. doi: 10.1111/j.1600-0838.2004.00380.x.
• Thorborg K, Holmich P, Christensen R, Petersen J, Roos EM. The Copenhagen Hip and Groin Outcome Score (HAGOS): development and validation according to the COSMIN checklist. Br J Sports Med. 2011 May;45(6):478-91. doi: 10.1136/bjsm.2010.080937.

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: February 3, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 26, 2025
• 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: 067/229211

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