NCT05716204

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

January 2, 2026

Status Verified

November 1, 2023

Enrollment Period

1.3 years

First QC Date

January 16, 2023

Last Update Submit

December 26, 2025

Conditions

Athletic PubalgiaOsteitis Pubis

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (9)

  • Pain in sports activities

    Baseline

  • Pain in sports activities

    Through study completion, an average of two weeks

  • Pain in sports activities

    3 months follow-up

  • Pain intensity during/after pain provocation tests: Single adductor, squeeze and bilateral adductor tests

    Baseline

  • Pain intensity after pain provocation tests: Single adductor, squeeze and bilateral adductor tests

    Through study completion, an average of two weeks

  • +4 more secondary outcomes

Other Outcomes (2)

  • Treatment expectancy and credibility

    Through study completion, an average of two weeks

  • Treatment expectancy and credibility

    3 months follow-up

Study Arms (2)

High force lateral distraction group

EXPERIMENTAL

High force lateral distraction of the hip in maximun adjusted position.

Other: High force lateral distraction

Placebo distraction group

SHAM COMPARATOR

Placebo lateral distraction of the affected hip in maximun adjusted position.

Other: Placebo distraction group

Interventions

High force lateral distractionOTHER

High force lateral distraction on the affected hip.

High force lateral distraction group
Placebo distraction groupOTHER

Placebo lateral distraction on the affected hip.

Placebo distraction group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Athletes diagnosed with osteitis pubis stage 1 with at least 3 months of evolution.
  • Internal rotation ROM limited.
  • Positive provocation pain tests.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Silvia Lahuerta Martín

Soria, 42004, Spain

Location

Related Publications (3)

  • 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.

    PMID: 15679570BACKGROUND

  • 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.

    PMID: 21478502BACKGROUND

  • 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.

    PMID: 11132119BACKGROUND

Study Officials

  • Silvia Lahuerta Martín

    University of Valladolid

    PRINCIPAL INVESTIGATOR

  • Luis Ceballos Laita

    University of Valladolid

    STUDY DIRECTOR

  • Sandra Jiménez del Barrio

    University of Valladolid

    STUDY DIRECTOR

  • Maria Teresa Mingo Gómez

    University of Valladolid

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 16, 2023

First Posted

February 8, 2023

Study Start

February 1, 2023

Primary Completion

June 1, 2024

Study Completion

September 1, 2024

Last Updated

January 2, 2026

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)