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

Primary Purpose

Osteitis Pubis, Athletic Pubalgia

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
High force lateral distraction
Placebo distraction group
Sponsored by
University of Valladolid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteitis Pubis

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

High force lateral distraction group

Placebo distraction group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Strength
Strength evaluate for internal and external hip rotators with a conical pulley.
Strength
Strength evaluate for internal and external hip rotators with a conical pulley.
Strength
Strength evaluate for internal and external hip rotators with a conical pulley.

Secondary Outcome Measures

Pain in sports activities
Appearance time of pain during activities
Pain in sports activities
Appearance time of pain during activities
Pain in sports activities
Appearance time of pain during activities
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.
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.
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.
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".
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".
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".

Full Information

First Posted
January 16, 2023
Last Updated
May 8, 2023
Sponsor
University of Valladolid
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1. Study Identification

Unique Protocol Identification Number
NCT05716204
Brief Title
Effects of Manual Therapy in Strenght, Pain and Functional Capacity for Sport Related Groin Pain
Official Title
Effects on Pain, Strength and Functional Capacity of High Force Distraction of the Hip in Athletes With Osteitis Pubis.
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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteitis Pubis, Athletic Pubalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High force lateral distraction group
Arm Type
Experimental
Arm Description
High force lateral distraction of the hip in maximun adjusted position.
Arm Title
Placebo distraction group
Arm Type
Sham Comparator
Arm Description
Placebo lateral distraction of the affected hip in maximun adjusted position.
Intervention Type
Other
Intervention Name(s)
High force lateral distraction
Intervention Description
High force lateral distraction on the affected hip.
Intervention Type
Other
Intervention Name(s)
Placebo distraction group
Intervention Description
Placebo lateral distraction on the affected hip.
Primary Outcome Measure Information:
Title
Strength
Description
Strength evaluate for internal and external hip rotators with a conical pulley.
Time Frame
Baseline
Title
Strength
Description
Strength evaluate for internal and external hip rotators with a conical pulley.
Time Frame
Through study completion, an average of two weeks
Title
Strength
Description
Strength evaluate for internal and external hip rotators with a conical pulley.
Time Frame
3 months follow-up
Secondary Outcome Measure Information:
Title
Pain in sports activities
Description
Appearance time of pain during activities
Time Frame
Baseline
Title
Pain in sports activities
Description
Appearance time of pain during activities
Time Frame
Through study completion, an average of two weeks
Title
Pain in sports activities
Description
Appearance time of pain during activities
Time Frame
3 months follow-up
Title
Pain intensity during/after pain provocation tests: Single adductor, squeeze and bilateral adductor tests
Description
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.
Time Frame
Baseline
Title
Pain intensity after pain provocation tests: Single adductor, squeeze and bilateral adductor tests
Description
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.
Time Frame
Through study completion, an average of two weeks
Title
Pain intensity after pain provocation tests: Single adductor, squeeze and bilateral adductor tests
Description
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.
Time Frame
3 months follow-up
Title
Functional capacity
Description
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".
Time Frame
Baseline
Title
Functional capacity
Description
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".
Time Frame
Through study completion, an average of two weeks
Title
Functional capacity
Description
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".
Time Frame
3 months follow-up
Other Pre-specified Outcome Measures:
Title
Treatment expectancy and credibility
Description
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.
Time Frame
Through study completion, an average of two weeks
Title
Treatment expectancy and credibility
Description
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.
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
First Name & Middle Initial & Last Name & Degree
Luis Ceballos Laita
Organizational Affiliation
University of Valladolid
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sandra Jiménez del Barrio
Organizational Affiliation
University of Valladolid
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Maria Teresa Mingo Gómez
Organizational Affiliation
University of Valladolid
Official's Role
Study Director
Facility Information:
Facility Name
Silvia Lahuerta Martín
City
Soria
ZIP/Postal Code
42004
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15679570
Citation
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.
Results Reference
background
PubMed Identifier
21478502
Citation
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. Erratum In: Br J Sports Med. 2011 Jul;45(9):742.
Results Reference
background
PubMed Identifier
11132119
Citation
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.
Results Reference
background

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

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