Osteitis PubisNCT05716204
Effects of Manual Therapy in Strenght, Pain and Functional Capacity for Sport Related Groin Pain
A study testing High force lateral distraction in people with Osteitis Pubis and Athletic Pubalgia, run by University of Valladolid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Osteitis Pubis, Athletic Pubalgia
- What is being tested?
- High force lateral distraction
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2023to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Athletes diagnosed with osteitis pubis stage 1 with at least 3 months of evolution.
- Internal rotation ROM limited.
- Positive provocation pain tests.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Osteitis Pubis, Athletic Pubalgia
- Being tested
- High force lateral distraction, Placebo distraction group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High force lateral distractionOther
High force lateral distraction on the affected hip.
Placebo distraction groupOther
Placebo lateral distraction on the affected hip.
| Study group | Role | What they receive |
|---|---|---|
| High force lateral distraction group | Experimental | High force lateral distraction of the hip in maximun adjusted position. Receives: Other: High force lateral distraction |
| Placebo distraction group | Sham comparator | Placebo lateral distraction of the affected hip in maximun adjusted position. Receives: Other: Placebo distraction group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength
Strength evaluate for internal and external hip rotators with a conical pulley.
Measured: Baseline
Strength
Strength evaluate for internal and external hip rotators with a conical pulley.
Measured: Through study completion, an average of two weeks
Strength
Strength evaluate for internal and external hip rotators with a conical pulley.
Measured: 3 months follow-up
Secondary outcomes (9)
Pain in sports activities
Appearance time of pain during activities
Measured: Baseline
Pain in sports activities
Appearance time of pain during activities
Measured: Through study completion, an average of two weeks
Pain in sports activities
Appearance time of pain during activities
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Feb 2023
- Primary completionJun 2024 (estimated)
- Study completionSep 2024 (estimated)
Why it stopped: This record was created in error.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Osteitis PubisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valladolid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Lahuerta Martín, University of Valladolid
- Investigators
- Silvia Lahuerta Martín, Principal investigator, University of ValladolidLuis Ceballos Laita, Study director, University of ValladolidSandra Jiménez del Barrio, Study director, University of ValladolidMaria Teresa Mingo Gómez, Study director, University of Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716204
- Sponsor's protocol ID
- 067/229211
- Status last verified
- Nov 2023
- First submitted
- 16 Jan 2023
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15679570Thorborg 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.
PubMed 21478502Devilly 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.
PubMed 11132119
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Pain, Strength and Functional Capacity of High Force Distraction of the Hip in Athletes With Osteitis Pubis.
- ClinicalTrials.gov ID
- NCT05716204
- Acronym / sponsor ID
- 067/229211
- Conditions
- Osteitis Pubis, Athletic Pubalgia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This record was created in error.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ValladolidUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High force lateral distraction group | Experimental | Other: High force lateral distractionHigh force lateral distraction of the hip in maximun adjusted position. |
| Placebo distraction group | Sham comparator | Other: Placebo distraction groupPlacebo lateral distraction of the affected hip in maximun adjusted position. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Athletes diagnosed with osteitis pubis stage 1 with at least 3 months of evolution.
- Internal rotation ROM limited.
- Positive provocation pain tests.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High force lateral distractionHigh force lateral distraction on the affected hip. | Other | High force lateral distraction group |
| Placebo distraction groupPlacebo lateral distraction on the affected hip. | Other | Placebo distraction group |
Primary outcome
Strength
Time frame: Baseline
Strength evaluate for internal and external hip rotators with a conical pulley.
Strength
Time frame: Through study completion, an average of two weeks
Strength evaluate for internal and external hip rotators with a conical pulley.
Strength
Time frame: 3 months follow-up
Strength evaluate for internal and external hip rotators with a conical pulley.
9 secondary outcomes
Pain in sports activities
Time frame: Baseline
Pain in sports activities
Time frame: Through study completion, an average of two weeks
Pain in sports activities
Time frame: 3 months follow-up
Pain intensity during/after pain provocation tests: Single adductor, squeeze and bilateral adductor tests
Time frame: Baseline
Pain intensity after pain provocation tests: Single adductor, squeeze and bilateral adductor tests
Time frame: Through study completion, an average of two weeks
Pain intensity after pain provocation tests: Single adductor, squeeze and bilateral adductor tests
Time frame: 3 months follow-up
Functional capacity
Time frame: Baseline
Functional capacity
Time frame: Through study completion, an average of two weeks
Functional capacity
Time frame: 3 months follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Background: PubMed 15679570Verrall 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.
- Background: PubMed 21478502Thorborg 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.
- Background: PubMed 11132119Devilly 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Lahuerta Martín principal investigator
University of Valladolid
Luis Ceballos Laita study director
University of Valladolid
Sandra Jiménez del Barrio study director
University of Valladolid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High force lateral distraction in people with Osteitis Pubis and Athletic Pubalgia, run by University of Valladolid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strength (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05716204, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.