Osteitis PubisNCT05712486
Manual Therapy for the Treatment of Athletic Pubalgia
A study testing High force hip Lateral distraction in people with Osteitis Pubis, run by University of Valladolid at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Osteitis Pubis
- What is being tested?
- High force hip Lateral distraction
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2023to 30 Oct 2025
- 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 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.
- Conditions
- Osteitis Pubis
- Being tested
- High force hip Lateral distraction, Placebo force hip lateral distraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High force hip Lateral distractionOther
Hip lateral distraction in adjusted position of maximun flexion and internal rotation, with neutral position of abduction/adduction applying high force of distraction.
Placebo force hip lateral distractionOther
Hip lateral distraction in adjusted position of maximun flexion and internal rotation, with neutral position of abduction/adduction applying placebo force of distraction.
| Study group | Role | What they receive |
|---|---|---|
| Lateral distraction group | Experimental | High force lateral distraction of affected hip. Receives: Other: High force hip Lateral distraction |
| Placebo distraction group | Sham comparator | Placebo lateral traction of affected hip. Receives: Other: Placebo force hip lateral distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actual PAIN
actual pain reported by the patient using visual analog scale (VAS) from 0 to 10, in which higher scores are worse.
Measured: Baseline
Actual PAIN
actual pain reported by the patient using visual analog scale (VAS)from 0 to 10, in which higher scores are worse.
Measured: 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.
Measured: 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.
Measured: after to two weeks of treatment
Secondary outcomes (13)
Range of Movement (ROM)
Hip ROM as described by Pua et al. (2008)
Measured: Baseline
Range of Movement (ROM)
Hip ROM as described by Pua et al. (2008)
Measured: after to two weeks of treatment
Pain in sport activities
Appearance time of pain during activities
Measured: Baseline
Pain in sport activities
Appearance time of pain during activities
Measured: After two weeks of treatment
Pain intensity in 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 in 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: After two weeks of treatment
Muscle function
Velocity (m/s), force (N) and power (W) evaluated for internal and external hip rotators with a rotary axis flywheel-encoder system.
Measured: Baseline
Muscle function
Velocity (m/s), force (N) and power (W) evaluated for internal and external hip rotators with a rotary axis flywheel-encoder system.
Measured: After two weeks of treatment
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: After two weeks of treatment
Treatment credibility and expectancy
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.
Measured: Day 1, before treatment
Global Rating of Change
Subjective impression as described in GROC scale by Jaeschke, Singer \& Guyat (1989)
Measured: after to two weeks of treatment
Group of treatment assignment
Question about which group of treatment was the patient assigned in.
Measured: after to two weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start1 Feb 2023
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 36 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 Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712486
- Sponsor's protocol ID
- CASVE-NM-22-623
- Status last verified
- Oct 2025
- First submitted
- 16 Jan 2023
- Last updated
- 25 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05712486
- Acronym / sponsor ID
- CASVE-NM-22-623
- Conditions
- Osteitis Pubis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of ValladolidUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 3 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lateral distraction group | Experimental | Other: High force hip Lateral distractionHigh force lateral distraction of affected hip. |
| Placebo distraction group | Sham comparator | Other: Placebo force hip lateral distractionPlacebo lateral traction of affected hip. |
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 hip Lateral distractionHip lateral distraction in adjusted position of maximun flexion and internal rotation, with neutral position of abduction/adduction applying high force of distraction. | Other | Lateral distraction group |
| Placebo force hip lateral distractionHip lateral distraction in adjusted position of maximun flexion and internal rotation, with neutral position of abduction/adduction applying placebo force of distraction. | Other | Placebo distraction group |
Primary outcome
Actual PAIN
Time frame: Baseline
actual pain reported by the patient using visual analog scale (VAS) from 0 to 10, in which higher scores are worse.
Actual PAIN
Time frame: after to two weeks of treatment
actual pain reported by the patient using visual analog scale (VAS)from 0 to 10, in which higher scores are worse.
Last week PAIN
Time frame: Baseline
past week pain reported by the patient using visual analog scale (VAS) from 0 to 10, in which higher scores are worse.
Last week PAIN
Time frame: after to two weeks of treatment
past week pain reported by the patient using visual analog scale (VAS) from 0 to 10, in which higher scores are worse.
13 secondary outcomes
Range of Movement (ROM)
Time frame: Baseline
Range of Movement (ROM)
Time frame: after to two weeks of treatment
Pain in sport activities
Time frame: Baseline
Pain in sport activities
Time frame: After two weeks of treatment
Pain intensity in pain provocation tests: Single adductor, squeeze and bilateral adductor tests
Time frame: Baseline
Pain intensity in pain provocation tests: Single adductor, squeeze and bilateral adductor tests
Time frame: After two weeks of treatment
Muscle function
Time frame: Baseline
Muscle function
Time frame: After two weeks of treatment
Functional capacity
Time frame: Baseline
Functional capacity
Time frame: After two weeks of treatment
Treatment credibility and expectancy
Time frame: Day 1, before treatment
Global Rating of Change
Time frame: after to two weeks of treatment
Group of treatment assignment
Time frame: after to two weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- 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
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 hip Lateral distraction in people with Osteitis Pubis, 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: finished, as of the sponsor's last update on 25 Mar 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Actual PAIN (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2026.