Osteoarthritis, HipPhase 3NCT02469025
Effects of Grade III Traction-mobilization in End-range Joint Position in Patients With Hip Osteoarthritis
A Phase 3 study testing Manual caudal traction mobilization in resting position, Manual caudal traction mobilization in end range position and Selftreatment in people with Osteoarthritis, Hip, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
Lower limb osteoarthritis is a major health problem in the westernized countries. The current gold standard treatment is joint replacement. However clinical guidelines recommend physical therapy as first option for these patients. Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- Manual caudal traction mobilization in resting position, Manual caudal traction mobilization in end range position and Selftreatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2014to Apr 2017
- Phase
- Phase 3
- 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 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hip osteoarthritis diagnosis
- Diminished range of motion
- Sign the informed consent
Who cannot join
- Contraindications to Manual Therapy.
- Sensitivity impairments in low back, pelvis, knee or foot regions.
- Being involved in other physical therapy treatments
- To change medication use during the study
Trial locations and contacts
1 site in 1 country.
Spain1 site
Unidad de Investigación en Fisioterapia. Universidad de Zaragoza
Zaragoza, 50009
About this study
Lower limb osteoarthritis is a major health problem in the westernized countries. The current gold standard treatment is joint replacement. However clinical guidelines recommend physical therapy as first option for these patients. Manual therapy has reported good reports in function, range of motion and pain in patients with hip osteoarthritis. The main aim of this study is to test the effects of a manual therapy protocol based on manual traction mobilization of the hip joint in an end range position and compare them with the effects achieve with the same protocol based on manual traction mobilization of the hip joint in a resting position. The investigators will use the caudal traction mobilization described by Kaltenborn. The study will test the effects of both treatments in passive range of motion, function and pain after three weeks of treatment, three weeks after finalizing the treatment and six weeks after.
- Conditions
- Osteoarthritis, Hip
- Being tested
- Manual caudal traction mobilization in resting position, Manual caudal traction mobilization in end range position, Selftreatment
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual caudal traction mobilization in resting positionOther
Manual caudal traction mobilization in end range positionOther
SelftreatmentOther
Each subject is advice to do some exercises at home
| Study group | Role | What they receive |
|---|---|---|
| Resting position mobilization group | Experimental | This group receive six manual therapy interventions based on manual traction mobilization in a resting position of the hip joint.
In addition the physical therapist teach the patients six exercises to do at home between manual mobilization sessions. Receives: Other: Manual caudal traction mobilization in resting position; Other: Selftreatment |
| End range position mobilization group | Experimental | This group receive six manual therapy interventions based on manual traction mobilization in an end range position of the hip joint.
In addition the physical therapist teach the patients six exercises to do at home between manual mobilization sessions. Receives: Other: Manual caudal traction mobilization in end range position; Other: Selftreatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Passive Hip Range of Motion after intervention, at 3 weeks post-intervention and at 6 weeks post intervention
Measured: 3 weeks, 6 weeks, 9 weeks
Secondary outcomes (3)
Changes from Baseline in Functional Tests (TUG, fast-paced walk test, stair climb test, 30sec. chair stand test), after intervention, at 3 weeks post-intervention and at 6 weeks post intervention
Measured: 3 weeks, 6 weeks, 9 weeks
Change from Baseline in Pain on the Visual Analog Scale after intervention, at 3 weeks post-intervention and at 6 weeks post intervention
Measured: 3 weeks, 6 weeks, 9 weeks
Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale after intervention and at 6 weeks post intervention
Measured: 3 weeks, 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startJan 2014
- Primary completionMay 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Fortun Agud, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469025
- Sponsor's protocol ID
- PI13/0030
- Status last verified
- May 2017
- First submitted
- 26 May 2015
- Last updated
- 2 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Grade III Traction-mobilization in End-range Joint Position in Patients With Hip Osteoarthritis
- ClinicalTrials.gov ID
- NCT02469025
- Acronym / sponsor ID
- PI13/0030
- Conditions
- Osteoarthritis, Hip
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 11 Jun 2015 (estimated)
- 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.
Lower limb osteoarthritis is a major health problem in the westernized countries. The current gold standard treatment is joint replacement. However clinical guidelines recommend physical therapy as first option for these patients. Manual therapy has reported good reports in function, range of motion and pain in patients with hip osteoarthritis. The main aim of this study is to test the effects of a manual therapy protocol based on manual traction mobilization of the hip joint in an end range position and compare them with the effects achieve with the same protocol based on manual traction mobilization of the hip joint in a resting position. The investigators will use the caudal traction mobilization described by Kaltenborn. The study will test the effects of both treatments in passive range of motion, function and pain after three weeks of treatment, three weeks after finalizing the treatment and six weeks after.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resting position mobilization group | Experimental | Other: Manual caudal traction mobilization in resting position, Other: SelftreatmentThis group receive six manual therapy interventions based on manual traction mobilization in a resting position of the hip joint. In addition the physical therapist teach the patients six exercises to do at home between manual mobilization sessions. |
| End range position mobilization group | Experimental | Other: Manual caudal traction mobilization in end range position, Other: SelftreatmentThis group receive six manual therapy interventions based on manual traction mobilization in an end range position of the hip joint. In addition the physical therapist teach the patients six exercises to do at home between manual mobilization sessions. |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hip osteoarthritis diagnosis
- Diminished range of motion
- Sign the informed consent
Key exclusion criteria (4 listed)
- Contraindications to Manual Therapy.
- Sensitivity impairments in low back, pelvis, knee or foot regions.
- Being involved in other physical therapy treatments
- To change medication use during the study
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 |
|---|---|---|
| Manual caudal traction mobilization in resting position | Other | Resting position mobilization group |
| Manual caudal traction mobilization in end range position | Other | End range position mobilization group |
| SelftreatmentEach subject is advice to do some exercises at home | Other | End range position mobilization group, Resting position mobilization group |
Primary outcome
Change from Baseline in Passive Hip Range of Motion after intervention, at 3 weeks post-intervention and at 6 weeks post intervention
Time frame: 3 weeks, 6 weeks, 9 weeks
3 secondary outcomes
Changes from Baseline in Functional Tests (TUG, fast-paced walk test, stair climb test, 30sec. chair stand test), after intervention, at 3 weeks post-intervention and at 6 weeks post intervention
Time frame: 3 weeks, 6 weeks, 9 weeks
Change from Baseline in Pain on the Visual Analog Scale after intervention, at 3 weeks post-intervention and at 6 weeks post intervention
Time frame: 3 weeks, 6 weeks, 9 weeks
Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale after intervention and at 6 weeks post intervention
Time frame: 3 weeks, 9 weeks
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 2 May 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Manual caudal traction mobilization in resting position, Manual caudal traction mobilization in end range position and Selftreatment in people with Osteoarthritis, Hip, run by Universidad de Zaragoza 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 2 May 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from Baseline in Passive Hip Range of Motion after intervention, at 3 weeks post-intervention and at 6 weeks post intervention (time frame: 3 weeks, 6 weeks, 9 weeks). 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 2 May 2017.