Hip OsteoarthritisNCT03702595
Effects of a Stretching Protocol in Patients With Hip Osteoarthritis
A study testing Hip flexors stretching protocol in people with Hip Osteoarthritis, run by Universidad de Zaragoza at 2 sites in Spain.
Trial summary
Hip osteoarthritis (OA) is one of the most prevalent chronic disease in the world. Clinical guidelines recommend non-pharmacological conservative treatments for the management of OA. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Hip flexors stretching protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Aug 2018to 30 Dec 2018
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed medically with a X-Ray test
- American College of Rheumatology Criteria
Who cannot join
- Secondary osteoarthritis by a traumatism, Paget disease, inflammatory or metabolic disease, congenital diseases etc.
- Vascular or neurological disease.
- Musculoskeletal pathologies in lumbar spine, pelvis or lower limbs
- Grade IV in Kellgren and Laurence Scale
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Sandra Jiménez del Barrio
Soria, 42004
Luis Ceballos Laita
Zaragoza, 50008
About this study
Official title: Effects of a Stretching Protocol of Hip Flexors in Patients With Mild to Moderate Hip Osteoarthritis
Hip osteoarthritis (OA) is one of the most prevalent chronic disease in the world. Clinical guidelines recommend non-pharmacological conservative treatments for the management of OA. Hip flexors seems to play an important role in the development of hip OA but there is no published studies evaluating the results of a stretching protocol of hip flexors in hip OA patients.
The objective of this trial is to evaluate if a stretching protocol of hip flexors is more effective in symptoms, functional capacity , range of motion, strength, muscular length, pain threshold and anxiety and depression compared to control.
Read more
For this purpose the investigators conduct a single-group, pretest-posttest clinical trial.The investigators included patients diagnosed of hip osteoarthritis Grade I-III by Scale of Kellgren and Lawrence.
The variables are measured at the beginning and at the end of treatment of the control phase, and at the end of the stretching protocol phase.
- Conditions
- Hip Osteoarthritis
- Being tested
- Hip flexors stretching protocol
- Keywords
- Hip Osteoarthritis, Manual therapy, physiotherapy
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip flexors stretching protocolOther
Stretching protocol of rectus femoris, vastus lateralis and iliopsoas according to Kaltenborn- Evjenth Orthopaedic Manual Therapy Concept (OMT)
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Hip flexors stretching protocol Receives: Other: Hip flexors stretching protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in pain intensity
Visual Analogic Scale
Measured: 3 weeks
Secondary outcomes (7)
Functional Capacity
The investigators measure the functional capacity with Timed Up and Go test (TUG)
Measured: 3 weeks
WOMAC questionnaire
WOMAC questionnaire
Measured: 3 weeks
Hip Range of Motion
Digital inclinometer according to Pua et al., 2008
Measured: 3 weeks
Muscular strength
The investigators measure the hip strength with a hand held dynamometer (Lafayette)
Measured: 3 weeks
Muscular length
The investigators measure the muscular length with an inclinometer
Measured: 3 weeks
Pressure Pain threshold
Pressure algometry measured by digital algometer
Measured: 3 weeks
Anxiety and Depression
Hospital Anxiety and Depression Scale (HADS)
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start1 Aug 2018
- Primary completion30 Nov 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Collaborators
- University of Valladolid
- Responsible party
- Principal investigator, Luis Ceballos Laita, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03702595
- Sponsor's protocol ID
- 1955
- Status last verified
- Jan 2020
- First submitted
- 17 Aug 2018
- Last updated
- 21 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The patient data were confidential and were assigned a number to each patient to maintain confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Stretching Protocol of Hip Flexors in Patients With Mild to Moderate Hip Osteoarthritis
- ClinicalTrials.gov ID
- NCT03702595
- Acronym / sponsor ID
- 1955
- Conditions
- Hip Osteoarthritis
- Keywords
- Hip Osteoarthritis, Manual therapy, physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Collaborators
- University of Valladolid
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 11 Oct 2018 (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.
Hip osteoarthritis (OA) is one of the most prevalent chronic disease in the world. Clinical guidelines recommend non-pharmacological conservative treatments for the management of OA. Hip flexors seems to play an important role in the development of hip OA but there is no published studies evaluating the results of a stretching protocol of hip flexors in hip OA patients.
The objective of this trial is to evaluate if a stretching protocol of hip flexors is more effective in symptoms, functional capacity , range of motion, strength, muscular length, pain threshold and anxiety and depression compared to control.
For this purpose the investigators conduct a single-group, pretest-posttest clinical trial.The investigators included patients diagnosed of hip osteoarthritis Grade I-III by Scale of Kellgren and Lawrence.
The variables are measured at the beginning and at the end of treatment of the control phase, and at the end of the stretching protocol phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Other: Hip flexors stretching protocolHip flexors stretching protocol |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed medically with a X-Ray test
- American College of Rheumatology Criteria
Key exclusion criteria (4 listed)
- Secondary osteoarthritis by a traumatism, Paget disease, inflammatory or metabolic disease, congenital diseases etc.
- Vascular or neurological disease.
- Musculoskeletal pathologies in lumbar spine, pelvis or lower limbs
- Grade IV in Kellgren and Laurence Scale
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 |
|---|---|---|
| Hip flexors stretching protocolStretching protocol of rectus femoris, vastus lateralis and iliopsoas according to Kaltenborn- Evjenth Orthopaedic Manual Therapy Concept (OMT) | Other | Interventional group |
Primary outcome
Changes from baseline in pain intensity
Time frame: 3 weeks
Visual Analogic Scale
7 secondary outcomes
Functional Capacity
Time frame: 3 weeks
WOMAC questionnaire
Time frame: 3 weeks
Hip Range of Motion
Time frame: 3 weeks
Muscular strength
Time frame: 3 weeks
Muscular length
Time frame: 3 weeks
Pressure Pain threshold
Time frame: 3 weeks
Anxiety and Depression
Time frame: 3 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 21 Jan 2020.
- Individual participant dataSharing planned: No. The patient data were confidential and were assigned a number to each patient to maintain confidentiality
Related trials for Hip Osteoarthritis
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hip flexors stretching protocol in people with Hip Osteoarthritis, run by Universidad de Zaragoza at 2 sites 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 2 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 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Changes from baseline in pain intensity (time frame: 3 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 21 Jan 2020.