Hip OsteoarthritisNCT02498314
Clinical Effects of Translatoric Grades of Movement in Hip Osteoarthritis Patients
A study testing Grade I-II SZ mobilization, Grade II TZ mobilization and Grade III mobilization in people with Hip Osteoarthritis, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
In orthopaedic manual therapy translatoric grades of movement are used to determine the intensity of force applied during the mobilization. Different clinical effects are described for each translatoric grade of movement but there are not published studies evaluating these clinical effects. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Grade I-II SZ mobilization, Grade II TZ mobilization and Grade III mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2015to Dec 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unilateral primary hip OA according to the clinical criteria of the American College of Reumathology,
- a grade III Kellgren \& Lawrence (K-L) classification in their most recent hip X-rays,
- mild to moderate pain from hip OA categorized using the WOMAC pain subscale (2 to 8 as mild pain; greater than 8 to 12 as moderate pain),
- the ability to walk at least 20 meters, with or without an aid.
Who cannot join
- neurological, vascular or other lower extremity musculoskeletal conditions that affected sensation, gait or functional performance,
- contraindications for manual therapy
- insufficient understanding of the Spanish language
Trial locations and contacts
1 site in 1 country.
About this study
In orthopaedic manual therapy translatoric grades of movement are used to determine the intensity of force applied during the mobilization. Different clinical effects are described for each translatoric grade of movement but there are not published studies evaluating these clinical effects.
The objective of this trial is to determine if force magnitude during hip traction in resting position affects immediate and short-term outcomes (pain, physical function, hip muscle length and hip range of motion) in patients with hip osteoarthritis. For this purpose, investigators conduct a randomized clinical trial, double-blind (patient and physical therapist examiner). Participants entering the study were randomized into 1 of 3 treatment groups: grade I- grade IISZ mobilization, grade IITZ mobilization or grade III mobilization. Participants attend three sessions on alternate days (monday, wednesday, friday) and at the same hour. Measurements are taken prior to treatment, immediately after each session treatment.
Read more
The participants are recruited from physiotherapy groups or referred by general practitioners and orthopedic surgeons.
Participants were assigned to 1 of the 3 study groups through concealed allocation (sealed envelopes) and independent blocked randomization, using a random number generator.
One physical therapist enroll patients in the study, while an independent research assistant performed the randomization and prepared the sealed envelopes, which are opened after baseline data collection by the physiotherapist performing the treatments. Participants are treated in a private treatment area and have no knowledge of treatments received by other participants.
A second experienced orthopaedic manual therapist applies the standardized hip traction mobilization in resting position at either level of force, during 10 minutes. This amount of mobilization is consistent with clinical practice and previous studies in osteoarthritis patients.
Two physiotherapists (third and fourth) with 5 years of experience, who were blinded to participant group, performed all measurements.The outcome measures are pain, physical function, hip muscle length and hip passive range of motion. Pain is registered with visual analogic scale (VAS), Pressure Pain Threshold ( PPT) and WOMAC pain subscale. Physical function is registered using Timed Up \& Go test (TUG), the 20-Meter Walking Test (20MWT) and the physical function subscale of WOMAC index. The hip muscle length is measured using Ely´s test, Active Knee Extension test and modified Ober´s test. The passive hip range of motion is measured using inclinometer or goniometer.
- Conditions
- Hip Osteoarthritis
- Being tested
- Grade I-II SZ mobilization, Grade II TZ mobilization, Grade III mobilization
- Keywords
- Manual therapy, Hip osteoarthritis, Mobilization
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grade I-II SZ mobilizationOther
Hip grade I-IISZ traction in a resting position is applied using gentle repetitive traction movements during 10 minutes. The mean peak force applied is 2,71N (S.D= 0,94), according to previous study. Peak forces were measured using dynamometer and the therapist used it as a feedback to ensure mean peak force levels remain consistent.
Grade II TZ mobilizationOther
Hip grade IITZ traction in a resting position is applied during 10 minutes. The traction force is applied during 45 seconds with 15 seconds rest, until complete the 10 minutes of treatment. The mean peak force applied is 5.94 N (S.D= 1), according to previous study. Peak forces were measured using dynamometer and the therapist used it as a feedback to ensure mean peak force levels remain consistent.
Grade III mobilizationOther
Hip grade III traction in a resting position is applied during 10 minutes. The traction force is applied during 30 seconds with 30 seconds rest, until complete the 10 minutes of treatment. The mean peak force applied is 7.04 N (S.D= 0.32), according to previous study. Peak forces were measured using dynamometer and the therapist used it as a feedback to ensure mean peak force levels remain consistent.
| Study group | Role | What they receive |
|---|---|---|
| Grade I-II SZ mobilization | Experimental | Grade I-IISZ hip traction in resting position Receives: Other: Grade I-II SZ mobilization |
| Grade II TZ mobilization | Experimental | Grade IITZ hip traction in resting position Receives: Other: Grade II TZ mobilization |
| Grade III mobilization | Experimental | Grade III hip traction in resting position Receives: Other: Grade III mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on the VAS scale
Measured: pre-intervention and post-intervention (baseline and 5 days)
Pressure Pain Threshold (PPT)
Measured: pre-intervention and post-intervention (baseline and 5 days)
Pain on the pain subscale of WOMAC index (WOMAC-P)
Measured: pre-intervention and the next day of the last treatment session (baseline and 6 days)
Secondary outcomes (7)
Physical Function on Timed Up & Go test (TUG)
Measured: pre-intervention and post-intervention (baseline and 5 days)
Physical Function on the 20-Meter Walking Test
Measured: pre-intervention and post-intervention (baseline and 5 days)
Physical Function on The physical function subscale of WOMAC index (WOMAC-PF)
Measured: pre-intervention and the next day of the last treatment session (baseline and 6 days)
Hip range of motion with digital inclinometer
Passive hip range of motion in the three planes is measured before and after each treatment sessions with a digital inclinometer
Measured: pre-intervention and post-intervention (baseline and 5 days)
Rectus femoris flexibility assessment: Ely´s test
Measured: pre-intervention and post-intervention (baseline and 5 days)
Hamstring flexibility assessment: Active Knee test
Measured: pre-intervention and post-intervention after each session (baseline and 5 days)
Iliotibial band tightness assessment: modified Ober´s test
Measured: pre-intervention and post-intervention (baseline and 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Estebanez de Miguel, Universidad de Zaragoza
- Investigators
- Elena Estebanez, PhD, Principal investigator, Unidad de Investigación en Fisioterapia. Zaragoza, Zaragoza, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498314
- Sponsor's protocol ID
- PI11/00061
- Other IDs
- PUZ/1
- Status last verified
- Jun 2017
- First submitted
- 8 Jul 2015
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Estebanez-de-Miguel E, Fortun-Agud M, Jimenez-Del-Barrio S, Caudevilla-Polo S, Bueno-Gracia E, Tricas-Moreno JM. Comparison of high, medium and low mobilization forces for increasing range of motion in patients with hip osteoarthritis: A randomized controlled trial. Musculoskelet Sci Pract. 2018 Aug;36:81-86. doi: 10.1016/j.msksp.2018.05.004. Epub 2018 May 29.
PubMed 29864710
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of Translatoric Grades of Movement in Hip Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT02498314
- Acronym / sponsor ID
- PI11/00061
- Conditions
- Hip Osteoarthritis
- Keywords
- Manual therapy, Hip osteoarthritis, Mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Jul 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.
In orthopaedic manual therapy translatoric grades of movement are used to determine the intensity of force applied during the mobilization. Different clinical effects are described for each translatoric grade of movement but there are not published studies evaluating these clinical effects.
The objective of this trial is to determine if force magnitude during hip traction in resting position affects immediate and short-term outcomes (pain, physical function, hip muscle length and hip range of motion) in patients with hip osteoarthritis. For this purpose, investigators conduct a randomized clinical trial, double-blind (patient and physical therapist examiner). Participants entering the study were randomized into 1 of 3 treatment groups: grade I- grade IISZ mobilization, grade IITZ mobilization or grade III mobilization. Participants attend three sessions on alternate days (monday, wednesday, friday) and at the same hour. Measurements are taken prior to treatment, immediately after each session treatment.
The participants are recruited from physiotherapy groups or referred by general practitioners and orthopedic surgeons.
Participants were assigned to 1 of the 3 study groups through concealed allocation (sealed envelopes) and independent blocked randomization, using a random number generator.
One physical therapist enroll patients in the study, while an independent research assistant performed the randomization and prepared the sealed envelopes, which are opened after baseline data collection by the physiotherapist performing the treatments. Participants are treated in a private treatment area and have no knowledge of treatments received by other participants.
A second experienced orthopaedic manual therapist applies the standardized hip traction mobilization in resting position at either level of force, during 10 minutes. This amount of mobilization is consistent with clinical practice and previous studies in osteoarthritis patients.
Two physiotherapists (third and fourth) with 5 years of experience, who were blinded to participant group, performed all measurements.The outcome measures are pain, physical function, hip muscle length and hip passive range of motion. Pain is registered with visual analogic scale (VAS), Pressure Pain Threshold ( PPT) and WOMAC pain subscale. Physical function is registered using Timed Up \& Go test (TUG), the 20-Meter Walking Test (20MWT) and the physical function subscale of WOMAC index. The hip muscle length is measured using Ely´s test, Active Knee Extension test and modified Ober´s test. The passive hip range of motion is measured using inclinometer or goniometer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Grade I-II SZ mobilization | Experimental | Other: Grade I-II SZ mobilizationGrade I-IISZ hip traction in resting position |
| Grade II TZ mobilization | Experimental | Other: Grade II TZ mobilizationGrade IITZ hip traction in resting position |
| Grade III mobilization | Experimental | Other: Grade III mobilizationGrade III hip traction in resting position |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- unilateral primary hip OA according to the clinical criteria of the American College of Reumathology,
- a grade III Kellgren \& Lawrence (K-L) classification in their most recent hip X-rays,
- mild to moderate pain from hip OA categorized using the WOMAC pain subscale (2 to 8 as mild pain; greater than 8 to 12 as moderate pain),
- the ability to walk at least 20 meters, with or without an aid.
Key exclusion criteria (3 listed)
- neurological, vascular or other lower extremity musculoskeletal conditions that affected sensation, gait or functional performance,
- contraindications for manual therapy
- insufficient understanding of the Spanish language
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 |
|---|---|---|
| Grade I-II SZ mobilizationHip grade I-IISZ traction in a resting position is applied using gentle repetitive traction movements during 10 minutes. The mean peak force applied is 2,71N (S.D= 0,94), according to previous study. Peak forces were measured using dynamometer and the therapist used it as a feedback to ensure mean peak force levels remain consistent. | Other | Grade I-II SZ mobilization |
| Grade II TZ mobilizationHip grade IITZ traction in a resting position is applied during 10 minutes. The traction force is applied during 45 seconds with 15 seconds rest, until complete the 10 minutes of treatment. The mean peak force applied is 5.94 N (S.D= 1), according to previous study. Peak forces were measured using dynamometer and the therapist used it as a feedback to ensure mean peak force levels remain consistent. | Other | Grade II TZ mobilization |
| Grade III mobilizationHip grade III traction in a resting position is applied during 10 minutes. The traction force is applied during 30 seconds with 30 seconds rest, until complete the 10 minutes of treatment. The mean peak force applied is 7.04 N (S.D= 0.32), according to previous study. Peak forces were measured using dynamometer and the therapist used it as a feedback to ensure mean peak force levels remain consistent. | Other | Grade III mobilization |
Primary outcome
Pain on the VAS scale
Time frame: pre-intervention and post-intervention (baseline and 5 days)
Pressure Pain Threshold (PPT)
Time frame: pre-intervention and post-intervention (baseline and 5 days)
Pain on the pain subscale of WOMAC index (WOMAC-P)
Time frame: pre-intervention and the next day of the last treatment session (baseline and 6 days)
7 secondary outcomes
Physical Function on Timed Up & Go test (TUG)
Time frame: pre-intervention and post-intervention (baseline and 5 days)
Physical Function on the 20-Meter Walking Test
Time frame: pre-intervention and post-intervention (baseline and 5 days)
Physical Function on The physical function subscale of WOMAC index (WOMAC-PF)
Time frame: pre-intervention and the next day of the last treatment session (baseline and 6 days)
Hip range of motion with digital inclinometer
Time frame: pre-intervention and post-intervention (baseline and 5 days)
Rectus femoris flexibility assessment: Ely´s test
Time frame: pre-intervention and post-intervention (baseline and 5 days)
Hamstring flexibility assessment: Active Knee test
Time frame: pre-intervention and post-intervention after each session (baseline and 5 days)
Iliotibial band tightness assessment: modified Ober´s test
Time frame: pre-intervention and post-intervention (baseline and 5 days)
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 Jul 2017.
- Derived from this study: PubMed 29864710Estebanez-de-Miguel E, Fortun-Agud M, Jimenez-Del-Barrio S, Caudevilla-Polo S, Bueno-Gracia E, Tricas-Moreno JM. Comparison of high, medium and low mobilization forces for increasing range of motion in patients with hip osteoarthritis: A randomized controlled trial. Musculoskelet Sci Pract. 2018 Aug;36:81-86. doi: 10.1016/j.msksp.2018.05.004. Epub 2018 May 29.
Related trials for Hip Osteoarthritis
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
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.
Elena Estebanez, PhD principal investigator
Unidad de Investigación en Fisioterapia. Zaragoza, Zaragoza, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grade I-II SZ mobilization, Grade II TZ mobilization and Grade III mobilization in people with Hip Osteoarthritis, 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 4 inclusion and 3 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 Jul 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.
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?
Pain on the VAS scale (time frame: pre-intervention and post-intervention (baseline and 5 days)). 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 NCT02498314, which also lists 1 linked publication.
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 Jul 2017.