Osteoarthritis, HipNCT02798900
The Effect of Functional Task Training Combined With Therapeutic Ultrasound on Adults With Hip Osteoarthritis
A study testing Functional task-training and Therapeutic Ultrasound in people with Osteoarthritis, Hip, run by Universidad del Rosario at 1 site in Colombia.
Trial summary
The aim of this study is to evaluate the effect of a functional task-training program combined with therapeutic ultrasound on pain, strength, gait biomechanics and functionality in adults with hip osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- Functional task-training and Therapeutic Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteColombia
- Study dates
- 10 Jan 2017to 9 Jan 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of hip osteoarthritis
Who cannot join
- Musculoskeletal disability in other lower extremity joints or trunk
- Acute injuries of lower extremity and trunk in past three months
- Arthroscopic surgery
- An intra-articular injection in past three months
- Candidate for surgery
- Patients with fibromyalgia
- Patients with neurologic disease
- Participation in a structured physical activity program in past three months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Functional Task-training Program Combined With Therapeutic Ultrasound on Pain, Strength, Gait Biomechanics and Functionality in Adults With Hip Osteoarthritis
The aim of this study is to evaluate the effect of a functional task-training program combined with therapeutic ultrasound on pain, strength, gait biomechanics and functionality in adults with hip osteoarthritis.
Read the detailed description
Design
The investigators propose a randomized double blind controlled clinical trial. It would include two comparison groups each with 25 participants with medical diagnosis of hip osteoarthritis classified severity II and III and inclusion criteria of the American College of Rheumatology for the classification and reporting of osteoarthritis of the hip.
All qualified participants will attend a pre-training (baseline) data collection session. During the data collection session, each participant will complete the Western Ontario and MacMaster Osteoarthritis Index (WOMAC). All participants will perform visual analog scale and six minutes walk test for assessing pain and functionality, respectively. They will be assessed their hip muscle strength using manual muscle dynamometer. Their biomechanics gait will be assessed through using an infrared motion capture system, force platforms and motion analysis software (120 Hz, BTS Smart DX100, Italy). All participants in both groups will be asked not to alter their regular physical activity or pain medications during the 15-sessions training program.
Each participant will be assessed pain, strength, gait biomechanics and functionality before and after 16 sessions of intervention. Pain and functionality will be further evaluated in sessions 5th and 10th. The first group will receive 16 sessions of a functional task training program and therapeutic ultrasound versus the second group who will only receive 16 sessions of the same functional task-training program.
Functional task-training program includes warm up, followed by a functional circuit with muscle strengthening exercises for the major groups of hip oriented to daily life activities and ends with stretching. Therapeutic ultrasound will be applied prior to functional task-training with an intensity of 2.2 W/cm2, frequency of 1 MHz and application time of 4 minutes. Temporal average intensity area corresponds to 0.44 W/cm2, the treatment area will be equal to 2 times the effective radiating area on the anterior, medial and lateral hip area.
The hypothesis of this study is the functional-task training program combined with therapeutic ultrasound will decrease the pain, improve the muscle hip strength the gait biomechanics and the functionality of the people with hip osteoarthritis.
In the statistical analysis of the results, the differences will be assessed in the three pain and functionality assessments with a repeated measures using ANOVA; the differences between initial and final measurement of strength, biomechanical gait variables and functionality will be evaluated with a paired Student t-test and Wilcoxon. The differences between groups will be assessed with a t-test for independent samples. Significant differences in the outcomes will be adjusted for covariates with binomial regressions, considering a significance level of p <0.05.
For patient registries:
The Mederi Hospital has an integrated system for collecting, storing, monitoring, reviewing, and reporting on registry data of the participants of the study. It also has a Manual documentation of procedures for each registry, includes protocols and data collection instrument. The manual explains how the investigators should create or assign the patient identification numbers and how duplicate records should be prevented and how to report adverse events.
The hospital takes plans for monitoring or auditing the screening practices trough the auditing department and training to educate data collectors.
Additionally, the investigators will make a Pilot Testing to assess understanding, acceptance and feasibility the patient registry processes.
In the other hand, all staffs involved in data collection will be identified, and their roles and job will be described in data collection and processing.
All data collection will be registered in the integrated system of the Mederi Hospital. The gait biomechanics data will be recorded first in the database of the Smart DX100 system of the Laboratory of Biomechanics if the University of Rosario. The investigators will have an external research (Fulbright Scholar) that will audit the register of the biomechanics data. Then, every participant of the study will have an electronic medical record (EMR) of health-related information.
The Mederi Hospital has a system security plan that includes the policies, standard operating procedures, administrative procedures, electronic signatures and it also has a technical security support.
The plan for missing data where variables are reported as missing,unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results the investigators will quantify the extent of missingness, identifying which individuals have missing data and at which assessment then, the investigators will treat the missing data across a statistical analysis.
- Conditions
- Osteoarthritis, Hip
- Being tested
- Functional task-training, Therapeutic Ultrasound
- Keywords
- Task-specific exercise, Ultrasonic Waves, Biomechanics, Gait, Rehabilitation, Exercise therapy
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional task-trainingOther
The functional task-training program includes warming up followed by a functional circuit with muscle strengthening exercises for the major groups of hip oriented to daily life activities and ends with stretching.
Therapeutic UltrasoundDevice
Therapeutic pulsed ultrasound will be applied prior to functional task-training with an intensity of 2.2 W/cm2, frequency of 1 MHz and application time of 4 minutes on the anterior, medial and lateral hip area.
| Study group | Role | What they receive |
|---|---|---|
| Functional task-training and Ultrasound | Experimental | This group will receive 16 sessions of functional task-training program and therapeutic ultrasound will be applied prior to functional task-training. Receives: Other: Functional task-training; Device: Therapeutic Ultrasound |
| Functional task-training | Active comparator | This group will receive 16 sessions of functional task-training program. Receives: Other: Functional task-training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale for pain
To measure the pain intensity
Measured: within the first 2 weeks before the intervention
Change from Baseline Visual Analog Scale for pain at 16th session of intervention
Measured: within the first 2 weeks after the intervention
Muscle strength
It is the muscle strength of gluteus maximus, medium, quadriceps and hamstrings measured using a manual muscle dynamometer.
Measured: within the first 2 weeks before the intervention
Change from Baseline Muscle strength at 16th session of intervention
Change of the muscle strength of gluteus maximus, medium, quadriceps and hamstrings after the intervention.
Measured: within the first 2 weeks after the intervention
Gait biomechanics
Assess the speed, hip range of motion, and peak hip flexion/extension in the gait phases by using motion analysis system BTS SmartDX100 Brand.
Measured: within the first 2 weeks before the intervention
Change from Baseline Gait biomechanics at 16th session of intervention
Measured: within the first 2 weeks after the intervention
Six minute walk test (To measure the physical function in terms of the basic mobility)
Measured: within the first 2 weeks before the intervention
Change from Baseline Six minute walk test at 16th session of intervention
Measured: within the first 2 weeks after the intervention
Secondary outcomes (4)
Change from Baseline Visual Analog Scale for pain at 5th session of intervention
Measured: After finishing the 5th session of intervention
Change from Baseline Visual Analog Scale for pain at 10th session of intervention
Measured: After finishing the 10th session of intervention
Change from Baseline Six minute walk test at 5th session of intervention
Measured: After finishing the 5th session of intervention
Change from Baseline Six minute walk test at 10th session of intervention
Measured: After finishing the 10th session of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study start10 Jan 2017
- Primary completion8 Jan 2018
- Study completion9 Jan 2018
Why it stopped: We did not get funding to develop the clinical trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (43)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad del Rosario
- Sponsor type
- University, hospital or other
- Collaborators
- CORPORACION HOSPITALARIA JUAN CIUDAD, MEDERI
- Responsible party
- Principal investigator, ROSY PAOLA CARDENAS SANDOVAL, Universidad del Rosario
- Investigators
- Songning Zhang, PhD, Study director, Director, Biomechanics/Sports Medicine Lab, Department of Kinesiology, Recreation, & Sport Studies College of Education, Health and Human Sciences. The University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798900
- Sponsor's protocol ID
- SAP1388
- Status last verified
- Sep 2021
- First submitted
- 23 May 2016
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Oakley EM. Application of continuous beam ultrasound at therapeutic levels. Physiotherapy. 1978 Jun;64(6):169-72. No abstract available.
PubMed 674399Farcic TS, Baldan CS, Cattapan CG, Parizotto NA, Joao SM, Casarotto RA. Treatment time of ultrasound therapy interferes with the organization of collagen fibers in rat tendons. Braz J Phys Ther. 2013 May-Jun;17(3):263-71. doi: 10.1590/s1413-35552012005000090.
PubMed 23966143CARTER EF Sr, HARRISS RR, PHILLIPS K, ROBINSON LF. Therapeutic application of ultrasound energy; results of broad clinical survey. J Fla Med Assoc (1914). 1956 Oct;43(4):341-6. No abstract available.
PubMed 13367362Chan AK, Myrer JW, Measom GJ, Draper DO. Temperature changes in human patellar tendon in response to therapeutic ultrasound. J Athl Train. 1998 Apr;33(2):130-5.
PubMed 16558499Demchak TJ, Stone MB. Effectiveness of clinical ultrasound parameters on changing intramuscular temperature. J Sport Rehabil. 2008 Aug;17(3):220-9. doi: 10.1123/jsr.17.3.220.
PubMed 18708676Draper DO, Castel JC, Castel D. Rate of temperature increase in human muscle during 1 MHz and 3 MHz continuous ultrasound. J Orthop Sports Phys Ther. 1995 Oct;22(4):142-50. doi: 10.2519/jospt.1995.22.4.142.
PubMed 8535471Zhou Q, Lau S, Wu D, Shung KK. Piezoelectric films for high frequency ultrasonic transducers in biomedical applications. Prog Mater Sci. 2011 Feb;56(2):139-174. doi: 10.1016/j.pmatsci.2010.09.001.
PubMed 21720451ter Haar G. Therapeutic applications of ultrasound. Prog Biophys Mol Biol. 2007 Jan-Apr;93(1-3):111-29. doi: 10.1016/j.pbiomolbio.2006.07.005. Epub 2006 Aug 4.
PubMed 16930682Hangiandreou NJ. AAPM/RSNA physics tutorial for residents. Topics in US: B-mode US: basic concepts and new technology. Radiographics. 2003 Jul-Aug;23(4):1019-33. doi: 10.1148/rg.234035034.
PubMed 12853678Draper DO, Sunderland S. Examination of the law of grotthus-draper: does ultrasound penetrate subcutaneous fat in humans? J Athl Train. 1993 Fall;28(3):246-50.
PubMed 16558239Leighton TG. What is ultrasound? Prog Biophys Mol Biol. 2007 Jan-Apr;93(1-3):3-83. doi: 10.1016/j.pbiomolbio.2006.07.026. Epub 2006 Aug 15.
PubMed 17045633Stewart HF, Abzug JL, Harris GR. Considerations in ultrasound therapy and equipment performance. Phys Ther. 1980 Apr;60(4):424-8. doi: 10.1093/ptj/60.4.424.
PubMed 7360798Humphrey VF. Ultrasound and matter--physical interactions. Prog Biophys Mol Biol. 2007 Jan-Apr;93(1-3):195-211. doi: 10.1016/j.pbiomolbio.2006.07.024. Epub 2006 Aug 15.
PubMed 17079004O'Brien WD Jr. Ultrasound-biophysics mechanisms. Prog Biophys Mol Biol. 2007 Jan-Apr;93(1-3):212-55. doi: 10.1016/j.pbiomolbio.2006.07.010. Epub 2006 Aug 8.
PubMed 16934858Zeni J Jr, Pozzi F, Abujaber S, Miller L. Relationship between physical impairments and movement patterns during gait in patients with end-stage hip osteoarthritis. J Orthop Res. 2015 Mar;33(3):382-9. doi: 10.1002/jor.22772. Epub 2014 Dec 9.
PubMed 25492583
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Functional Task-training Program Combined With Therapeutic Ultrasound on Pain, Strength, Gait Biomechanics and Functionality in Adults With Hip Osteoarthritis
- ClinicalTrials.gov ID
- NCT02798900
- Acronym / sponsor ID
- SAP1388
- Conditions
- Osteoarthritis, Hip
- Keywords
- Task-specific exercise, Ultrasonic Waves, Biomechanics, Gait, Rehabilitation, Exercise therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We did not get funding to develop the clinical trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universidad del RosarioUniversity, hospital or other
- Collaborators
- CORPORACION HOSPITALARIA JUAN CIUDAD, MEDERI
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- 8 Jan 2018 (actual)
- Study completion
- 9 Jan 2018 (actual)
- First posted
- 14 Jun 2016 (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.
The aim of this study is to evaluate the effect of a functional task-training program combined with therapeutic ultrasound on pain, strength, gait biomechanics and functionality in adults with hip osteoarthritis.
Detailed description
Design
The investigators propose a randomized double blind controlled clinical trial. It would include two comparison groups each with 25 participants with medical diagnosis of hip osteoarthritis classified severity II and III and inclusion criteria of the American College of Rheumatology for the classification and reporting of osteoarthritis of the hip.
All qualified participants will attend a pre-training (baseline) data collection session. During the data collection session, each participant will complete the Western Ontario and MacMaster Osteoarthritis Index (WOMAC). All participants will perform visual analog scale and six minutes walk test for assessing pain and functionality, respectively. They will be assessed their hip muscle strength using manual muscle dynamometer. Their biomechanics gait will be assessed through using an infrared motion capture system, force platforms and motion analysis software (120 Hz, BTS Smart DX100, Italy). All participants in both groups will be asked not to alter their regular physical activity or pain medications during the 15-sessions training program.
Each participant will be assessed pain, strength, gait biomechanics and functionality before and after 16 sessions of intervention. Pain and functionality will be further evaluated in sessions 5th and 10th. The first group will receive 16 sessions of a functional task training program and therapeutic ultrasound versus the second group who will only receive 16 sessions of the same functional task-training program.
Functional task-training program includes warm up, followed by a functional circuit with muscle strengthening exercises for the major groups of hip oriented to daily life activities and ends with stretching. Therapeutic ultrasound will be applied prior to functional task-training with an intensity of 2.2 W/cm2, frequency of 1 MHz and application time of 4 minutes. Temporal average intensity area corresponds to 0.44 W/cm2, the treatment area will be equal to 2 times the effective radiating area on the anterior, medial and lateral hip area.
The hypothesis of this study is the functional-task training program combined with therapeutic ultrasound will decrease the pain, improve the muscle hip strength the gait biomechanics and the functionality of the people with hip osteoarthritis.
In the statistical analysis of the results, the differences will be assessed in the three pain and functionality assessments with a repeated measures using ANOVA; the differences between initial and final measurement of strength, biomechanical gait variables and functionality will be evaluated with a paired Student t-test and Wilcoxon. The differences between groups will be assessed with a t-test for independent samples. Significant differences in the outcomes will be adjusted for covariates with binomial regressions, considering a significance level of p <0.05.
For patient registries:
The Mederi Hospital has an integrated system for collecting, storing, monitoring, reviewing, and reporting on registry data of the participants of the study. It also has a Manual documentation of procedures for each registry, includes protocols and data collection instrument. The manual explains how the investigators should create or assign the patient identification numbers and how duplicate records should be prevented and how to report adverse events.
The hospital takes plans for monitoring or auditing the screening practices trough the auditing department and training to educate data collectors.
Additionally, the investigators will make a Pilot Testing to assess understanding, acceptance and feasibility the patient registry processes.
In the other hand, all staffs involved in data collection will be identified, and their roles and job will be described in data collection and processing.
All data collection will be registered in the integrated system of the Mederi Hospital. The gait biomechanics data will be recorded first in the database of the Smart DX100 system of the Laboratory of Biomechanics if the University of Rosario. The investigators will have an external research (Fulbright Scholar) that will audit the register of the biomechanics data. Then, every participant of the study will have an electronic medical record (EMR) of health-related information.
The Mederi Hospital has a system security plan that includes the policies, standard operating procedures, administrative procedures, electronic signatures and it also has a technical security support.
The plan for missing data where variables are reported as missing,unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results the investigators will quantify the extent of missingness, identifying which individuals have missing data and at which assessment then, the investigators will treat the missing data across a statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional task-training and Ultrasound | Experimental | Other: Functional task-training, Device: Therapeutic UltrasoundThis group will receive 16 sessions of functional task-training program and therapeutic ultrasound will be applied prior to functional task-training. |
| Functional task-training | Active comparator | Other: Functional task-trainingThis group will receive 16 sessions of functional task-training program. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of hip osteoarthritis
Key exclusion criteria (8 listed)
- Musculoskeletal disability in other lower extremity joints or trunk
- Acute injuries of lower extremity and trunk in past three months
- Arthroscopic surgery
- An intra-articular injection in past three months
- Candidate for surgery
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 |
|---|---|---|
| Functional task-trainingThe functional task-training program includes warming up followed by a functional circuit with muscle strengthening exercises for the major groups of hip oriented to daily life activities and ends with stretching. | Other | Functional task-training, Functional task-training and Ultrasound |
| Therapeutic UltrasoundTherapeutic pulsed ultrasound will be applied prior to functional task-training with an intensity of 2.2 W/cm2, frequency of 1 MHz and application time of 4 minutes on the anterior, medial and lateral hip area. | Device | Functional task-training and Ultrasound |
Primary outcome
Visual Analog Scale for pain
Time frame: within the first 2 weeks before the intervention
To measure the pain intensity
Change from Baseline Visual Analog Scale for pain at 16th session of intervention
Time frame: within the first 2 weeks after the intervention
Muscle strength
Time frame: within the first 2 weeks before the intervention
It is the muscle strength of gluteus maximus, medium, quadriceps and hamstrings measured using a manual muscle dynamometer.
Change from Baseline Muscle strength at 16th session of intervention
Time frame: within the first 2 weeks after the intervention
Change of the muscle strength of gluteus maximus, medium, quadriceps and hamstrings after the intervention.
Gait biomechanics
Time frame: within the first 2 weeks before the intervention
Assess the speed, hip range of motion, and peak hip flexion/extension in the gait phases by using motion analysis system BTS SmartDX100 Brand.
Change from Baseline Gait biomechanics at 16th session of intervention
Time frame: within the first 2 weeks after the intervention
Six minute walk test (To measure the physical function in terms of the basic mobility)
Time frame: within the first 2 weeks before the intervention
Change from Baseline Six minute walk test at 16th session of intervention
Time frame: within the first 2 weeks after the intervention
4 secondary outcomes
Change from Baseline Visual Analog Scale for pain at 5th session of intervention
Time frame: After finishing the 5th session of intervention
Change from Baseline Visual Analog Scale for pain at 10th session of intervention
Time frame: After finishing the 10th session of intervention
Change from Baseline Six minute walk test at 5th session of intervention
Time frame: After finishing the 5th session of intervention
Change from Baseline Six minute walk test at 10th session of intervention
Time frame: After finishing the 10th session of intervention
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 10 Sep 2021.
- Background: PubMed 674399Oakley EM. Application of continuous beam ultrasound at therapeutic levels. Physiotherapy. 1978 Jun;64(6):169-72. No abstract available.
- Background: PubMed 23966143Farcic TS, Baldan CS, Cattapan CG, Parizotto NA, Joao SM, Casarotto RA. Treatment time of ultrasound therapy interferes with the organization of collagen fibers in rat tendons. Braz J Phys Ther. 2013 May-Jun;17(3):263-71. doi: 10.1590/s1413-35552012005000090.
- Background: PubMed 13367362CARTER EF Sr, HARRISS RR, PHILLIPS K, ROBINSON LF. Therapeutic application of ultrasound energy; results of broad clinical survey. J Fla Med Assoc (1914). 1956 Oct;43(4):341-6. No abstract available.
- Background: PubMed 16558499Chan AK, Myrer JW, Measom GJ, Draper DO. Temperature changes in human patellar tendon in response to therapeutic ultrasound. J Athl Train. 1998 Apr;33(2):130-5.
- Background: PubMed 18708676Demchak TJ, Stone MB. Effectiveness of clinical ultrasound parameters on changing intramuscular temperature. J Sport Rehabil. 2008 Aug;17(3):220-9. doi: 10.1123/jsr.17.3.220.
- Background: PubMed 8535471Draper DO, Castel JC, Castel D. Rate of temperature increase in human muscle during 1 MHz and 3 MHz continuous ultrasound. J Orthop Sports Phys Ther. 1995 Oct;22(4):142-50. doi: 10.2519/jospt.1995.22.4.142.
- Background: PubMed 21720451Zhou Q, Lau S, Wu D, Shung KK. Piezoelectric films for high frequency ultrasonic transducers in biomedical applications. Prog Mater Sci. 2011 Feb;56(2):139-174. doi: 10.1016/j.pmatsci.2010.09.001.
- Background: PubMed 16930682ter Haar G. Therapeutic applications of ultrasound. Prog Biophys Mol Biol. 2007 Jan-Apr;93(1-3):111-29. doi: 10.1016/j.pbiomolbio.2006.07.005. Epub 2006 Aug 4.
- Background: PubMed 12853678Hangiandreou NJ. AAPM/RSNA physics tutorial for residents. Topics in US: B-mode US: basic concepts and new technology. Radiographics. 2003 Jul-Aug;23(4):1019-33. doi: 10.1148/rg.234035034.
- Background: PubMed 16558239Draper DO, Sunderland S. Examination of the law of grotthus-draper: does ultrasound penetrate subcutaneous fat in humans? J Athl Train. 1993 Fall;28(3):246-50.
- Background: PubMed 17045633Leighton TG. What is ultrasound? Prog Biophys Mol Biol. 2007 Jan-Apr;93(1-3):3-83. doi: 10.1016/j.pbiomolbio.2006.07.026. Epub 2006 Aug 15.
- Background: PubMed 7360798Stewart HF, Abzug JL, Harris GR. Considerations in ultrasound therapy and equipment performance. Phys Ther. 1980 Apr;60(4):424-8. doi: 10.1093/ptj/60.4.424.
- Individual participant dataSharing planned: Undecided
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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.
Songning Zhang, PhD study director
Director, Biomechanics/Sports Medicine Lab, Department of Kinesiology, Recreation, & Sport Studies College of Education, Health and Human Sciences. The University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional task-training and Therapeutic Ultrasound in people with Osteoarthritis, Hip, run by Universidad del Rosario at 1 site in Colombia.
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 1 inclusion and 8 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 10 Sep 2021. 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 Colombia. 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 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?
Visual Analog Scale for pain (time frame: within the first 2 weeks before the intervention). The study lists 8 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 NCT02798900, which also lists 43 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 10 Sep 2021.