Osteoarthritis of the HipPhase 2NCT01312285
Low Level Magnetic Fields for the Treatment of Osteoarthritis of the Hip
A Phase 2 study testing Resonator device in people with Osteoarthritis of the Hip, run by pico-tesla Magnetic Therapies, LLC at 1 site in United States.
Trial summary
The purpose of this study is to see if using a device called the Resonator, that puts out very low level electromagnetic fields will help symptoms of painful hip(s) Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Osteoarthritis of the Hip
- What is being tested?
- Resonator device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Mar 2012
- Phase
- Phase 2
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > Diagnosis of osteoarthritis of the hip for at least one hip (right or left hip, or both hips) determined by satisfaction of BOTH of the following (as outlined in the STUDY TEST BATTERY section above):
- the American College of Rheumatology (ACR) Classification Criteria for osteoarthritis of the hip, AND
- Rating of current Degree of Pain in the hip on the 0-100 Visual Analog Scale of 40 or greater.
- N.B.: If both hips satisfy both of the above criteria for diagnosis of osteoarthritis of the hip, the hip with the highest VAS pain rating will be selected for evaluation in this study. That is, only one hip per subject will be evaluated in this study.
- Hip pain was present on most days of the prior three months.
- Subject is ambulatory.
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- Subject's use of pain relief medication(s) has been stable over the past 30 days, and the subject is willing and able to maintain this existing use of pain relief medication(s) as his or her sole pain relief medication use, as needed, throughout study participation.
- Subject has been on current non-pain relief medication regimen (for any indication or condition such as hypertension, pulmonary disease or cardiac disease), unchanged, or on no current non-pain relief medication regimen, for at least 30 days prior to study enrollment, and is willing and able to maintain his or her regular non-pain relief medication regimen, unchanged, throughout the course of his or her study participation unless the subject's physician states that a medication change is needed for the subject's safety and well-being, in which case the subject agrees to inform the study PI of the change(s) made ,.
- Willing and able to abstain from partaking in other/new treatments (other than the study procedures) to improve osteoarthritis of the hip pain and other symptoms during the course of participation in the study. Such treatments include new medications, dietary/herbal supplements/ minerals, weight loss programs, water or other new exercise programs, physical therapy, occupational therapy, surgical procedures, and alternative therapies such as acupuncture, massage, or hypnotherapy.
- Adequate contraceptive measures for female subjects. > 18 years of age or older.
- Male or female.
Who cannot join
- > Neither the right nor the left hip satisfies BOTH of the following criteria for a diagnosis of osteoarthritis of the hip (as outlined in the STUDY TEST BATTERY section):
- the American College of Rheumatology (ACR) Classification Criteria for osteoarthritis of the hip, AND
- Rating of current Degree of Pain in the hip on the 0-100 Visual Analog Scale of 40 or greater.
- Hip pain was not present on most days of the prior three months.
- Subject is non-ambulatory.
- Any factors that might prevent the subject from completing a full course of therapy with the Resonator™ device, or from attending any of the scheduled study visits during the planned study duration, or from completing any of the study measures.
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- Any other significant comorbidities that might impact the ability to evaluate the subject's satisfaction of the American College of Rheumatology Classification Criteria for osteoarthritis of the hip, or for the subject to complete any of the study assessment tools.
- Subject's use of pain relief medication(s) has not been stable over the past 30 days and/or the subject is not willing and/or unable to maintain this existing use of pain relief medication(s) as his or her sole pain relief medication use, as needed, throughout study participation.
- Not willing and/or unable to abstain from partaking in new treatments (other than the study procedures) to improve osteoarthritis of the hip pain and other symptoms during the course of participation in the study. Such treatments include new medications, dietary/herbal supplements/minerals, weight loss programs, water or other new exercise programs, physical therapy, occupational therapy, surgical procedures, and alternative therapies such as acupuncture, massage, or hypnotherapy.
- An intra-articular hip injection (with any corticosteroid, hyaluronic acid preparation or other) within the prior three months.
- Known inflammatory rheumatic disease.
- Epilepsy/history of seizures/taking medication for epilepsy.
- HIV and other autoimmune disorders.
- Active cancer or treatment for cancer within last 6 months.
- Confirmed active infection(s).
- Signs of clinically important active inflammation of the hip joint including redness, warmth, swelling and/or a large, bulging effusion with the loss of normal contour.
- Acute inflammation or ischaemic necrosis.
- Inflammatory arthropathy of the hip.
- Inflammatory system diseases that could interfere with the evaluation of the study procedure.
- Hip arthropathy due to diabetes mellitus.
- Charcot's joint.
- Villous synovitis.
- Chondromatosis of the synovium.
- Rapid destructive hip.
- History of crystalline arthropathy or inflammatory arthritis, neuropathic arthropathy.
- Secondary osteoarthritis of the study hip joint including, but not limited to, septic arthritis, inflammatory joint disease, gout, Paget's disease of bone, articular fracture, major dysplasias or congenital abnormality, ochronosis, acromegaly, hemochromatosis, Wilson's disease, avascular necrosis, or primary osteochondromatosis.
- History of acute inflammatory arthritis or pseudogout of the study hip.
- History of ECT.
- Uncontrolled hypertension.
- Advanced pulmonary disease.
- Unstable cardiac disease, such as any history of cardiac arrhythmias (including atrial fibrillation, ventricular fibrillation, or irregular atrial-ventricular conduction time), or any incidences of congestive heart failure, or myocardial infarction, within the last six months.
- Prosthetics or implants comprised of ferrous metals.
- History of surgery, including arthroscopy, or major trauma to the study hip joint in the prior six months.
- Endoprothetic replacement of study hip joint.
- Pacemakers, vagus nerve stimulators, or other functional electrical stimulators such as those commonly used for pain.
- Reported consumption of more than 21 alcoholic drinks per week.
- Pregnant, breast feeding, or planning pregnancy prior to the end of participation.
- Current or past history of major psychiatric disturbance (e.g., schizophrenia, bipolar disorder, substance abuse). However, subjects with a history of adequately treated depression or anxiety disorders will not be excluded. Anti-depressant drug therapy must be stable for at least 4 weeks prior to study entry and must remain stable throughout study duration.
- Developmental disability or other cognitive impairment that would in the judgment of the PI impair adequate comprehension of the informed consent form or complete any of the study-related activities.
- Worker's compensation (current or pending), current receipt of disability or present /past litigation for monetary compensation pertaining to the subject's osteoarthritis of the hip condition.
- Participation in investigational drug or medical device research within 30 days of enrollment in this current pilot study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Evaluation of the Application of Magnetic Fields Using the Resonator Device for the Treatment of Osteoarthritis of the Hip: Pilot Study Protocol
The purpose of this study is to see if using a device called the Resonator, that puts out very low level electromagnetic fields will help symptoms of painful hip(s)
Read the detailed description
The purpose of this pilot study is to assess the efficacy of the Resonator™ device, manufactured by Pico-Tesla, the MAGNECEUTICAL® company (the Sponsor), as an adjunctive therapy to reducing pain and improving function for individuals with osteoarthritis of the hip.
- Conditions
- Osteoarthritis of the Hip
- Being tested
- Resonator device
- Keywords
- osteoarthritis, painful hips
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resonator deviceDevice
low level magnetic fields
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Device: Resonator device |
| Resonator Device | Experimental | Not described Receives: Device: Resonator device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean change from baseline to study endpoint in the 3-recording average of the subject's Daily Pain Rating on the 0-100 VAS for the study hip recorded each morning upon waking and prior to consuming any pain medication for the day.
Measured: 14 days
Secondary outcomes (1)
Daily morning recordings of pain intensity ratings for the study hip on the 0-100 VAS
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2012 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- pico-tesla Magnetic Therapies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312285
- Sponsor's protocol ID
- 10276-01
- Status last verified
- May 2011
- First submitted
- 10 Jan 2011
- Last updated
- 30 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Evaluation of the Application of Magnetic Fields Using the Resonator Device for the Treatment of Osteoarthritis of the Hip: Pilot Study Protocol
- ClinicalTrials.gov ID
- NCT01312285
- Acronym / sponsor ID
- 10276-01
- Conditions
- Osteoarthritis of the Hip
- Keywords
- osteoarthritis, painful hips
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- pico-tesla Magnetic Therapies, LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 10 Mar 2011 (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 purpose of this study is to see if using a device called the Resonator, that puts out very low level electromagnetic fields will help symptoms of painful hip(s)
Detailed description
The purpose of this pilot study is to assess the efficacy of the Resonator™ device, manufactured by Pico-Tesla, the MAGNECEUTICAL® company (the Sponsor), as an adjunctive therapy to reducing pain and improving function for individuals with osteoarthritis of the hip.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Device: Resonator device |
| Resonator Device | Experimental | Device: Resonator device |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- > Diagnosis of osteoarthritis of the hip for at least one hip (right or left hip, or both hips) determined by satisfaction of BOTH of the following (as outlined in the STUDY TEST BATTERY section above):
- N.B.: If both hips satisfy both of the above criteria for diagnosis of osteoarthritis of the hip, the hip with the highest VAS pain rating will be selected for evaluation in this study. That is, only one hip per subject will be evaluated in this study.
- Hip pain was present on most days of the prior three months.
- Subject is ambulatory.
- Subject's use of pain relief medication(s) has been stable over the past 30 days, and the subject is willing and able to maintain this existing use of pain relief medication(s) as his or her sole pain relief medication use, as needed, throughout study participation.
Key exclusion criteria (41 listed)
- > Neither the right nor the left hip satisfies BOTH of the following criteria for a diagnosis of osteoarthritis of the hip (as outlined in the STUDY TEST BATTERY section):
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 |
|---|---|---|
| Resonator devicelow level magnetic fields | Device | Placebo, Resonator Device |
Primary outcome
The mean change from baseline to study endpoint in the 3-recording average of the subject's Daily Pain Rating on the 0-100 VAS for the study hip recorded each morning upon waking and prior to consuming any pain medication for the day.
Time frame: 14 days
1 secondary outcome
Daily morning recordings of pain intensity ratings for the study hip on the 0-100 VAS
Time frame: 14 days
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 30 May 2011.
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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 2 study testing Resonator device in people with Osteoarthritis of the Hip, run by pico-tesla Magnetic Therapies, LLC at 1 site in United States.
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 11 inclusion and 41 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 30 May 2011. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
The mean change from baseline to study endpoint in the 3-recording average of the subject's Daily Pain Rating on the 0-100 VAS for the study hip recorded each morning upon waking and prior to consuming any pain medication for the day. (time frame: 14 days). 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 30 May 2011.