Chronic Musculoskeletal DiseaseNCT02974023
Efficacy of "Pain Gear" in Patients With Chronic Musculoskeletal Pain
An observational study of Chronic Musculoskeletal Disease, run by PharmEvo Pvt Ltd.
Trial summary
The current study was designed to evaluate the effectiveness and safety of the device in the common areas of the body affected by different causes of musculoskeletal pain in Vietnamese population in real life situation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Musculoskeletal Disease
- What is being tested?
- Pain Gear
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2017to Dec 2017
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from Low back pain and arthritis.
Who may be able to join
- Chronic musculoskeletal pain of more than 6 month duration
- Participant is willing and able to give informed consent for participation in the trial.
- In the Investigator's opinion, is able and willing to comply with all trial requirements.
- Male or female ages 18-80 years old
- A current VAS pain rating ≥5/10
- Able to complete and tolerate treatment for the study period.
Who cannot join
- Pregnant Woman
- Current implanted cardiac demand pacemakers, defibrillators, cardiac pumps, spinal stimulators or other implanted electronic devices.
- Patients using personal home based electrical stimulation devices
- Active psychiatric disorders (as evidenced by use of antipsychotic or medication).
- Patients diagnosed with history of significant mood disorder will be excluded (depression or anxiety with adequate control would be acceptable).
- Scheduled elective surgery or other procedures requiring general anesthesia during the trial.
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- Participant with life expectancy of less than 6 months, or inappropriate for placebo medication.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
- Participants who are not able to understand verbal or written English, and for whom adequate translation/interpretation cannot be readily obtained
About this study
The current study was designed to evaluate the effectiveness and safety of the device in the common areas of the body affected by different causes of musculoskeletal pain in Vietnamese population in real life situation.
Read the detailed description
PainGear [ActiPatch®] (BioElectronics Corporation, MD, USA) has been recently introduced as an 'topical' analgesic for localized musculoskeletal pain. PainGear is a noninvasive, low power, easy to use, pulsed shortwave therapy device for localized musculoskeletal pain. The device does not produce heat or any sensation. There are two basic requirements to use the device, switching it on via an on/off switch, and affixing the device over the target area of the body. The area of treatment is confined to the area within the 11.5-cm diameter loop antenna covering an area of 100 cm2, the antennae is circular, soft and flexible and can be shaped to fit the area/location being treated as required. The device can be used up to 24 h per day and is placed over the area of localized pain either using medical tape or a specifically designed wrap.
In a randomized, double-blind, placebo-controlled clinical trial, patients with radiographic evidence of knee OA (osteoarthritis) and persistent pain higher than 40mm on the visual analog scale (VAS) were recruited. The trial consisted of 12 h daily treatment for 1 month in 60 knee OA patients. After 1 month, PainGear induced a significant reduction in VAS pain and Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores compared with placebo. Additionally, pain tolerance and physical health improved in PainGear -treated patients. Twenty-six per cent of patients in the PainGear group stopped NSAID/analgesic therapy. No adverse events were detected.
- Conditions
- Chronic Musculoskeletal Disease
- Being tested
- Pain Gear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain GearDevice
Also called ActiPatch
PainGear [ActiPatch®] (BioElectronics Corporation, MD, USA) has been recently introduced as an 'topical' analgesic for localized musculoskeletal pain. PainGear is a noninvasive, low power, easy to use, pulsed shortwave therapy device for localized musculo¬skeletal pain.
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess difference in subjective pain with the use of PainGear for 2 weeks.
[ Time Frame: Change from baseline visual analogue score over the course of 2 weeks]
Measured: 2 weeks
Secondary outcomes (3)
To record change in frequency of other analgesic modalities utilization
[ Time Frame: Change from baseline analgesic modalities usage over the course of 2 weeks period, to be recorded in modalities chart]
Measured: 2 weeks period
To assess difference in Pain-related disability, indexed by the Oswestry Disability Index (ODI)
[ Time Frame: Change from baseline ODI score at 2 weeks, recorded on 1st and 14th day ]
Measured: 2 weeks, recorded on 1st and 14th day
To assess patients satisfaction with two weeks therapy of PainGear
[Time Frame: 14th day]
Measured: 14th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study start30 Jun 2017
- Primary completion30 Oct 2017
- Study completionDec 2017 (estimated)
Why it stopped: Study not started due to the Regulatory and administrative issues of Universities in Vietnam
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Musculoskeletal DiseaseStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmEvo Pvt Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioElectronics Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974023
- Sponsor's protocol ID
- PE/PAINGEAR/09/2016
- Status last verified
- Dec 2016
- First submitted
- 22 Nov 2016
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of "Pain Gear" in Patients With Chronic Musculoskeletal Pain
- ClinicalTrials.gov ID
- NCT02974023
- Acronym / sponsor ID
- PE/PAINGEAR/09/2016
- Conditions
- Chronic Musculoskeletal Disease
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study not started due to the Regulatory and administrative issues of Universities in Vietnam
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PharmEvo Pvt LtdIndustry (pharma, biotech, devices)
- Collaborators
- BioElectronics Corporation
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 28 Nov 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 current study was designed to evaluate the effectiveness and safety of the device in the common areas of the body affected by different causes of musculoskeletal pain in Vietnamese population in real life situation.
Detailed description
PainGear [ActiPatch®] (BioElectronics Corporation, MD, USA) has been recently introduced as an 'topical' analgesic for localized musculoskeletal pain. PainGear is a noninvasive, low power, easy to use, pulsed shortwave therapy device for localized musculoskeletal pain. The device does not produce heat or any sensation. There are two basic requirements to use the device, switching it on via an on/off switch, and affixing the device over the target area of the body. The area of treatment is confined to the area within the 11.5-cm diameter loop antenna covering an area of 100 cm2, the antennae is circular, soft and flexible and can be shaped to fit the area/location being treated as required. The device can be used up to 24 h per day and is placed over the area of localized pain either using medical tape or a specifically designed wrap.
In a randomized, double-blind, placebo-controlled clinical trial, patients with radiographic evidence of knee OA (osteoarthritis) and persistent pain higher than 40mm on the visual analog scale (VAS) were recruited. The trial consisted of 12 h daily treatment for 1 month in 60 knee OA patients. After 1 month, PainGear induced a significant reduction in VAS pain and Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores compared with placebo. Additionally, pain tolerance and physical health improved in PainGear -treated patients. Twenty-six per cent of patients in the PainGear group stopped NSAID/analgesic therapy. No adverse events were detected.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from Low back pain and arthritis.
Key inclusion criteria (6 listed)
- Chronic musculoskeletal pain of more than 6 month duration
- Participant is willing and able to give informed consent for participation in the trial.
- In the Investigator's opinion, is able and willing to comply with all trial requirements.
- Male or female ages 18-80 years old
- A current VAS pain rating ≥5/10
Key exclusion criteria (9 listed)
- Pregnant Woman
- Current implanted cardiac demand pacemakers, defibrillators, cardiac pumps, spinal stimulators or other implanted electronic devices.
- Patients using personal home based electrical stimulation devices
- Active psychiatric disorders (as evidenced by use of antipsychotic or medication).
- Patients diagnosed with history of significant mood disorder will be excluded (depression or anxiety with adequate control would be acceptable).
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 |
|---|---|---|
| Pain GearAlso: ActiPatchPainGear [ActiPatch®] (BioElectronics Corporation, MD, USA) has been recently introduced as an 'topical' analgesic for localized musculoskeletal pain. PainGear is a noninvasive, low power, easy to use, pulsed shortwave therapy device for localized musculo¬skeletal pain. | Device | – |
Primary outcome
To assess difference in subjective pain with the use of PainGear for 2 weeks.
Time frame: 2 weeks
[ Time Frame: Change from baseline visual analogue score over the course of 2 weeks]
3 secondary outcomes
To record change in frequency of other analgesic modalities utilization
Time frame: 2 weeks period
To assess difference in Pain-related disability, indexed by the Oswestry Disability Index (ODI)
Time frame: 2 weeks, recorded on 1st and 14th day
To assess patients satisfaction with two weeks therapy of PainGear
Time frame: 14th day
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 3 Oct 2018.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Musculoskeletal Disease, run by PharmEvo Pvt Ltd.
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 6 inclusion and 9 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 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
To assess difference in subjective pain with the use of PainGear for 2 weeks. (time frame: 2 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 3 Oct 2018; AzTrials last refreshed its copy on 8 Nov 2026.