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The ActiPatch is a cutaneous device which is CE marked approved for relief of pain. It is taped over the affected area and stimulation at a high frequency is reported to alleviate pain with no sensation. However there is no class 1 evidence for this on back pain. By randomising patients between application of an active device or a dummy device and assessment of disability and pain scores at two weeks, the efficacy or otherwise can be established. Low back pain is a major health problem and if effective this has major economic implications as the device is cheap and safe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | Subjects given active ActiPatch device before or after crossover (randomised) |
|
| Placebo | Placebo Comparator | Subjects given placebo ActiPatch device before or after crossover (randomised) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ActiPatch (active) | Device | Active version of the ActiPatch pulsed shortwave therapy device. Emits shortwave radiofrequency pulsed energy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain-related disability, indexed by the Oswestry Disability Index (ODI) | Change from baseline ODI score at 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective pain, indexed by Visual analogue pain scale | Change from baseline visual analogue score over the course of 2 weeks, recorded daily during the 2 week period by participant as part of a pain diary | |
| Medication intake | Change from baseline medication intake rate over the course of 2 weeks, recorded daily during the 2 week period by participant as part of a pain diary |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tipu Z Aziz | Contact | 01865231885 | tipu.aziz@nds.ox.ac.uk | |
| Laurie Pycroft | Contact | 07788804011 | laurie.pycroft@nds.ox.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Radcliffe Hospital | Recruiting | Oxford | Oxfordshire | OX3 9DU | United Kingdom |
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ActiPatch (placebo) | Device | Placebo version of the ActiPatch pulsed shortwave therapy device. Emits no radiofrequency energy but otherwise appears identical to the active device. |
|
|
| Pain related disability, indexed by the Roland Morris Instrument | Change from baseline Roland Morris Instrument scores at 2 weeks |
| Quality of life, indexed by the EQ-5D-5L questionnaire | Change from baseline EQ-5D-5L scores at 2 weeks |