Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The ActiPatch is a cutaneous device which is CE marked approved for relief of pain and has FDA clearance as an over the counter device for the adjunctive treatment of osteoarthritis of the knee and plantar fasciitis. It is taped over the affected area and stimulation at a high frequency is reported to alleviate pain with no sensation. By randomising patients between application of an active device or a dummy device and assessment of disability and pain scores at four weeks the efficacy or otherwise can be established. Chronic low back pain is a major health problem and if effective this has major economic implications as the device is cheap and safe.
Chronic low back pain is a major public heath challenge for a number of reasons including prevalence, seriousness, vulnerable populations, the utility of population health strategies, and the importance of prevention at both the population and individual levels. Its incidence and prevalence are increasing with an aging population and the rise in obesity. When considering the location of chronic pain and its aetiology, back pain was the most common location with arthritis/osteoarthritis being the most common cause. Chronic low back back pain is costly to nations-not just in terms of health care expenditures and disability compensation but also in terms of lost school days, lost productivity and employment, reduced incomes, and lost potential and quality of life.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Active Comparator | Subjects in this group will receive an active pulsed shortwave therapy device. |
|
| Control Group | Placebo Comparator | Subjects in this group will receive a placebo pulsed shortwave device that it does not emit energy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed Shortwave Therapy | Device | Pulsed Shortwave Therapy device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index | Quality of life measure for chronic lower back pain | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Pain score | assessment of pain being experienced | 4 weeks |
| The Pain and Sleep Questionnaire three-item index | Assessment of the impact of pain on the subjects sleep |
Not provided
Inclusion Criteria:
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 or above with stable chronic lower back pain
Females of childbearing must be on birth control or practice abstinence during the study period
o Women of childbearing age will be screened with a urine pregnancy test. Women of childbearing potential are defined as any female who has experienced menarche and who is not permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.
≥3 months duration of chronic low back pain
a current VAS pain rating ≥5/10
no radiating pain below the knee
Most of the pain in the body is present in the lower back or buttock, NOT in the lower extremities, as determined during screening by the principal investigator. The investigator will verbally ask the participant if most of the pain being experienced is in the lower back/buttock area, and rely on the response for inclusion into the study.
able to complete and tolerate treatment for the study period.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chandra Koneru, MD | North Alabama Primary Care | Principal Investigator |
| Sree Koneru, Ph.D | BioElectronics Corporation | Study Director |
| Ian Rawe, Ph.D. | BioElectronics Corporation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Alabama Primary Care | Athens | Alabama | 35611 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Devices will be coded, the placebo device is Identical to the active device in all ways except emitting the electromagnetic field. The energy emitted causes no sensation so can not be unmasked by user.
| 4 weeks |
| Analgesic Medication use | Quantify the use of analgesic medications | 4 weeks |