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| Name | Class |
|---|---|
| BioElectronics Corporation | INDUSTRY |
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A single-centre, randomised controlled, double blind study comparing use of the Allay pulsed shortwave therapy treatment versus a placebo device or no treatment for management of primary dysmenorrhea.
Women participating in the trial will be randomly allocated to any of the three arms of the study.
Primary Outcome measures are:
A reduction in dysmenorrhea as measured by the highest pain score on a 10cm visual analogue scale.
A reduction in average pain score on a 10cm visual analogue scale
A reduction in use of analgesia as recorded in a pain diary
Improvement in quality of life as measured through a validated quality of life assessment tool (SF-36 questionnaire)
- Improvement in menstrual symptoms as recorded through a validated questionnaire (the Modified Menorrhagia Multi-attribute Scale (MMAS)).
Device acceptability as measured on a 5-point Likert scale ranging from "unacceptable" to "totally acceptable".
Impact upon associated cyclical symptoms as recorded in a patient symptom diary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment | Active Comparator | Treatment for 2 menstrual cycles using the pulsed shortwave therapy Allay® device (BioElectronics Corp, Frederick USA) |
|
| Placebo | Placebo Comparator | Treatment for 2 menstrual cycles using a placebo device which is identical in appearance to the active device but does not emit any pulsed shortwave therapy. |
|
| No treatment | No Intervention | No intervention is given and a menstrual diary is completed for 2 cycles. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allay | Device | pulsed shortwave therapy treatment for painful periods |
| |
| Measure | Description | Time Frame |
|---|---|---|
| A reduction in dysmenorrhea as measured by the highest pain score on a 10cm visual analogue scale. | Measured as highest pain score on a 10cm visual analogue scale | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Impact upon associated cyclical symptoms | Measured through the validated menstrual symptoms questionnaire the Menorrhagia Multi-Attribute Scale | 2 months |
| Improvement in quality of life as measured through a validated quality of life assessment tool (SF-36 questionnaire). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Justin Clark | Contact | 07967724697 | t.j.clark@doctors.org.uk | |
| helen stevenson | Contact | 07854031663 | h_stevenson27@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Justin Clark | Birmingham Women's NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Birmimgham | Recruiting | Birmingham | United Kingdom |
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| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
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Participants are allocated to 1 of 3 arms: either treatment with an active device, treatment with a placebo device, or no treatment.
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Participants will be randomly allocated to a treatment arm through telephone randomisation. If they are allocated to "no treatment" they will be aware of the management, however if allocated to use of a device the participant and care provider will be blinded to weather it is an active device or placebo device. The outcome assessor will be blinded to the treatment allocation.
| Placebo |
| Device |
A placebo device is given which is identical to the Allay device but emits no pulsed shortwave therapy. |
|
Measured through a validated quality of life questionnaire (SF36) |
| 2 months |
| Device acceptability as measured on a 5-point Likert scale ranging from "unacceptable" to "totally acceptable". | Measured by those allocated a device on a 5-point Likert scale ranging from "unacceptable" to "totally acceptable". | 2 months |
| Reduction in use of analgesia | Measured through a record of analgesia used during menstrual cycle | 2 months |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |