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| ID | Type | Description | Link |
|---|---|---|---|
| WCC# 63 | Other Identifier | University of Minnesota Women's Cancer Center |
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This is a 2-armed, randomized, sham-controlled, double-blinded clinical trial of photobiomodulation therapy using the Realief Therapy system. The patients will be randomized in a 3:4 ratio to treatment or sham arms.
The treatments will be administered by a Realief Neuropathy Center therapist. The target surface area and treatment durations will be dictated by the Realief Therapy protocol according to their proprietary algorithm, which includes assessment of geographic areas involved and the degree of neuropathy experienced. For the trial, each patient will be given 18 treatments of 30-minute duration, scheduled every three times weekly. The treatments will include laser exposure of any or all of 27 differentiated areas of the legs, feet, cervical spine region and lumbar spine region, for durations of 3 to 30 minutes, based on the symptom presentation at the time. Power densities will vary from 5 to 12 watts, based on the symptom presentations through the course of therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Realief Therapy | Experimental | Each patient will be given 15-18 treatments depending on response of 30-minute duration of photobiomodulation with the Realief Therapy system, scheduled every three times weekly for 5-6 weeks. The treatments will include laser exposure of any or all of 27 differentiated areas of the legs, feet, cervical spine region and lumbar spine region, for durations of 3 to 30 minutes, based on the symptom presentation at the time. Power densities will vary from 5 to 12 watts, based on the symptom presentations through the course of therapy. |
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| Sham Treatment | Sham Comparator | The placebo group will receive sham treatment, during which a heat probe will be guided over both lower extremities over a period of 30 minutes, consistent with the treatment arm. The laser device will be activated during the treatment so that the visual and auditory environment prior to therapy will be the same for both treatment and sham control. After 8 weeks of sham treatment the subjects in this arm will be offered the photobiomodulation combined with physiotherapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| photobiomodulation | Device | The photobiomodulation delivered by Realief Therapy involves amplitude wavelength light delivered by a class IV therapeutic laser. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change of Total Neuropathy Score | For each patient, we will compute the difference between the total neuropathy score at 8 weeks (the end of treatment) and the total neuropathy score at the time of randomization. The mean change in score for the experimental group patients will be compared to the mean change in score for the control group patients using a two-sample t-test. Scale scoring is 0-<20 0 being no pain <20 =severe | Baseline 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Argenta, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota Gynecologic Cancer Center | Minneapolis | Minnesota | 55455 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Realief Therapy | Each patient will be given 15-18 treatments depending on response of 30-minute duration of photobiomodulation with the Realief Therapy system, scheduled every three times weekly for 5-6 weeks. The treatments will include laser exposure of any or all of 27 differentiated areas of the legs, feet, cervical spine region and lumbar spine region, for durations of 3 to 30 minutes, based on the symptom presentation at the time. Power densities will vary from 5 to 12 watts, based on the symptom presentations through the course of therapy. photobiomodulation: The photobiomodulation delivered by Realief Therapy involves amplitude wavelength light delivered by a class IV therapeutic laser. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Sham treatment | Other | All patients in sham treatment arm cross over to laser therapy followed by physiotherapy |
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| Physiotherapy | Other | Chiropractic massage and lymphedema treatment |
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| FG001 | Sham Treatment | The placebo group will receive sham treatment, during which a heat probe will be guided over both lower extremities over a period of 30 minutes, consistent with the treatment arm. The laser device will be activated during the treatment so that the visual and auditory environment prior to therapy will be the same for both treatment and sham control. After 8 weeks of sham treatment the subjects in this arm will be offered the photobiomodulation combined with physiotherapy. photobiomodulation: The photobiomodulation delivered by Realief Therapy involves amplitude wavelength light delivered by a class IV therapeutic laser. Sham treatment: All patients in sham treatment arm cross over to laser therapy followed by physiotherapy Physiotherapy: Chiropractic massage and lymphedema treatment |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Realief Therapy | Each patient will be given 15-18 treatments depending on response of 30-minute duration of photobiomodulation with the Realief Therapy system, scheduled every three times weekly for 5-6 weeks. The treatments will include laser exposure of any or all of 27 differentiated areas of the legs, feet, cervical spine region and lumbar spine region, for durations of 3 to 30 minutes, based on the symptom presentation at the time. Power densities will vary from 5 to 12 watts, based on the symptom presentations through the course of therapy. photobiomodulation: The photobiomodulation delivered by Realief Therapy involves amplitude wavelength light delivered by a class IV therapeutic laser. |
| BG001 | Sham Treatment | The placebo group will receive sham treatment, during which a heat probe will be guided over both lower extremities over a period of 30 minutes, consistent with the treatment arm. The laser device will be activated during the treatment so that the visual and auditory environment prior to therapy will be the same for both treatment and sham control. After 8 weeks of sham treatment the subjects in this arm will be offered the photobiomodulation combined with physiotherapy. photobiomodulation: The photobiomodulation delivered by Realief Therapy involves amplitude wavelength light delivered by a class IV therapeutic laser. Sham treatment: All patients in sham treatment arm cross over to laser therapy followed by physiotherapy Physiotherapy: Chiropractic massage and lymphedema treatment |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change of Total Neuropathy Score | For each patient, we will compute the difference between the total neuropathy score at 8 weeks (the end of treatment) and the total neuropathy score at the time of randomization. The mean change in score for the experimental group patients will be compared to the mean change in score for the control group patients using a two-sample t-test. Scale scoring is 0-<20 0 being no pain <20 =severe | Posted | Mean | Standard Error | units on a scale | Baseline 8 weeks |
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16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Realief Therapy | Each patient will be given 15-18 treatments depending on response of 30-minute duration of photobiomodulation with the Realief Therapy system, scheduled every three times weekly for 5-6 weeks. The treatments will include laser exposure of any or all of 27 differentiated areas of the legs, feet, cervical spine region and lumbar spine region, for durations of 3 to 30 minutes, based on the symptom presentation at the time. Power densities will vary from 5 to 12 watts, based on the symptom presentations through the course of therapy. photobiomodulation: The photobiomodulation delivered by Realief Therapy involves amplitude wavelength light delivered by a class IV therapeutic laser. | 0 | 30 | 0 | 30 | 0 | 30 |
| EG001 | Sham Treatment | The placebo group will receive sham treatment, during which a heat probe will be guided over both lower extremities over a period of 30 minutes, consistent with the treatment arm. The laser device will be activated during the treatment so that the visual and auditory environment prior to therapy will be the same for both treatment and sham control. After 8 weeks of sham treatment the subjects in this arm will be offered the photobiomodulation combined with physiotherapy. photobiomodulation: The photobiomodulation delivered by Realief Therapy involves amplitude wavelength light delivered by a class IV therapeutic laser. Sham treatment: All patients in sham treatment arm cross over to laser therapy followed by physiotherapy Physiotherapy: Chiropractic massage and lymphedema treatment | 0 | 40 | 0 | 40 | 1 | 40 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Superficial Burn | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Argenta MD | University of Minnesota | 612-626-3111 | argenta@umn.edu |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
| D012046 | Rehabilitation |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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