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Photobiomodulation Therapy Using the Realief Therapy System for the Treatment of Chemotherapy-associated Peripheral Neuropathy

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ClinicalTrials.gov Identifier: NCT02000908
Recruitment Status : Completed
First Posted : December 4, 2013
Results First Posted : February 11, 2019
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition Chemotherapy-induced Peripheral Neuropathy
Interventions Device: photobiomodulation
Other: Sham treatment
Other: Physiotherapy
Enrollment 70
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Realief Therapy Sham Treatment
Hide Arm/Group Description

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.

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

Period Title: Overall Study
Started 30 40
Completed 28 36
Not Completed 2 4
Arm/Group Title Realief Therapy Sham Treatment Total
Hide Arm/Group Description

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.

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

Total of all reporting groups
Overall Number of Baseline Participants 30 40 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 40 participants 70 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
  30.0%
30
  75.0%
39
  55.7%
>=65 years
21
  70.0%
10
  25.0%
31
  44.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 40 participants 70 participants
Female
30
 100.0%
40
 100.0%
70
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 40 participants 70 participants
American Indian or Alaska Native
0
   0.0%
1
   2.5%
1
   1.4%
Asian
1
   3.3%
0
   0.0%
1
   1.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   2.5%
1
   1.4%
White
29
  96.7%
38
  95.0%
67
  95.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants 40 participants 70 participants
30 40 70
1.Primary Outcome
Title Change of Total Neuropathy Score
Hide Description

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

Time Frame Baseline 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Realief Therapy Sham Treatment
Hide Arm/Group Description:

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.

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

Overall Number of Participants Analyzed 30 38
Mean (Standard Error)
Unit of Measure: units on a scale
-6.8  (52.6) 0.2  (1.5)
Time Frame 16 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Realief Therapy Sham Treatment
Hide Arm/Group Description

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.

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

All-Cause Mortality
Realief Therapy Sham Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)      0/40 (0.00%)    
Hide Serious Adverse Events
Realief Therapy Sham Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/40 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Realief Therapy Sham Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      1/40 (2.50%)    
Skin and subcutaneous tissue disorders     
Superficial Burn *  0/30 (0.00%)  0 1/40 (2.50%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Peter Argenta MD
Organization: University of Minnesota
Phone: 612-626-3111
EMail: argenta@umn.edu
Layout table for additonal information
Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02000908    
Other Study ID Numbers: 2013LS085
WCC# 63 ( Other Identifier: University of Minnesota Women's Cancer Center )
First Submitted: November 27, 2013
First Posted: December 4, 2013
Results First Submitted: February 14, 2017
Results First Posted: February 11, 2019
Last Update Posted: February 11, 2019