Trial Outcomes & Findings for Clinical Trial of the invisaRED® IR REHAB Device When Used as an Adjunctive Therapy for Nociceptive Musculoskeletal Pain (NCT NCT06393088)

Last Updated: 2025-03-18

Results Overview

Participants pain levels will be measured using a visual analog scale of 0-100mm where a smaller number indicates a lower perceived pain level and a larger number indicates a higher level of pain. The participant will personally manipulate a visual analog scale with a manual slide indicator to record their pain levels

Recruitment status

COMPLETED

Study phase

Target enrollment

31 participants

Primary outcome timeframe

Participants pain levels will be recorded over a period of three weeks.

Results posted on

2025-03-18

Participant Flow

The Trial recruitment period had a start date of July 22nd and ended on August 7th 2024. (A total of 17 days) All participant recruitment and interviews were conducted at the Abbycare Clinic in Woodstock, GA.

Participant milestones

Participant milestones
Measure	IR REHAB Device Participants will receive 6 treatments of 15 minutes each with an active IR REHAB device over the period of three weeks. IR REHAB: Participants undergo therapy sessions with active, dual wavelength, low level laser therapy device	Sham Device Participants will receive 6 treatments of 15 minutes each with a disabled (sham) IR REHAB device over the period of three weeks. Sham: Participants undergo therapy sessions with disabled device producing no laser energy
Overall Study STARTED	16	15
Overall Study COMPLETED	16	13
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	IR REHAB Device Participants will receive 6 treatments of 15 minutes each with an active IR REHAB device over the period of three weeks. IR REHAB: Participants undergo therapy sessions with active, dual wavelength, low level laser therapy device	Sham Device Participants will receive 6 treatments of 15 minutes each with a disabled (sham) IR REHAB device over the period of three weeks. Sham: Participants undergo therapy sessions with disabled device producing no laser energy
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

Clinical Trial of the invisaRED® IR REHAB Device When Used as an Adjunctive Therapy for Nociceptive Musculoskeletal Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IR REHAB Device n=16 Participants Participants will receive 6 treatments of 15 minutes each with an active IR REHAB device over the period of three weeks. IR REHAB: Participants undergo therapy sessions with active, dual wavelength, low level laser therapy device	Sham Device n=13 Participants Participants will receive 6 treatments of 15 minutes each with a disabled (sham) IR REHAB device over the period of three weeks. Sham: Participants undergo therapy sessions with disabled device producing no laser energy	Total n=29 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	13 Participants n=5 Participants	8 Participants n=7 Participants	21 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Race · Hispanic	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
IR REHAB Clinical Trial Participants	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants

PRIMARY outcome

Timeframe: Participants pain levels will be recorded over a period of three weeks.

Outcome measures

Outcome measures
Measure	IR REHAB Device n=16 Participants Participants will receive 6 treatments of 15 minutes each with an active IR REHAB device over the period of three weeks. IR REHAB: Participants undergo therapy sessions with active, dual frequency, low level laser therapy device	Sham Device n=13 Participants Participants will receive 6 treatments of 15 minutes each with a disabled (sham) IR REHAB device over the period of three weeks. Sham: Participants undergo therapy sessions with disabled device producing no laser energy
Measured Change in the Participants Pain Levels	61.46 Score on a scale Interval 47.7 to 72.63	19.79 Score on a scale Interval 4.89 to 37.34

Adverse Events

IR REHAB Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Consulting Director of Clinical Trials

IR Technology LLC

Phone: 404 915-5938

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place