Pilot Study on the Effects of Low-Level Laser Therapy Treatment for Acute and Persistent Discomfort
Primary Purpose
Chronic Pain, Acute Pain
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-Level Laser Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria:
- subjects having persistent or acute discomfort/pain in a muscle or joint of their body
- ability to speak English or provide own translator
- ability to complete the pre-test/post-test session
- ability to attend three times per week
Exclusion Criteria:
- pregnant women
- currently undergoing immunosuppression therapy
- subjects with photosensitivity concerns
Sites / Locations
- Arkansas Colleges of Health EducationRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Low-Level Laser Therapy
Arm Description
Over the course of the study, participants within this group will receive 12 sessions of Low-Level Laser Therapy (LLLT) treatment over a duration of 4 weeks using the Richmar TheraTouch LX2 device. Treatment location will be determined through assessment of each qualifying participant. Treatment sessions will be limited to a single area of the body associated with the qualifying participant's primary pain complaint.
Outcomes
Primary Outcome Measures
Numeric Pain Rating Scale (NPRS)
The NPRS is an eleven point scale (0-10) where the subject is asked to provide a rating of their pain current, best and worst pain intensity over the past 24 hours. Subjects are asked to rate their pain on a scale of 0 to 10 with 0 being "No Pain" and 10 being "Worst Pain Imaginable". Data will be collected at baseline during Visit 1.
Numeric Pain Rating Scale (NPRS)
The NPRS is an eleven point scale (0-10) where the subject is asked to provide a rating of their pain current, best and worst pain intensity over the past 24 hours. Subjects are asked to rate their pain on a scale of 0 to 10 with 0 being "No Pain" and 10 being "Worst Pain Imaginable". Data will be collected post-treatment during Visit 12.
Patient-Specific Functional Scale (PSFS)
The PSFS is a device used to quantify the extent of a subject's perceived functional limitations due to a particular problem or condition. The subject is asked to identify up to three activities in which they feel their performance is limited. For each of the activities identified, the subject will rate their perceived level of limitation using an eleven point scale (0-10) with 0 being "Unable to perform activity" and 10 being "Able to perform activity at the same level as before injury or problem". Data will be collected at baseline during Visit 1.
Patient-Specific Functional Scale (PSFS)
The PSFS is a device used to quantify the extent of a subject's perceived functional limitations due to a particular problem or condition. The subject is asked to identify up to three activities in which they feel their performance is limited. For each of the activities identified, the subject will rate their perceived level of limitation using an eleven point scale (0-10) with 0 being "Unable to perform activity" and 10 being "Able to perform activity at the same level as before injury or problem". Data will be collected post-treatment during Visit 12.
Joint Range of Motion
Relevant range of motion data will be collected from each qualifying subject at baseline during Visit 1.
Joint Range of Motion
Relevant range of motion data will be collected from each qualifying subject post-treatment during Visit 12.
Muscle Strength
Relevant muscle strength data will be collected from each qualifying subject via manual muscle test or dynamometer at baseline during Visit 1.
Muscle Strength
Relevant muscle strength data will be collected from each qualifying subject via manual muscle test or dynamometer post-treatment during Visit 12.
Secondary Outcome Measures
Full Information
NCT ID
NCT04774783
First Posted
February 20, 2021
Last Updated
February 24, 2021
Sponsor
Arkansas Colleges of Health Education
1. Study Identification
Unique Protocol Identification Number
NCT04774783
Brief Title
Pilot Study on the Effects of Low-Level Laser Therapy Treatment for Acute and Persistent Discomfort
Official Title
Pilot Study on the Effects of Low-Level Laser Therapy Treatment for Acute and Persistent Discomfort
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 22, 2021 (Actual)
Primary Completion Date
March 26, 2021 (Anticipated)
Study Completion Date
March 26, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arkansas Colleges of Health Education
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will examine the effectiveness of Low-Level Laser Therapy (LLLT) for the management of pain in various locations of the body. All subjects selected for participation in the study will be assigned to a LLLT treatment group for a duration of 12 sessions.
Detailed Description
Low-Level Laser Therapy (LLLT) is a treatment modality that is gaining popularity in the field of physical therapy for its proposed mediation of pain. LLLT is typically used in conjunction with other more conventional physical therapy treatment sessions; therefore, it is not clear if the benefits are from the LLLT or the conventional treatment, or the combination of them both. The research question: Does low-level laser therapy treatment with a class 3B Laser decrease pain and improve function in persons with persistent or acute joint/muscle discomfort as compared to before treatment?
Study participants presenting with pain will be interviewed regarding the location and intensity of their primary pain complaints. Participants will also be asked to identify functional limitations associated with their pain. Participants will undergo an initial screening process to identify the presence of any exclusion factors and precautions associated with the delivery of LLLT. Investigators will collect pre-test and post-test information from participants regarding pain intensity and perceived functional limitations. Investigators will also collect relevant joint range of motion and muscle strength data during the first and last sessions. Treatment location for the study will vary within the participant group and will be determined during the initial screening process. The intervention will include LLLT treatment using a combination of LED and laser light delivered by the Richmar TheraTouch LX2 device.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Acute Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low-Level Laser Therapy
Arm Type
Experimental
Arm Description
Over the course of the study, participants within this group will receive 12 sessions of Low-Level Laser Therapy (LLLT) treatment over a duration of 4 weeks using the Richmar TheraTouch LX2 device. Treatment location will be determined through assessment of each qualifying participant. Treatment sessions will be limited to a single area of the body associated with the qualifying participant's primary pain complaint.
Intervention Type
Device
Intervention Name(s)
Low-Level Laser Therapy
Intervention Description
The TheraTouch LX2 device includes a 9-diode cluster probe which emits a combination of LED and laser light. The cluster probe includes four 650 nm LED diodes capable of delivering a total of 40 mW and five 850 nm laser diodes capable of delivering a total of 1000 mW of power. LLLT will the applied with the cluster probe directly in contact with the subject's skin. LLLT dosages will vary according to the location of the subject's pain and may require multiple applications during a session. Each individual application will typically range from 4-16 Joules.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
The NPRS is an eleven point scale (0-10) where the subject is asked to provide a rating of their pain current, best and worst pain intensity over the past 24 hours. Subjects are asked to rate their pain on a scale of 0 to 10 with 0 being "No Pain" and 10 being "Worst Pain Imaginable". Data will be collected at baseline during Visit 1.
Time Frame
Visit 1, Week 1 of 4
Title
Numeric Pain Rating Scale (NPRS)
Description
The NPRS is an eleven point scale (0-10) where the subject is asked to provide a rating of their pain current, best and worst pain intensity over the past 24 hours. Subjects are asked to rate their pain on a scale of 0 to 10 with 0 being "No Pain" and 10 being "Worst Pain Imaginable". Data will be collected post-treatment during Visit 12.
Time Frame
Visit 12, Week 4 of 4
Title
Patient-Specific Functional Scale (PSFS)
Description
The PSFS is a device used to quantify the extent of a subject's perceived functional limitations due to a particular problem or condition. The subject is asked to identify up to three activities in which they feel their performance is limited. For each of the activities identified, the subject will rate their perceived level of limitation using an eleven point scale (0-10) with 0 being "Unable to perform activity" and 10 being "Able to perform activity at the same level as before injury or problem". Data will be collected at baseline during Visit 1.
Time Frame
Visit 1, Week 1 of 4
Title
Patient-Specific Functional Scale (PSFS)
Description
The PSFS is a device used to quantify the extent of a subject's perceived functional limitations due to a particular problem or condition. The subject is asked to identify up to three activities in which they feel their performance is limited. For each of the activities identified, the subject will rate their perceived level of limitation using an eleven point scale (0-10) with 0 being "Unable to perform activity" and 10 being "Able to perform activity at the same level as before injury or problem". Data will be collected post-treatment during Visit 12.
Time Frame
Visit 12, Week 4 of 4
Title
Joint Range of Motion
Description
Relevant range of motion data will be collected from each qualifying subject at baseline during Visit 1.
Time Frame
Visit 1, Week 1 of 4
Title
Joint Range of Motion
Description
Relevant range of motion data will be collected from each qualifying subject post-treatment during Visit 12.
Time Frame
Visit 12, Week 4 of 4
Title
Muscle Strength
Description
Relevant muscle strength data will be collected from each qualifying subject via manual muscle test or dynamometer at baseline during Visit 1.
Time Frame
Visit 1, Week 1 of 4
Title
Muscle Strength
Description
Relevant muscle strength data will be collected from each qualifying subject via manual muscle test or dynamometer post-treatment during Visit 12.
Time Frame
Visit 12, Week 4 of 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
subjects having persistent or acute discomfort/pain in a muscle or joint of their body
ability to speak English or provide own translator
ability to complete the pre-test/post-test session
ability to attend three times per week
Exclusion Criteria:
pregnant women
currently undergoing immunosuppression therapy
subjects with photosensitivity concerns
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Curtis
Phone
479-401-6022
Email
daniel.curtis@acheedu.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Curtis, DPT
Organizational Affiliation
Arkansas Colleges of Health Education
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arkansas Colleges of Health Education
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Curtis
Phone
479-401-6022
Email
daniel.curtis@acheedu.org
12. IPD Sharing Statement
Plan to Share IPD
No
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Pilot Study on the Effects of Low-Level Laser Therapy Treatment for Acute and Persistent Discomfort
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