Chronic Pain Clinical Trial
Official title:
Pilot Study on the Effects of Low-Level Laser Therapy Treatment for Acute and Persistent Discomfort
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | March 26, 2021 |
Est. primary completion date | March 26, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Arkansas Colleges of Health Education | Fort Smith | Arkansas |
Lead Sponsor | Collaborator |
---|---|
Arkansas Colleges of Health Education |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Visit 1, Week 1 of 4 | |
Primary | 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. | Visit 12, Week 4 of 4 | |
Primary | 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. | Visit 1, Week 1 of 4 | |
Primary | 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. | Visit 12, Week 4 of 4 | |
Primary | Joint Range of Motion | Relevant range of motion data will be collected from each qualifying subject at baseline during Visit 1. | Visit 1, Week 1 of 4 | |
Primary | Joint Range of Motion | Relevant range of motion data will be collected from each qualifying subject post-treatment during Visit 12. | Visit 12, Week 4 of 4 | |
Primary | Muscle Strength | Relevant muscle strength data will be collected from each qualifying subject via manual muscle test or dynamometer at baseline during Visit 1. | Visit 1, Week 1 of 4 | |
Primary | Muscle Strength | Relevant muscle strength data will be collected from each qualifying subject via manual muscle test or dynamometer post-treatment during Visit 12. | Visit 12, Week 4 of 4 |
Status | Clinical Trial | Phase | |
---|---|---|---|
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