Pilot Study on the Effects of Low-Level Laser Therapy Treatment for Acute and Persistent Discomfort

Chronic Pain Clinical Trial

Official title:

Pilot Study on the Effects of Low-Level Laser Therapy Treatment for Acute and Persistent Discomfort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04774783
• Other study ID #: PT-2020-006
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2021
• Est. completion date: March 26, 2021

Study information

• Verified date: February 2021
• Source: Arkansas Colleges of Health Education
• Contact: Daniel Curtis
• Phone: 479-401-6022
• Email: daniel.curtis[@]acheedu.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acute Pain
• Chronic Pain

Intervention

Device:
• Low-Level Laser Therapy
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.

Locations

Country	Name	City	State
United States	Arkansas Colleges of Health Education	Fort Smith	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Arkansas Colleges of Health Education

Country where clinical trial is conducted

United States, 

Outcome

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