Clinical trial NCT04774783: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Acute Pain
Lead sponsor: Arkansas Colleges of Health Education
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Visit 1, Week 1 of 4
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Visit 12, Week 4 of 4
measure: Patient-Specific Functional Scale (PSFS)
timeFrame: Visit 1, Week 1 of 4
measure: Patient-Specific Functional Scale (PSFS)
timeFrame: Visit 12, Week 4 of 4
measure: Joint Range of Motion
timeFrame: Visit 1, Week 1 of 4
measure: Joint Range of Motion
timeFrame: Visit 12, Week 4 of 4
measure: Muscle Strength
timeFrame: Visit 1, Week 1 of 4
measure: Muscle Strength
timeFrame: Visit 12, Week 4 of 4
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Smith
country: United States
facility: Arkansas Colleges of Health Education
state: Arkansas
Study officials:
affiliation: Arkansas Colleges of Health Education
name: Daniel Curtis, DPT
role: PRINCIPAL_INVESTIGATOR
References: