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

NCT ID: NCT04774783

Last Updated: 2021-03-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-22
• Study Completion Date: 2021-03-26

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.

Conditions

Chronic Pain; Acute Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low-Level Laser Therapy

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.

Group Type: EXPERIMENTAL

Low-Level Laser Therapy

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arkansas Colleges of Health Education

OTHER

Sponsor Role: lead

Responsible Party

Daniel Curtis

Director of Clinical Education

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Curtis, DPT

Role: PRINCIPAL_INVESTIGATOR

Arkansas Colleges of Health Education

Locations

Arkansas Colleges of Health Education

Fort Smith, Arkansas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Daniel Curtis

Role: CONTACT

daniel.curtis@acheedu.org

479-401-6022

Facility Contacts

Daniel Curtis

Role: primary

daniel.curtis@acheedu.org

479-401-6022

Other Identifiers

PT-2020-006

Identifier Type: -

Identifier Source: org_study_id