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

NCT04774783 | Unknown FDA Device

• 1 other identifier: PT-2020-006
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Acute Pain

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

Low-Level Laser Therapy

EXPERIMENTAL

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.

Device: Low-Level Laser Therapy

Interventions

Low-Level Laser Therapy 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.

Low-Level Laser Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• pregnant women
• currently undergoing immunosuppression therapy
• subjects with photosensitivity concerns

Sponsors & Collaborators

• Arkansas Colleges of Health Education: lead

Study Sites (1)

Arkansas Colleges of Health Education

Fort Smith, Arkansas, 72916, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Acute Pain

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Daniel Curtis, DPT

  Arkansas Colleges of Health Education

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Curtis

CONTACT

479-401-6022; daniel.curtis@acheedu.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Education

Study Record Dates

• First Submitted: February 20, 2021
• First Posted: March 1, 2021
• Study Start: February 22, 2021
• Primary Completion: March 26, 2021
• Study Completion: March 26, 2021
• Last Updated: March 1, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)