Recruiting

Low-Level Laser Therapy

Sponsor:

Arkansas Colleges of Health Education

Code:

NCT04774783

Conditions

Chronic Pain

Acute Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Low-Level Laser Therapy

Study Details

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

Study ID

NCT04774783

Start date

Feb 22, 2021

Status verified date

Feb, 2021

Completion date

Mar 26, 2021

Anticipated

Primary completion date

Mar 26, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

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.

Primary outcome measure

  • Numeric Pain Rating Scale (NPRS) [ Time Frame: Visit 1, Week 1 of 4 ]
  • Numeric Pain Rating Scale (NPRS) [ Time Frame: Visit 12, Week 4 of 4 ]
  • Patient-Specific Functional Scale (PSFS) [ Time Frame: Visit 1, Week 1 of 4 ]
  • Patient-Specific Functional Scale (PSFS) [ Time Frame: Visit 12, Week 4 of 4 ]
  • Joint Range of Motion [ Time Frame: Visit 1, Week 1 of 4 ]
  • Joint Range of Motion [ Time Frame: Visit 12, Week 4 of 4 ]
  • Muscle Strength [ Time Frame: Visit 1, Week 1 of 4 ]
  • Muscle Strength [ Time Frame: Visit 12, Week 4 of 4 ]

Central Contacts and Locations

Central contacts

Daniel Curtis

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

Locations

Arkansas Colleges of Health Education

Recruiting

Fort Smith, Arkansas, United States, 72916

Contacts

Daniel Curtis

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

More Information

Sponsor

Arkansas Colleges of Health Education

Last update posted

Mar 1, 2021

Last verified

Feb, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Arkansas Colleges of Health Education on 2021-03-01.