- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04774783
Pilot Study on the Effects of Low-Level Laser Therapy Treatment for Acute and Persistent Discomfort
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arkansas
-
Fort Smith, Arkansas, United States, 72916
- Recruiting
- Arkansas Colleges of Health Education
-
Contact:
- Daniel Curtis
- Phone Number: 479-401-6022
- Email: daniel.curtis@acheedu.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric Pain Rating Scale (NPRS)
Time Frame: Visit 1, Week 1 of 4
|
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)
Time Frame: Visit 12, Week 4 of 4
|
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)
Time Frame: Visit 1, Week 1 of 4
|
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)
Time Frame: Visit 12, Week 4 of 4
|
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
Time Frame: Visit 1, Week 1 of 4
|
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
Time Frame: Visit 12, Week 4 of 4
|
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
Time Frame: Visit 1, Week 1 of 4
|
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
Time Frame: Visit 12, Week 4 of 4
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Daniel Curtis, DPT, Arkansas Colleges of Health Education
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PT-2020-006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Pain
-
Pain ConcernThe Thistle Foundation; Health and Social Care Alliance Scotland (the ALLIANCE) and other collaboratorsCompletedChronic Pain | Chronic Pain Syndrome | Chronic Pain, Widespread | Chronic Pain Due to Trauma | Chronic Pain Due to Malignancy (Finding) | Chronic Pain Due to Injury | Chronic Pain Post-Procedural | Chronic Pain HipUnited Kingdom
-
Vastra Gotaland RegionCompletedPain, Chronic | Widespread Chronic PainSweden
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Consorci Sanitari de l'Alt Penedès i GarrafRecruitingChronic Post Operative Pain | Chronic Post-surgical Pain | Chronic Knee PainSpain
-
University of Alabama, TuscaloosaPatient-Centered Outcomes Research Institute; East Carolina University; Whatley...CompletedPain | Chronic Pain | Chronic Pain Syndrome | Widespread Chronic Pain | Chronic Pain Due to InjuryUnited States
-
University of UtahRecruitingChronic Pain | Chronic Pain Syndrome | Widespread Chronic PainUnited States
-
Societa Italiana Anestesia Analgesia Rianimazione...RecruitingPost Operative Pain | Postoperative Pain, Chronic | Post Surgical PainItaly
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
University Health Network, TorontoAcademic Medical Organization of Southwestern Ontario; York University; Toronto...Not yet recruitingPain, Acute | Pain, Chronic | Post-surgical Pain | Post-Surgical Pain, ChronicCanada
-
Evolve Restorative CenterFlowonix Medical; Celéri Health, Inc.; Advanced Infusion SolutionsCompletedPain, Chronic | Pain, Intractable | Chronic Nonmalignant PainUnited States
Clinical Trials on Low-Level Laser Therapy
-
Universidade Federal de Sao CarlosConselho Nacional de Desenvolvimento Científico e TecnológicoCompleted
-
University of BergenCompleted
-
University of BergenNorwegian Fund for Postgraduate Training in PhysiotherapyCompleted
-
University of Nove de JulhoSimone Aparecida Penimpedo Calamita; Fabiana Sarilho de Mendonça; Daniela Aparecida... and other collaboratorsCompleted
-
St. Elisabethen Krankenhaus Frankfurt GmbHRecruitingSurgical Scar Tissue of Cesarean Section or Vaginal Tear or EpisiotomyGermany
-
Universidade Federal de Sao CarlosFundação de Amparo à Pesquisa do Estado de São Paulo; Faculty of Medicine of... and other collaboratorsCompleted
-
University of OttawaBioFlexTM Laser TherapyCompletedProvoked VestibulodyniaCanada
-
NYU Langone HealthCompleted
-
Universidade do Vale do SapucaiCompletedBreast Neoplasms | Radiotherapy; Adverse Effect, Dermatitis or EczemaBrazil
-
Universidade Federal do Rio Grande do NorteCompleted