Chronic PainNCT04774783
Pilot Study on the Effects of Low-Level Laser Therapy Treatment for Acute and Persistent Discomfort
A study testing Low-Level Laser Therapy in people with Chronic Pain and Acute Pain, run by Arkansas Colleges of Health Education at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Acute Pain
- What is being tested?
- Low-Level Laser Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2021to 26 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnant women
- currently undergoing immunosuppression therapy
- subjects with photosensitivity concerns
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Arkansas Colleges of Health Education
Fort Smith, Arkansas, 72916
Daniel Curtis, 479-401-6022, daniel.curtis@acheedu.org
About this study
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.
Read the 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
- Being tested
- Low-Level Laser Therapy
- Medical subject headings
- Chronic Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Level Laser TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Low-Level Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Visit 12, Week 4 of 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start22 Feb 2021
- Primary completion26 Mar 2021 (estimated)
- Study completion26 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arkansas Colleges of Health Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Curtis, Arkansas Colleges of Health Education
- Investigators
- Daniel Curtis, DPT, Principal investigator, Arkansas Colleges of Health Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774783
- Sponsor's protocol ID
- PT-2020-006
- Status last verified
- Feb 2021
- First submitted
- 20 Feb 2021
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Effects of Low-Level Laser Therapy Treatment for Acute and Persistent Discomfort
- ClinicalTrials.gov ID
- NCT04774783
- Acronym / sponsor ID
- PT-2020-006
- Conditions
- Chronic Pain, Acute Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Arkansas Colleges of Health EducationUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 26 Mar 2021 (estimated)
- Study completion
- 26 Mar 2021 (estimated)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low-Level Laser Therapy | Experimental | Device: Low-Level Laser TherapyOver 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- pregnant women
- currently undergoing immunosuppression therapy
- subjects with photosensitivity concerns
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Level Laser TherapyThe 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. | Device | Low-Level Laser Therapy |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Curtis, DPT principal investigator
Arkansas Colleges of Health Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Level Laser Therapy in people with Chronic Pain and Acute Pain, run by Arkansas Colleges of Health Education at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Curtis (479-401-6022, daniel.curtis@acheedu.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (NPRS) (time frame: Visit 1, Week 1 of 4). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2021.