Low Back Pain (LBP)NCT04287725
Effects of Laser Therapy and Exercise in Participants With Chronic Low Back Pain
A study testing exercise + photobiomodulation therapy in people with Low Back Pain (LBP), run by Federal University of the Valleys of Jequitinhonha and Mucuri.
Trial summary
The objective of this clinical trial is to evaluate the additional effects of Laser Therapy in participants with chronic non-specific low back pain in the short and long term. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain (LBP)
- What is being tested?
- exercise + photobiomodulation therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 2 Jun 2021to 31 Dec 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with non-specific chronic LBP, defined as pain or discomfort between the costal margins and inferior gluteal folds with or without referred pain to the lower limbs;
- Persistent LBP for at least 3 months;
- Low back pain of intensity reported 3 or higher by the Visual Analogue Scale (VAS), at least once in the previous 7 days;
- Aged between 18 and 65 years;
- Both genders.
Who cannot join
- Patients with severe skin diseases (eg, skin cancer, erysipelas, severe eczema, severe dermatitis, severe psoriasis and severe hives lupus);
- Participants with known or suspected serious spinal pathology (e.g., fractures, tumors, inflammatory, rheumatologic disorders, or infective diseases of the spine);
- Nerve root compromise;
- History of previous spinal surgery (even in a segment other than the lumbar spine) or scheduled surgery;
- Pain due to or associated with pregnancy or structural deformity (for example, scoliosis);
- Pregnancy;
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- Comorbid health conditions that could prevent active participation in the exercise programs such as high blood pressure, pregnancy, or cardio-respiratory illnesses;
- Having answered "yes" to any of the questions in the Physical Activity Readiness Questionnaire (PAR-Q);
- Be treated with PBMT;
- Being under physiotherapeutic treatment or perform physical exercise;
- Who are using NSAID or start it during the trial;
- Who have inability to tolerate the proposed experimental procedures (such as tests of mobility and strength of the lumbar muscles).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Additional Effects Of The Association Of The Photobiomodulation Therapy (904 Nm) With Exercise In Participants With Chronic Non-Specific Low Back Pain In The Long Term
The objective of this clinical trial is to evaluate the additional effects of Laser Therapy in participants with chronic non-specific low back pain in the short and long term.
Read the detailed description
The objective of this clinical trial is to evaluate the additional effects of Photobiomodulation Therapy in participants with chronic non-specifc low back pain in the short and long term.
- Conditions
- Low Back Pain (LBP)
- Being tested
- exercise + photobiomodulation therapy
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise + photobiomodulation therapyDevice
Treatment sessions will be provided twice a week for 6 weeks (totaling 12 sessions) with participants receiving either placebo or active PBMT + exercise protocol.
| Study group | Role | What they receive |
|---|---|---|
| exercise + active Photobiomodulation therapy (PBMT) | Experimental | Exercise protocol: The program will consist of individual sessions of progressive and submaximal exercises with aerobic training on a treadmill and spine strengthening exercise.
Photobiomodulation therapy: will be performed using the active super pulsed laser (904nm). Receives: Device: exercise + photobiomodulation therapy |
| exercise + placebo Photobiomodulation therapy (PBMT) | Placebo comparator | Exercise protocol: The program will consist of individual sessions of progressive and submaximal exercises with aerobic training on a treadmill and spine strengthening exercise.
Photobiomodulation therapy: will be performed using the placebo super pulsed laser (904nm). Receives: Device: exercise + photobiomodulation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Of Pain intensity at post-intervention
Measured by the Visual Analogue Scale (VAS). The VAS evaluates pain intensity levels perceived by the patient on an 11-point scale ranging from 0 to 10, with 0 being 'no pain' and 10 'the worst possible pain'.
Measured: Baseline; Immediately after the last intervention
Change Of Pain intensity at 3 months post-intervention
Measured by the Visual Analogue Scale (VAS). The VAS evaluates pain intensity levels perceived by the patient on an 11-point scale ranging from 0 to 10, with 0 being 'no pain' and 10 'the worst possible pain'.
Measured: Baseline; 3 months after the last intervention
Change of Disability associated with low back pain at post-intervention
Measured by the Roland-Morris Disability Questionnaire. The questionnaire consists of 24 items that describe situations that patients may have difficulty performing on a daily basis due to LBP. The greater the number of affirmative answers is, the higher the level of functional disability associated with LBP.
Measured: Baseline; Immediately after the last intervention
Change of Disability associated with low back pain at 3 months post-intervention
Measured by the Roland-Morris Disability Questionnaire. The questionnaire consists of 24 items that describe situations that patients may have difficulty performing on a daily basis due to LBP. The greater the number of affirmative answers is, the higher the level of functional disability associated with LBP.
Measured: Baseline; 3 months after the last intervention
Secondary outcomes (6)
Change Of Pain intensity at 12 months post-intervention
Measured by the Visual Analogue Scale (VAS). The VAS evaluates pain intensity levels perceived by the patient on an 11-point scale ranging from 0 to 10, with 0 being 'no pain' and 10 'the worst possible pain'.
Measured: Baseline; 12 months after the last intervention
Change of Disability associated with low back pain at 12 months post-intervention
Measured by the Roland-Morris Disability Questionnaire. The questionnaire consists of 24 items that describe situations that patients may have difficulty performing on a daily basis due to LBP. The greater the number of affirmative answers is, the higher the level of functional disability associated with LBP.
Measured: Baseline; 12 months after the last intervention
Changes os Mental health
Measured by the reduced version of the Anxiety, Depression and Stress Scale-21. It is a self-report instrument composed of three subscales with seven items each, to assess depression, anxiety and stress in the previous week. The variations in scores correspond to symptom levels, which vary between "normal" and "very severe".
Measured: Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention
Changes of Disability associated with low back pain
Measured by the Oswestry Low Back Pain Disability Questionnaire. The scale consists of 10 questions with six alternatives, the value of which ranges from 0 to 5. It is classified into: minimum disability (0 - 20%), moderate disability (21- 40%), severe disability (41 - 60%) , a patient who is disabled (61 - 80%), and an individual restricted to bed (81 - 100%).
Measured: Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention
Changes of Mobility of the lumbar and sacral segments
Measured by the modified Schober test
Measured: Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention
Changes of Strength of the trunk extensor muscle
Measured by the Sorensen Test
Measured: Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start2 Jun 2021 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain (LBP)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of the Valleys of Jequitinhonha and Mucuri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Flávia Santos, Principal investigator, Federal University of the Valleys of Jequitinhonha and Mucuri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287725
- Sponsor's protocol ID
- 18022020
- Status last verified
- Mar 2021
- First submitted
- 18 Feb 2020
- Last updated
- 8 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Effects Of The Association Of The Photobiomodulation Therapy (904 Nm) With Exercise In Participants With Chronic Non-Specific Low Back Pain In The Long Term
- ClinicalTrials.gov ID
- NCT04287725
- Acronym / sponsor ID
- 18022020
- Conditions
- Low Back Pain (LBP)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Federal University of the Valleys of Jequitinhonha and MucuriUniversity, hospital or other
- Study start
- 2 Jun 2021 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 27 Feb 2020 (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.
The objective of this clinical trial is to evaluate the additional effects of Laser Therapy in participants with chronic non-specific low back pain in the short and long term.
Detailed description
The objective of this clinical trial is to evaluate the additional effects of Photobiomodulation Therapy in participants with chronic non-specifc low back pain in the short and long term.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise + active Photobiomodulation therapy (PBMT) | Experimental | Device: exercise + photobiomodulation therapyExercise protocol: The program will consist of individual sessions of progressive and submaximal exercises with aerobic training on a treadmill and spine strengthening exercise. Photobiomodulation therapy: will be performed using the active super pulsed laser (904nm). |
| exercise + placebo Photobiomodulation therapy (PBMT) | Placebo comparator | Device: exercise + photobiomodulation therapyExercise protocol: The program will consist of individual sessions of progressive and submaximal exercises with aerobic training on a treadmill and spine strengthening exercise. Photobiomodulation therapy: will be performed using the placebo super pulsed laser (904nm). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with non-specific chronic LBP, defined as pain or discomfort between the costal margins and inferior gluteal folds with or without referred pain to the lower limbs;
- Persistent LBP for at least 3 months;
- Low back pain of intensity reported 3 or higher by the Visual Analogue Scale (VAS), at least once in the previous 7 days;
- Aged between 18 and 65 years;
- Both genders.
Key exclusion criteria (12 listed)
- Patients with severe skin diseases (eg, skin cancer, erysipelas, severe eczema, severe dermatitis, severe psoriasis and severe hives lupus);
- Participants with known or suspected serious spinal pathology (e.g., fractures, tumors, inflammatory, rheumatologic disorders, or infective diseases of the spine);
- Nerve root compromise;
- History of previous spinal surgery (even in a segment other than the lumbar spine) or scheduled surgery;
- Pain due to or associated with pregnancy or structural deformity (for example, scoliosis);
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 |
|---|---|---|
| exercise + photobiomodulation therapyTreatment sessions will be provided twice a week for 6 weeks (totaling 12 sessions) with participants receiving either placebo or active PBMT + exercise protocol. | Device | exercise + active Photobiomodulation therapy (PBMT), exercise + placebo Photobiomodulation therapy (PBMT) |
Primary outcome
Change Of Pain intensity at post-intervention
Time frame: Baseline; Immediately after the last intervention
Measured by the Visual Analogue Scale (VAS). The VAS evaluates pain intensity levels perceived by the patient on an 11-point scale ranging from 0 to 10, with 0 being 'no pain' and 10 'the worst possible pain'.
Change Of Pain intensity at 3 months post-intervention
Time frame: Baseline; 3 months after the last intervention
Measured by the Visual Analogue Scale (VAS). The VAS evaluates pain intensity levels perceived by the patient on an 11-point scale ranging from 0 to 10, with 0 being 'no pain' and 10 'the worst possible pain'.
Change of Disability associated with low back pain at post-intervention
Time frame: Baseline; Immediately after the last intervention
Measured by the Roland-Morris Disability Questionnaire. The questionnaire consists of 24 items that describe situations that patients may have difficulty performing on a daily basis due to LBP. The greater the number of affirmative answers is, the higher the level of functional disability associated with LBP.
Change of Disability associated with low back pain at 3 months post-intervention
Time frame: Baseline; 3 months after the last intervention
Measured by the Roland-Morris Disability Questionnaire. The questionnaire consists of 24 items that describe situations that patients may have difficulty performing on a daily basis due to LBP. The greater the number of affirmative answers is, the higher the level of functional disability associated with LBP.
6 secondary outcomes
Change Of Pain intensity at 12 months post-intervention
Time frame: Baseline; 12 months after the last intervention
Change of Disability associated with low back pain at 12 months post-intervention
Time frame: Baseline; 12 months after the last intervention
Changes os Mental health
Time frame: Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention
Changes of Disability associated with low back pain
Time frame: Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention
Changes of Mobility of the lumbar and sacral segments
Time frame: Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention
Changes of Strength of the trunk extensor muscle
Time frame: Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 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.
Flávia Santos principal investigator
Federal University of the Valleys of Jequitinhonha and Mucuri
Questions about this trial
What is this clinical trial studying?
A study testing exercise + photobiomodulation therapy in people with Low Back Pain (LBP), run by Federal University of the Valleys of Jequitinhonha and Mucuri.
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 5 inclusion and 12 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 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Murilo Oliveira (3532-1200 ext. 8972, muriloxavier@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change Of Pain intensity at post-intervention (time frame: Baseline; Immediately after the last intervention). The study lists 4 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 8 Mar 2021.