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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exercise + photobiomodulation therapy | Device | Treatment sessions will be provided twice a week for 6 weeks (totaling 12 sessions) with participants receiving either placebo or active PBMT + exercise protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| 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'. | 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'. | 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. | 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. | Baseline; 3 months after the last intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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'. | Baseline; 12 months after the last intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Murilo Oliveira | Contact | 3532-1200 | 8972 | muriloxavier@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Flávia Santos | Federal University of the Valleys of Jequitinhonha and Mucuri | Principal Investigator |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| 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. |
| 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". | 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%). | 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 | 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 | Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013812 |
| Therapeutics |
| D026741 | Physical Therapy Modalities |
| D053685 | Laser Therapy |
| D010789 | Phototherapy |