The ECEALT Chronic Low Back Pain Study

Study Overview
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Brief Summary
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The primary objective of this double-blind randomized control trial (RCT) is to evaluate the clinical effectiveness of LLLT as adjunctive therapy to standard exercise treatment in patients with non-specific chronic LBP. Specifically, the study will aim to evaluate the effectiveness of adjunct LLLT in the reduction of pain in patients as well as determine its long-term functional outcomes.

Detailed Description
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Low back pain (LBP) is one of the most common musculoskeletal disorders and the leading cause of years lived with disability worldwide with significant socioeconomic impacts. Around 10-15 % of LBP patients develop chronic symptoms lasting more than 3 months, and this is considered chronic, with the causes often being non-specific with no identifiable causes. Despite the availability of medication-based protocols, the management of non-specific chronic LBP (NSCLBP) is an increasing challenge to clinicians and their patients. Adjunctive therapy can play an important role in the treatment of NSCLBP. In recent decades, low-level laser therapy (LLLT) has been widely used to relieve pain caused by different musculoskeletal disorders. Though widely used and reported as a safe, non-invasive treatment with minimal side effects; reported therapeutic outcomes of LLLT are varied and conflicting, due in part to methodological concerns, lack of data and unclear results.

Official Title
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Evaluating the Clinical Effectiveness of Adjunct Low-level Laser Therapy (ECEALT) in the Management of Chronic Low-Back Pain: A Long-Term, Double-Blind, Randomized Control Trial in Physiotherapy Clinics in Ontario, Canada

Conditions
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Chronic Low-back Pain

Intervention / Treatment
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* Other: Standard Exercise Therapy
* Device: BTL 4110 Smart Laser Therapy Equipment (BTL Industries Ltd, United Kingdom (UK))


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: are 18-65 years with the ability to give informed consent report with non - specific chronic low back pain, which is defined as pain of >3 months duration that occurs in the lumbosacral area of the spine, which may or not have the characteristics of limiting the patient's range of movements, and is not attributable to a recognizable, known pathology (e.g., infection, tumor, osteoporosis, lumbar spine fracture, structural deformity, inflammatory disorder, radicular syndrome, or cauda equina syndrome). are experiencing pain measured using the Quadruple Visual Analogue Scale between 4 and 7 at the time of assessment will be included to keep homogeneity of pain. Exclusion Criteria: are under 18 years, and those over 65 years of age have had past fractures of the bone structures of the spine have had previous surgery of the spine have a history of previous surgery of the spine or vertebra; spondylosis, spinal stenosis, lumbar disc herniation use pacemakers (cardiac or brain) are pregnant, or those who plan to become pregnant during the course of the study have acute and/or chronic cardiovascular diseases have dermatological conditions in the area of irradiation and/or inflammatory skin lesions have tattoo/tattoos around the area of irradiation have any sensory deficits as defined by the World Health Organization's working definition are sensitive/allergic to phototherapy have neurological disorders as defined by the World Health Organization's working definition are taking anti-inflammatories or analgesic or psychotropic medications have any current infections have a history of drug abuse, either recreational, over the counter or prescription over the last 3 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be allocated to three groups and provided with one of the following interventions: (i) Low Level Laser Therapy (LLLT) therapy in combination with standard exercise therapy (Arm 1), (ii) sham LLLT therapy in combination with standard exercise therapy (Arm 2), or (iii) exercise therapy alone (Arm 3). Participants will receive treatment three times per week for four consecutive weeks (i.e., each participant will receive a total of 12 treatment sessions; see section 2, Trial Design).
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Level Laser Therapy + standard exercise therapy<br>This group of participants will first receive the standard therapy of strengthening and stretching exercises followed by the Low Lever Laser Therapy. | Device: BTL 4110 Smart Laser Therapy Equipment (BTL Industries Ltd, United Kingdom (UK))<br>* Participants will receive 12 LLLT sessions during the course of the trial, thrice weekly for 4 consecutive weeks. Doses will be as per the recommendations of the Wold Association of Laser Therapy.<br>Other: Standard Exercise Therapy<br>* Exercise therapy will consist of strengthening and stretching exercises. At each visit, participants will perform each of the exercises under the supervision of a licensed physiotherapist.<br>|
| Sham Comparator: Sham Low Level Laser Therapy + standard exercise therapy<br>This group of participants will first receive the standard therapy of strengthening and stretching exercises followed by a sham Low Level Laser Therapy (LLLT). The laser equipment will be deactivated and not switched on. | Device: BTL 4110 Smart Laser Therapy Equipment (BTL Industries Ltd, United Kingdom (UK))<br>* Participants will receive 12 LLLT sessions during the course of the trial, thrice weekly for 4 consecutive weeks. Doses will be as per the recommendations of the Wold Association of Laser Therapy.<br>Other: Standard Exercise Therapy<br>* Exercise therapy will consist of strengthening and stretching exercises. At each visit, participants will perform each of the exercises under the supervision of a licensed physiotherapist.<br>|
| Active Comparator: Standard Exercise Therapy<br>Trial participants in this group will only receive the standard exercise therapy. The exercise therapy will consist of strengthening and stretching exercises. | Other: Standard Exercise Therapy<br>* Exercise therapy will consist of strengthening and stretching exercises. At each visit, participants will perform each of the exercises under the supervision of a licensed physiotherapist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain using the Quadruple Visual Analog Scale | The change in Pain measured using the Quadruple Visual Analog Scale (QVAS) measured at weeks 1, 2, 3, 6, 8, 12, 26 and 52. Pain reduction measured on a 10-point Likert scale from 0 (no pain) to 10 (worst possible pain). Overall score interpreted based on QVAS scoring manual of <50(Low intensity) and >50 (high intensity). | Weeks 1, 2, 3, 6, 8, 12, 26 and 52 | 
| Change in Pain using the McGill Pain Questionnaire | The change in Pain measured using the McGill Pain Questionnaire measured at weeks 1, 2, 3, 6, 8, 12, 26 and 52. Pain reduction assessed based on an overall score ranging from 0 (would not be seen in a person with true pain) to 78(seen in a person with the greatest pain). | Weeks 1, 2, 3, 6, 8, 12, 26 and 52 | 
| Change in Pain using the Brief Pain Inventory | The change in Pain measured using the Brief Pain Inventory measured at weeks 6, 8, 12, 26 and 52. Pain reduction assessed based on an overall score ranging from 0 (no pain or does not interfere) to 10(pain as bad as be imagined or completely interferes). | Weeks 1, 2, 3, 6, 8, 12, 26 and 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliance on medication for pain management using the Brief Pain Inventory | Reliance on medication for pain management measured using the Brief Pain Inventory (short form) measured at weeks 6, 8, 12, 26 and 52. Pain reduction assessed based on an overall score ranging from 0% (no relief) to 100% (complete relief). | Weeks 1, 2, 3, 6, 8, 12, 26 and 52 | 
| Mean Pain Free Days/Months using the Brief Pain Inventory | Mean Pain Free Days measured using the Brief Pain Inventory measured at weeks 6, 8, 12, 26 and 52. Pain reduction assessed based on an overall score ranging from 0 (no pain or does not interfere) to 10(pain as bad as can be imagined or completely interferes). | Weeks 1, 2, 3, 6, 8, 12, 26 and 52 | 
| Fear of Pain measured using the McGill Pain Questionnaire | Fear of pain measured using the McGill Pain Questionnaire at weeks 1, 2, 3, 6, 8, 12, 26 and 52. Fear of Pain assessed on a 3-point scale from 1(fearful), 2 (frightful) or 3 (terrifying). | Weeks 1, 2, 3, 6, 8, 12, 26 and 52 | 
| Frequency of Low Back Pain Episodes assessed using patients personal daily pain records | Frequency of LBP episodes during trial measured using patients personal daily pain records at weeks 1, 2, 3, 4, 6, 8, 12, 26 and 52. Each episode of pain recorded as a single occurrence. | Weeks 1, 2, 3, 6, 8, 12, 26 and 52 | 
| Mean number of days absent from work measured using patients personal daily pain record | Mean number of days absent from work measured using patients personal daily pain records at weeks 1, 2, 3, 4, 6, 8, 12, 26 and 52. Not being able to work completely due to pain within a work day recorded as a single day, while working for less than 4 hours due to pain recorded as partial work day. | Weeks 1, 2, 3, 6, 8, 12, 26 and 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laser Therapy, Low Back Pain, Randomized Control Trial