Clinical trial NCT05040633: The ECEALT Chronic Low Back Pain Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: Laser Therapy
Low Back Pain
Randomized Control Trial
Lead sponsor: Health Rehab and Research Clinic
Sponsor class: OTHER
First posted: 2021-09-10
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Pain using the Quadruple Visual Analog Scale
timeFrame: Weeks 1, 2, 3, 6, 8, 12, 26 and 52
measure: Change in Pain using the McGill Pain Questionnaire
timeFrame: Weeks 1, 2, 3, 6, 8, 12, 26 and 52
measure: Change in Pain using the Brief Pain Inventory
timeFrame: Weeks 1, 2, 3, 6, 8, 12, 26 and 52
Secondary outcomes:
measure: Reliance on medication for pain management using the Brief Pain Inventory
timeFrame: Weeks 1, 2, 3, 6, 8, 12, 26 and 52
measure: Mean Pain Free Days/Months using the Brief Pain Inventory
timeFrame: Weeks 1, 2, 3, 6, 8, 12, 26 and 52
measure: Fear of Pain measured using the McGill Pain Questionnaire
timeFrame: Weeks 1, 2, 3, 6, 8, 12, 26 and 52
measure: Frequency of Low Back Pain Episodes assessed using patients personal daily pain records
timeFrame: Weeks 1, 2, 3, 6, 8, 12, 26 and 52
measure: Mean number of days absent from work measured using patients personal daily pain record
timeFrame: Weeks 1, 2, 3, 6, 8, 12, 26 and 52
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Health and Rehab Research Inc.
state: Ontario
Study officials:
affiliation: Health and Rehab Research Inc
name: Hammad Qazi, PhD
role: PRINCIPAL_INVESTIGATOR
References: