The ECEALT Chronic Low Back Pain Study

Not Applicable

• Conditions: Chronic Low-back Pain

• Registration Number: NCT05040633
• Lead Sponsor: Health Rehab and Research Clinic

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.

Study Timeline

• Study First Submitted: 2021-07-10
• Study First Submitted QC: 2021-09-03
• Study First Posted: 2021-09-10
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-03
• Study Start: 2022-10-01
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 216

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Pain using the Quadruple Visual Analog Scale	Weeks 1, 2, 3, 6, 8, 12, 26 and 52	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).
Change in Pain using the McGill Pain Questionnaire	Weeks 1, 2, 3, 6, 8, 12, 26 and 52	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).
Change in Pain using the Brief Pain Inventory	Weeks 1, 2, 3, 6, 8, 12, 26 and 52	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).

Secondary Outcome Measures

Name	Time	Method
Mean Pain Free Days/Months using the Brief Pain Inventory	Weeks 1, 2, 3, 6, 8, 12, 26 and 52	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).
Mean number of days absent from work measured using patients personal daily pain record	Weeks 1, 2, 3, 6, 8, 12, 26 and 52	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.
Fear of Pain measured using the McGill Pain Questionnaire	Weeks 1, 2, 3, 6, 8, 12, 26 and 52	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).
Frequency of Low Back Pain Episodes assessed using patients personal daily pain records	Weeks 1, 2, 3, 6, 8, 12, 26 and 52	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.
Reliance on medication for pain management using the Brief Pain Inventory	Weeks 1, 2, 3, 6, 8, 12, 26 and 52	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).

Trial Locations

Locations (1)

Health and Rehab Research Inc.; 🇨🇦 Mississauga, Ontario, Canada