NCT05040633

The ECEALT Chronic Low Back Pain Study

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Health Rehab and Research Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Low-back Pain

Interventions

Type	Name	Description
DEVICE	BTL 4110 Smart Laser Therapy Equipment (BTL Industries Ltd, United Kingdom (UK))	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.
OTHER	Standard Exercise Therapy	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.

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-04-30
• Completion: 2024-04-30
• First posted: 2021-09-10
• Last updated: 2022-08-03

Locations

1 site across 1 country: Canada