The ECEALT Chronic Low Back Pain Study

NCT ID: NCT05040633

Last Updated: 2022-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-04-30

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.

Conditions

Chronic Low-back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Low Level Laser Therapy + standard exercise therapy

This group of participants will first receive the standard therapy of strengthening and stretching exercises followed by the Low Lever Laser Therapy.

Group Type: EXPERIMENTAL

BTL 4110 Smart Laser Therapy Equipment (BTL Industries Ltd, United Kingdom (UK))

Intervention Type: DEVICE

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.

Standard Exercise Therapy

Intervention Type: OTHER

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.

Sham Low Level Laser Therapy + standard exercise therapy

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.

Group Type: SHAM_COMPARATOR

BTL 4110 Smart Laser Therapy Equipment (BTL Industries Ltd, United Kingdom (UK))

Intervention Type: DEVICE

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.

Standard Exercise Therapy

Intervention Type: OTHER

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.

Standard Exercise Therapy

Trial participants in this group will only receive the standard exercise therapy. The exercise therapy will consist of strengthening and stretching exercises.

Group Type: ACTIVE_COMPARATOR

Standard Exercise Therapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Health Rehab and Research Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hammad Qazi, PhD

Role: PRINCIPAL_INVESTIGATOR

Health and Rehab Research Inc

Locations

Health and Rehab Research Inc.

Mississauga, Ontario, Canada

Countries

Canada

Central Contacts

Hammad Qazi, PhD

Role: CONTACT

hammadali400@hotmail.com

+1 (647)4578908

Lamin Massaquoi, PhD

Role: CONTACT

lamindmassaquoi@gmail.com

+1 (306)5353719

Facility Contacts

Muhammad Wasiuddin Arfi, PhD

Role: primary

healthrehabresearch@gmail.com

4168417918

Other Identifiers

V2/0518

Identifier Type: -

Identifier Source: org_study_id