The ECEALT Chronic Low Back Pain Study

Health Rehab and Research Clinic

Status: Not yet enrolling

Conditions: Chronic Low-back Pain

Treatments: Other: Standard Exercise Therapy; Device: BTL 4110 Smart Laser Therapy Equipment (BTL Industries Ltd, United Kingdom (UK))

Study type: Interventional

Funder types: Other

Identifiers

NCT05040633

V2/0518

Details and patient eligibility

About

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.

Full 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.

Enrollment: 216 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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216 participants in 3 patient groups

Low Level Laser Therapy + standard exercise therapy

Experimental group

Description:

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

Treatment:

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

Other: Standard Exercise Therapy

Sham Low Level Laser Therapy + standard exercise therapy

Sham Comparator group

Description:

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.

Treatment:

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

Other: Standard Exercise Therapy

Standard Exercise Therapy

Active Comparator group

Description:

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

Treatment:

Other: Standard Exercise Therapy