Low Back Pain
Conditions
Brief summary
The goal of this clinical trial is to evaluate whether combining high-intensity laser therapy with Mulligan mobilization techniques can effectively treat chronic non-specific low back pain in adult patients aged 18-60 years, including both males and females. The main questions it aims to answer are: Does the combined intervention reduce pain intensity more effectively than standard or single-modality treatment? Does the combined intervention improve functional disability and lumbar range of motion? Researchers will compare high-intensity laser therapy combined with Mulligan mobilization to \[control group: Mulligan alone\] to determine whether the combined approach produces superior clinical outcomes. Participants will: Receive high-intensity laser therapy according to a standardized treatment protocol Undergo Mulligan mobilization techniques administered by a trained therapist Attend multiple treatment sessions over a defined intervention period Complete assessments of pain intensity, functional disability, and lumbar range of motion before and after treatment
Detailed description
Chronic non-specific low back pain is a prevalent musculoskeletal condition associated with pain, reduced functional capacity, and decreased quality of life. Conservative management often includes manual therapy and physical modalities; however, the optimal combination of these approaches remains unclear. High-intensity laser therapy (HILT) has been proposed to provide analgesic and anti-inflammatory effects and to promote tissue healing. Mulligan mobilization techniques, particularly sustained natural apophyseal glides (SNAGs), are commonly used to restore pain-free movement and improve spinal function. While both interventions have shown individual benefits, evidence regarding their combined effect is limited. This pilot randomized controlled trial aims to explore the feasibility and preliminary clinical effectiveness of combining HILT with Mulligan mobilization in adults with chronic non-specific low back pain. The study will evaluate changes in pain intensity, functional disability, and lumbar range of motion following the intervention period. Participants will be randomly allocated to intervention groups, and outcomes will be assessed at baseline and post-intervention using standardized clinical measures. Findings from this pilot study will help inform the design of larger trials and clarify whether a multimodal approach incorporating HILT and Mulligan techniques offers added clinical value in this population.
Interventions
DEVICEHigh-intensity laser therapy and Mulligan mobilization
Combined high-intensity laser therapy and Mulligan mobilization
OTHERMulligan Mobilization
Mulligan Mobilization alone
Sponsors
Anas Radi Hassan Alashram
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Male and female participants aged 18-60 years * Diagnosis of chronic non-specific low back pain (pain persisting for ≥3 months) * Pain localized between the lower costal margins and gluteal folds, with or without referred pain * Baseline pain intensity of ≥3 on the Numeric Pain Rating Scale (NPRS) * Ability to understand and follow instructions and provide informed consent * Not currently receiving other forms of physiotherapy or structured treatment for low back pain during the study period
Exclusion criteria
* Specific spinal pathology (e.g., fracture, tumor, infection, inflammatory diseases such as ankylosing spondylitis) * History of spinal surgery * Neurological deficits or signs of nerve root compression (e.g., severe radiculopathy) * Pregnancy * Severe osteoporosis or other contraindications to manual therapy * Contraindications to high-intensity laser therapy (e.g., malignancy in the treatment area, photosensitivity disorders) * Current use of medications that significantly affect pain perception (e.g., high-dose opioids) * Participation in another clinical trial within the last 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Rating Scale (NPRS) | Change from baseline NPRS at 4-week | The Numeric Pain Rating Scale (NPRS) is a self-reported measure used to assess pain intensity. It typically consists of an 11-point scale ranging from 0 to 10, where 0 indicates "no pain" and 10 represents "the worst imaginable pain." Participants are asked to select the number that best reflects their current level of pain, or their average pain over a specified period. The NPRS is widely used in clinical and research settings due to its simplicity, reliability, and validity in measuring pain intensity in individuals with musculoskeletal conditions, including chronic low back pain. Changes in NPRS scores over time are used to evaluate the effectiveness of therapeutic interventions, with a reduction of approximately 2 points often considered clinically meaningful. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index (ODI) | Change from baseline ODI at 4-week | The Oswestry Disability Index (ODI) is a validated self-reported questionnaire used to assess functional disability related to low back pain. It consists of 10 sections evaluating different aspects of daily living, including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and employment/homemaking. Each section is scored on a 6-point scale (0-5), with higher scores indicating greater disability. The total score is calculated by summing the section scores and converting them into a percentage, where 0% represents no disability and 100% represents maximum disability. The ODI is widely used in both clinical practice and research due to its reliability, validity, and sensitivity to change in patients with low back pain. It is commonly used to monitor patient progress and evaluate the effectiveness of interventions over time. |
| Lumbar Flexion Range of Motion (ROM) | Change from baseline Lumbar Flexion Range of Motion (ROM) at 4-week | Lumbar Flexion Range of Motion (ROM) refers to the degree of forward bending movement of the lumbar spine. It is commonly measured in degrees using instruments such as a goniometer, inclinometer, or dual inclinometer technique. During assessment, the participant is typically asked to bend forward as far as possible from a standing position while keeping the knees straight. The angle of movement is then recorded in degrees, reflecting the flexibility and mobility of the lumbar spine. Lumbar flexion ROM is an important clinical outcome in patients with low back pain, as reduced flexion is often associated with pain, stiffness, and functional limitations. Improvements in lumbar flexion degree following intervention indicate enhanced spinal mobility and functional capacity. |
Countries
Jordan
Contacts
CONTACTAnas Radi Alashram, PhD
Outcome results
None listed