High-intensity Laser Therapy and Stretching Exercises for Chronic Non-specific Neck Pain
NCT Number: NCT06465524
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Non-specific Neck Pain
Interventions: DEVICE: High-intensity laser therapy
Sponsor: Quiropraxia y Equilibrio
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-03-01
Locations: Universidad Andrés Bello, Santiago de Chile, Las Condes, 7591538, Chile

Summary:
Chronic non-specific neck pain (CNNP) poses a significant challenge in healthcare, sparking interest in conservative and innovative therapeutic options such as high-intensity laser therapy (HILT). While evidence of its efficacy in this specific context remains limited, there is a robust foundation supporting the use of HILT in managing chronic neck pain, demonstrating effectiveness in pain reduction and functional improvement. Therefore, the aim of this study is to evaluate the clinical response to HILT treatment in patients with CNNP, investigating its potential therapeutic benefits and adverse effects. The findings of this study will provide valuable insights into the clinical experience with HILT in this population, serving as a pivotal starting point for future research in this field.

In a clinical trial, patients with CNNP will undergo a treatment regimen consisting of two weekly sessions of HILT and stretching exercises over four weeks. The study aims to assess primary outcomes such as resting pain intensity (RPI), movement pain intensity (MPI), and pain pressure threshold (PPT), measured using the numerical pain rating scale and algometry. Secondary outcomes will include cervical range of motion (CROM) and neck disability, assessed through inclinometry and the Neck Disability Index (NDI). Evaluations will occur post-treatment, with a follow-up assessment scheduled one month later.

Primary Outcome Measures: Pain intensity at rest (numeric pain rating scale, NPRS), Magnitude of neck pain reported by participants at rest. The pain intensity at rest will be measured with the numeric pain rating scale (NPRS). The scale quantifies pain from 0 to 10, where 0 represents the absence of pain and 10 represents the maximum tolerable pain., Baseline, 4 weeks (8 sessions) and 4 weeks (follow-up)|Pain intensity at movement (numeric pain rating scale, NPRS), Magnitude of pain reported by participants during active cervical movements, including flexion, extension, lateral bending, and rotation. The pain intensity during movement will be measured with the numeric pain rating scale (NPRS).The scale quantifies pain from 0 to 10, where 0 represents the absence of pain and 10 represents the maximum tolerable pain., Baseline, 4 weeks (8 sessions) and 4 weeks (follow-up)|Pain pressure threshold (algometry), The maximum mechanical pressure tolerated by the patient was assessed using algometry. Six bilateral points were evaluated: 2 cm lateral to the spinous processes of C2, C5, T4, and T8; the midpoint of the upper trapezius muscle (between C7 and the acromion); the levator scapulae (2 cm superior to the superior angle of the scapula); and the middle third of the right tibialis anterior muscle. The pain pressure threshold will be evaluated with pressure algometry (FPX Wagner (R) equipment). The pain pressure threshold measurement unit will be evaluated in pounds per square centimeter., Baseline, 4 weeks (8 sessions) and 4 weeks (follow-up)
Secondary Outcome Measures: Cervical range of movement (inclinometer), The cervical range of motion refers to the extent of movement achievable by the cervical spine in various directions, including flexion (forward bending), extension (backward bending), lateral flexion (side bending to the left and right), and rotation (turning left and right). The cervical range of motion will be assessed using an inclinometry device (CROM device). The degrees of movement are quantified for each active osteokinematic movement performed by the participant., Baseline, 4 weeks (8 sessions) and 4 weeks (follow-up)|Neck disability (neck disability index), Neck disability refers to the extent or degree to which cervical pain and associated symptoms impact a person's ability to perform daily activities and participate in normal life roles. It will be assessed using the Neck Disability Index (NDI), which will evaluate the functional limitations and subjective experiences related to neck pain and its effects on a person's quality of life. Cervical disability will be quantified as a percentage (0% absence of disability and 100% maximum disability reported by the participant)., Baseline, 4 weeks (8 sessions) and 4 weeks (follow-up)