High-intensity Laser Therapy and Stretching Exercises for Chronic Non-specific Neck Pain

Chronic Non-specific Neck Pain Clinical Trial

Official title: Effects of High-Intensity Laser Therapy and Stretching Exercises on Non-Specific Chronic Neck Pain: Findings From a Clinical Trial

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

1. Study Type and Design:

Experimental design for a non-controlled clinical trial.

2. Ethical Considerations:

The study received approval from the Ethics Committee of the Metropolitan East Health Service of Santiago, Chile, on October 26, 2022, in accordance with the principles of the Declaration of Helsinki (approval number 20200234).

3. Participants:

Participants will be recruited from the community of Universidad Andrés Bello. The study will be advertised through official channels, including email distribution and publication on the institutional website. Additionally, communication channels such as emails, social media, and panels within the Physical Therapy Department will be utilized. Volunteers will be contacted via telephone or email to attend the Electrophysical Agents Laboratory at the Faculty of Rehabilitation Sciences.

4. Sample size:

The sample size will be determined using G-Power software, considering a power of 90% (1-β), a confidence level of 95%, a significance level of 5% (α), and an effect size of 0.6. Previous studies in individuals with CNP have shown differences in pain intensity, favoring HILT plus exercise over ultrasound plus exercise. Therefore, a minimum sample size of 17 participants will be established. To accommodate potential dropouts during the study or follow-up, an additional 15% will be added to the sample, resulting in a total of at least 20 participants.

5. Intervention:

Participants will form a study group receiving HILT as an intervention. Alongside laser therapy, they will undergo a regimen of passive bilateral static stretching exercises targeting the upper trapezius, levator scapulae, and scalene muscles, with each stretch held for 30 seconds per set. These stretching exercises will be conducted immediately following the HILT treatment. The interventions will take place twice weekly over a span of four weeks, totaling eight sessions. These interventions will occur twice a week for four weeks, totaling eight sessions. Each treatment will be administered by an independent therapist ensuring intervention blindness.

• High-intensity laser therapy. For laser therapy, the BTL-6000 device with 12W power and a wavelength of 1,064 nm will be used. The treatment protocol integrates manual scanning and point techniques following De la Barra et al. It consists of three phases: Phase 1, manual scanning with 12 W power for 42 seconds per upper trapezius muscle, delivering 1,000 J in total; Phase 2, point technique (static) using 4 W power for 10 seconds per point, delivering 120 J in total; Phase 3, manual scanning with 6 W power for 83 seconds per upper trapezius muscle, delivering 1,000 J in total.

• Stretching exercise. Participants will also undergo passive bilateral static stretching exercises targeting the upper trapezius, levator scapulae, and scalene muscles. A therapist will administer these exercises, lasting 30 seconds each with a 30-second rest between sets, following the HILT treatment.

6. Outcomes of Interest:

The primary outcome measures will include resting pain intensity (RPI), pain intensity during movement (MPI), both assessed using the Numerical Pain Rating Scale (NPRS), and pain pressure threshold (PPT), evaluated with algometry. Algometry will assess six bilateral points across the cervical region, shoulders, and interscapular region. Secondary outcomes will encompass cervical range of motion (CROM), evaluated using inclinometry, and cervical disability, assessed with the Neck Disability Index (NDI). Evaluations will occur at three time points: baseline (before treatment), immediately post-treatment, and four weeks post-treatment (follow-up assessment). Two independent evaluators will conduct the assessments to ensure blindness in the evaluation process: one will handle the algometry assessment and NPRS application, while the other will handle the CROM evaluation. Neck disability will be assessed using the self-administered NDI questionnaire.

7. Statistical Analysis:

Descriptive statistics such as means, standard deviations, medians, and interquartile ranges will be used to analyze the variables RPI, MPI, PPT, CROM, and ND, based on data distribution. Tables will be created with demographic data such as gender and body mass index. For inferential analysis, tests for normality and homoscedasticity, such as the Shapiro-Wilk test and Bartlett's test, respectively, will be employed. Depending on the results, parametric or non-parametric tests will be selected: a one-way ANOVA or Kruskal-Wallis test to evaluate differences between sessions. Post-hoc analyses will be conducted using Tukey's or Bonferroni's tests for multiple comparisons. The significance level will be set at 0.05, and data analysis will be performed using IBM Statistical Package for the Social Sciences (SPSS) software (version 26; SPSS Inc.; Chicago, IL). ;

Related Conditions & MeSH terms

• Chronic Non-specific Neck Pain
• Neck Pain

• NCT number: NCT06465524
• Study type: Interventional
• Source: Quiropraxia y Equilibrio
• Contact: Hernán Andrés de la Barra Ortiz, PhD(c)
• Phone: 984706322
• Email: hdelabarra@unab.cl
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Completion date: March 1, 2025