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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06465524
• Other study ID #: 13062024
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: June 2024
• Source: Quiropraxia y Equilibrio
• Contact: Hernán Andrés de la Barra Ortiz, PhD(c)
• Phone: 984706322
• Email: hdelabarra[@]unab.cl
• Is FDA regulated: No
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or older

• Both sexes

• Experiencing chronic neck pain: Defined as pain or discomfort in the cervical region between the upper nuchal line and the T1 spinous process or the shoulder girdle. Lasting at least three months

• Neck Disability Index (NDI) score of 5 or higher

• Pain intensity of at least three on the Numerical Pain Rating Scale (NPRS) at rest

Exclusion Criteria:

• Any musculoskeletal injuries sustained in the neck or shoulders within the past three months

• The presence of osteosynthesis materials in the vicinity of the shoulders, neck, or surrounding areas

• The existence of skin wounds or changes, such as psoriasis, scars, or burns, in the neck or shoulder region.

• Continuous usage of analgesic medication, anti-inflammatories, or muscle relaxants.

• Neurological disorders, which include paresthesias, partial or total loss of sensation, decreased strength, and color changes in the neck, arms, forearms, or hands.

• Diagnosis of photosensitivity

• Skin types V and VI, as determined by the Fitzpatrick scale

• Solar urticaria or adverse reactions to sunlight are present.

• Diagnosis of autoimmune diseases (e.g., dermatomyositis, systemic lupus erythematosus, hepatic porphyria, carcinoid syndrome, pellagra)

• Diagnosis of cancer or tumors within the past five years

• Epilepsy

Related Conditions & MeSH terms

• Chronic Non-specific Neck Pain
• Neck Pain

Intervention

Device:
• High-intensity laser therapy
High-intensity laser therapy (HILT), also referred to as Class IV laser therapy, involves the administration of collimated and monochromatic electromagnetic radiation within the infrared or red spectrum. It operates at power levels exceeding 500 milliwatts (0.5 W), leveraging both photobiomodulation and thermal effects. This distinguishes HILT from Class III lasers (low-level laser therapy, or LLLT), which lack photothermal effects when operating below 500 mW.

Locations

Country	Name	City	State
Chile	Universidad Andrés Bello	Santiago de Chile	Las Condes

Sponsors (1)

Lead Sponsor	Collaborator
Quiropraxia y Equilibrio

Country where clinical trial is conducted

Chile, 

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* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)

External Links

•   A Randomized Comparative Study between High-Intensity Laser Therapy and Ultrasound Therapy on Chronic Neck Pain among Adult Patients