Ignite Creation Date:
2024-07-17 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465524
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-13
Brief Title:
High-intensity Laser Therapy and Stretching Exercises for Chronic Non-specific Neck Pain a Feasibility Study
Sponsor:
Quiropraxia y Equilibrio
Organization:
Quiropraxia y Equilibrio
Study Overview
Official Title:
Effects of High-Intensity Laser Therapy and Stretching Exercises on Chronic Non-Specific Neck Pain Findings From a Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
11 Study Type and Design Experimental design for a non-controlled clinical trialThe study will be conducted in the Electrophysical Agents Laboratory KIN 401 at the School of Physical Therapy Faculty of Rehabilitation Sciences Casona de las Condes Campus Universidad Andrés Bello located at Calle Fernández Concha Nº700 Las Condes Santiago Chile The sample will be selected from the university population of the same faculty The study group will be determined through a non-probabilistic sampling process Participants will be recruited via a closed-ended questionnaire constructed according to selection criteria The minimum number of participants required for the study will be calculated using the G-Power program with a minimum of 20 participants Subjects with CNNP pain will be recruited and will receive 8 sessions of HILT and stretching exercises over 4 weeks Relevant outcomes will include resting pain intensity RPI movement pain intensity MPI and pressure pain threshold PPT Additionally cervical range of motion CROM and neck disability ND will be assessed Evaluations will be conducted at three time points before treatment at the end of treatment and at a one-month follow-up evaluation
12 Overall Objective To evaluate the effect of high-intensity laser therapy on reducing pain increasing pain pressure threshold improving cervical range of motion and decreasing cervical disability in patients with non-specific chronic neck pain
13 Specific Objectives - Determine the difference in cervical pain intensity before and after high-intensity laser therapy treatment
Assess the change in cervical pain pressure threshold before and after treatment with high-intensity laser therapy
Measure improvement in cervical range of motion in terms of flexion extension rotation and lateral bending following high-intensity laser therapy
Evaluate the reduction in cervical disability using the cervical disability index before and after treatment with high-intensity laser therapy
Investigate the correlation between pain reduction pain pressure threshold improvement in range of motion and reduction in cervical disability in response to high-intensity laser therapy
14 Phases of the clinical trial
Study Preparation and Design In this initial stage the experimental design of the non-controlled clinical trial will be established defining study objectives and selecting key variables for measurement Additionally the laboratory environment will be prepared and the research protocol will be designed
Treatment Implementation and Execution During this phase the study will be implemented involving sample selection through a non-probabilistic sampling process administration of the treatment HILT and stretching exercises to recruited participants and collection of relevant clinical data
Evaluation and Results Analysis The final stage will focus on evaluating the obtained results including measurement of variables such as pain intensity pain pressure threshold cervical range of motion and cervical disability Statistical analyses will be conducted to determine treatment efficacy and conclusions will be drawn based on the study findings
21 Conceptual Definition of Variables
- Pain intensity at rest discomfort or more intense forms of pain localized in the cervical region lateral neck shoulders or scapular region reported by participants while at rest
Pain intensity at movement discomfort or more intense forms of pain localized in the cervical region lateral neck shoulders or scapular region manifested by participants during neck movements
Pain pressure threshold the minimum amount of pressure applied to a specific area of the body that induces the sensation of pain
Cervical range of motion capacity of movement in the cervical spine including movements in various anatomical planes such as flexion extension lateral bending and rotation
Neck disability limitation or restriction in neck functional capacity manifested as difficulty in performing daily activities such as neck movement maintaining an upright posture performing work tasks or engaging in recreational activities
Stretching exercises static passive stretching exercises performed bilaterally by the therapist on the upper trapezius levator scapulae and scalene muscles each held for 30 seconds with 30-second intervals totaling 3 sets for each muscle group
High-intensity laser therapy uses concentrated laser light with power greater than 05 watts to treat musculoskeletal injuries chronic pain and promote healing through thermal effects and photobiomodulation
22 Operational Definition of Variables - Pain intensity at rest assessed using the Numeric Pain Rating Scale NPRS from Gymna R measured on a scale from 0 to 10 where 0 represents no pain and 10 represents the most pain the participant reported
- Pain intensity at movement assessed using the Numeric Pain Rating Scale NPRS from Gymna R measured on a scale from 0 to 10 where 0 represents no pain and 10 represents the most pain the participant reported
- Pain pressure threshold assessed using pressure algometry with the FPX Wagner pressure algometer R The pressure threshold will be measured in pounds per square centimeter lbcm2
- Cervical range of motion assessed using inclinometry with the CROM device The range of motion will be quantified in degrees
- Neck disability is assessed using the Neck Disability Index NDI Cervical disability will be expressed as a percentage where 0 indicates no disability and 100 indicates maximum disability
Stretching exercises static and passive stretching exercises performed bilaterally by the therapist on the upper trapezius levator scapulae and scalene muscles Each exercise will be held for 30 seconds with 30-second intervals and 3 sets will be performed for each muscle group
High-intensity laser application of a high-power laser using the BTL-6000 device at 12 Watts
23 Types of Variables
- Pain intensity at rest dependent variable ordinal qualitative
Pain intensity at movement dependent variable ordinal qualitative
Pain pressure threshold dependent variable continuous quantitative
Cervical range of motion dependent variable continuous quantitative
Neck disability dependent variable continuous quantitative
Cervical stretching exercises independent variable nominal qualitative
High-intensity laser therapy independent variable continuous quantitative
3 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
4 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
5 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 06 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
6 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 1064 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 1000 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 1000 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
7 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
8 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 Bartletts 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 Tukeys or Bonferronis tests for multiple comparisons The significance level will be set at 005 and data analysis will be performed using IBM Statistical Package for the Social Sciences SPSS software version 26 SPSS Inc Chicago IL
12 Overall Objective To evaluate the effect of high-intensity laser therapy on reducing pain increasing pain pressure threshold improving cervical range of motion and decreasing cervical disability in patients with non-specific chronic neck pain
13 Specific Objectives - Determine the difference in cervical pain intensity before and after high-intensity laser therapy treatment
Assess the change in cervical pain pressure threshold before and after treatment with high-intensity laser therapy
Measure improvement in cervical range of motion in terms of flexion extension rotation and lateral bending following high-intensity laser therapy
Evaluate the reduction in cervical disability using the cervical disability index before and after treatment with high-intensity laser therapy
Investigate the correlation between pain reduction pain pressure threshold improvement in range of motion and reduction in cervical disability in response to high-intensity laser therapy
14 Phases of the clinical trial
Study Preparation and Design In this initial stage the experimental design of the non-controlled clinical trial will be established defining study objectives and selecting key variables for measurement Additionally the laboratory environment will be prepared and the research protocol will be designed
Treatment Implementation and Execution During this phase the study will be implemented involving sample selection through a non-probabilistic sampling process administration of the treatment HILT and stretching exercises to recruited participants and collection of relevant clinical data
Evaluation and Results Analysis The final stage will focus on evaluating the obtained results including measurement of variables such as pain intensity pain pressure threshold cervical range of motion and cervical disability Statistical analyses will be conducted to determine treatment efficacy and conclusions will be drawn based on the study findings
21 Conceptual Definition of Variables
- Pain intensity at rest discomfort or more intense forms of pain localized in the cervical region lateral neck shoulders or scapular region reported by participants while at rest
Pain intensity at movement discomfort or more intense forms of pain localized in the cervical region lateral neck shoulders or scapular region manifested by participants during neck movements
Pain pressure threshold the minimum amount of pressure applied to a specific area of the body that induces the sensation of pain
Cervical range of motion capacity of movement in the cervical spine including movements in various anatomical planes such as flexion extension lateral bending and rotation
Neck disability limitation or restriction in neck functional capacity manifested as difficulty in performing daily activities such as neck movement maintaining an upright posture performing work tasks or engaging in recreational activities
Stretching exercises static passive stretching exercises performed bilaterally by the therapist on the upper trapezius levator scapulae and scalene muscles each held for 30 seconds with 30-second intervals totaling 3 sets for each muscle group
High-intensity laser therapy uses concentrated laser light with power greater than 05 watts to treat musculoskeletal injuries chronic pain and promote healing through thermal effects and photobiomodulation
22 Operational Definition of Variables - Pain intensity at rest assessed using the Numeric Pain Rating Scale NPRS from Gymna R measured on a scale from 0 to 10 where 0 represents no pain and 10 represents the most pain the participant reported
- Pain intensity at movement assessed using the Numeric Pain Rating Scale NPRS from Gymna R measured on a scale from 0 to 10 where 0 represents no pain and 10 represents the most pain the participant reported
- Pain pressure threshold assessed using pressure algometry with the FPX Wagner pressure algometer R The pressure threshold will be measured in pounds per square centimeter lbcm2
- Cervical range of motion assessed using inclinometry with the CROM device The range of motion will be quantified in degrees
- Neck disability is assessed using the Neck Disability Index NDI Cervical disability will be expressed as a percentage where 0 indicates no disability and 100 indicates maximum disability
Stretching exercises static and passive stretching exercises performed bilaterally by the therapist on the upper trapezius levator scapulae and scalene muscles Each exercise will be held for 30 seconds with 30-second intervals and 3 sets will be performed for each muscle group
High-intensity laser application of a high-power laser using the BTL-6000 device at 12 Watts
23 Types of Variables
- Pain intensity at rest dependent variable ordinal qualitative
Pain intensity at movement dependent variable ordinal qualitative
Pain pressure threshold dependent variable continuous quantitative
Cervical range of motion dependent variable continuous quantitative
Neck disability dependent variable continuous quantitative
Cervical stretching exercises independent variable nominal qualitative
High-intensity laser therapy independent variable continuous quantitative
3 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
4 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
5 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 06 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
6 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 1064 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 1000 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 1000 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
7 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
8 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 Bartletts 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 Tukeys or Bonferronis tests for multiple comparisons The significance level will be set at 005 and data analysis will be performed using IBM Statistical Package for the Social Sciences SPSS software version 26 SPSS Inc Chicago IL
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None