Ignite Creation Date:
2024-05-06 @ 1:33 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04059692
Status:
COMPLETED
Last Update Posted:
2020-04-20
First Post:
2019-08-14
Brief Title:
Immediate Effect of a Single Cervical Spinal Manipulation
Sponsor:
University of Valencia
Organization:
University of Valencia
Study Overview
Official Title:
Immediate Effect of a Single Cervical Spinal Manipulation on Cervical Movement Pattern
Status:
COMPLETED
Status Verified Date:
2020-04
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:
SMCervical
Brief Summary:
Objective The aim of the present study is to analyze the immediate effect of a single cervical spinal manipulation on cervical movement pattern Further To perform the sample size calculation the investigators took into consideration that the investigators pretend to achieve a medium effect size d05 of the differences with two groups EG and CG and two aimed to explore the impact on pain disability and patients improvement-perceived sensation comparing with a placebo
Methods The study design is experimental and purposive sampling was used to select the study participants The grouping allocation was randomized The people volunteer to participate in the study are assigned to the experimental group EG that will receive a single manipulation to the control group CG that will receive a single placebo treatment
The participants will be assessed twice one before the treatment and the other after the end Head movement is recorded by means of a video-photogrammetry system from the coordinates of a set of eight reflective markers located on a helmet The movements will be record at 200 fps
In each evaluation the perceived pain and the neck disability index are also recorded And the impression of change is evaluated only in the second evaluation
Outcomes Pain Disability of the neck Impression of Change Range of motion RoM Maximum angular velocity MAV Maximum angular acceleration MAA and Harmonicity HARM
Intervention The intervention in both groups it includes only one session that lasted 15 minutes approximately a Cervical manipulation intervention and bPlacebo intervention
Methods The study design is experimental and purposive sampling was used to select the study participants The grouping allocation was randomized The people volunteer to participate in the study are assigned to the experimental group EG that will receive a single manipulation to the control group CG that will receive a single placebo treatment
The participants will be assessed twice one before the treatment and the other after the end Head movement is recorded by means of a video-photogrammetry system from the coordinates of a set of eight reflective markers located on a helmet The movements will be record at 200 fps
In each evaluation the perceived pain and the neck disability index are also recorded And the impression of change is evaluated only in the second evaluation
Outcomes Pain Disability of the neck Impression of Change Range of motion RoM Maximum angular velocity MAV Maximum angular acceleration MAA and Harmonicity HARM
Intervention The intervention in both groups it includes only one session that lasted 15 minutes approximately a Cervical manipulation intervention and bPlacebo intervention
Detailed Description:
INTRODUCTION Non-specific neck pain is defined as pain in the posterior and lateral aspect of the neck between the superior nuchal line and the spinous process of the first thoracic vertebra with no signs or symptoms of major structural pathology It is a common musculoskeletal disorder that leads to substantial disability discomfort and reduced cervical mobility resulting in enormous health costs in terms of treatment and work absenteeism The American Physical Therapy Associations guidelines on neck pain recommends utilizing cervical manipulation CM and mobilization procedures to reduce neck pain based on strong evidence Spinal manipulation is defined as a passive high velocity low amplitude thrust applied to a joint complex within its anatomical limit with the intent to restore optimal motion function andor to reduce pain and its effectiveness concretely of a continuous program of cervical manipulations CM on neck pain has been largely studied A previous systematic review concluded that treatments based on CM are effective both alone and in combination with exercises whilst other systematic reviews and an evidence-based guideline showed that CM combined with exercises resulted to be more effective for neck pain function and global perceived effect than a therapeutic program based exclusively on CM
Nevertheless the underlying mechanisms of the pain decrease with this therapeutic approach are not completely understood A recent study aimed at analyzing the biomechanics of a single CM used a complex system of synchronized biplane radiographs to measure the facet gapping during a single manipulation Authors demonstrated that target and adjacent motion segments undergo facet joint gapping during a manipulation and that segmental and global range of motion ROM increases in all three planes of motion immediately after one manipulation
In the clinical setting the best of our knowledge only one previous clinical trial have analyzed the effectiveness of a single cervical manipulation on cervical range of motion comparing with placebo demonstrating an improvement in all the global maximum cervical movements measured with the goniometer However pain may affect other movement characteristics beside the maximum range of motion ROM as velocity variability or movement harmony
Nevertheless no previous study has analyzed the characteristics of the patients cervical motion pattern after a single manipulation which could provide information about functional changes in cervical movements People with neck pain has shown more slow movements less harmonic movements in the points close to pain and exponential trend at the ends of the range even when cervical spine motion ranges remain within normal limits
The investigators hypothesized that functional assessment of the cervical spine based on the analysis of the motion pattern will let us know if a single manipulation is effective in the improvement of those variables
The aim of the present study is to analyze the immediate effect of a single cervical spinal manipulation on cervical movement pattern Further the investigators aimed to explore the impact on pain disability and patients improvement-perceived sensation comparing with a placebo
METHODS Participants The study design is experimental and purposive sampling was used to select the study participants The grouping allocation was randomized The people volunteer to participate in the study are assigned to the experimental group EG that will receive a single CM to the control group CG that will receive a single placebo treatment
All the participants should meet the following inclusion criteria perceived pain scored 3 or above in a visual analogue scale and neck functional status revealing a mild disability Additionally patients had symptoms duration less than 30 days
For both groups the exclusion criteria include an inflammatory rheumatic disease or an inner ear disorder the use of antidepressant opioid or sedative drugs current vertigo or dizziness visual loss neurological disorder and trunk or shoulder surgery within the past year
Sample size To perform the sample size calculation the investigators took into consideration to achieve a medium effect size d05 of the differences with two groups EG and CG and two assessments pre and post-treatment Further the investigators set a type I error of 5 and a type II error of 20 This power calculation resulted in 17 patients on each group
Assessment procedures The participants will be assessed twice one before the treatment and the other after the end Head movement is recorded by means of a video-photogrammetry system from the coordinates of a set of eight reflective markers located on a helmet The movements will be record at 200 fps
Participants sit in a chair with the trunk fixed at the back by means of belts In each session they perform three movements flexion-extension FE lateral flexion LB and axial rotation AR whose order was randomized Each movement will be perform seven consecutive times without stopping and achieving a continuous and smooth cyclic movement with the maximum achievable range at their preferred speed The participants are encouraged to practice the three movements before the test begins to avoid the learning effect
In each evaluation the perceived pain and the neck disability index are also recorded And the impression of change is evaluated only in the second evaluation
Outcomes Pain with the Visual Analogue Scale VAS in which the patients marked their level of pain intensity on a 10-cm horizontal line 0 no pain to 10 maximum pain at the time the assessment was carried out
Disability of the neck with the Neck Disability Index a self-report questionnaire used to determine how neck pain affects a patients daily life Scoring is reported on a 0-50 scale 0 being the best possible score
Impression of Change with the self-reported measure Patient Global Impression of Change that reflects a patients belief about the efficacy of treatment
Range of motion RoM angular excursion of the cervical motion Maximum angular velocityMAV it is measured as percentile 95 of angular velocity during the test
Maximum angular accelerationMAA it is measas percentile 95 of angular acceleration during the test
Harmonicity HARM is the absolute value of the correlation coefficient between two motion Thus HARM quantifies the fit between the actual movement and the simple harmonic motion
Intervention The intervention in both groups it includes only one session that lasted 15 minutes approximately Participants should wear a sleeveless shirt that allows the physiotherapist to treat the neck region Evaluations and manipulations are performed by the same experienced physiotherapist
Cervical manipulation intervention Prior to intervention a screened for any signs of vertebrobasilar insufficiency is performed by means of the vertebral artery compromise test as well as the root compression test using the Jackson test and the screening for upper cervical spine ligamentous instability through Sharp-Purser test alar ligament stress test and transverse ligament test
To perform the evaluation and detect the cervical vertebral level with mobility restriction with the patient in supine position a cervical examination is carried out to determine the mobility restriction both in flexo-extension as in inclination and rotation To check the level of restriction the post-anterior sliding test is performed
Once the vertebral levels with restriction have been detected high speed and low amplitude manipulation is carried out based on the location of the pain and the detection of the perceived joint hypomobility using the clinical criterion for this with a maximum of 2 manipulative attempts by vertebral level regardless of having achieved joint cavitation The manipulation is performed following the criteria of thrust manipulations A maximum of 3 manipulations are applied in total per subject one for each level high level C1-C2 medium level C3-C6 and low level C7 if necessary
Placebo intervention This group will receive 15 minutes of sham techniques in a supine position over the stretcher First a series of short-time and no pressure contact with physiotherapists hands is performed in several points of head and shoulders for 10 minutes Subsequently light touch is applied on standardized anatomic areas equal to those treated with manipulative intervention for 2 minutes each time adding a total duration of approximately 15 minutes similar to the intervention group
Statistics Standard statistical methods will be use to obtain the mean and standard deviation of the mean SD For the inferential analysis of the data a mixed two-factor multivariate analysis of variance MANOVA with a between-subject factor group ie CG and EG ant a within-subject factor time with two groups pre and post-intervention Multiple comparison techniques are performed using Bonferroni correction The investigators will evaluate the assumption of homoscedasticity and it will be assumed in each variable In addition the investigators will compare the perceived changes after treatment between the two groups with an independent Student T test Type I error will be set as 5 p 05
Nevertheless the underlying mechanisms of the pain decrease with this therapeutic approach are not completely understood A recent study aimed at analyzing the biomechanics of a single CM used a complex system of synchronized biplane radiographs to measure the facet gapping during a single manipulation Authors demonstrated that target and adjacent motion segments undergo facet joint gapping during a manipulation and that segmental and global range of motion ROM increases in all three planes of motion immediately after one manipulation
In the clinical setting the best of our knowledge only one previous clinical trial have analyzed the effectiveness of a single cervical manipulation on cervical range of motion comparing with placebo demonstrating an improvement in all the global maximum cervical movements measured with the goniometer However pain may affect other movement characteristics beside the maximum range of motion ROM as velocity variability or movement harmony
Nevertheless no previous study has analyzed the characteristics of the patients cervical motion pattern after a single manipulation which could provide information about functional changes in cervical movements People with neck pain has shown more slow movements less harmonic movements in the points close to pain and exponential trend at the ends of the range even when cervical spine motion ranges remain within normal limits
The investigators hypothesized that functional assessment of the cervical spine based on the analysis of the motion pattern will let us know if a single manipulation is effective in the improvement of those variables
The aim of the present study is to analyze the immediate effect of a single cervical spinal manipulation on cervical movement pattern Further the investigators aimed to explore the impact on pain disability and patients improvement-perceived sensation comparing with a placebo
METHODS Participants The study design is experimental and purposive sampling was used to select the study participants The grouping allocation was randomized The people volunteer to participate in the study are assigned to the experimental group EG that will receive a single CM to the control group CG that will receive a single placebo treatment
All the participants should meet the following inclusion criteria perceived pain scored 3 or above in a visual analogue scale and neck functional status revealing a mild disability Additionally patients had symptoms duration less than 30 days
For both groups the exclusion criteria include an inflammatory rheumatic disease or an inner ear disorder the use of antidepressant opioid or sedative drugs current vertigo or dizziness visual loss neurological disorder and trunk or shoulder surgery within the past year
Sample size To perform the sample size calculation the investigators took into consideration to achieve a medium effect size d05 of the differences with two groups EG and CG and two assessments pre and post-treatment Further the investigators set a type I error of 5 and a type II error of 20 This power calculation resulted in 17 patients on each group
Assessment procedures The participants will be assessed twice one before the treatment and the other after the end Head movement is recorded by means of a video-photogrammetry system from the coordinates of a set of eight reflective markers located on a helmet The movements will be record at 200 fps
Participants sit in a chair with the trunk fixed at the back by means of belts In each session they perform three movements flexion-extension FE lateral flexion LB and axial rotation AR whose order was randomized Each movement will be perform seven consecutive times without stopping and achieving a continuous and smooth cyclic movement with the maximum achievable range at their preferred speed The participants are encouraged to practice the three movements before the test begins to avoid the learning effect
In each evaluation the perceived pain and the neck disability index are also recorded And the impression of change is evaluated only in the second evaluation
Outcomes Pain with the Visual Analogue Scale VAS in which the patients marked their level of pain intensity on a 10-cm horizontal line 0 no pain to 10 maximum pain at the time the assessment was carried out
Disability of the neck with the Neck Disability Index a self-report questionnaire used to determine how neck pain affects a patients daily life Scoring is reported on a 0-50 scale 0 being the best possible score
Impression of Change with the self-reported measure Patient Global Impression of Change that reflects a patients belief about the efficacy of treatment
Range of motion RoM angular excursion of the cervical motion Maximum angular velocityMAV it is measured as percentile 95 of angular velocity during the test
Maximum angular accelerationMAA it is measas percentile 95 of angular acceleration during the test
Harmonicity HARM is the absolute value of the correlation coefficient between two motion Thus HARM quantifies the fit between the actual movement and the simple harmonic motion
Intervention The intervention in both groups it includes only one session that lasted 15 minutes approximately Participants should wear a sleeveless shirt that allows the physiotherapist to treat the neck region Evaluations and manipulations are performed by the same experienced physiotherapist
Cervical manipulation intervention Prior to intervention a screened for any signs of vertebrobasilar insufficiency is performed by means of the vertebral artery compromise test as well as the root compression test using the Jackson test and the screening for upper cervical spine ligamentous instability through Sharp-Purser test alar ligament stress test and transverse ligament test
To perform the evaluation and detect the cervical vertebral level with mobility restriction with the patient in supine position a cervical examination is carried out to determine the mobility restriction both in flexo-extension as in inclination and rotation To check the level of restriction the post-anterior sliding test is performed
Once the vertebral levels with restriction have been detected high speed and low amplitude manipulation is carried out based on the location of the pain and the detection of the perceived joint hypomobility using the clinical criterion for this with a maximum of 2 manipulative attempts by vertebral level regardless of having achieved joint cavitation The manipulation is performed following the criteria of thrust manipulations A maximum of 3 manipulations are applied in total per subject one for each level high level C1-C2 medium level C3-C6 and low level C7 if necessary
Placebo intervention This group will receive 15 minutes of sham techniques in a supine position over the stretcher First a series of short-time and no pressure contact with physiotherapists hands is performed in several points of head and shoulders for 10 minutes Subsequently light touch is applied on standardized anatomic areas equal to those treated with manipulative intervention for 2 minutes each time adding a total duration of approximately 15 minutes similar to the intervention group
Statistics Standard statistical methods will be use to obtain the mean and standard deviation of the mean SD For the inferential analysis of the data a mixed two-factor multivariate analysis of variance MANOVA with a between-subject factor group ie CG and EG ant a within-subject factor time with two groups pre and post-intervention Multiple comparison techniques are performed using Bonferroni correction The investigators will evaluate the assumption of homoscedasticity and it will be assumed in each variable In addition the investigators will compare the perceived changes after treatment between the two groups with an independent Student T test Type I error will be set as 5 p 05
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