Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06334978
Status:
COMPLETED
Last Update Posted:
2024-03-28
First Post:
2024-03-13
Brief Title:
The Effectiveness of Osteopathic Treatment in Cervical Whiplash
Sponsor:
Hospital San Juan de Dios del Aljarafe de Sevilla
Organization:
Hospital San Juan de Dios del Aljarafe de Sevilla
Study Overview
Official Title:
The Effectiveness of Osteopathic Treatment in Cervical Whiplash
Status:
COMPLETED
Status Verified Date:
2024-03
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:
Introduction Whiplash is common after road traffic accidents and affects millions of people worldwide 50 develop chronic symptoms and 15 have their ability to work compromised The aim of this study was to evaluate an osteopathic intervention in whiplash and determine whether pain mobility and quality of life improve with respect to conventional treatment
Methodology A randomised controlled clinical trial between 13012021_10082022 conducted at Hospital San Juan de Dios del Aljarafe The control group followed the hospitals protocol and the experimental group also received an osteopathic intervention Statistical analysis Statistical Package for the Social Sciences SPSS-vs270 intra-subject comparison Students t-test for dependent samples Wilcoxons test inter-group comparisons Students t-test for independent samples Mann-Whitney U chi-squared
Methodology A randomised controlled clinical trial between 13012021_10082022 conducted at Hospital San Juan de Dios del Aljarafe The control group followed the hospitals protocol and the experimental group also received an osteopathic intervention Statistical analysis Statistical Package for the Social Sciences SPSS-vs270 intra-subject comparison Students t-test for dependent samples Wilcoxons test inter-group comparisons Students t-test for independent samples Mann-Whitney U chi-squared
Detailed Description:
A controlled randomised clinical trial RCT was carried out between 13 January 2021 and 10 August 2022 at the Hospital San Juan de Dios del Aljarafe in Bormujos Seville Spain a regional hospital covering a population of 300000
The main objective of the study was to determine whether the intervention proposed resulted in an improvement in terms of pain mobility and quality of life compared with the local conventional treatment The secondary objectives were to determine the decrease in medication and number of pain sites as well as the influence of age and sex on the findings
Patients were randomised to the control and intervention groups using the Quickcalcs program The study was blinded patients were unaware of the group to which they had been assigned Patient evaluations at the start and end were performed by a physiotherapist different to the one performing the intervention who was also unaware of the patient assignment The same person performed all therapies for both the control and intervention groups and was unaware of the pre-intervention measurements The statistician who analysed the data was also unaware of the group to which each patient belonged
The inclusion criteria were patients diagnosed with WAD grade II Quebec classification aged between 18 and 55 years who started physiotherapy treatment less than 10 days prior to joining the trial and who agreed to join the trial and provided informed consent Patients with a history of neck pain in the previous three months other than the whiplash or with a prior history of WAD or who had previously received osteopathic treatment for WAD were excluded Pregnant women patients suspected to be simulating or exaggerating their symptoms for financial reasons and those who presented difficulties carrying out the evaluation correctly due to their culture or a language barrier were also excluded Patients with a history of chest head or upper limb surgery those diagnosed with a neurological condition such as congenital or diabetic polyneuritis or any neurological condition rheumatic alterations such as osteoarthritis arthritis ankylosing spondylitis etc malformations or surgical interventions that prevented correct conduct of the evaluation test andor contraindications for the application of osteopathic andor conventional treatment were also excluded
The sample size was calculated using the GRANMO calculator required for the main dependent variables namely pain visual analogue scale VAS and quality of life Whiplash Disability Questionnaire WDQ18 and Neck Disability Index NDI19 The highest of the three sample sizes calculated that for WAD was used with 46 subjects being required in each group to detect a difference of 20 units or more accepting an alpha risk of 005 and a beta risk of 02 in a two-sided comparison and assuming a common standard deviation of 25 a correlation coefficient between the initial and final measurement of 016 and a loss to follow-up of 10
A file was created for each patient containing their age sex height weight race and pharmacological treatment
The initial PRE evaluation was carried out immediately prior to starting treatment day 1 and the final POST evaluation involving pressure algometry inclinometry VAS NDI and WDQ was carried out after treatment for 21 days The WDQ was applied again at 4 weeks after completing treatment by way of a phone call
The android application Clinometer was used to perform inclinometry2021 The parameters flexionextension and right and left cervical lateral flexion were measured with the patient sitting with their feet on the floor and knees and hips at 90º and a band was used to maintain the thoracic spine and arms attached to the rest while measurements were taken Right and left cervical rotation were measured in a supine position
An FPX 25 algometer Wagner Instruments Greenwich CT USA was used to perform algometry2223 bilaterally at two points the mid-region of the anterior edge of the upper trapezius when sitting and the sternocleidomastoid when supine The tip of the middle or index finger was placed under the trigger point and the tip of the algometer on the trigger point perpendicular to it The pressure was increased gradually at a rate of 1 kgcm2s until the patient reported a change from a sensation of pressure to one of pain Three measurements were performed at each point with a rest time of 30 seconds between each measurement and an additional 30 seconds before moving to the other point The mean of the three measurements performed at each point was calculated The algometer screen was placed facing the floor so that the results could not be seen until the measurement was complete
The initial and final PRE and POST evaluations were recorded in a Google Form linked to each patient by way of their medical record number
In addition the patient completed a daily pain log using the VAS indicated the location of the pain using a picture of the human body from an anteroposterior viewpoint and recorded any medication taken if required This information was recorded twice daily in the morning and evening for 21 days
The physiotherapist recorded the treatment administered in a document and in the case of the experimental group added the osteopathic tests and techniques used
The standard treatment protocol for the Rehabilitation Service at the Hospital San Juan de Dios del Aljarafe is as follows 30-minute sessions from Monday to Friday Infrared radiation is applied to the cervical region for 15 minutes and session is completed by alternating massage and electrical currents TENS to the trapezii for 15 minutes The patient is given a list of flexibility exercises for the cervical spine on the first day and performs them during the daily infrared treatment This is the treatment for the control group
The experimental group received the same treatment as the control group along with one osteopathic intervention per week for the 21 days of the study days 2 9 and 16 Each session was performed independently and on a different day from the manual therapy performed as part of the conventional treatment to prevent possible interactions interferences and biases
In order to adjust the treatment to the needs of each patient based on their pathophysiology and the findings of the tests used a personalised osteopathic intervention was proposed as part of the characteristics of a pragmatic study Before selecting the techniques the physiotherapist performed an osteopathic assessment involving a staticdynamic inspection and palpation and other osteopathic tests The most common such tests were the Mitchell test Quick Scanning standing flexion Piedallu test Gillet test sphenobasilar synchondrosis SBS test sutural palpation test and diaphragm test
The techniques used most often were the dog technique in flexion scalene muscle energy technique Jones first rib adjustment first rib trust in posterior subluxation occipitomastoid thrust Sutherlands posterior needle-scratch SBS decompression semi-direct thrust for the sacrum Sutherlands sacrum posterior occipital condyle thrust SBS equilibration
The statistical analysis was performed using Statistical Package for the Social Sciences SPSS version 270 For the comparative intra-subject analysis Students t-test was used for dependent variables those with a normal distribution and Wilcoxons test for those with a non-normal distribution Similarly Students t-test for independent samples and the Mann-Whitney U test were used to compare the results for the various dependent variables depending on whether the distribution thereof was normal or not The chi-squared test sex as qualitative variable Students t-test for independent samples variables with a normal distribution and the Mann-Whitney U test non-normal distribution were used to evaluate the characteristics of the samples from each group Statistical significance p005
The ethical principles for medical research involving human subjects set out in the Declaration of Helsinki and its updates and Law 142007 of 03 July on biomedical research were taken into consideration This trial was approved by the Research Ethics Committee of the Virgen del Rocío University Hospital internal code 2015-N-18 All participants received information prior to the study and provided written informed consent The treatment communication and transfer of participants personal data is in accordance with Organic Law 32018 of 05 December on personal data protection and the guarantee of digital rights
The main objective of the study was to determine whether the intervention proposed resulted in an improvement in terms of pain mobility and quality of life compared with the local conventional treatment The secondary objectives were to determine the decrease in medication and number of pain sites as well as the influence of age and sex on the findings
Patients were randomised to the control and intervention groups using the Quickcalcs program The study was blinded patients were unaware of the group to which they had been assigned Patient evaluations at the start and end were performed by a physiotherapist different to the one performing the intervention who was also unaware of the patient assignment The same person performed all therapies for both the control and intervention groups and was unaware of the pre-intervention measurements The statistician who analysed the data was also unaware of the group to which each patient belonged
The inclusion criteria were patients diagnosed with WAD grade II Quebec classification aged between 18 and 55 years who started physiotherapy treatment less than 10 days prior to joining the trial and who agreed to join the trial and provided informed consent Patients with a history of neck pain in the previous three months other than the whiplash or with a prior history of WAD or who had previously received osteopathic treatment for WAD were excluded Pregnant women patients suspected to be simulating or exaggerating their symptoms for financial reasons and those who presented difficulties carrying out the evaluation correctly due to their culture or a language barrier were also excluded Patients with a history of chest head or upper limb surgery those diagnosed with a neurological condition such as congenital or diabetic polyneuritis or any neurological condition rheumatic alterations such as osteoarthritis arthritis ankylosing spondylitis etc malformations or surgical interventions that prevented correct conduct of the evaluation test andor contraindications for the application of osteopathic andor conventional treatment were also excluded
The sample size was calculated using the GRANMO calculator required for the main dependent variables namely pain visual analogue scale VAS and quality of life Whiplash Disability Questionnaire WDQ18 and Neck Disability Index NDI19 The highest of the three sample sizes calculated that for WAD was used with 46 subjects being required in each group to detect a difference of 20 units or more accepting an alpha risk of 005 and a beta risk of 02 in a two-sided comparison and assuming a common standard deviation of 25 a correlation coefficient between the initial and final measurement of 016 and a loss to follow-up of 10
A file was created for each patient containing their age sex height weight race and pharmacological treatment
The initial PRE evaluation was carried out immediately prior to starting treatment day 1 and the final POST evaluation involving pressure algometry inclinometry VAS NDI and WDQ was carried out after treatment for 21 days The WDQ was applied again at 4 weeks after completing treatment by way of a phone call
The android application Clinometer was used to perform inclinometry2021 The parameters flexionextension and right and left cervical lateral flexion were measured with the patient sitting with their feet on the floor and knees and hips at 90º and a band was used to maintain the thoracic spine and arms attached to the rest while measurements were taken Right and left cervical rotation were measured in a supine position
An FPX 25 algometer Wagner Instruments Greenwich CT USA was used to perform algometry2223 bilaterally at two points the mid-region of the anterior edge of the upper trapezius when sitting and the sternocleidomastoid when supine The tip of the middle or index finger was placed under the trigger point and the tip of the algometer on the trigger point perpendicular to it The pressure was increased gradually at a rate of 1 kgcm2s until the patient reported a change from a sensation of pressure to one of pain Three measurements were performed at each point with a rest time of 30 seconds between each measurement and an additional 30 seconds before moving to the other point The mean of the three measurements performed at each point was calculated The algometer screen was placed facing the floor so that the results could not be seen until the measurement was complete
The initial and final PRE and POST evaluations were recorded in a Google Form linked to each patient by way of their medical record number
In addition the patient completed a daily pain log using the VAS indicated the location of the pain using a picture of the human body from an anteroposterior viewpoint and recorded any medication taken if required This information was recorded twice daily in the morning and evening for 21 days
The physiotherapist recorded the treatment administered in a document and in the case of the experimental group added the osteopathic tests and techniques used
The standard treatment protocol for the Rehabilitation Service at the Hospital San Juan de Dios del Aljarafe is as follows 30-minute sessions from Monday to Friday Infrared radiation is applied to the cervical region for 15 minutes and session is completed by alternating massage and electrical currents TENS to the trapezii for 15 minutes The patient is given a list of flexibility exercises for the cervical spine on the first day and performs them during the daily infrared treatment This is the treatment for the control group
The experimental group received the same treatment as the control group along with one osteopathic intervention per week for the 21 days of the study days 2 9 and 16 Each session was performed independently and on a different day from the manual therapy performed as part of the conventional treatment to prevent possible interactions interferences and biases
In order to adjust the treatment to the needs of each patient based on their pathophysiology and the findings of the tests used a personalised osteopathic intervention was proposed as part of the characteristics of a pragmatic study Before selecting the techniques the physiotherapist performed an osteopathic assessment involving a staticdynamic inspection and palpation and other osteopathic tests The most common such tests were the Mitchell test Quick Scanning standing flexion Piedallu test Gillet test sphenobasilar synchondrosis SBS test sutural palpation test and diaphragm test
The techniques used most often were the dog technique in flexion scalene muscle energy technique Jones first rib adjustment first rib trust in posterior subluxation occipitomastoid thrust Sutherlands posterior needle-scratch SBS decompression semi-direct thrust for the sacrum Sutherlands sacrum posterior occipital condyle thrust SBS equilibration
The statistical analysis was performed using Statistical Package for the Social Sciences SPSS version 270 For the comparative intra-subject analysis Students t-test was used for dependent variables those with a normal distribution and Wilcoxons test for those with a non-normal distribution Similarly Students t-test for independent samples and the Mann-Whitney U test were used to compare the results for the various dependent variables depending on whether the distribution thereof was normal or not The chi-squared test sex as qualitative variable Students t-test for independent samples variables with a normal distribution and the Mann-Whitney U test non-normal distribution were used to evaluate the characteristics of the samples from each group Statistical significance p005
The ethical principles for medical research involving human subjects set out in the Declaration of Helsinki and its updates and Law 142007 of 03 July on biomedical research were taken into consideration This trial was approved by the Research Ethics Committee of the Virgen del Rocío University Hospital internal code 2015-N-18 All participants received information prior to the study and provided written informed consent The treatment communication and transfer of participants personal data is in accordance with Organic Law 32018 of 05 December on personal data protection and the guarantee of digital rights
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