Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06334978 |
| Other study ID # |
1-2024 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 13, 2021 |
| Est. completion date |
August 10, 2022 |
Study information
| Verified date |
March 2024 |
| Source |
Hospital San Juan de Dios del Aljarafe de Sevilla |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 13/01/2021_10/08/2022 conducted
at Hospital San Juan de Dios del Aljarafe. The control group followed the hospital's
protocol, and the experimental group also received an osteopathic intervention. Statistical
analysis: Statistical Package for the Social Sciences (SPSS-vs27.0); intra-subject
comparison: Student's t-test for dependent samples, Wilcoxon's test; inter-group comparisons:
Student's t-test for independent samples, Mann-Whitney U, chi-squared.
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 300,000.
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 and/or
contraindications for the application of osteopathic and/or 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 (WDQ)18 and Neck Disability Index (NDI))19. 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 0.05 and a beta risk of
0.2 in a two-sided comparison and assuming a common standard deviation of 25, a correlation
coefficient between the initial and final measurement of 0.16 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 inclinometry20,21. The parameters
flexion/extension 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
algometry22,23 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 kg/cm2/s,
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 static/dynamic 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, Sutherland's posterior needle-scratch, SBS decompression, semi-direct
thrust for the sacrum, Sutherland's sacrum, posterior occipital condyle thrust, SBS
equilibration.
The statistical analysis was performed using Statistical Package for the Social Sciences
(SPSS) version 27.0. For the comparative intra-subject analysis, Student's t-test was used
for dependent variables (those with a normal distribution) and Wilcoxon's test for those with
a non-normal distribution. Similarly, Student's 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), Student's 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: p<0.05.
The ethical principles for medical research involving human subjects set out in the
Declaration of Helsinki, and its updates, and Law 14/2007, 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 3/2018, of 05 December, on personal data protection and the guarantee of
digital rights.
