Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03081091 |
| Other study ID # |
EUSESTE-CT-1 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
March 5, 2017 |
| Last updated |
March 14, 2017 |
| Start date |
January 2017 |
| Est. completion date |
May 31, 2017 |
Study information
| Verified date |
March 2017 |
| Source |
University of Girona |
| Contact |
Jordi Casado Borrull, Director |
| Phone |
0034639732682 |
| Email |
jordi.casado[@]euseste.es |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background: Chronic Widespread Pain (CWP) is a multidimensional disorder for which treatment
as yet remains unsatisfactory. Acupuncture is one of the most sought therapeutic methods
when it comes to alternative medicine, due to its minimal adverse effects and its ease of
use in clinical practice. Currently, acupuncture is successfully used in China for the
treatment of many chronic diseases. The work to be carried out aims to assess the effects of
acupuncture on pain management and quality of life of people suffering from CWP.
Methods/design: The study is a single-center, controlled triple-blind prospective study. A
total of 100 participants will be randomly distributed into two groups, the intervention
group, which will receive an individualized acupuncture treatment; and control group, which
will receive sham acupuncture. The treatments performed will be personalized and the
treatment criteria will be based on the use of the Yuan and Luo points. They will be
evaluated using a specific measurement system, constituted of the Visual Analogue Scale, The
Fibromyalgia Impact Questionnaire and The Medical Outcomes Study Sleep Scale. The primary
outcome measures assess whether acupuncture can bring about a decrease in pain and an
improvement in the quality of life of people suffering from chronic widespread pain; the
secondary outcomes assess whether the use of acupuncture leads to improved sleep quality.
The results obtained will be analysed at 1st, 4th and 8th weeks from the start of treatment.
Discussion: This technique is aimed to restore some of the imbalances suffered by patients
affected with CWP and to improve their symptomatology. We expect to observe a significant
improvement in the pain, quality of life and sleep quality of people affected with CWP. The
study will be conducted according to the STRICTA guidelines, which lay down the right way to
proceed when carrying out scientific studies in the field of acupuncture.
Description:
Chronic Widespread Pain (CWP) is defined as spinal pain that lasts at least three months
involving both the right and left side of the body, above and below the waist.
CWP is a highly prevalent condition. According to Clauw et al., it affects 10-12% of the
population and, according to Bergman et al., 10-11%. More recent studies show similar data.
For their part, Mas et al. (2008) found in a nationwide study that the prevalence of
fibromyalgia in Spain was of 4.2% in women and 0.2% in men, mainly in the age range between
40-49 years. All these studies have been performed in countries in the developed world and,
most of the time, they have also analysed the prevalence of fibromyalgia (FM) among the same
population.
Currently, acupuncture is successfully used in China for the treatment of many chronic
diseases. However, in the West, the situation is quite different: acupuncture is little
known and not commonly used, giving thus rise to mistrust and misunderstandings.
Nevertheless, in recent years, studies have been published both in the East and in the West
showing, on the one hand, the intention of traditional Chinese medicine to examine the
technique and, on the other, the importance and recognition that the Western medical world
is starting to bestow upon Chinese medicine.
METHODS/DESIGN
Objectives
This study seeks to meet the following objectives: assess whether acupuncture can bring
about a decrease in pain and an improvement in the quality of life of people suffering from
chronic widespread pain; assess whether the use of acupuncture leads to improved sleep
quality.
Hypothesis
Acupuncture succeeds in reducing the pain suffered by people affected with chronic
widespread pain (CWP) and in improving their quality of life. Acupuncture can improve pain
and different items that have an impact on the quality of life (sleep quality and
performance of daily activities).
Design
Clinical trial. Controlled triple-blind prospective study. 100 participants will be randomly
distributed into two groups: intervention group (A), which will receive an individualized
acupuncture treatment; and control group (S), which will receive sham acupuncture using a
randomization 1:1.
Recruitment
The participants in the study will be people over 18 years old belonging to different
associations of people affected with fibromyalgia from the area of Terres de l'Ebre,
particularly from associations of the towns of Deltebre, Amposta, Sant Carles de la Rápita
and Tortosa. Researchers will come to these entities in order to present the study in a
public conference. Once the requests for participation have been received and all cases have
been assessed on the basis of the inclusion and exclusion criteria, participants will be
informed of the whole research process in a personal interview. After that, they will all
receive an information sheet and an informed consent form, which they will be encouraged to
read and sign.
Inclusion and exclusion criteria
Inclusion criteria
- Meeting the criteria set by the American College of Rheumatology for the diagnosis of
chronic widespread pain.
- Accepting to sign the informed consent of participation in the study.
- Being older than 18 years.
Exclusion criteria
- Suffering from malignant diseases or active rheumatologic disorders (osteoporosis,
rheumatoid arthritis, lupus erythematosus, etc.).
- Suffering from coxarthrosis or severe gonarthrosis.
- Having previously received acupuncture treatments.
Randomization
People meeting the inclusion criteria, being subsequently informed of the nature of the
study and having signed the informed consent, will be assigned to one of the groups of the
study. Randomization will be carried out by personnel other than the one performing the
treatments and on the basis of a list obtained through the software EPIDAT (Xunta de
Galicia), in such a manner that there shall be 50 people in each group: one will be treated
with acupuncture according to the traditional technique to improve pain, whereas the other
will act as a control group and will receive sham acupuncture. The researcher conducting the
treatments will be provided with the patients' medical history together with their
corresponding allocation.
Masking
Participants are blinded to the intervention. They will be provided with eye masks so that
they cannot see which needles are used in their intervention. Moreover, the same type of
equipment will be used with all the participants (although the guide tube to insert the
needle is not necessary in true acupuncture).
Given the fact that the person who carries out the intervention is different than the one
assessing its effects and the latter does not know which group the evaluated subjects belong
to, as well as the fact that the person responsible for the statistics is a third person who
ignores which of the two groups has received true acupuncture, this is a triple-blind study.
Intervention
The study will be conducted according to the STRICTA guidelines, which lay down the right
way to proceed when carrying out scientific studies in the field of acupuncture.
Patients taking part in the trial will receive a total of 5 sessions of acupuncture (true or
sham, depending on the group to which they belong within the study): 4 sessions (one per
week) and a 5th session 15 days after the last one.
Intervention group (A)
The treatments performed will be personalized and the treatment criteria will be based on
the use of the Yuan and Luo points. In clinical practice, the Yuan (source) points and the
Luo (connecting) points can be used jointly, linking the two associated meridians
(external-internal) in such a way that, after assessing the state of a meridian's path, its
Yuan point will be combined with the Luo point of its coupled meridian and vice versa; all
this depending on the condition of the muscle fibres and on the path that wants to be
treated for these. Generally, it is used to transfer energy from one meridian to the other
and vice versa, depending on the condition presented by the patient.
The needles used for the treatments will be single-use needles of two different gauge sizes.
One size or the other will be used depending on the area to be treated and the physical
condition of the patient. The needles and gauge sizes used in the study are as follows:
Dong Bang siliconized needle 0.25 mm x 40 mm Dong Bang siliconized needle 0.20 mm x 30 mm
The therapist will assess the patient's condition according to traditional Chinese medicine
and will look at the relationship between the patient's most affected areas and the paths of
the acupuncture meridians. Subsequently, the combination of Yuan and Luo points to be
treated will be determined. This procedure will be followed before every acupuncture
session, in such a way that the combination of the points used will depend on the evolution
of the symptoms.
Control group (C)
Sham acupuncture:
The course of action with the patient from the group that will use sham acupuncture will be
the same as in the group that receives real treatment: patient in supine position, cleaning
of the treated area, use of eye mask during the treatments and selection of points following
the previously described Yuan and Luo points' criteria, based on traditional Chinese
medicine.
The difference of sham acupuncture will lie on the way of performing the acupuncture
technique. It will follow the validated technique of sham acupuncture with the Park device,
without needle penetration in the patient's body.
The Park device for the performance of sham acupuncture consists of two plastic tubes, one
sliding within the other, and inside which the needle created for the device slides. The
longest tube is attached to a circular base, which has an adhesive surface that sticks to
the skin so that the device and the needle cannot fall. Blunt ended needles will be used for
this technique and thus the needle does not get to pass through the skin but produces a
cutaneous stimulation similar to conventional acupuncture needles. These needles are
supplied with the kit that contains the Park sham acupuncture device and are registered in
the European Union as CE 0120.
Study variables
The main study variables are pain and quality of life.
Pain will be assessed using the Visual Analogue Scale (VAS). The VAS consisted of a 10 mm
line with the endpoints 'no pain' and 'worst pain imaginable'.
The Fibromyalgia Impact Questionnaire (FIQ) will be used to analyse the quality of life. The
FIQ is a multidimensional questionnaire designed specifically to assess the functional
capacity of fibromyalgia patients. It is designed so that it can be self-administered by the
patient. The values of the FIQ are between 0 and 100, 0 being the best state of health and
100 the worst. It takes five minutes to complete the FIQ. In this study, the Spanish version
of the Revised Fibromyalgia Impact Questionnaire (FIQR) was used, which has proved its
reliability and good construct validity.
The secondary variables are sleep quality and the subjective perception of participants
regarding the effects of the treatment. The Medical Outcomes Study Sleep Scale (MOS-SS) will
be used to assess the sleep quality. This specific questionnaire includes 12 items assessing
data such as the quantity and quality of sleep. Items' responses were assigned scores using
conventional scoring rules, with higher scores indicating a greater severity of sleep
disturbance. The subjective perception of participants regarding the effects of the
treatment will be assessed through the Patient Global Impression of Improvement Scale
(PGI-I). The PGI-I consists of a single question in which patients are asked to classify the
relief obtained with the treatment that they are following according to a seven-point scale
from 'very much better to very much worse'. Only responses 'very much better' or 'much
better' are associated with a successful treatment. All the other response options are
defined as treatment failure.
These variables will be collected during the 8 weeks of the study, based on the individual
interviews with the patients before each session and once the intervention is completed.
The interview with the patient will be conducted in the first session, when the
physiotherapy clinical record will be created and the study tests will be taken for the
first time. During the next 3 weeks, one weekly session of acupuncture will take place, thus
adding up to 4 acupuncture sessions. Before the fourth study session, the tests will be
taken again. Then, there will be another week of rest from interventions and, during the 6th
week of the study, a new acupuncture intervention will be performed. One more week without
intervention will then follow and the eighth week of the study will be only devoted to
carrying out the tests in order to retrieve the survey data.
It is important to note that, in this last week of the study, a particular test will be
conducted for the first time: the one related to the patient's impression of improvement
with the treatment (PGI-I).
The data will be collected by researcher #2, blinded to the specific intervention group the
subjects belong to.
Calculation of sample size
Acupuncture is considered to be effective in pain management if improvement according to the
VAS scale is equal to or greater than 20%. On the basis of previous studies, it has been
calculated that, in order to obtain an alpha error of 0.05 and a study power of 80%, a
sample of 90 people is required (45 per group). Since a dropout of 10% is foreseen, this
number has been extended to 100 (50 per group).
Statistical analysis
Demographic and basal variables will be defined using different measures. For a quantitative
variable, the following will be used: mean, standard deviation and confidence interval at
95%. In addition to this, in case the variable did not have normal distribution, more robust
descriptive statistics will be foreseen for the calculations, such as the median, the
interquartile range and the minimum and maximum values. In the case of a qualitative
variable, a frequency distribution will be drawn.
In order to assess potential changes in the instruments and scales used in the study over
time, contrasts for dependent variables will be used, namely the ANOVA test for repeated
measures or the Friedman test, depending on whether or not the distribution of the variable
is normal. The Shapiro-Wilks test will be used for the normality test.
On the other hand, if differences existed among the different moments in which the
instrument is evaluated, the ANOVA test for repeated measures will allow for the analysis of
whether these differences are the same or different depending on the type of intervention
performed.
Similarly, a variable that assesses changes in the main variables during the study will be
created and a non-parametric contrast will be done in order to analyse whether such changes
have been equal among the two groups. To finalise, a multivariate model will be applied in
order to verify whether the intervention group has improved the parameters to be measured
(linear or logistic regression depending on the dependent variable's nature). Such a model
will be validated through the standard procedures.
Processing of data
In order to ensure a proper collection and processing of the data obtained, these will be
managed by qualified staff from the same university and will be implemented by the clinical
research coordinator.
Safety
Participants in the study will be controlled at all times against any adverse effects or
complications, such as swelling, pain, hematomas in the needle insertion areas, discomfort,
dizziness or heart palpitations after receiving the treatment. After every session and
before starting the next one, questions will be asked to the participants and a visual
inspection will be carried out in order to assess the potential undesirable effects of the
last intervention.
Ethical principles
The Clinical Research Ethics Committee (CREC) of the Hospital Universitario Sant Joan de
Reus has approved this protocol under approval reference number (15-07-30/7aclaproj1). The
patients' data will be protected and will only be used for the purposes of this research.
