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Trial registered on ANZCTR


Registration number
ACTRN12616000115437
Ethics application status
Approved
Date submitted
10/11/2015
Date registered
2/02/2016
Date last updated
2/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of an individualized physiotherapy program versus group therapy in acute and subacute mechanical neck pain
Scientific title
Effectiveness of an individualized physiotherapy program versus group therapy on neck pain, disability, range of motion and quality of life in patients with acute and subacute mechanical neck pain: a randomized controlled trial
Secondary ID [1] 287783 0
Nil known
Universal Trial Number (UTN)
U1111-1175-2731
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute and subacute mechanical neck pain 296671 0
Condition category
Condition code
Musculoskeletal 296893 296893 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 296894 296894 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Individualized program; program conducted by a qualified physiotherapist during three weeks at 5 sessions a week in a one-on-one consultation for 45 minutes each sesssion.

1.- Surface thermotherapy, infrared for 15 minutes, at a distance of 50 cm from the source of emission.

2.- Therapeutic massage in neck area in the following pattern:
- Surface effleurage for 5 minutes.
- Deep friction for 5 minutes
- Petrissage for 5 minutes
- Surface effleurage for 5 minutes.
3.- Specific/analitic stretching in the following pattern on the muscles affected (trapezius, right and left, and levator scapular, right and left) :
- First, start stretching slowly and softly.
- Second, maintain the stretching
- Third, relaxing slowly
- Forth, keep the position for 15 seconds.
Intervention code [1] 293174 0
Rehabilitation
Comparator / control treatment
Group therapy/control group; program carried out by a quilified physiotherapist for the whole group.

1.- Relaxing exercises by means of abdominal breathing, for 5 minutes.
2.- Trapezius and levator scapular auto-stretching exercises maintaining each position during five seconds. This section includes 4 exercises. Each exercise was perfomed in series of repetitions, so that three series of three repetitions were executed.
Exercise 1.- Up and down shoulders.
Exercise 2.- Flexion and extension of the neck
Exercise 3.- Left and right neck rotation
Exercise 4.- Left and right neck lateroflexion

3.- Isometric neck exercises, using the patient´s hand resistance, in the following pattern, (three series with three repetitions, each one for 6 seconds):

Exercise 1.- Neck flexion, resisted in forehead
Exercise 2.- Neck extension, resisted in occipital area
Exercise 3.- Neck sidebending, resisted in
tempoparietal area (left and right)
Exercise 4.- From a neck rotation of 30 degrees, try to flex it
towards the homolateral shoulder. Repeat
in the other side.
4.- Ergonomic education in a session during 45 minutes, on postural hygiene standards in daily life activities. This session was carried out by a quilified physiotherapist for the whole group as a masterclass.
Control group
Active

Outcomes
Primary outcome [1] 296499 0
Neck pain, assessed by a Visual Analogue Scale (VAS), and algometry in the following muscles´ trigger points: trapezius and levator scapular, in both sides.
Timepoint [1] 296499 0
At baseline and after the intervention (15 sesssions during three weeks)
Primary outcome [2] 296500 0
Disability, assessed using the Neck Disability Index
Timepoint [2] 296500 0
At baseline and after the intervention (15 sesssions during three weeks)
Secondary outcome [1] 318625 0
- Range of neck motion, measured with inclinometer
Timepoint [1] 318625 0
At baseline and after the intervention (15 sesssions during three weeks)
Secondary outcome [2] 318626 0
Quality of life, assessed with SF-12
Timepoint [2] 318626 0
At baseline and after the intervention (15 sesssions during three weeks)

Eligibility
Key inclusion criteria
Patients diagnosed of mechanical neck pain from the Dr. Fleming Public Medical Center, under 7 weeks of evolution (pain with an evolution of less than 7 weeks), with a correct mental stage to understand the requirements of the study and without any pharmacological treatment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Neck pain with neurogical and/or discal signs
- Ostheoporosis
- Inflamatory diseases
- Previous neck surgery

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The patients from the Dr. Fleming Medical Center were received by the main researcher who confirmed their elegibility to participate in the study.
After signing the informed consent and the initial assessment, patients were randomly allocated to groups (individualized and groupal) and with concealed allocation by means of sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using 90 sealed opaque envelopes procedure, 45 for individual treatment and 45 for groupal treatment. Each patient choosed one envelope specifying the group in which was allocated.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was calculated with the G Power 3.0 program, the following parameters were selected depending on the type of study: one tail hipothesis, a large effect size (0.8), and a probabilistic alpha error of 0, 05.
n = 35 subjects for each study group was/were obtained as sample size. The sample was increased in a 30% in order to considering possible drop-outs, being n = 90 (45 in each group) the final sample.

The recorded data were processed using SPSS v.17.0 for Windows. All the variables were checked by Kolmogorov-Smirnov test to know the normal distribution.
Subsequently, descriptive analysis of the variables of the study (pre and posttest) and Wilcoxon signed-rank test were performed.

Finally, to compare the effectiveness of both treatments, U Mann-Whitney test was conducted.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/01/2012
Date of last participant enrolment
Anticipated
Actual
30/11/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
90
Recruitment outside Australia
Country [1] 7290 0
Spain
State/province [1] 7290 0
Seville

Funding & Sponsors
Funding source category [1] 292316 0
Hospital
Name [1] 292316 0
Centro de Especilaidades Dr. Fleming. Area Sanitaria Hospital Virgen del Rocio.
Country [1] 292316 0
Spain
Primary sponsor type
Other
Name
Research Group CTS-305
Address
c/ Avicena s/s
41009 Sevilla
Country
Spain
Secondary sponsor category [1] 290994 0
None
Name [1] 290994 0
Address [1] 290994 0
Country [1] 290994 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293788 0
Comite Etico de Experimentacion de la Universidad de Sevilla
Ethics committee address [1] 293788 0
Unknown
Ethics committee country [1] 293788 0
Spain
Date submitted for ethics approval [1] 293788 0
19/01/2011
Approval date [1] 293788 0
22/03/2011
Ethics approval number [1] 293788 0

Summary
Brief summary
Introduction:
Mechanical neck pain is one of the most common diseases, which has important implications for both, health and labor sector. Due to the heavy workload, the health authorities argue that its physiotherapy treatment should be performed in a group, rather than in a personalized way, how it has been done so far. The aim of this study is to know which of these two modalities of treatment is the most effective to improve this health problem.
Material and Methods:
Our study is a randomized and controlled clinical trial, with two groups formed by simple chance, 90 subjects (45 per group) were included: 69 women (76.7%) and 21 men (23.3%) of 20-52 years (mean 39.50 and standard deviation 9.05).
Personalized treatment was applied in one group and group treatment in the other one, both during 15 sessions. The following variables were measured at the beginning and the end of the treatment (pre and posttreatment): pain with Visual Analog Scale (VAS) and algometer on trapezius and levator sacapula’s trigger points; cervical joint range with inclinometer; neck disability with Neck Disability Index; and quality of life with SF-12 questionnaire.
Data analysis were made by Wilcoxon signed ranks test and U Mann-Whitney test. A significance level of p <0.05 was considered.
Results:
In personalized treatment group Wilcoxon test showed a significant decrease in pain and disability index and an increase in joint range and quality of life (p> 0.05).
Group treatment patients showed significant, but very small (not clinically relevant), differences between pretest and posttest values for all variables (p <0.05).
The comparison between the two groups showed significant differences in favor of personalized treatment in all variables (p <0.05) with a high or moderate effect size.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 633 633 0 0
/AnzctrAttachments/369564-Ethical approval.pdf

Contacts
Principal investigator
Name 61314 0
Dr Maria de la Casa Almeida
Address 61314 0
Facultad de Enfermeria, Fisioterapia y Podologia. Universidad de Sevilla. Departamento Fisioterapia.
C/ Avicena s/n
41009 Sevilla
Country 61314 0
Spain
Phone 61314 0
+34654217360
Fax 61314 0
Email 61314 0
[email protected]
Contact person for public queries
Name 61315 0
Maria de la Casa Almeida
Address 61315 0
Facultad de Enfermeria, Fisioterapia y Podologia. Universidad de Sevilla. Departamento Fisioterapia.
C/ Avicena s/n
41009 Sevilla
Country 61315 0
Spain
Phone 61315 0
+34654217360
Fax 61315 0
Email 61315 0
[email protected]
Contact person for scientific queries
Name 61316 0
Carmen Maria Suarez Serrano
Address 61316 0
Facultad de Enfermeria, Fisioterapia y Podologia. Universidad de Sevilla. Departamento Fisioterapia.
C/ Avicena s/n
41009 Sevilla
Country 61316 0
Spain
Phone 61316 0
+34616439514
Fax 61316 0
Email 61316 0
[email protected]

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