Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000364976p
Ethics application status
Submitted, not yet approved
Date submitted
13/01/2020
Date registered
16/03/2020
Date last updated
16/03/2020
Date data sharing statement initially provided
16/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Deep dry needling with or without median nerve tension in patients with neck pain
Scientific title
A comparison of effects of deep dry needling with or without median nerve tension in the upper trapezius of patients with neck pain on skin conductance and heart rate variability: a randomised observer-blind clinical trial
Secondary ID [1] 299440 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-specific neck pain 314639 0
Condition category
Condition code
Physical Medicine / Rehabilitation 312980 312980 0 0
Physiotherapy
Musculoskeletal 314639 314639 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of applying median nerve tension and deep dry needling in the upper trapezius of 14 patients with non-specific neck pain. A physiotherapist will administer the intervention at a single 30 min session, performing the needling plus median nerve tension in the most painful location of the upper trapezius as well as gathering data about every other variables measured. Another physiotherapist will be present for any help requiered.
The main variables measured are:
- Activation of the Autonomic Nervous System by measuring skin conductance and heart rate variability: both variables will be monitored by biofeedback NeXus 10 MK-II 5 minutes pre-intervention, during the intervention and 10 minutes post-intervention.
- Amount of pain using the Verbal Rating Scale: participants must answer how much pain from zero (no pain) to ten (maximum pain) do they feel both before and after the procedure.
- Pressure pain threshold: minimum pressure (mean of three measurements) at which participants experience pain in C5-C6 facet joint will be registered using an analog algometer Wagner Force Dial™ both pre and post-intervention.
- 'Pain Catastrophizing Scale' and 'Neck Disability Index': both questionnaires must be filled in before the procedure begins.
Intervention code [1] 315689 0
Rehabilitation
Intervention code [2] 316932 0
Treatment: Other
Comparator / control treatment
The control group is an active group of 14 patients with non-specific neck pain that will undergo deep dry needling in the most painful location of the upper trapezius without stressing nerve roots.
Same variables as in the intervention group will be measured.
Control group
Active

Outcomes
Primary outcome [1] 321552 0
Skin conductance measured by biofeedback Nexus-10 MK-II
Timepoint [1] 321552 0
Variable monitored by biofeedback 5 minutes pre-intervention, during the intervention and 10 minutes post-intervention
Secondary outcome [1] 375344 0
Heart Rate Variability measured by biofeedback Nexus-10 MK-II
Timepoint [1] 375344 0
Variable monitored by biofeedback 5 minutes pre-intervention, during the intervention and 10 minutes post-intervention
Secondary outcome [2] 375346 0
Pain - Verbal Rating Scale
Timepoint [2] 375346 0
Measured 5 minutes pre-intervention and 10 minutes post-intervention
Secondary outcome [3] 375347 0
Pressure pain threshold using an analog algometer
Timepoint [3] 375347 0
Measured 5 minutes pre-intervention and 10 minutes post-intervention

Eligibility
Key inclusion criteria
• Be between 18 and 65 years old
• Suffer from non-specific chronic or acute neck pain
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Whiplash
• Record of shoulder or spinal pathologies
• Neurological disorders
• Heart diseases
• Inmune system disorders
• Fibromyalgia
• Epilepsy
• Narcolepsy
• Coagulation disorders
• Use of sedatives, antipsychotics or antidepressants drugs
• Irrational fear for needles
• Cervical o thoracic skin injuries
• Skin disorders
• Pregnancy

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)
Allocation was concealed by central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software named Epidat
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Following a previous pilot study, skin consuctance (µs) was chosen as the main variable and sample size calculations were determined by using Gpower 3.1.9.1.® software. Considering that type I error is 0,05, the power of the study is 80%, Eta is 0,098 and the effect size is 0.25; the number of participants requested is 28.
To evaluate normality Shapiro-Wilk test will be carried out. In order to describe the data for cualitative variables absolute frequency will be used, while standard deviation and mean or median will be used for cuantitative variables. Homogeneity will be analysed by T-Student ot Fisher exact test. Finally, differences between groups will be determined by using ANOVA. A 95% confidence interval will be used.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2020
Actual
Date of last participant enrolment
Anticipated
30/04/2020
Actual
Date of last data collection
Anticipated
30/05/2020
Actual
Sample size
Target
28
Accrual to date
Final
Recruitment outside Australia
Country [1] 21894 0
Spain
State/province [1] 21894 0
Alcalá de Henares, Madrid

Funding & Sponsors
Funding source category [1] 303947 0
University
Name [1] 303947 0
Universidad de Alcalá
Country [1] 303947 0
Spain
Primary sponsor type
University
Name
Universidad de Alcalá
Address
Av. de León, 3A
Edificio de Enfermería y Fisioterapia en Campus Científico-Tecnológico
28805 Alcalá de Henares, Madrid
Country
Spain
Secondary sponsor category [1] 304107 0
None
Name [1] 304107 0
Address [1] 304107 0
Country [1] 304107 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304447 0
Comité de Ética de Investigación y Experimentación Animal de la Universidad de Alcalá
Ethics committee address [1] 304447 0
Ethics committee country [1] 304447 0
Spain
Date submitted for ethics approval [1] 304447 0
15/09/2019
Approval date [1] 304447 0
Ethics approval number [1] 304447 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96974 0
Miss Cristina Hernando Porras
Address 96974 0
Avenida del Cid Campeador, 72 3ºA
09005 Burgos, Spain

Universidad de Alcalá
Country 96974 0
Spain
Phone 96974 0
+34636160039
Fax 96974 0
Email 96974 0
[email protected]
Contact person for public queries
Name 96975 0
Cristina Hernando Porras
Address 96975 0
Avenida del Cid Campeador, 72 3ºA
09005 Burgos, Spain

Universidad de Alcalá
Country 96975 0
Spain
Phone 96975 0
+34636160039
Fax 96975 0
Email 96975 0
[email protected]
Contact person for scientific queries
Name 96976 0
Cristina Hernando Porras
Address 96976 0
Avenida del Cid Campeador, 72 3ºA
09005 Burgos, Spain

Universidad de Alcalá
Country 96976 0
Spain
Phone 96976 0
+34636160039
Fax 96976 0
Email 96976 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD are not planned to be shared in order to protect participant's privacy


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.