Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001016729
Ethics application status
Approved
Date submitted
7/07/2022
Date registered
20/07/2022
Date last updated
5/08/2022
Date data sharing statement initially provided
20/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Dry needling-related objective signs of the referred pain presence
Scientific title
Dry needling-related objective signs of the referred pain presence based on the latent trigger point in healthy adults
Secondary ID [1] 307502 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
myofascial pain - latent trigger points 326933 0
Condition category
Condition code
Musculoskeletal 324111 324111 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study aims to observe dry needling-related distant reactivity of the muscles and autonomic nervous system, taking into account the latent component of the trigger point form. A single assessment will be made of: (i) latent trigger point examination according to Travell& Simons diagnostic criteria and Delphy study recommendation and the measurement of the pressure pain threshold - PPT, using an AlgoMed; (ii) dry needling under infrared camera control according to the Skorupska Protocol combine with the heart rate variability (HRV) and surface electromyography (sEMG); (iii) analysis of negative emotion and pain assessment questionnaires. A group of active athletes aged 18-35 who train in sports characterized by an asymmetric movement structure and healthy volunteers will be studied. All measurements will be performed in university laboratories. The dry needling intervention will be performed by a leading authority in the field of pain diagnosis, certified in dry needling, and who has extensive experience from international training.
The intervention will include one session of 10 minutes. The intervention will be carried out by a specialist who is certified and internationally certified in the intervention to be carried out.
Intervention code [1] 323961 0
Diagnosis / Prognosis
Comparator / control treatment
The control group will be volunteers, aged 18-35, who will be informed about the purpose and conduct of the study. The group will be subjected to the same study procedure, however, it will be a non-sporting group. All measurements will be performed in university laboratories.
Control group
Active

Outcomes
Primary outcome [1] 331928 0
Dry needling-related muscle bioelectrical activity within latent trigger points referred pain. Distant muscle bioelectrical activity assessed using electromyography. NORAXON MR-XP 1.07 Master Editionx software will be used for signal processing and EMG analysis.
Timepoint [1] 331928 0
During the 10-minute dry needling intervention. Analysis of the signal will take place at 1 minute intervals, in which subjects will be asked about the sensation of pain and the location of the pain.
Primary outcome [2] 331970 0
The amplified vasomotor reactivity within the trigger point referred to pain assessed using a validated SP test method.
Timepoint [2] 331970 0
After the intervention of dry needling
Secondary outcome [1] 411607 0
Assessment of pain scale (Visual Analogue Scale -VAS)
Timepoint [1] 411607 0
During a 10-minute dry needling intervention (sensations determined after each minute)
Secondary outcome [2] 411775 0
Dry needling-related heart rate variability (HRV) depends on the referred pain objective signs. HRV assessment - vector and scalar assessment (Faros 360 Holter device (Bittium, Oulu, Finland); Kubios HRV Premium software).
Timepoint [2] 411775 0
During the 10-minute dry needling intervention
Secondary outcome [3] 411954 0
Personality traits assessed using the EPQ-R - Eysenck Personality Questionnaire
Timepoint [3] 411954 0
After the intervention of dry needling
Secondary outcome [4] 411955 0
Emotional states assessed using the SUPIN questionnaire (Positive and Negative Feelings Scale)
Timepoint [4] 411955 0
After the intervention of dry needling
Secondary outcome [5] 411956 0
Anxiety assessed using the STAI - State and Trait Anxiety Inventory
Timepoint [5] 411956 0
After the intervention of dry needling
Secondary outcome [6] 411957 0
The Fear of Pain Questionnaire-III (FPQ-III) will be used to assess fear of pain in a clinical trial.
Timepoint [6] 411957 0
After the intervention of dry needling
Secondary outcome [7] 411958 0
The Anxiety Sensitivity Index-3 (ASI-3) will be used to assess various anxiety-related concerns
Timepoint [7] 411958 0
After the intervention of dry needling
Secondary outcome [8] 411959 0
The Whiteley Index will be used to screen patients for health anxiety.
Timepoint [8] 411959 0
After the intervention of dry needling

Eligibility
Key inclusion criteria
Healthy athletes and healthy volunteers
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- lack of informed consent to participate in the study
- cardiovascular diseases,
- chronic disease that impairs musculoskeletal function,
- diabetes,
- epilepsy,
- pregnancy,
- infections,
- inflammatory diseases,
- stroke,
- oncological diseases.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size and effect size will be determined using the G*Power program following a pilot study. The statistical significance of the studied variables will be determined by the ANOVA test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2022
Actual
Date of last participant enrolment
Anticipated
30/11/2022
Actual
Date of last data collection
Anticipated
30/11/2022
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 24879 0
Poland
State/province [1] 24879 0
Poland

Funding & Sponsors
Funding source category [1] 311780 0
University
Name [1] 311780 0
Poznan University of Medical Sciences
Country [1] 311780 0
Poland
Primary sponsor type
University
Name
Opole University of Technology
Address
Proszkowska 76,
45-758 Opole, Poland
Country
Poland
Secondary sponsor category [1] 313250 0
University
Name [1] 313250 0
Poznan University of Medical Sciences
Address [1] 313250 0
Fredry 10 61-701 Poznan, Poland
Country [1] 313250 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311221 0
Ethics Committee of Poznan University of Medical Sciences
Ethics committee address [1] 311221 0
Fredry street 10
61-701 Poznan
Poland
Ethics committee country [1] 311221 0
Poland
Date submitted for ethics approval [1] 311221 0
24/02/2022
Approval date [1] 311221 0
10/03/2022
Ethics approval number [1] 311221 0
110/22

Summary
Brief summary
The aim of the study is to observe objective signs of the latent trigger points dry needling based on the distant bioelectrical muscle activity and autonomic nervous system measurement.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120382 0
Dr Mariusz Konieczny
Address 120382 0
Opole University of Technology
Proszkowska 76,
45-758 Opole, Poland
Country 120382 0
Poland
Phone 120382 0
+48774498250
Fax 120382 0
Email 120382 0
[email protected]
Contact person for public queries
Name 120383 0
Dr Mariusz Konieczny
Address 120383 0
Opole University of Technology
Proszkowska 76,
45-758 Opole, Poland
Country 120383 0
Poland
Phone 120383 0
+48774498250
Fax 120383 0
Email 120383 0
[email protected]
Contact person for scientific queries
Name 120384 0
Dr Mariusz Konieczny
Address 120384 0
Opole University of Technology
Proszkowska 76,
45-758 Opole, Poland
Country 120384 0
Poland
Phone 120384 0
+48774498250
Fax 120384 0
Email 120384 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All raw data will be shared via an external drive
When will data be available (start and end dates)?
The data will be available for 5 years after the conclusion of the study.
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
For any purpose
How or where can data be obtained?
Access is subject to approvals by [email protected]


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
SourceTitleYear of PublicationDOI
EmbaseRelationship between latent trigger points, lower limb asymmetry and muscle fatigue in elite short-track athletes.2023https://dx.doi.org/10.1186/s13102-023-00719-y
N.B. These documents automatically identified may not have been verified by the study sponsor.