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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]

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

Condition category

Condition code

Musculoskeletal

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]

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]

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]

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]

The amplified vasomotor reactivity within the trigger point referred to pain assessed using a validated SP test method.

Timepoint [2]

After the intervention of dry needling

Secondary outcome [1]

Assessment of pain scale (Visual Analogue Scale -VAS)

Timepoint [1]

During a 10-minute dry needling intervention (sensations determined after each minute)

Secondary outcome [2]

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]

During the 10-minute dry needling intervention

Secondary outcome [3]

Personality traits assessed using the EPQ-R - Eysenck Personality Questionnaire

Timepoint [3]

After the intervention of dry needling

Secondary outcome [4]

Emotional states assessed using the SUPIN questionnaire (Positive and Negative Feelings Scale)

Timepoint [4]

After the intervention of dry needling

Secondary outcome [5]

Anxiety assessed using the STAI - State and Trait Anxiety Inventory

Timepoint [5]

After the intervention of dry needling

Secondary outcome [6]

The Fear of Pain Questionnaire-III (FPQ-III) will be used to assess fear of pain in a clinical trial.

Timepoint [6]

After the intervention of dry needling

Secondary outcome [7]

The Anxiety Sensitivity Index-3 (ASI-3) will be used to assess various anxiety-related concerns

Timepoint [7]

After the intervention of dry needling

Secondary outcome [8]

The Whiteley Index will be used to screen patients for health anxiety.

Timepoint [8]

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]

Poland

State/province [1]

Poland

Funding & Sponsors

Funding source category [1]

University

Name [1]

Poznan University of Medical Sciences

Address [1]

Fredry 10 61-701 Poznan, Poland

Country [1]

Poland

Primary sponsor type

University

Name

Opole University of Technology

Address

Proszkowska 76,
45-758 Opole, Poland

Country

Poland

Secondary sponsor category [1]

University

Name [1]

Poznan University of Medical Sciences

Address [1]

Fredry 10 61-701 Poznan, Poland

Country [1]

Poland

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics Committee of Poznan University of Medical Sciences

Ethics committee address [1]

Fredry street 10
61-701 Poznan
Poland

Ethics committee country [1]

Poland

Date submitted for ethics approval [1]

24/02/2022

Approval date [1]

10/03/2022

Ethics approval number [1]

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

Dr Mariusz Konieczny

Address

Opole University of Technology
Proszkowska 76,
45-758 Opole, Poland

Country

Poland

Phone

+48774498250

Fax

[email protected]

Contact person for public queries

Name

Mariusz Konieczny

Address

Opole University of Technology
Proszkowska 76,
45-758 Opole, Poland

Country

Poland

Phone

+48774498250

Fax

[email protected]

Contact person for scientific queries

Name

Mariusz Konieczny

Address

Opole University of Technology
Proszkowska 76,
45-758 Opole, Poland

Country

Poland

Phone

+48774498250

Fax

[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

Source	Title	Year of Publication	DOI
Embase	Relationship between latent trigger points, lower limb asymmetry and muscle fatigue in elite short-track athletes.	2023	https://dx.doi.org/10.1186/s13102-023-00719-y

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically