Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000460404
Ethics application status
Approved
Date submitted
18/01/2025
Date registered
15/05/2025
Date last updated
15/05/2025
Date data sharing statement initially provided
15/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of self-implemented sliding versus tensioning neurodynamic techniques on objective and subjective parameters in adults with carpal tunnel syndrome.
Scientific title
Effect of self-implemented sliding versus tensioning neurodynamic techniques on objective and subjective parameters in adults with carpal tunnel syndrome.
Secondary ID [1] 313755 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
carpal tunnel syndrome 336355 0
Condition category
Condition code
Physical Medicine / Rehabilitation 332889 332889 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm.1 – Group 1 (manual therapy) –carpal tunnel syndrome treatment will use manual therapy based on self-implemented sliding neurodynamic techniques. The therapy will be performed independently by the patient in the form of self-therapy.
a. Sliding neurodynamic techniques for median nerve; position supine; neurodynamic sequence: arm adduction 90 degree and external rotation, wrist and finger extension, forearm supination, elbow extension; neurodynamic technique: one-direction proximal slide mobilisation (movement – rhythmically elbow flexion and extension –large amplitude of motion), one-direction distal slide mobilisation (movement – rhythmically wist flexion and extension –large amplitude of motion).

Physiotherapist will be providing instructions to enable participants to self-implement the techniques, the level of intensity – moderate, standard protocol consisted of ten series of 60 repetitions neurodynamic techniques separated by inter-series intervals of 1 minute. The duration of one therapy session will be approximately 30 minutes. The session will be performed in the patient’s home. Strategies used to assess or monitor adherence to the intervention – exercise diaries, reminder and telephone check-up by a physiotherapist.

The therapy will be administered 5 times a week for 2 weeks (10 therapeutic sessions in total).
Intervention code [1] 330336 0
Rehabilitation
Comparator / control treatment
Arm.2 – Group 2 (manual therapy) –carpal tunnel syndrome treatment will use manual therapy based on self-implemented tensioning neurodynamic techniques. The therapy will be performed independently by the patient in the form of self-therapy.
a. Tensioning neurodynamic techniques for median nerve; position supine; neurodynamic sequence: arm adduction 90 degree and external rotation, wrist and finger extension, forearm supination, elbow extension; neurodynamic technique: one-direction proximal slide mobilisation (movement – rhythmically elbow flexion and extension – small amplitude of motion et the end of the movement), one-direction distal slide mobilisation (movement – rhythmically wist flexion and extension – small amplitude of motion et the end of the movement).

Physiotherapist will be providing instructions to enable participants to self-implement the techniques, the level of intensity – moderate, standard protocol consisted of ten series of 60 repetitions neurodynamic techniques separated by inter-series intervals of 1 minute. The duration of one therapy session will be approximately 30 minutes. The session will be performed in the patient’s home. Strategies used to assess or monitor adherence to the intervention – exercise diaries, reminder and telephone check-up by a physiotherapist.

The therapy will be administered 5 times a week for 2 weeks (10 therapeutic sessions in total).
Control group
Active

Outcomes
Primary outcome [1] 340417 0
Nerve conduction study
Timepoint [1] 340417 0
Baseline, 1 week post completion of treatment (primary timepoint), 6 months follow-up post treatment.
Primary outcome [2] 340418 0
Ultrasound test (surface area, share wave elastography)
Timepoint [2] 340418 0
Baseline, 1 day post completion of treatment (primary timepoint), 6 months follow-up post treatment.
Primary outcome [3] 340419 0
Pain assessment
Timepoint [3] 340419 0
Baseline, 1 day post completion of treatment (primary timepoint), 6 months follow-up post treatment.
Secondary outcome [1] 443987 0
Assessment of subjective symptoms
Timepoint [1] 443987 0
Baseline, 1 day post completion of treatment, 6 months follow-up post treatment.
Secondary outcome [2] 443988 0
Muscle strength
Timepoint [2] 443988 0
Baseline, 1 day post completion of treatment, 6 months follow-up post treatment.
Secondary outcome [3] 443989 0
Two-point discrimination sense
Timepoint [3] 443989 0
Before treatment, after treatment, 6 month follow-up
Secondary outcome [4] 443990 0
Cutaneous sensory perceptron threshold
Timepoint [4] 443990 0
Before treatment, after treatment, 6 month follow-up
Secondary outcome [5] 447430 0
Kinesthetic differentiation of muscle strength
Timepoint [5] 447430 0
Before treatment, after treatment, 6 month follow-up
Secondary outcome [6] 447431 0
Assessment functional status
Timepoint [6] 447431 0
Baseline, 1 day post completion of treatment, 6 months follow-up post treatment.

Eligibility
Key inclusion criteria
- Carpal tunnel syndrome diagnosed clinically and neurophysiologically by specialist
- Subjective and objective symptoms of carpal tunnel syndrome
- No other diseases that could affect the test results
- No contraindications to therapy
- Consent to participate in research
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Lack of consent
- Lack of cooperation from the patient
- Contraindications to therapy
- No symptoms of carpal tunnel syndrome
- Previous surgical treatment
- Other causes of symptoms
- Mental illness

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)
Patients diagnosed with carpal tunnel syndrome who met the diagnostics criteria will be eligible for the study. Each consecutive patient who will meet the inclusion criteria will be randomly assigned to the experimental or control group. Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The basic parameters will be compared between groups using the independent t-test (age, body mass, height, BMI – kilograms per square meter) and the chi2 test (gender distribution, side of hand dominance etc.). A one-way ANOVA for repeated measurements (independent factor was group: “experimental” versus “control”, and repeated factor on time: before therapy versus after therapy) will be used in order to evaluate the differences in carpal tunnel syndrome nerve conduction study, ultrasound test, pain assessment, subjective symptoms and functional status, strength, ,kinaesthetic differentiation of strength, two point discrimination, cutaneous sensory perceptron threshold, overall health status. For significant differences in the main effect for group, time Or interaction (group x time), post hoc test will be used. The results will be presented as the mean and 95% confidence interval (CI). For all analyses, the threshold of the P value considered as significant will be set at <0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2025
Actual
Date of last participant enrolment
Anticipated
1/11/2025
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 26831 0
Poland
State/province [1] 26831 0

Funding & Sponsors
Funding source category [1] 318208 0
University
Name [1] 318208 0
The Jerzy Kukuczka Academy of Physical Education in Katowice
Country [1] 318208 0
Poland
Primary sponsor type
Government body
Name
The Jerzy Kukuczka Academy of Physical Education in Katowice
Address
Country
Poland
Secondary sponsor category [1] 320597 0
None
Name [1] 320597 0
Address [1] 320597 0
Country [1] 320597 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316858 0
Bioethics Committee for Scientific Research of the Jerzy Kukuczka Academy of Physical Education in Katowice
Ethics committee address [1] 316858 0
Ethics committee country [1] 316858 0
Poland
Date submitted for ethics approval [1] 316858 0
01/03/2023
Approval date [1] 316858 0
29/06/2023
Ethics approval number [1] 316858 0

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

Contacts
Principal investigator
Name 139222 0
A/Prof Tomasz Wolny
Address 139222 0
The Jerzy Kukuczka Academy of Physical Education in Katowice, Poland, 40-065, Mikolowska 72B
Country 139222 0
Poland
Phone 139222 0
+48604820416
Fax 139222 0
Email 139222 0
[email protected]
Contact person for public queries
Name 139223 0
Tomasz Wolny
Address 139223 0
The Jerzy Kukuczka Academy of Physical Education in Katowice, Poland, 40-065, Mikolowska 72B
Country 139223 0
Poland
Phone 139223 0
+48604820416
Fax 139223 0
Email 139223 0
[email protected]
Contact person for scientific queries
Name 139224 0
Tomasz Wolny
Address 139224 0
The Jerzy Kukuczka Academy of Physical Education in Katowice, Poland, 40-065, Mikolowska 72B
Country 139224 0
Poland
Phone 139224 0
+48604820416
Fax 139224 0
Email 139224 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: No possibility to share personal data in the European Union.



What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24462Ethical approval    Bioetyczna 2023 002.jpg



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.