Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000461493
Ethics application status
Approved
Date submitted
12/01/2025
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
Sliding versus tensioning neurodynamic techniques in the conservative treatment of carpal tunnel syndrome.
Scientific title
Efficacy of pain and symptom relief using sliding versus tensioning neurodynamic techniques in the conservative treatment of carpal tunnel syndrome.
Secondary ID [1] 313687 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
carpal tunnel syndrome 336261 0
Condition category
Condition code
Physical Medicine / Rehabilitation 332804 332804 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 sliding neurodynamic techniques. The therapy will be performed by physiotherapists with more than 10 years of experience in neurodynamic techniques.
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 wrist flexion and extension –large amplitude of motion).

Arm.2 – Group 2 (manual therapy) –carpal tunnel syndrome treatment will use manual therapy based on tensioning neurodynamic techniques. The therapy will be performed by physiotherapists with more than 10 years of experience in neurodynamic techniques.
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 wrist flexion and extension – small amplitude of motion et the end of the movement).
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 therapy will be administered twice a week for 5 weeks (10 therapeutic sessions in total). Research will take place in the outpatient clinic. Therapy sessions every other working day.

Monitoring of the intervention will be done through attendance checklists.
Intervention code [1] 330282 0
Rehabilitation
Comparator / control treatment
Arm.3 – Group 3 (placebo treatment) - carpal tunnel syndrome treatment will use sham sliding and tensioning neurodynamic techniques of medial nerve. The therapy will be performed by physiotherapists with more than 10 years of experience in neurodynamic techniques.
a. Sliding sham neurodynamic techniques for median nerve; position supine, without neurodynamic sequence – upper extremity in neutral position; neurodynamic technique: one-direction proximal slide mobilisation (movement – rhythmically elbow flexion and extension –large amplitude of motion), one-direction distal slide mobilisation (movement – rhythmically wrist flexion and extension –large amplitude of motion).
b. Tensioning sham neurodynamic techniques for median nerve; position supine, without neurodynamic sequence – upper extremity in neutral position; 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 wrist flexion and extension – small amplitude of motion et the end of the movement).

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 therapy will be administered twice a week for 5 weeks (10 therapeutic sessions in total).
Control group
Placebo

Outcomes
Primary outcome [1] 340335 0
nerve conduction study
Timepoint [1] 340335 0
before treatment, after completion of 2-weeks treatment, 6 month follow-up
Primary outcome [2] 340336 0
ultrasound test (surface area, share wave elastography)
Timepoint [2] 340336 0
before treatment, after completion of 2-weeks treatment, 6 month follow-up
Primary outcome [3] 340337 0
pain assessment
Timepoint [3] 340337 0
before treatment, after completion of 2-weeks treatment, 6 month follow-up
Secondary outcome [1] 443729 0
Assessment of subjective symptoms and functional status. This will be assessed as a composite outcome
Timepoint [1] 443729 0
before treatment,after completion of 2-weeks treatment, 6 month follow-up
Secondary outcome [2] 443730 0
Muscle strength and kinesthetic differentiation of muscle strength. This will be assessed as a composite outcome
Timepoint [2] 443730 0
before treatment, after completion of 2-weeks treatment, 6 month follow-up
Secondary outcome [3] 443731 0
two-point discrimination sense
Timepoint [3] 443731 0
before treatment, after completion of 2-weeks treatment, 6 month follow-up
Secondary outcome [4] 443732 0
cutaneous sensory perceptron threshold
Timepoint [4] 443732 0
before treatment, after completion of 2-weeks treatment, 6 month follow-up
Secondary outcome [5] 443733 0
Overall health status
Timepoint [5] 443733 0
before treatment, after completion of 2-weeks treatment, 6 month follow-up

Eligibility
Key inclusion criteria
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
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 using a computer random number generator. A table with random numbers '1' and '2' will be generated and numbers will be placed in sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software. Sealed opaque envelopes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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
1/12/2025
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 26816 0
Poland
State/province [1] 26816 0

Funding & Sponsors
Funding source category [1] 318153 0
University
Name [1] 318153 0
The Jerzy Kukuczka Academy of Physical Education in Katowice
Country [1] 318153 0
Poland
Primary sponsor type
University
Name
The Jerzy Kukuczka Academy of Physical Education in Katowice
Address
Country
Poland
Secondary sponsor category [1] 320534 0
None
Name [1] 320534 0
Address [1] 320534 0
Country [1] 320534 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316799 0
Bioethics Committee for Scientific Research of the Jerzy Kukuczka Academy of Physical Education in Katowice
Ethics committee address [1] 316799 0
Ethics committee country [1] 316799 0
Poland
Date submitted for ethics approval [1] 316799 0
01/02/2023
Approval date [1] 316799 0
29/06/2023
Ethics approval number [1] 316799 0

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

Contacts
Principal investigator
Name 139042 0
A/Prof Tomasz Wolny
Address 139042 0
The Jerzy Kukuczka Academy of Physical Education in Katowice, Poland, 40-065, Mikolowska 72B
Country 139042 0
Poland
Phone 139042 0
+48604820416
Fax 139042 0
Email 139042 0
[email protected]
Contact person for public queries
Name 139043 0
Tomasz Wolny
Address 139043 0
The Jerzy Kukuczka Academy of Physical Education in Katowice, Poland, 40-065, Mikolowska 72B
Country 139043 0
Poland
Phone 139043 0
+48604820416
Fax 139043 0
Email 139043 0
[email protected]
Contact person for scientific queries
Name 139044 0
Tomasz Wolny
Address 139044 0
The Jerzy Kukuczka Academy of Physical Education in Katowice, Poland, 40-065, Mikolowska 72B
Country 139044 0
Poland
Phone 139044 0
+48604820416
Fax 139044 0
Email 139044 0
[email protected]

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



What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24441Ethical approval    Bioetyczna 2023 002.jpg



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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