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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 26 October 2021
Main ID:  ACTRN12617000672358
Date of registration: 09/05/2017
Prospective Registration: Yes
Primary sponsor: The Jerzy Kukuczka Academy of Physical Education in Katowice
Public title: Efficacy of neurodynamic techniques in conservative treatment of carpal tunnel syndrome (CTS).
Scientific title: Efficacy of neurodynamic techniques in conservative treatment of carpal tunnel syndrome patients
Date of first enrolment: 16/05/2017
Target sample size: 350
Recruitment status: Completed
URL:  https://anzctr.org.au/ACTRN12617000672358.aspx
Study type:  Interventional
Study design:  Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;  
Phase: 
Countries of recruitment
Poland
Contacts
Name: Dr Pawel Linek   
Address:  The Jerzy kukuczka Academy of Physical Education, Katowicach, ul. Mikolowska 72A, 40-065 Katowice Poland
Telephone: +48 661768601
Email: linek.fizjoterapia@vp.pl
Affiliation: 
Name: Dr Pawel Linek   
Address:  The Jerzy kukuczka Academy of Physical Education, Katowicach, ul. Mikolowska 72A, 40-065 Katowice Poland
Telephone: +48 661768601
Email: linek.fizjoterapia@vp.pl
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: - Peripheral neuropathy (CTS) diagnosed by physician
- Positive nerve conduction study test
- Subjective and objective symptoms of peripheral neuropathy
- Consent to participate in research
- No contraindications to therapy
[Subjective and objective symptoms of peripheral neuropathy: numbness and tingling in the area of the median nerve; nighttime paresthesia; positive Phalen test; positive Tinel sign; pain in the wrist area radiating to the shoulder]

Inclusion criteria for healthy participants in the control group: good general health, consent to participate in the research, and a lack of symptoms listed for CTS patients.

Exclusion criteria: - Lack of consent
- Lack of cooperation from the patient
- Pharmacological therapy which may affect the sensory disturbances
- Previous surgical treatment
- Cervical myelopathy
- Cervical and lumbar radiculopathy
- Rheumatoid diseases
- Pregnancy
- Fibromyalgia
- Mental illness


Age minimum: 20 Years
Age maximum: No limit
Gender: Both males and females
Health Condition(s) or Problem(s) studied
carpal tunnel syndrome;
carpal tunnel syndrome
Musculoskeletal - Other muscular and skeletal disorders
Neurological - Other neurological disorders
Physical Medicine / Rehabilitation - Physiotherapy
Intervention(s)
Arm. 1 - Group 1 (neurodynamic techniques treatment) - gliding and tension neurodynamic techniques of median nerve, one-direction proximal and distal glide mobilisation and one-direction proximal and distal tension mobilisation.
a. neurodynamic techniques for medial nerve – position supine, neurodynamic sequence: arm adduction 90 degrees and external rotation, wrist and finger extension, forearm supination, elbow extension; one-direction proximal glide mobilisation (movement – elbow extension –large amplitude of motion), one-direction distal glide mobilisation (movement – wrist extension –large amplitude of motion), one-direction proximal tension mobilisation (movement – elbow extension –small amplitude of motion et the end of the movement), one-direction distal tension mobilisation (movement – wrist extension – small amplitude of motion et the end of the movement).
Standard protocol consisted of three series of 60 repetitions of glide and tension neurodynamic techniques separated by inter-series intervals of 15 s, twice a week for 10 sessions.
The therapy will be performed by physiotherapists with more than 10 years of experience in neurodynamic techniques. The study will be performed in 2 medical clinics in the Silesia province of Poland. Approximate duration of each session – 15 minutes.

Arm. 2 - Group 2 (placebo treatment) – sham gliding and tension neurodynamic techniques of median nerve, one-direction proximal and distal glide mobilisation and one-direction proximal and distal tension mobilisation.
a. neurodynamic techniques for medial nerve – position supine, without neurodynamic sequence – upper extremity in neutral position; one-direction proximal glide mobilisation (movement – elbow extension –large amplitude of motion), one-direction d
Primary Outcome(s)
Nerve conduction:
Examinations of nervous conduction is performed in the electromyography laboratory by experienced personnel. The examination is performed by an antidromic method using a Neuro-Mep instrument, with superficial electrodes.
Nerve conduction study is performed on median nerve.[Baseline and after therapy completion (5 weeks), and 6 months later post completion of therapy.]
neuropathy symptom score (Boston Carpal Tunnel Questionnaire - BCTQ)
[Baseline and after therapy completion (5 weeks), and 6 months later post completion of therapy.]
Feeling two-point discrimination:
The examination of two-point discrimination sensation was performed with the use of its static variety by assessing innervation density in slowly adapting touch receptors. A standardised Dellon discriminator was used for the study[Baseline and after therapy completion (5 weeks), and 6 months later post completion of therapy.]
Secondary Outcome(s)
Kinesthetic differentiation of movement (radiocarpal joint) – Saunders Inclinometer[Baseline and after therapy completion (5 weeks), and 6 months later post completion of therapy.]
overall health status -
36 Health Survey Questionnaire[Baseline and after therapy completion (5 weeks), and 6 months later post completion of therapy.]
Grip strength
Dynamometer Jamar
[Baseline and after therapy completion (5 weeks), and 6 months later post completion of therapy.]
Kinesthetic differentiation of strength (cylindric and pinch grip kinaesthetic differentiation) – Jamar Dynamometer
[Baseline and after therapy completion (5 weeks), and 6 months later post completion of therapy.]
Sensation threshold - Calibrated Softip Monofilament NerveTester – WEST-hand, Connecticute Bioinstruments, USA)[Baseline and after therapy completion (5 weeks), and 6 months later post completion of therapy.]
The range of movement
Inclinometer Saunders[Baseline and after therapy completion (5 weeks), and 6 months later post completion of therapy.]
Severity of pain:
Laitinen scale and a Numerical Pain Rating Scale (NPRS), which is a subjective method of pain evaluation by the patient, was used.[Baseline and after therapy completion (5 weeks), and 6 months later post completion of therapy.]
Secondary ID(s)
Nill know
Source(s) of Monetary Support
The Jerzy Kukuczka Academy of Physical Education in Katowice,
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 08/03/2012
Contact:
Bioethics Committee for Scientific Studies at the Physical Education College of Katowice
Results
Results available: Yes
Date Posted: 15/10/2021
Date Completed: 26/10/2018
URL:
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