Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000672358
Ethics application status
Approved
Date submitted
12/04/2017
Date registered
9/05/2017
Date last updated
15/10/2021
Date data sharing statement initially provided
15/10/2021
Date results provided
15/10/2021
Type of registration
Prospectively registered

Titles & IDs
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
Secondary ID [1] 291689 0
Nill know
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
carpal tunnel syndrome 302853 0
Condition category
Condition code
Musculoskeletal 302334 302334 0 0
Other muscular and skeletal disorders
Neurological 302335 302335 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 302336 302336 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 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.
Intervention code [1] 297773 0
Treatment: Other
Comparator / control treatment
Group 3 (no treatment) – control group (patients with CTS)
a. no treatment

Group 4 (no treatment) – control group (healthy volunteers)
a. no treatment
Control group
Placebo

Outcomes
Primary outcome [1] 301758 0
neuropathy symptom score (Boston Carpal Tunnel Questionnaire - BCTQ)
Timepoint [1] 301758 0
Baseline and after therapy completion (5 weeks), and 6 months later post completion of therapy.
Primary outcome [2] 301759 0
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.
Timepoint [2] 301759 0
Baseline and after therapy completion (5 weeks), and 6 months later post completion of therapy.
Primary outcome [3] 301760 0
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
Timepoint [3] 301760 0
Baseline and after therapy completion (5 weeks), and 6 months later post completion of therapy.
Secondary outcome [1] 333776 0
Sensation threshold - Calibrated Softip Monofilament NerveTester – WEST-hand, Connecticute Bioinstruments, USA)
Timepoint [1] 333776 0
Baseline and after therapy completion (5 weeks), and 6 months later post completion of therapy.
Secondary outcome [2] 333778 0
Grip strength
Dynamometer Jamar
Timepoint [2] 333778 0
Baseline and after therapy completion (5 weeks), and 6 months later post completion of therapy.
Secondary outcome [3] 333779 0
The range of movement
Inclinometer Saunders
Timepoint [3] 333779 0
Baseline and after therapy completion (5 weeks), and 6 months later post completion of therapy.
Secondary outcome [4] 333780 0
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.
Timepoint [4] 333780 0
Baseline and after therapy completion (5 weeks), and 6 months later post completion of therapy.
Secondary outcome [5] 333782 0
overall health status -
36 Health Survey Questionnaire
Timepoint [5] 333782 0
Baseline and after therapy completion (5 weeks), and 6 months later post completion of therapy.
Secondary outcome [6] 334390 0
Kinesthetic differentiation of strength (cylindric and pinch grip kinaesthetic differentiation) – Jamar Dynamometer
Timepoint [6] 334390 0
Baseline and after therapy completion (5 weeks), and 6 months later post completion of therapy.
Secondary outcome [7] 334391 0
Kinesthetic differentiation of movement (radiocarpal joint) – Saunders Inclinometer
Timepoint [7] 334391 0
Baseline and after therapy completion (5 weeks), and 6 months later post completion of therapy.

Eligibility
Key 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.
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

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)
Simple randomisation using procedures like coin-tossing and dice-rolling
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
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 neuropathy symptom score, nerve conduction study (sensory, motor conduction and latency), two point discrimination sensation, sensation threshold, kinaesthetic differentiation of strength, kinaesthetic differentiation of range of motion, pain score, 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
Completed
Date of first participant enrolment
Anticipated
22/05/2017
Actual
16/05/2017
Date of last participant enrolment
Anticipated
5/11/2018
Actual
15/01/2018
Date of last data collection
Anticipated
17/12/2018
Actual
26/10/2018
Sample size
Target
350
Accrual to date
Final
350
Recruitment outside Australia
Country [1] 8796 0
Poland
State/province [1] 8796 0

Funding & Sponsors
Funding source category [1] 296188 0
University
Name [1] 296188 0
The Jerzy Kukuczka Academy of Physical Education in Katowice,
Country [1] 296188 0
Poland
Primary sponsor type
University
Name
The Jerzy Kukuczka Academy of Physical Education in Katowice
Address
Katowice
Poland, 40-065, Mikolowska 72B
Country
Poland
Secondary sponsor category [1] 295100 0
None
Name [1] 295100 0
Address [1] 295100 0
Country [1] 295100 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297431 0
Bioethics Committee for Scientific Studies at the Physical Education College of Katowice
Ethics committee address [1] 297431 0
Ethics committee country [1] 297431 0
Poland
Date submitted for ethics approval [1] 297431 0
08/02/2012
Approval date [1] 297431 0
08/03/2012
Ethics approval number [1] 297431 0
Decision No. 7/2012 and annex No. KB/6/17, 28 februrary 2017

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

Contacts
Principal investigator
Name 74014 0
Dr Tomasz Wolny
Address 74014 0
The Jerzy kukuczka Academy of Physical Education, Katowicach, ul. Mikolowska 72A, 40-065 Katowice
Country 74014 0
Poland
Phone 74014 0
+48 604820416
Fax 74014 0
Email 74014 0
[email protected]
Contact person for public queries
Name 74015 0
Pawel Linek
Address 74015 0
The Jerzy kukuczka Academy of Physical Education, Katowicach, ul. Mikolowska 72A, 40-065 Katowice
Country 74015 0
Poland
Phone 74015 0
+48 661768601
Fax 74015 0
Email 74015 0
[email protected]
Contact person for scientific queries
Name 74016 0
Pawel Linek
Address 74016 0
The Jerzy kukuczka Academy of Physical Education, Katowicach, ul. Mikolowska 72A, 40-065 Katowice
Country 74016 0
Poland
Phone 74016 0
+48 661768601
Fax 74016 0
Email 74016 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
EmbaseLong-term patient observation after conservative treatment of carpal tunnel syndrome: A summary of two randomised controlled trials.2019https://dx.doi.org/10.7717/peerj.8012
N.B. These documents automatically identified may not have been verified by the study sponsor.