Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001681448
Ethics application status
Approved
Date submitted
14/11/2016
Date registered
6/12/2016
Date last updated
9/03/2020
Date data sharing statement initially provided
2/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of physiotherapy in different sensory disturbances in selected peripheral neuropathies
Scientific title
Effectiveness of physiotherapy in different sensory disturbances in selected peripheral neuropathies
Secondary ID [1] 290497 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral neuropathies 300887 0
Condition category
Condition code
Physical Medicine / Rehabilitation 300705 300705 0 0
Physiotherapy
Neurological 300867 300867 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group (neurodynamic techniques) - gliding and tension neurodynamic techniques of peripheral nerve (upper limb, lower limb), one-direction proximal and distal glide mobilisation and one-direction proximal and distal tension mobilisation.
Upper limb:
a. medial nerve – position supine, neurodynamic sequence: arm adduction 90 degree 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)
b. ulnar nerve - position supine, neurodynamic sequence: wrist and finger extension, forearm pronation, arm external rotation, elbow flection, arm adduction; one-direction proximal glide mobilisation (movement – arm adduction –large amplitude of motion), one-direction distal glide mobilisation (movement – wrist extension –large amplitude of motion), one-direction proximal tension mobilisation (movement – arm adduction –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)
c. radial nerve – position supine, neurodynamic sequence: elbow extension, arm interial rotation, wrist flexion, arm adduction and extension; one-direction proximal glide mobilisation (movement – elbow extension –large amplitude of motion), one-direction distal glide mobilisation (movement – wrist flexion –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 flexion – small amplitude of motion et the end of the movement)
Lower limb:
a. tibial nerve - position supine, neurodynamic sequence: feet extension and pronation, knee extension, hip flexion (SLR – straight leg raise); one-direction proximal glide mobilisation (movement – knee extension –large amplitude of motion), one-direction distal glide mobilisation (movement – feet extension –large amplitude of motion), one-direction proximal tension mobilisation (movement – knee extension –small amplitude of motion et the end of the movement), one-direction distal tension mobilisation (movement – feet extension – small amplitude of motion et the end of the movement)
b. peroneal nerve - position supine, neurodynamic sequence: feet flexion and supination, knee extension, hip flexion (SLR – straight leg raise), hip abduction; one-direction proximal glide mobilisation (movement – knee extension –large amplitude of motion), one-direction distal glide mobilisation (movement – feet extension –large amplitude of motion), one-direction proximal tension mobilisation (movement – knee extension –small amplitude of motion et the end of the movement), one-direction distal tension mobilisation (movement – feet extension – small amplitude of motion at the end of the movement)
c. femoral nerve - position side lying, neurodynamic sequence: maximum hip and knee flection of untested lower limb, hip extension and knee flexion of tested lower limb; one-direction proximal glide mobilisation (movement – hip extension –large amplitude of motion), one-direction distal glide mobilisation (movement – knee flexion –large amplitude of motion), one-direction proximal tension mobilisation (movement – hip extension –small amplitude of motion et the end of the movement), one-direction distal tension mobilisation (movement – knee flexion – small amplitude of motion at 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 intervention will be delivered by experienced in neurodynamic techniques physiotherapist..
The intervention will be performed in two outpatient clinic in Silesia region of Poland.
The duration of the each therapy session is 45 min.
Therapy will be performed on peripheral nerves in lower and upper limb in patients with toxic or/and diabetic neuropathies, All participants receive all six nerve treatments.
Intervention code [1] 296395 0
Rehabilitation
Intervention code [2] 296396 0
Treatment: Other
Comparator / control treatment
Arm 1 - Placebo group - (placebo treatment) – sham gliding and tension neurodynamic techniques of peripheral nerve (upper limb, lower limb), one-direction proximal and distal glide mobilisation and one-direction proximal and distal tension mobilisation.
Upper limb:
d. 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)
e. ulnar nerve - position supine, without neurodynamic sequence – upper extremity in neutral position; one-direction proximal glide mobilisation (movement – arm adduction –large amplitude of motion), one-direction distal glide mobilisation (movement – wrist extension –large amplitude of motion), one-direction proximal tension mobilisation (movement – arm adduction –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)
f. radial 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 flexion –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 flexion – small amplitude of motion et the end of the movement)
Lower limb:
d. tibial nerve - position supine, without neurodynamic sequence – upper extremity in neutral position; one-direction proximal glide mobilisation (movement – knee extension –large amplitude of motion), one-direction distal glide mobilisation (movement – feet extension –large amplitude of motion), one-direction proximal tension mobilisation (movement – knee extension –small amplitude of motion et the end of the movement), one-direction distal tension mobilisation (movement – feet extension – small amplitude of motion et the end of the movement)
e. peroneal nerve - position supine, without neurodynamic sequence – upper extremity in neutral position, hip abduction; one-direction proximal glide mobilisation (movement – knee extension –large amplitude of motion), one-direction distal glide mobilisation (movement – feet extension –large amplitude of motion), one-direction proximal tension mobilisation (movement – knee extension –small amplitude of motion et the end of the movement), one-direction distal tension mobilisation (movement – feet extension – small amplitude of motion et the end of the movement)
f. femoral nerve - position side lying, without neurodynamic sequence – upper extremity in neutral position; one-direction proximal glide mobilisation (movement – hip extension –large amplitude of motion), one-direction distal glide mobilisation (movement – knee flexion –large amplitude of motion), one-direction proximal tension mobilisation (movement – hip extension –small amplitude of motion et the end of the movement), one-direction distal tension mobilisation (movement – knee flexion – 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.

Arm 2 -Control group – no treatment
Control group
Placebo

Outcomes
Primary outcome [1] 300184 0
neuropathy symptom score
Timepoint [1] 300184 0
baseline and week 5 (following completion of 10 sessions)
Primary outcome [2] 300185 0
nerve conduction study will be performed by specialists in an independent, off-site electromyography (EMG) laboratory and prescribed by the treating physician.
Timepoint [2] 300185 0
baseline and week 5 (following completion of 10 sessions)
Primary outcome [3] 300186 0
two point discrimination sensation - Dellon discriminator
Timepoint [3] 300186 0
baseline and week 5 (following completion of 10 sessions)
Secondary outcome [1] 329267 0
sensation threshold - semmes-weinstein monofilaments
Timepoint [1] 329267 0
baseline and week 5 (following completion of 10 sessions)
Secondary outcome [2] 329268 0
vibration - Rydel-Seiffer tuning-fork
Timepoint [2] 329268 0
baseline and week 5 (following completion of 10 sessions)
Secondary outcome [3] 329269 0
kinaesthetic differentiation of strenght - grip dynamometer and pinch dynamometer, kinaesthetic platform
Timepoint [3] 329269 0
baseline and week 5 (following completion of 10 sessions)
Secondary outcome [4] 329270 0
pain (Laitinen scale, numerical pain scale)
Timepoint [4] 329270 0
baseline and week 5 (following completion of 10 sessions)

Eligibility
Key inclusion criteria
- Peripheral neuropathy diagnosed by physican
- Subjective and objective symptoms of peripheral neuropathy
- Consent to participate in research
- No contraindications to therapy
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
- Pharmacological therapy which may affect the sensory disturbances
- 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)
Patients will be randomised by drawing lots with the group number.
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 assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/12/2016
Actual
20/02/2017
Date of last participant enrolment
Anticipated
29/06/2018
Actual
21/01/2019
Date of last data collection
Anticipated
31/05/2019
Actual
11/06/2019
Sample size
Target
300
Accrual to date
Final
318
Recruitment outside Australia
Country [1] 8390 0
Poland
State/province [1] 8390 0
Silesia

Funding & Sponsors
Funding source category [1] 294966 0
University
Name [1] 294966 0
The Jerzy Kukuczka Academy of Physical Education in Katowice
Country [1] 294966 0
Poland
Primary sponsor type
University
Name
The Jerzy Kukuczka Academy of Physical Education in Katowice
Address
Poland, 40-065, Mikolowska 72B Katowice
Country
Poland
Secondary sponsor category [1] 293786 0
None
Name [1] 293786 0
Address [1] 293786 0
Country [1] 293786 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296325 0
Bioethics Committee for Scientific Studies at the Physical Education College of Katowice
Ethics committee address [1] 296325 0
Ethics committee country [1] 296325 0
Poland
Date submitted for ethics approval [1] 296325 0
15/05/2016
Approval date [1] 296325 0
23/06/2016
Ethics approval number [1] 296325 0
Decision No. 4/2016

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1228 1228 0 0
/AnzctrAttachments/371810-Scan komisja pdf.pdf (Ethics approval)

Contacts
Principal investigator
Name 70298 0
Dr Tomasz Wolny
Address 70298 0
The Jerzy Kukuczka Academy of Physical Education in Katowice, Poland, 40-065, Mikolowska 72B, Poland,
Country 70298 0
Poland
Phone 70298 0
+48 604820416
Fax 70298 0
Email 70298 0
[email protected]
Contact person for public queries
Name 70299 0
Pawel Linek
Address 70299 0
The Jerzy Kukuczka Academy of Physical Education in Katowice, Poland, 40-065, Mikolowska 72B, Poland,
Country 70299 0
Poland
Phone 70299 0
+48661768601
Fax 70299 0
Email 70299 0
[email protected]
Contact person for scientific queries
Name 70300 0
Pawel Linek
Address 70300 0
The Jerzy Kukuczka Academy of Physical Education in Katowice, Poland, 40-065, Mikolowska 72B, Poland,
Country 70300 0
Poland
Phone 70300 0
+48661768601
Fax 70300 0
Email 70300 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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
No additional documents have been identified.