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Trial registered on ANZCTR


Registration number
ACTRN12621001623886
Ethics application status
Approved
Date submitted
13/05/2021
Date registered
29/11/2021
Date last updated
7/10/2023
Date data sharing statement initially provided
29/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Changes in neurophysiological, ultrasound, and clinical parameters in cubital tunnel syndrome after manual therapy
Scientific title
Changes in neurophysiological, ultrasound, and clinical parameters in cubital tunnel syndrome after manual therapy
Secondary ID [1] 303452 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cubital tunnel syndrome 320762 0
Condition category
Condition code
Neurological 319636 319636 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 321091 321091 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm.1 – Group 1 (manual therapy) – cubital tunnel syndrome treatment will use manual therapy based on neurodynamic techniques (sliding and tensioning techniques of the ulnar nerve).
a. Neurodynamic techniques for ulnar nerve 1 (NTUN1) – position: supine; neurodynamic sequence: wrist and finger extension, forearm pronation, shoulder external rotation, elbow flection, shoulder girdle depression, shoulder abduction; neurodynamic techniques: one-direction distal glide mobilisation (movement – rhythmically hand flexion and extension – large amplitude of motion), one-direction distal tension mobilisation (movement – rhythmically hand flexion and extension – small amplitude of motion et the end of the movement), one-direction proximal glide mobilisation (movement – rhythmically elbow flexion and extension – large amplitude of motion), one-direction proximal tension mobilisation (movement – rhythmically elbow flexion and extension – small amplitude of motion et the end of the movement),
b. Neurodynamic techniques for ulnar nerve 2 (NTUN2) position: supine; neurodynamic sequence: wrist and finger extension and radial adduction, forearm pronation, shoulder internal rotation, elbow extension, shoulder girdle depression, shoulder abduction; neurodynamic techniques: one-direction distal glide mobilisation (movement – rhythmically hand flexion and extension – large amplitude of motion), one-direction distal tension mobilisation (movement – rhythmically hand flexion and extension – small amplitude of motion et the end of the movement), one-direction proximal glide mobilisation (movement – rhythmically elbow flexion and extension – large amplitude of motion), one-direction proximal tension mobilisation (movement – rhythmically elbow flexion and extension – small amplitude of motion et the end of the movement).
Standard protocol consisted of 1 series of 60 repetitions of glide and tension proximal and distal neurodynamic techniques in both positions (NTUN1, NTUN2) separated by inter-series intervals of 15 s, five times a week for 10 sessions. The duration of therapy will be lasted 2 weeks. The therapy will be performed by physiotherapists with more than 10 years of experience in neurodynamic techniques. The study will be performed in some medical clinics in the Silesia province of Poland. Approximate duration of each session –around 32 minutes.

Arm.2 - Group (physical therapy treatment) - cubital tunnel syndrome treatment will use laser and ultrasound therapy
a. Low-level laser therapy (LLLT) and ultrasound therapy (US) together (LUST). LLLT therapy will be perform using a contact method at 3 points (cubital tunnel, 2cm proximal and 2cm distal to cubital tunnel). Each procedure will start with a red laser (using an R650/50 probe) emitting 658 nm of light at 50 W. The duration of stimulation will 1 minute and 40 seconds for a total dose of 5 J. Next, an infrared laser (with an IR810/400 probe) emitting 808 nm of light at 400mW will be used for the duration of 1 minute for a total dose of 24 J. The entire laser procedure lasted 8 minutes. Next direct contact US therapy will used to treat area of cubital tunnel and 2cm proximal and distal to cubital tunnel. The following parameters will used: frequency, 1 MHz; intensity, 1.0 W/cm; and 75% pulsed for 15 minutes [Wolny et al., 2016, 2017] Therapy will be conducted five times a week for 10 sessions. The duration of the therapy will be lasted 2 weeks. The therapy will be performed by physiotherapists with more than 10 years of experience. The study will be performed in some medical clinics in the Silesia province of Poland. The total duration of each session –around 30 minutes.

Monitoring of the intervention and attendance at therapy will be carried out by checking attendance at the therapeutic session and signatures made by the therapist and the subject on a specially prepared treatment card.
Intervention code [1] 320550 0
Rehabilitation
Intervention code [2] 321646 0
Treatment: Other
Comparator / control treatment
Cubital tunnel syndrome patients waiting for therapy.
At the end of the follow-up period, all study participants will receive treatment.
Control group
Active

Outcomes
Primary outcome [1] 327498 0
Nerve conduction study
Examinations of nerve conduction will be performed in the electromyography laboratory by experienced personnel. The examination will be performed by an antidromic method using a Neuro-Mep equipment (Russia), with superficial electrodes. Nerve conduction study will be performed on ulnar nerve.
Timepoint [1] 327498 0
2 weeks before treatment, 2 weeks post-treatment commencement (primary endpoint), 6 months post-treatment completion
Primary outcome [2] 327499 0
ultrasound test (surface area, share wave elastography) of the ulnar nerve.

Ultrasound examinations will be performed in the ultrasound and elastography laboratory by experienced personnel. The examination will be performed by Aixplorer device (Supersonic Imagine, Aix en Provence, France) coupled with SL10-2 probe (2-10 MHz, SuperLinear 10-2, Vermon, Tours, France). Ultrasound assessment will be performed on ulnar nerve

This is a composite primary outcome.
Timepoint [2] 327499 0
1 week before treatment, 2 weeks post-treatment commencement (primary endpoint), 6 months post-treatment completion
Primary outcome [3] 327500 0
pain assessment (numerical pain rating scale, algometer)

The innervation area of the ulnar nerve.
This is a composite primary outcome.
Timepoint [3] 327500 0
1 day before treatment, 1 day post-treatment commencement (primary endpoint), 6 months post-treatment completion
Secondary outcome [1] 395415 0
muscle strength with the use of a dynamometer according to our own developed methodology [Wolny et al., 2016]; The strength of the pincer grip will measure using Jamar dynamometers. Strength will measured in kilogrammes (kg)
Timepoint [1] 395415 0
1 day before treatment, 1 day after treatment, post treatment 6 month follow-up
Secondary outcome [2] 395416 0
kinesthetic differentiation of muscle strength (KDS) with the use of a dynamometer according to our own developed methodology [Wolny et al., 2016]; To assess the amount of error in KDS, the maximum strength will measure as well as 50% of the maximum strength. Cylindrical hand grip strength will measured using a Jamar hydraulic dynamometer, than the error make by subject will calculated
Timepoint [2] 395416 0
1 day before treatment, 1 day after treatment, post treatment 6 month follow-up
Secondary outcome [3] 395417 0
range of motion (ROM) with the use of a digital inclinometer according to our own developed methodology [Wolny et al., 2016]; Flexion and extension of radiocarpal joint will be assessed. The Saunders digital inclinometer will be used. The measurements were carried out in accordance with the guidelines set by the manufacturer on the basis of the American Medical Association guidelines
Timepoint [3] 395417 0
1 day before treatment, 1 day after treatment, post treatment 6 month follow-up
Secondary outcome [4] 395418 0
kinesthetic differentiation of motion (KDM) with the use of a digital inclinometer according to our own developed methodology [Wolny et al., 2016]; Flexion and extension of radiocarpal joint will be measures as well as 50% of the maximum ROM, than the error make by the subject will be calculated
Timepoint [4] 395418 0
1 day before treatment, 1 day after treatment, post treatment 6 month follow-up
Secondary outcome [5] 395419 0
assessment of the perception of two-point discrimination sense (2PD). Study according to our own methodology taken from the assessment of CTS patients [Wolny et al., 2016] and adapted to the assessment of cubital tunnel syndrome performed on 4 and 5 finger and hypothenar performed by Dellon discriminator; Testing of the 2PD sense will be performed in its static variety. The Dellon discriminator will be used for the test. The discriminator spikes will be applied perpendicularly to the distal phalanges of fingers and in the middle of hypothenar. The discriminator will be placed on the skin with a little pressure to determine 2PD sense
Timepoint [5] 395419 0
1 day before treatment, 1 day after treatment, post treatment 6 month follow-up
Secondary outcome [6] 395420 0
assessment of cutaneous sensory perception threshold. Study according to our own methodology taken from the assessment of CTS patients [Wolny et al. 2020] and adapted to the assessment of cubital tunnel syndrome performed on 4 and 5 finger and hypothenar performed by Semmes–Weinstein-type monofilaments; The monofilament will be applied perpendicularly to the fingertip with such force until it bends. The study begin with the thinnest fiber, and if the subject will not feel the touch, then the appropriate thicker one will be used until the sensory threshold will be established.
Timepoint [6] 395420 0
1 day before treatment, 1 day after treatment, post treatment 6 month follow-up
Secondary outcome [7] 395421 0
Tinnel sign; The test consists in tapping with a neurological hammer on the course of the ulnar nerve in the area of the groove. The test is positive when it triggers symptoms
Timepoint [7] 395421 0
1 day before treatment, 1 day after treatment, post treatment 6 month follow-up
Secondary outcome [8] 395422 0
elbow flexion test; The test consists in keeping the elbow joint fully flexed for 1 minute. The test is positive when it triggers symptoms
Timepoint [8] 395422 0
1 day before treatment, 1 day after treatment, post treatment 6 month follow-up
Secondary outcome [9] 395423 0
(Overall health status) assessment using the questionnaire SF-36
Timepoint [9] 395423 0
1 day before treatment, 1 day after treatment, post treatment 6 month follow-up
Secondary outcome [10] 395424 0
DASH (Disabilities of Arm Shoulder and Hand) questionnaire for self-assessment of upper limb functions
Timepoint [10] 395424 0
1 day before treatment, 1 day after treatment, post treatment 6 month follow-up
Secondary outcome [11] 395425 0
The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)
Timepoint [11] 395425 0
1 day before treatment, 1 day after treatment, post treatment 6 month follow-up
Secondary outcome [12] 395426 0
The Global Rating of Change Score (GRoC) - the outcome is used to independently score self-perceived improvement in a patient and has been used as an anchor method to determine minimal clinically important change scores.
Timepoint [12] 395426 0
1 day before treatment, 1 day after treatment, post treatment 6 month follow-up
Secondary outcome [13] 400696 0
muscle strength with the use of a dynamometer according to our own developed methodology [Wolny et al., 2016]; The strength of the cylindrical grip will measure using Jamar dynamometers. Strength will measured in kilogrammes (kg)
Timepoint [13] 400696 0
1 day before treatment, 1 day after treatment, post treatment 6 month follow-up
Secondary outcome [14] 400697 0
kinesthetic differentiation of muscle strength (KDS) with the use of a dynamometer according to our own developed methodology [Wolny et al., 2016]; To assess the amount of error in KDS, the maximum strength will measure as well as 50% of the maximum strength. Pinch grip strength will measured using a Jamar hydraulic dynamometer, than the error make by subject will calculated
Timepoint [14] 400697 0
1 day before treatment, 1 day after treatment, post treatment 6 month follow-up

Eligibility
Key inclusion criteria
- Cubital tunnel syndrome diagnosed by specialist
- Cubital tunnel syndrome diagnosed by nerve conduction study
- Subjective and objective symptoms of cubital tunnel syndrome
- 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
- No symptoms of cubital tunnel syndrome
- Previous surgical treatment
- Other causes of pain
- 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 cubital tunnel syndrome who met the diagnostic criteria will be eligible for the study. Each consecutive patient who will meet the inclusion criteria will be randomly assigned to each group (Arm 1 or Arm 2 or control).
Numbered containers.
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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/07/2022
Actual
7/07/2022
Date of last participant enrolment
Anticipated
30/12/2022
Actual
29/12/2022
Date of last data collection
Anticipated
31/03/2023
Actual
10/04/2023
Sample size
Target
120
Accrual to date
Final
160
Recruitment outside Australia
Country [1] 23704 0
Poland
State/province [1] 23704 0

Funding & Sponsors
Funding source category [1] 307869 0
University
Name [1] 307869 0
The Jerzy Kukuczka Academy of Physical Education in Katowice
Country [1] 307869 0
Poland
Primary sponsor type
University
Name
The Jerzy Kukuczka Academy of Physical Education in Katowice
Address
40-065, Mikolowska 72A Katowice
Country
Poland
Secondary sponsor category [1] 308578 0
None
Name [1] 308578 0
Address [1] 308578 0
Country [1] 308578 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307872 0
Bioethics Committee for Scientific Studies at the Physical Education College of Katowice
Ethics committee address [1] 307872 0
40-065, Mikolowska 72A
Katowice
Ethics committee country [1] 307872 0
Poland
Date submitted for ethics approval [1] 307872 0
Approval date [1] 307872 0
14/11/2019
Ethics approval number [1] 307872 0
No. 8/2019

Summary
Brief summary
To assess the effectiveness of manual therapy in the conservative treatment of cubital tunnel syndrome. We hypothesised that the use of manual therapy and electrophysiologal modalities (LLLT, ultrasound) compare to no treatment will be effective in the treatment of cubital tunnel syndrome.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108770 0
A/Prof Tomasz Wolny
Address 108770 0
The Jerzy Kukuczka Academy of Physical Education in Katowice, Poland, 40-065, Mikolowska 72A, Poland,
Country 108770 0
Poland
Phone 108770 0
+48 604820416
Fax 108770 0
Email 108770 0
[email protected]
Contact person for public queries
Name 108771 0
Pawel Linek
Address 108771 0
The Jerzy Kukuczka Academy of Physical Education in Katowice, Poland, 40-065, Mikolowska 72A, Poland,
Country 108771 0
Poland
Phone 108771 0
+48 661768601
Fax 108771 0
Email 108771 0
[email protected]
Contact person for scientific queries
Name 108772 0
Pawel Linek
Address 108772 0
The Jerzy Kukuczka Academy of Physical Education in Katowice, Poland, 40-065, Mikolowska 72A, Poland,
Country 108772 0
Poland
Phone 108772 0
+48 661768601
Fax 108772 0
Email 108772 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11659Ethical approval    381428-(Uploaded-13-05-2021-04-59-47)-Study-related document.pdf



Results publications and other study-related documents

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