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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cubital tunnel syndrome

Condition category

Condition code

Neurological

Other neurological disorders

Physical Medicine / Rehabilitation

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]

Rehabilitation

Intervention code [2]

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]

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]

2 weeks before treatment, 2 weeks post-treatment commencement (primary endpoint), 6 months post-treatment completion

Primary outcome [2]

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]

1 week before treatment, 2 weeks post-treatment commencement (primary endpoint), 6 months post-treatment completion

Primary outcome [3]

pain assessment (numerical pain rating scale, algometer)

The innervation area of the ulnar nerve.
This is a composite primary outcome.

Timepoint [3]

1 day before treatment, 1 day post-treatment commencement (primary endpoint), 6 months post-treatment completion

Secondary outcome [1]

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]