Clinical trial NCT07001111: Investigation of the Effectiveness of Kinesiological Taping in Cubital Tunnel Syndrome
Official title: Investigation of the Effectiveness of Kinesiological Taping in Cubital Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cubital Tunnel Syndrome
Kinesio Taping
Ulnar Neuropathies
Keywords: Cubital Tunnel Syndrome
Kinesio taping
ulnar neuropathies
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective Experimental (Randomized Controlled) Study
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the effect of kinesiological taping, applied in addition to exercise, on clinical symptoms in patients diagnosed with Cubital Tunnel Syndrome. The patients will be randomized into three groups (exercise, exercise + kinesiological taping, exercise + sham taping) and will be evaluated at the 1st and 3rd months after a 3-week treatment period.

Detailed description: Cubital Tunnel Syndrome (CuTS), characterized by the compression of the ulnar nerve at the elbow, is a condition that causes symptoms such as pain, numbness, paresthesia, and muscle weakness in the affected limb. Ulnar nerve compression is the second most common entrapment neuropathy after median nerve entrapment . The ulnar nerve can become compressed at various locations, including the elbow and wrist. The nerve is formed by the C8 and T1 spinal nerve roots, which make up the lower trunk and medial cord of the brachial plexus. It travels along the medial aspect of the humerus, passes through Struthers' arcade, the retro-epicondylar groove, and enters the cubital tunnel. The roof of the cubital tunnel is known as the cubital tunnel retinaculum. The ulnar nerve then passes beneath the aponeurosis of the flexor carpi ulnaris muscle and its two heads, where the upper edge of the aponeurosis forms the Osborne ligament, which is likely the most commonly affected area in ulnar nerve entrapment. In the forearm, the ulnar nerve is located beneath the flexor carpi ulnaris muscle and innervates this muscle along with the ulnar half of the flexor digitorum profundus muscle. The nerve then proceeds toward Guyon's canal along with the ulnar artery. Distally, the nerve branches into three divisions: the dorsal sensory branch, the volar superficial sensory branch, and the deep motor branch. The deep motor branch descends into the deep part of the hand beneath the edge of the aponeurosis surrounding the hook of the hamate bone, innervating most of the hypothenar and intrinsic muscles. The dorsal sensory branch leaves the main trunk approximately 5-8 cm proximal to Guyon's canal and innervates the dorsal ulnar portion of the hand .

In patients with Cubital Tunnel Syndrome, pain, numbness, paresthesia in the 4th and 5th fingers, and in advanced stages, muscle weakness leading to atrophy of the hypothenar muscles and claw hand deformity may be observed. The diagnosis is made through electrophysiological studies (EMG/NCS).

Treatment options include both conservative and surgical approaches. Surgical options include cubital tunnel decompression, medial epicondylectomy, and ulnar nerve transposition . Surgical treatment is generally preferred for patients with muscle weakness and atrophy, as well as those who do not respond to conservative treatments. Conservative treatment options include avoiding positions of the elbow that may exacerbate symptoms, splinting, exercise, electrotherapy, and local steroid injections .

Kinesiotaping, developed by chiropractor and acupuncturist Kenzo Kase in the late 1970s, is a commonly used conservative treatment option for musculoskeletal pathologies in physical therapy clinics. The tape is made of cotton, stretches longitudinally up to 40%, is water-resistant, and can stay on the skin for up to 7 days.

Kinesiotaping is believed to support muscles, correct joint movement, enhance blood and lymph circulation, provide proprioceptive input, and reduce pain and muscle spasms . Various physical therapy modalities, steroid injections, and dry needling have been studied for their effects on Cubital Tunnel Syndrome. Kinesiotaping has been shown to be effective in patients with Carpal Tunnel Syndrome. However, there is no study available on the use of kinesiotaping in CuTS patients. This simple, cost-effective treatment modality, commonly used in physical therapy practice for various pathologies, will be investigated for its efficacy in patients with Cubital Tunnel Syndrome.

Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 65 years
* Patients with at least 3 points of pain according to the Numeric Rating Scale (NRS)
* Patients diagnosed with Cubital Tunnel Syndrome via Electroneuromyography (ENMG)
* Literate
* Willing to consent to participate in the study

Exclusion Criteria:

* Having any secondary entrapment neuropathy such as diabetes, inflammatory arthritis, or hypothyroidism
* Pregnancy
* Active cancer presence
* Skin infection, burns, wounds, or scars on the forearm
* History of elbow trauma
* Cervical radiculopathy or brachial plexopathy
* Polyneuropathy
* Having previously undergone Cubital Tunnel decompression surgery
* Having received a corticosteroid injection into the Cubital Tunnel within the last 3 months
* Illiterate
* Not consenting to participate in the study

Primary outcomes:
measure: Numeric Rating Scale (NRS)
timeFrame: 3 months
Secondary outcomes:
measure: the ulnar nerve cross-sectional area measured by ultrasound
timeFrame: 3 months
measure: Neuropathic pain scale (measured using the DN-4 scale
timeFrame: 3 months
measure: SF-12 Quality of Life Scale
timeFrame: 3 months
measure: QUICK-DASH
timeFrame: 3 months
measure: Grip strength measured with a hand dynamometer
timeFrame: 3 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Health Sciences University
state: Uskudar
city: Istanbul
country: Turkey
facility: Sultan 2. Abdülhamid Han Eğitim ve Araştırma Hastanesi
state: Üsküdar
Study officials:
References:
citation: Stewart JD. The variable clinical manifestations of ulnar neuropathies at the elbow. J Neurol Neurosurg Psychiatry. 1987 Mar;50(3):252-8. doi: 10.1136/jnnp.50.3.252.