Investigation of the Effectiveness of Kinesiological Taping in Cubital Tunnel Syndrome
1 other identifier
interventional
36
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2025
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 21, 2025
CompletedFirst Submitted
Initial submission to the registry
May 23, 2025
CompletedFirst Posted
Study publicly available on registry
June 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2026
CompletedSeptember 12, 2025
September 1, 2025
6 months
May 23, 2025
September 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Numeric Rating Scale (NRS)
To demonstrate that kinesiological taping will result in a reduction of pain intensity associated with Cubital Tunnel Syndrome, as measured by the Numeric Rating Scale (NRS) ranging from 0 to 10.
3 months
Secondary Outcomes (5)
the ulnar nerve cross-sectional area measured by ultrasound
3 months
Neuropathic pain scale (measured using the DN-4 scale
3 months
SF-12 Quality of Life Scale
3 months
QUICK-DASH
3 months
Grip strength measured with a hand dynamometer
3 months
Study Arms (3)
Control
OTHERAll patients will be provided with information and an exercise sheet containing pictures on ulnar nerve gliding exercises. To monitor whether patients are performing the exercises correctly, they will be asked to come to the hospital once a week, where they will perform the exercises under the supervision of a physiotherapist. In the exercise program, different positions will be held for 30 seconds, with a 1-minute rest between them, and the exercises will be performed twice a day .
Kinesio Taping
ACTIVE COMPARATORIt will be applied once a week for 3 weeks to the affected elbow by an experienced practitioner. During taping, the space correction technique will be used. In this technique, the kinesiological tape is applied with a hole cut in the center, slightly larger than the area to be treated .
Sham Taping
SHAM COMPARATORIt will be applied in the same way as kinesiological taping with adhesive tape.
Interventions
All patients will be provided with information and an exercise sheet containing pictures on ulnar nerve gliding exercises. To monitor whether patients are performing the exercises correctly, they will be asked to come to the hospital once a week, where they will perform the exercises under the supervision of a physiotherapist. In the exercise program, different positions will be held for 30 seconds, with a 1-minute rest between them, and the exercises will be performed twice a day .
It will be applied in the same way as kinesiological taping with adhesive tape.
Description: To demonstrate that kinesiological taping will result in a reduction of pain intensity associated with Cubital Tunnel Syndrome, as measured by the Numeric Rating Scale (NRS) ranging from 0 to 10.
The measurements will be taken with the patient in a supine position, the affected arm in shoulder abduction and external rotation, and the elbow flexed at 70°-90°. After applying a generous amount of gel, the lateral edge of the ultrasound probe will be placed on the medial epicondyle, and the medial edge of the probe will be positioned on the olecranon; the ulnar nerve will be directly examined in the retroepicondylar groove. Once the nerve is visualized, the widest point will be identified, and cross-sectional area (CSA) measurements will be taken with the probe perpendicular to the nerve at the center of the screen . The measurements will be repeated twice, and the average will be calculated.
The DN4 questionnaire consists of two main sections and a total of ten questions. The first section includes seven questions related to pain characteristics and sensory information obtained through patient interview. These questions are about burning, electric shocks, coldness, tingling, pricking, numbness, and itching. The second section contains three statements related to physical examination (touch hypoesthesia, pinprick hypoesthesia, and allodynia). For each statement, "yes" or "no" responses are given. A score of "1" is assigned for "yes" answers and "0" for "no" answers, and the scores are summed. A total score of 4 or more out of 12 is interpreted as neuropathic pain.
The SF-12 Quality of Life Scale is a short form of the SF-36 Quality of Life Scale. While the SF-36 is used for chronic conditions (states), the SF-12 is used for short-term assessments (clinical findings). Similarly, it is also used to gather information about the patient's general health status. The SF-12 provides the same summary component scores as the SF-36, but with fewer items, making it a significant advantage due to its shorter application time. The scale asks the patient about their health opinions, how they feel, and how easily they can perform their usual activities. Scores range from 0 to 100, with higher scores indicating better quality of life.
QUICK-DASH (Shoulder, Arm, and Hand Problems Questionnaire): This questionnaire assesses both the ability to perform certain physical activities as well as the symptoms of the disease. Each question is answered based on the condition of the past week, and the appropriate score is marked. The answer is given based solely on the ability to perform the physical activity, without considering which hand or arm is injured. Scoring: 1. = No difficulty 2. = Mild difficulty 3. = Moderate difficulty 4. = Severe difficulty 5. = Unable to perform QUICK DASH DISABILITY/SYMPTOM SCORE: (\[(n total score\] - 1) x 25; where n represents the number of questions answered. If more than one question is unanswered, the Quick DASH score cannot be calculated. SCORE FOR OPTIONAL MODELS: For each model, divide the total score by 4, subtract 1, and multiply by 25. If more than one question is unanswered, the score for optional models cannot be calculated. Based on the results of the questionnaire, a score b
Grip strength will be measured using a hand dynamometer, with the average of three measurements taken, each followed by a 30-second rest period.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Health Sciences University
Istanbul, Uskudar, 34100, Turkey (Türkiye)
Sultan 2. Abdülhamid Han Eğitim ve Araştırma Hastanesi
Istanbul, Üsküdar, 34668, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 3031220BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- The study is designed as a single-blind trial, where patients will be blinded to the treatment group they are assigned to. In order to assess the effectiveness of the treatment, it is essential that the patient is unaware of being in the placebo group.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 23, 2025
First Posted
June 3, 2025
Study Start
April 21, 2025
Primary Completion
November 1, 2025
Study Completion
February 1, 2026
Last Updated
September 12, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share
Data sharing not planned