Clinical trial NCT06882603: Efficacy of Corticosteroid Injection and Nerve Hydrodissection in Carpal Tunnel Syndrome
Official title: Comparison of the Efficacy of Corticosteroid Injection and Saline Nerve Hydrodissection on Electrophysiological Study, Pain, Function and Sonographic Findings in the Treatment of Carpal Tunnel Syndrome: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carpal Tunnel Syndrome (CTS)
Keywords: steroid injection
nerve hydrodissection
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 90
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: randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The subject of the study is to use current treatment methods in patients with nerve compression in the wrist and compare their effects. The purpose of the study is to determine the most appropriate method by comparing the benefits of cortisone and serum injection in addition to exercise therapy in volunteers like you who have nerve compression in the wrist and have pain and numbness.

Detailed description: Carpal tunnel syndrome (CTS) was first described by Paget in 1854, and detailed information and surgical techniques regarding its clinical course were provided by Phalen. Carpal tunnel syndrome (CTS) is a clinical picture consisting of symptoms resulting from compression of the median nerve within the carpal tunnel at the wrist level, and is the most common focal entrapment neuropathy. Although it is due to idiopathic and secondary causes, the pathophysiology of CTS is not fully understood. It is 3 times more common in women than in men. The fact that CTS occurs more frequently in the dominant hand supports the important role of hand activity in the development of the disease. Since the sensory branches of the median nerve innervate the first three fingers and half of the 4th finger, CTS patients typically complain of burning, pins and needles, tingling and numbness in these fingers. In some cases, the pain may not correspond to the normal sensory area of the median nerve in the hand. CTS is easily diagnosed by history and physical examination. Imaging and electrodiagnostic studies help confirm the diagnosis. Treatment varies according to the degree of CTS. Different conservative treatment methods are used in the treatment of mild and moderate CTS. The most commonly used methods are splint, local corticosteroid injection (LCE) and conventional treatment agents (TENS, hotpack, ultrasound). Local corticosteroid injection is an injection method with proven efficacy, applied in clinical practice and included in the guidelines. Another method that has become popular recently is hydrodissection of the median nerve. Isotonic sodium chloride solution is injected in the hydrodissection method. It does not contain drugs. Hydrodissection is a minimally invasive procedure that involves injecting fluid into anatomical spaces to facilitate dissection and reduce adhesion during surgery. Smith et al. described lidocaine and corticosteroid injection under ultrasound guidance in patients with CTS and proposed the concept of nerve hydrodissection. The therapeutic effect of nerve hydrodissection is based on the theory that it can separate the nerve from the surrounding soft tissue and reduce the risk of chronic compression injury. The hydrodissection method does not cause side effects related to blood sugar regulation in patients with comorbidities such as diabetes mellitus. Injections under USG guidance both increase the reliability of the injection and are targeted. In this study, all injection procedures will be performed under USG guidance in our clinic.

USG-guided corticosteroid injection is already a procedure applied in the treatment of patients with carpal tunnel syndrome in our clinic. In hydrodissection, the same procedure will be performed under USG guidance and isotonic sodium chloride solution will be used instead of corticosteroid.

The aim of this study is to compare the effectiveness of median nerve hydrodissection with 0.9% isotonic sodium chloride and local corticosteroid injection on electrophysiological studies, pain, function and sonographic findings and to investigate whether it is superior to the control group.

Female and male patients between the ages of 18-65 who apply to Kırşehir Ahi Evran University Hospital PMR outpatient clinic and meet the inclusion criteria will be included in the study. In the prospective randomized controlled single-blind planned study, evaluations will be made at week 0 before treatment, week 3 at the end of treatment and week 12. The estimated number of volunteers expected to participate in the study was determined according to power analysis. The sensory nerve and Tm velocity score, which was the primary outcome measure in the study conducted by Şahin et al. in carpal tunnel syndrome, was taken as reference. The disease will be diagnosed with clinical, physical examination and enmg studies, and no additional techniques will be requested. The patients will be randomly divided into 3 groups. They will be selected by simple random sampling using the closed envelope method and will then be divided into Group 1 (steroid injection + tendon and median nerve gliding exercise), Group 2 (hydrodissection + tendon and median nerve gliding exercise) and Group 3 (tendon and median nerve gliding exercise). The patient will be evaluated with Bostan Carpal Tunnel Syndrome Questionnaire (BCSQT) before treatment, at the end of treatment, in the 3rd and 12th weeks, DN-4 Neuropathic Pain Questionnaire, EMG median sensory nerve conduction velocity and median nerve distal motor latency data, and USG will be used to examine the cross-sectional area of the median nerve at the scaphoid-pisiform bone level.

In this study, three different treatment methods will be grouped in three different ways.

Eligibility criteria: Inclusion Criteria:

1. Female and male patients aged 18-65 who applied to Ahi Evran University Physical Medicine and Rehabilitation Polyclinic and diagnosed with carpal tunnel syndrome through clinical and EMG
2. Patients who can understand the information form correctly and are cooperative
3. Patients who consented to participate in the study according to the informed consent form

Exclusion Criteria:

1. Cervical radiculopathy
2. Polyneuropathy
3. Brachial plexopathy
4. Systemic corticosteroid use
5. History of fracture and trauma in the forearm and wrist on the treated side 6- Inflammatory rheumatic disease

7- Pregnant and breastfeeding patients 8- Systemic diseases such as renal failure, peptic ulcer, diabetes, hypothyroidism, coagulation disorders 9- Patients who have undergone carpal tunnel syndrome surgery 10- Thoracic outlet syndrome 11- Thenar atrophy, severe carpal tunnel syndrome 12- Patient is unwilling or states that they cannot participate for any reason

Primary outcomes:
measure: Electrophysiological Study
timeFrame: 0 day
measure: Electrophysiological Study
timeFrame: 12th week
Secondary outcomes:
measure: Measurement of the median nerve cross-sectional area with USG
timeFrame: 0 day
measure: Measurement of the median nerve cross-sectional area with USG
timeFrame: 4th week
measure: Measurement of the median nerve cross-sectional area with USG
timeFrame: 12th week
measure: Boston Carpal Tunnel Questionnaire
timeFrame: 0 day
measure: Boston Carpal Tunnel Questionnaire
timeFrame: 4th week
measure: Boston Carpal Tunnel Questionnaire
timeFrame: 12th week
measure: DN4 Neuropathic Pain Questionnaire
timeFrame: 0 day
measure: DN4 Neuropathic Pain Questionnaire
timeFrame: 4th week
measure: DN4 Neuropathic Pain Questionnaire
timeFrame: 12th week
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Ahi Evran University
state: City Centre
city: Kırsehir
country: Turkey
facility: Ahi Evran University
Study officials:
affiliation: Kirsehir Ahi Evran Universitesi
name: Basak Cigdem Karacay, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sahin MA, Cigdem-Karacay B, Konar NM, Tuncay F. Comparison of the Effectiveness of 2 Different Kinesio Taping Techniques Added to Exercises in the Treatment of Carpal Tunnel Syndrome: Randomized Controlled Trial, Double-Blind, Parallel Groups. Arch Phys Med Rehabil. 2024 Sep;105(9):1657-1665. doi: 10.1016/j.apmr.2024.05.023. Epub 2024 Jun 6.
citation: Wu YT, Chen SR, Li TY, Ho TY, Shen YP, Tsai CK, Chen LC. Nerve hydrodissection for carpal tunnel syndrome: A prospective, randomized, double-blind, controlled trial. Muscle Nerve. 2019 Feb;59(2):174-180. doi: 10.1002/mus.26358. Epub 2018 Dec 4.
citation: Wipperman J, Goerl K. Carpal Tunnel Syndrome: Diagnosis and Management. Am Fam Physician. 2016 Dec 15;94(12):993-999.