Clinical trial NCT06986668: Efficacy of Paraffin Bath and Peloidotherapy in Carpal Tunnel Syndrome
Official title: Comparison of the Efficacy of Paraffin Bath and Peloidotherapy in Patients With Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Carpal Tunnel Syndrome (CTS)
Peloidotherapy
Paraffin Bath
Exercise
Keywords: carpal tunnel syndrome (CTS)
Peloidotherapy
paraffin bath
exercise
ultrasound
pain
Lead sponsor: Konya Beyhekim Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2025-05-23
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: single-blind, randomized, prospective
Primary purpose: TREATMENT

Brief summary: Patients diagnosed with mild and moderate idiopathic CTS will be randomly divided into three groups. Patients who received 15 sessions of peloid therapy along with a home exercise program will constitute the first group. The second group will consist of patients who receive 15 sessions of paraffin bath and a home exercise program. Patients who were given only a home exercise program will be included in the third group. "Patients will be evaluated in detail in terms of clinical examination and outcomes three weeks after the end of treatment and again at three months.

Detailed description: Carpal tunnel syndrome (CTS) is the most common compression neuropathy caused by entrapment of the median nerve in the carpal tunnel. There are 2 methods for the treatment of CTS: conservative and surgical. Conservative treatment is mostly applied in patients with mild and moderate CTS. In this study, we aim to evaluate the efficacy of peloid therapy and kinesiobanding technique, which are conservative treatment methods. Patients will be evaluated in terms of pain, functional/symptom status, hand-finger strength, median nerve ultrasonography measurements.

Patients who were evaluated by detailed clinical examination and medical history according to the inclusion and exclusion criteria were given written informed consent and assigned to one of the three treatment groups using block randomization. Basic sociodemographic information (age, gender, body mass index, employment status, education level, marital status,etc) and clinical data (dominant hand, duration of symptoms, comorbidities, hand to be treated, Tinel/Phalen sign, pain intensity, baseline electrophysiological parameters) will be recorded. The first group will consist of patients who have received peloid therapy at 45 degrees for a total of 15 sessions of 20 minutes, 5 days a week for 3 weeks with a home-based exercise program. The second group is a program consisting of adults who receive a total of 15 sessions of 20 minutes, paraffin bath treatment and home exercise program, 5 days a week for 3 weeks. Patients who only received home-based exercise program will be included in the 3rd group. During the treatment period, patients will be allowed to take only paracetamol for pain, if necessary, except for the medications they use continuously for comorbid reasons.

All groups were evaluated by a blinded assessor based on examination findings (Tinel/Phalen tests), pain intensity (VAS), hand grip strength (HGS), finger pinch strength (FGS), the Turkish version of the Boston Carpal Tunnel Questionnaire, the 4-Question Neuropathic Pain Questionnaire (DN4),Quick DASH Score, and ultrasound measurements (median nerve cross-sectional areas \[CSA\]) at the proximal insertion of the carpal tunnel (at the level of the scaphoid and pisiform bones and the distal wrist crease), both after treatment (three weeks/W3) and at three months post-treatment (W12).

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-65
* Agreeing to participate voluntarily in the study
* Being diagnosed with mild or moderate idiopathic chronic CTS as a result of anamnesis, clinical examination and nerve conduction study

Exclusion Criteria:

* Presence of predisposing etiological factors for CTS such as diabetes mellitus, chronic kidney and liver disease, acromegaly, rheumatological diseases, acute trauma, hypothyroidism, etc.
* Being diagnosed with severe CTS
* Having a history of previous wrist surgery or trauma
* Having atrophy in the thenar region or weakness in the thenar muscles
* Having cervical radiculopathy, thoracic outlet syndrome, polyneuropathy, brachial neuropathy or proximal median nerve neuropathy
* Having had steroid injections in the last 3 months and taking oral steroid medications
* Being pregnant
* Having an open wound or rash in the wrist and its surroundings that would prevent treatment
* Patients who are receiving or will receive another/additional treatment for CTS
* Patients with a bifid median nerve, persistent median artery, ganglion cyst, tenosynovitis, or tendinitis in the wrist.

Primary outcomes:
measure: VAS pain
timeFrame: baseline, week 3 and week 12
measure: The Boston Carpal Tunnel Syndrome Questionnaire
timeFrame: baseline, week 3 and week 12
Secondary outcomes:
measure: Hand grip strength
timeFrame: baseline, week 3 and week 12
measure: Finger pinch strength
timeFrame: baseline, week 3 and week 12
measure: Douleur Neuropathique 4
timeFrame: baseline, week 3 and week 12
measure: Quick DASH Score
timeFrame: baseline, week 3 and week 12
measure: Ultrasonographic evaluation of the median nerve
timeFrame: baseline, week 3 and week 12
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya Beyhekim Training and Research Hospital
Study officials:
References: