Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2025-12-28 @ 7:16 AM
Study NCT ID:
NCT06986668
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-23
First Post:
2025-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Paraffin Bath and Peloidotherapy in Carpal Tunnel Syndrome
Sponsor:
Konya Beyhekim Training and Research Hospital
Organization:
Study Overview
Official Title:
Comparison of the Efficacy of Paraffin Bath and Peloidotherapy in Patients With Carpal Tunnel Syndrome
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: