Comparison of the Efficacy of Paraffin Bath and Peloidotherapy in Patients With Carpal Tunnel Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- VAS pain
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Peloidotherapy
This group will consist of patients who have received peloid therapy for a total of 15 sessions of 20 minutes at 45 degrees for 3 weeks, 5 days a week, along with a home exercise program.
Intervention: Peloidotherapy (Other)
Peloidotherapy
This group will consist of patients who have received peloid therapy for a total of 15 sessions of 20 minutes at 45 degrees for 3 weeks, 5 days a week, along with a home exercise program.
Intervention: home exersize (Other)
paraffin bath
This group will consist of patients who have received paraffin bath for a total of 15 sessions of 20 minutes for 3 weeks, 5 days a week, along with a home exercise program.
Intervention: paraffin bath (Other)
paraffin bath
This group will consist of patients who have received paraffin bath for a total of 15 sessions of 20 minutes for 3 weeks, 5 days a week, along with a home exercise program.
Intervention: home exersize (Other)
Home exercise
This group will consist of patients who have only been given a home exercise program. Flexor tendon gliding exercises, median nerve gliding exercises, and isometric wrist strengthening exercises will be given as exercises.
Intervention: home exersize (Other)
Outcomes
Primary Outcomes
VAS pain
Time Frame: baseline, week 3 and week 12
A 10 cm long line is drawn, this line is divided into 10 intervals of 10 mm width, 0: no pain and 10: the most severe pain is explained, and the patient is asked to mark the value corresponding to the resting pain and the pain during movement on the scale.
The Boston Carpal Tunnel Syndrome Questionnaire
Time Frame: baseline, week 3 and week 12
The Turkish version of the Boston Carpal Tunnel Questionnaire score. It is used to evaluate the symptom severity and functionality of the patients. BCTQ is a questionnaire consisting of 2 parts: symptom severity scale (SSS) and functional status scale (FSS). Each item in both sections has 5 different answers that score between 1 and 5. The mean score is obtained by dividing the total score by the number of questions and ranges from 1 to 5, with a higher score indicating severe symptom.
Secondary Outcomes
- Hand grip strength(baseline, week 3 and week 12)
- Finger pinch strength(baseline, week 3 and week 12)
- Douleur Neuropathique 4(baseline, week 3 and week 12)
- Quick DASH Score(baseline, week 3 and week 12)
- Ultrasonographic evaluation of the median nerve(baseline, week 3 and week 12)
Investigators
Ümmü Habibe Sarı
MD
Konya Beyhekim Training and Research Hospital