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

Overview

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).

Interventions

• Other Peloidotherapy
  Peloidotherapy stands out among superficial heating physical therapy modalities with its mineral and natural origin.
• Other paraffin bath
  It is an effective treatment for the treatment of patients' hands, arms and feet by applying the brushing method to different body parts, relieving pain and improving function, thus providing freedom of life.
• Other home exersize
  Flexor tendon gliding exercises, median nerve gliding exercises, and isometric wrist strengthening exercises will be given as exercises.

Primary outcome measures

• VAS pain [Time frame: baseline, week 3 and week 12]
• The Boston Carpal Tunnel Syndrome Questionnaire [Time frame: baseline, week 3 and week 12]

Secondary outcome measures (5)

• Hand grip strength [Time frame: baseline, week 3 and week 12]
• Finger pinch strength [Time frame: baseline, week 3 and week 12]
• Douleur Neuropathique 4 [Time frame: baseline, week 3 and week 12]
• Quick DASH Score [Time frame: baseline, week 3 and week 12]
• Ultrasonographic evaluation of the median nerve [Time frame: baseline, week 3 and week 12]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Konya Beyhekim Training and Research Hospital — Konya

Identifiers

NCT: NCT06986668 · KonyaBeyhekimTRH9188

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗