Comparison of the Efficacy of Ultrasound-Guided Corticosteroid Injection and Paraffin Therapy in Carpal Tunnel Syndrome

The aim of this study is to compare the efficacy of paraffin therapy, a physical therapy modality, and ultrasound-guided corticosteroid injection in the treatment of carpal tunnel syndrome, the most common entrapment neuropathy. By doing so, the study will evaluate the effectiveness and feasibility of these two alternative, low-side-effect treatments for managing this frequently encountered condition.

Study Overview

• Status: Recruiting
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Other: No intervention

Detailed Description

A total of 46 patients, aged 18-65, diagnosed with mild to moderate carpal tunnel syndrome based on electrophysiological studies, will be included in the study.Pain levels will be assessed using the Visual Analog Scale (VAS), and functional impairment will be measured with the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ). Electrophysiological evaluations will be performed by a neurology specialist at the 1st and 3rd month follow-ups outside of working hours and without being billed to the Social Security Institution (SGK). VAS, BCTQ scores, and electrophysiological parameters will be evaluated at baseline, and at the 4th and 12th-week follow-ups post-treatment. Electrophysiological measurements will include median nerve distal motor latency (MMNDL), median nerve distal sensory latency (MNSDL), sensory nerve conduction velocity (SNCV), compound muscle action potential (CMAP), and sensory nerve action potential (SNAP) amplitudes.

• Study Type: Observational
• Enrollment (Estimated): 46

Contacts and Locations

• Study Contact: Name: Büşra Şirin Ahısha, MD; Phone Number: (0212) 856 27 40; Email: bsrn080@gmail.com
• Study Contact Backup: Name: Büşra Şirin Ahısha; Phone Number: 02124443322; Email: bsrn080@gmail.com

Study Locations

• Turkey
  • Beylikdüzü
    • Istanbul, Beylikdüzü, Turkey, 34147
      • Recruiting
      • Beylikduzu State Hospital
      • Contact: Büşra Şirin; Phone Number: 02124443322; Email: bsrn080@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Mild and moderate carpal tunnel syndrome

Description

Inclusion Criteria:

• Patients aged 18-65.
• Diagnosed with mild to moderate carpal tunnel syndrome based on electrophysiological studies.
• Received either ultrasound-guided corticosteroid injection or paraffin therapy.
• Symptoms persisting for at least 3 months.

Exclusion Criteria:

• Diagnosis of other conditions causing neuropathic symptoms (e.g., polyneuropathy, brachial plexopathy, thoracic outlet syndrome).
• History of previous injection or surgery for carpal tunnel syndrome.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Paraffin treatment group; Patients with carpal tunnel syndrome who have received paraffin therapy	Other: No intervention; No intervention
Injection group; Patients with carpal tunnel syndrome who have applied ultrasound-guided steroid injection	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS):	The VAS will be used to measure pain intensity. Patients will mark their pain level on a 10 cm scale, where 0 represents "no pain" and 10 represents the "worst imaginable pain." This will be evaluated at baseline, and at the 4th and 12th weeks post-treatment.	0 day, 4th week and 12th week
Boston Carpal Tunnel Syndrome Questionnaire Symptom Severity Scale (BCTQ-SSS)	The SSS assesses the severity of carpal tunnel symptoms such as pain, tingling, and numbness. The total score for this scale ranges from a minimum of 11 to a maximum of 55. A lower score indicates mild or no symptoms, while a higher score suggests more severe symptoms. As the score increases, the severity of symptoms worsens, with a score closer to 55 reflecting a significantly greater impact on daily life.	0 day, 4th week and 12th week
Boston Carpal Tunnel Syndrome Questionnaire Functional Status Scale (BCTQ-FSS)	The SSS assesses the severity of carpal tunnel symptoms such as pain, tingling, and numbness. The total score for this scale ranges from a minimum of 11 to a maximum of 55. A lower score indicates mild or no symptoms, while a higher score suggests more severe symptoms. As the score increases, the severity of symptoms worsens, with a score closer to 55 reflecting a significantly greater impact on daily life.	0 day, 4th week and 12th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median nerve distal motor latency	It is a finding from electrophysiological evaluation	0 day, 4th week and 12th week
Median nerve distal sensory latency	It is a finding from electrophysiological evaluation	0 day, 4th week and 12th week
Sensory nerve conduction velocity	It is a finding from electrophysiological evaluation	0 day, 4th week and 12th week
Motor nerve conduction velocity	It is a finding from electrophysiological evaluation	0 day, 4th week and 12th week
Sensory nerve action potential amplitude	It is a finding from electrophysiological evaluation	0 day, 4th week and 12th week
Motor nerve action potential amplitude	It is a finding from electrophysiological evaluation	0 day, 4th week and 12th week

Collaborators and Investigators

• Sponsor: Beylikduzu State Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2024
• Primary Completion (Estimated): February 25, 2025
• Study Completion (Estimated): February 25, 2025

Study Registration Dates

• First Submitted: October 22, 2024
• First Submitted That Met QC Criteria: October 23, 2024
• First Posted (Actual): October 26, 2024

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Pathologic Processes; Neuromuscular Diseases; Peripheral Nervous System Diseases; Disease; Median Neuropathy; Mononeuropathies; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: BeylikduzuStateH9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No