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

NCT06658886 | Recruiting

• 1 other identifier: BeylikduzuStateH9
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Median nerve distal motor latency

  0 day, 4th week and 12th week

• Median nerve distal sensory latency

  0 day, 4th week and 12th week

• Sensory nerve conduction velocity

  0 day, 4th week and 12th week

• Motor nerve conduction velocity

  0 day, 4th week and 12th week

• Sensory nerve action potential amplitude

  0 day, 4th week and 12th week

Study Arms (2)

Paraffin treatment group

Patients with carpal tunnel syndrome who have received paraffin therapy

Other: No intervention

Injection group

Patients with carpal tunnel syndrome who have applied ultrasound-guided steroid injection

Other: No intervention

Interventions

No intervention OTHER

No intervention

Injection group; Paraffin treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Mild and moderate carpal tunnel syndrome

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beylikduzu State Hospital: lead

Study Sites (1)

Beylikdüzü State Hospital

Istanbul, Beylikdüzü, 34147, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Central Study Contacts

Büşra Şirin Ahısha, MD

CONTACT

(0212) 856 27 40; bsrn080@gmail.com

Büşra Şirin Ahısha

CONTACT

02124443322; bsrn080@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 26, 2024
• Study Start: November 10, 2024
• Primary Completion: February 25, 2025
• Study Completion: February 25, 2025
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)