Validation of the Polish Version of the Boston Carpal Tunnel Syndrome Questionnaire

NCT03782558 | Completed

• 1 other identifier: JagiellonianU60
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 2

Brief Summary

Carpal tunnel syndrome is the most common compression neuropathy. The compression of the median nerve occurs in the carpal tunnel and results in pain and other unpleasant sensations in hand and wrist. In more advanced stage, weakness and wasting of the thenar and other muscles innervated by median nerve occurs, which may lead to permanent impairment of manual performance. The Boston carpal tunnel questionnaire (BCTQ) is one of the most commonly used tools for monitoring of the disease progression and of the effect of therapy. Originally created in English, it has been translated into many languages and subsequently validated. Recently the Polish version has been created and the purpose of this study is to validate it.

Conditions

Carpal Tunnel Syndrome

Keywords

carpal tunnel syndrome; pBCTQ; validation; nerve conduction study

Outcome Measures

Primary Outcomes (3)

• Internal Consistency

  Consistency between two subscales of pBCTQ (Symptom severity scale and Functional status scale) will be evaluated using Cronbach alfa test.

  Through study completion, an average of six months.

• Validity

  Validity will be tested by calculating the correlation of the subscore of each of two parts of the questionnaire with the electrophysiologic, six-grade severity level according to Padua et al. (1997).

  Through study completion, an average of six months.

• Reactivity: Correlation between changes in pBCTQ and electrophysiologic severity of CTS

  The reactivity will be evaluated as correlation between change in electrophysiologic severity level of CTS and changes in both pBCTQ subscales after treatment.

  Before treatment and then three months after surgical treatment of CTS

Study Arms (1)

Patients with CTS

Surgical transection of transverse ligament

Procedure: Surgical transection of transverse ligament

Interventions

Surgical transection of transverse ligament PROCEDURE

Standard therapy for CTS. An incision is made at the base of the palm of the hand. Then the transverse ligament is cut, which releases the compression of the median nerve and improves the symptoms.

Also known as: Surgical transection of flexor retinaculum

Patients with CTS

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from the patients referred to Krakowska Akademia Neurologii Centrum Neurologii Klinicznej for electrohysiologic verification of their initial, clinical diagnosis of CTS. After the electrophysiology confirms the CTS, the patient will be asked if she/he would like to take part in the study.

You may qualify if:

• Presence of at least one symptom within hand and / or wrist, from the following: paresthesias, sensory loss, tingling, burning sensation, impression of swelling.
• Electrophysiologic confirmation of CTS, which will base on the abnormal latency difference in sensory or motor conduction between median and ulnar nerve or on sensory conduction slowing in median nerve, or on the prolongation of distal motor latency of the median nerve.
• (bilateral CTS will be included. pBCTQ will be filled out separately for each hand and the outcomes wil be measured separately for each hand).

You may not qualify if:

• Clinical signs or symptoms and /or electrophysiologic results indicative of more generalized peripheral neuropathy.
• Presence of conditions, which may lead to the development of peripheral neuropathy such as diabetes, renal insufficiency, hypothyroidism or amyloidosis.
• Presence of conditions, which may clinically resemble CTS, such as cervical radiculopathy or myelopathy or thoracic outlet syndrome

Sponsors & Collaborators

• Jakub Antczak: lead
• Centrum Neurologii Klinicznej Krakowska Akademia Neurologii: collaborator

Study Sites (2)

Krakowska Akademia Neurologii Centrum Neurologii Klinicznej

Krakow, 31505, Poland

Location

Jagiellonian University Medical College

Krakow, Poland

Location

Related Publications (2)

• Padua L, LoMonaco M, Gregori B, Valente EM, Padua R, Tonali P. Neurophysiological classification and sensitivity in 500 carpal tunnel syndrome hands. Acta Neurol Scand. 1997 Oct;96(4):211-7. doi: 10.1111/j.1600-0404.1997.tb00271.x.

  PMID: 9325471 BACKGROUND

• Levine DW, Simmons BP, Koris MJ, Daltroy LH, Hohl GG, Fossel AH, Katz JN. A self-administered questionnaire for the assessment of severity of symptoms and functional status in carpal tunnel syndrome. J Bone Joint Surg Am. 1993 Nov;75(11):1585-92. doi: 10.2106/00004623-199311000-00002.

  PMID: 8245050 BACKGROUND

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

Study Officials

• Jakub Antczak, MD

  Jagiellonian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 8, 2018
• First Posted: December 20, 2018
• Study Start: January 22, 2019
• Primary Completion: September 1, 2023
• Study Completion: September 9, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

PL (2)