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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06464809
Other study ID # CMUH103-REC3-072
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 24, 2014
Est. completion date December 30, 2015

Study information

Verified date June 2024
Source China Medical University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study was to investigate the effectiveness of KT versus TENS combining self-myofascial stretching in treatment of CTS through clinical, functional assessment and sensory measurements. Primary hypothesis The KT group has a more substantial improvement in hand grip, pain relief, enhancing proprioceptive sensitivity and dexterity compare to the TENS group. treatment program,


Description:

Objective: To compare the effectiveness of a home-based treatment program involving Kinesio taping (KT) or transcutaneous electrical nerve stimulation (TENS) among carpal tunnel syndrome (CTS) patients. Methods: 30 participants with CTS were enrolled, age range, 30 to 60 years. The participants who met the inclusion criteria were randomized into one of two treatment groups: KT group and TENS group. Participants were blinded to the treatments used in the other group. Patients with CTS received aforementioned treatments compared with reliable qualitative and quantitative evaluation tools before and after 4-week treatment, as well as at a additional 4-week follow-up. The main parameters include the Symptom Severity Scale (SSS) and Functional Status Scale (FSS), hand grip and key pinch strengths, two-point discrimination (2PD), Modified Moberg pick-up test (MMPUT), and Pain assessment (visual analog scale, VAS).


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 30, 2015
Est. primary completion date November 30, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 60 Years
Eligibility Inclusion Criteria: - numbness and tingling in the median nerve territory of the hand. - nocturnal paresthesia. - induction test (Tinel's sign and Phalen's test) showing a positive finding., - is defined as mild and moderate CTS according to nerve conduction studies (NCSs). Exclusion Criteria: - is defined severe CTS symptoms. - are currently pregnant or have any secondary entrapment neuropathy (e.g., diabetes, inflammatory arthritis, hypothyroidism, previous wrist trauma). - cervical radiculopathy or polyneuropathy. - previous history of carpal tunnel decompression surgery. - corticosteroid injection into the carpal tunnel.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
kinesio taping (KT)


Locations

Country Name City State
Taiwan China Medical University Taichung

Sponsors (2)

Lead Sponsor Collaborator
China Medical University Hospital Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The SSS and FSS of the Boston Carpal Tunnel Questionnaire (BCTQ) Assess symptoms and functional status. The SSS subscale includes 11 items assessing pain, paresthesia, numbness, weakness, nocturnal symptoms and over-all functional status. The FSS subscale includes 8 items assessing the hand function during common daily activities. Each item is scored on a 5-point scale (1-5), from 1(no symptoms) to 5 (the worst symptoms) for SSS, and from 1 (no difficulty) to 5 (cannot perform the activity at all) for FSS. The overall SSS and FSS scores are calculated as the mean of the scores for 11 and 8 individual items respectively, such that the higher the score obtained, the worse the SSS or FSS. pre-intervention, 4-week intervention, and 4-week follow-up.
Primary Hand grip and key pinch strengths pinch strength included palmar, three-jaw chuck, tip, and lateral pinches. pre-intervention, 4-week intervention, and 4-week follow-up.
Primary Two-point discrimination (2PD) cutaneous sensory perception threshold. The larger the value of distance, the worse the sensory ability. pre-intervention, 4-week intervention, and 4-week follow-up.
Primary Modified Moberg pick-up test (MMPUT) hand dexterity. The shorter the time, the more dexterity the hand. pre-intervention, 4-week intervention, and 4-week follow-up.
Primary The visual analog scale (VAS) pain measurement. 100 mm straight line, with 0 mm on the far left and 100 mm on the far right, 0 mm positions It is not painful, and 100 mm is extremely painful. pre-intervention, 4-week intervention, and 4-week follow-up.
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