Treatment Intervention of Patients With Carpal Tunnel Syndrome (CTS)

Treatment Effects of Transcutaneous Electrical Nerve Stimulation and Kinesio Taping on Hand Functions for Patients With Carpal Tunnel Syndrome

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,

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Other: kinesio taping (KT)

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 406040
    • China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: kinesio taping (KT) group; Three precut KT I strips with a width of 5 cm were used. The first strip is applied with the subject's wrist in fully extended hand position. Middle and ring fingers through the holes with the base of the tape as anchored to the knuckles, and then the tape was applied with 15%-25% tension covering the palm and the wrist, and the remainder of the tape without any tension from the wrist up to the forearm. The same process is repeated for the second I-strip, which was applied from the dorsum of the hand to wrist while the wrist in a downward flexed position. The final strip was applied to the carpal tunnel region with 25%-35% tension.	Other: kinesio taping (KT); Other Names: transcutaneous electrical nerve stimulation (TENS)
Active Comparator: transcutaneous electrical nerve stimulation (TENS) group; A portable TENS unit (Gem-Stim, Gemore Technology Co., LTD. Taiwan) was used, and delivered a bi-phasic symmetric waveform at a continuous frequency of 100 Hz and phase duration of 200 µsec. The intensity was gradually adjusted up to a strong but comfortable l level, as reported by the subject. Two electrodes were placed 2 cm apart, respectively attached to the carpal ligament of the affected side and the proximal end along the direction of the median nerve.	Other: kinesio taping (KT); Other Names: transcutaneous electrical nerve stimulation (TENS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Collaborators: Ministry of Science and Technology, Taiwan
• Investigators: Principal Investigator: Wei-Hsien Hong, PhD, China Medical University, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2014
• Primary Completion (Actual): November 30, 2015
• Study Completion (Actual): December 30, 2015

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 18, 2024

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: kinesio taping; Carpal tunnel syndrome; paresthesia; home-based treatment program; thenar eminence
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: CMUH103-REC3-072

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