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NCT Number: NCT03360344

Non-surgical Intervention for Carpal Tunnel Syndrome

This randomized controlled trial graduate student research study will explore the effect of non-surgical intervention of the dorsal application of Kinesio Tape for carpal tunnel syndrome, and forearm wrist hand pain.

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Key information

Conditions

Carpal Tunnel Syndrome, Susceptibility to Carpal Tunnel Syndrome Cumulative Trauma Disorders Hypesthesia Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Sensation Disorders Signs and Symptoms Somatosensory Disorders Sprains and Strains Wounds and Injuries

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University

Loma Linda, California, 92350, United States

About this study

This randomized controlled trial graduate student research study will explore the effect of non-surgical intervention of the dorsal application of Kinesio Tape for carpal tunnel syndrome, and forearm wrist hand pain. Little evidence exists for an effective non-surgical intervention. Semi-structured interviews will be conducted to explore changes in occupational performance and compliance in order to understand if Kinesio Tape contributed to results and if so, how the participants perceived the interventions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults > 18 years of age
  • Fluent in English
  • Report signs and symptoms of carpal tunnel syndrome
  • Pain, numbness, and tingling of the forearm, wrist, or hand, which worsen at night
  • Demonstrate positive Phalen's Test or Tinel's Test of the affected extremity

Exclusion criteria

  • Currently receiving treatment for carpal tunnel syndrome
  • History of surgical carpal tunnel release
  • Pregnant
  • Diabetes not controlled by medication
  • Radiculopathy ie: cervical radiculopathy, diabetic radiculopathy
  • Thoracic outlet syndrome
  • Allergy to adhesives or compromised skin integrity
  • Past history of traumatic event, surgery, or congenital impairment of the forearm, wrist, or hand

Treatment and study plan

Kinesio 12 inch Tape

Device

Kinesio Tape approximately 12-inch strip will be applied to the dorsal surface of the forearm of the affected side for three-day increments over three weeks of the study.

Kinesio 4 inch Tape

Device

Kinesio Tape for the control group will be a 4 inch Kinesio Tape applied to the scapular spine for three day increments over three weeks of the study.

Cock up Splint and Lumbrical exercises

Device

A general cock-up splint will be supplied, fitted, and checked on each of the four return visits by the researchers. Lumbrical exercises are also used and consist of active joint ranges for the wrist and hand. The exercises will be demonstrated by the researchers for 3-sets of 10 times each, daily, to be recorded in a log by the participants.

Primary outcomes

  1. Numerical Pain Rating Scale (NRS Pain)

    Time frame: change between baseline and 3 weeks

    Numerical Pain Rating Scale (NRS Pain) involves patient circling a number from 0-10 with "0" meaning no pain and "5" moderate pain, and "10" is worst possible pain. The NRS is a segmented numeric scale, which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. Higher scores indicate greater pain intensity.

  2. Visual Analog Scale for Pain (VAS Pain)

    Time frame: 3 weeks

    The Visual Analogue Scale (VAS) is unidimensional measure of pain intensity, which has been widely used in diverse adult populations. The VAS measures participants perception of pain on a continuous scale. Individuals place a mark on a 10cm-long line. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. These are measured every 3 days for 3 weeks from baseline in the forearm, wrist and fingers.

Secondary outcomes

  1. Grip Strength and Pinch Strength

    Time frame: change between baseline and 3 weeks

    Grip strength is measured by Jamar Dynamometer hydraulic gauge following standard protocol. A Jamar hydraulic pinch meter gauge is used to measure finger strength in the following positions: Lateral pinch, pad to pad, and 3 Jaw-chuck pinch positions are used. Grip and pinch strength will be measured every 3 days for 3 weeks from baseline.

  2. Boston Carpal Tunnel Questionnaire Symptom Severity (BCTQ SS)

    Time frame: change between baseline and 3 weeks

    The Boston Carpal Tunnel Questionnaire (BCTQ SS) is a standardised, patient-based outcome measure of symptom severity in patients with carpal tunnel syndrome. The questionnaire has 11 questions and uses a five-point rating scale. Each scale generates a final score (sum of individual scores divided by number of items) which ranges from 1 to 5, with a higher score indicating greater disability. It is measured every 3 days for 3 weeks from baseline.

  3. Boston Carpal Tunnel Questionnaire Functional Scale (BCTQ FS)

    Time frame: 3-weeks

    The Boston Carpal Tunnel Questionnaire Functional Scale (BCTQ FS) is self report 8-item questionnarie on functional activities for individuals with carpal tunnel, which have to be rated for degree of difficulty on a five-point scale. Each scale generates a final score (sum of individual scores divided by number of items) which ranges from 1 to 5, with a higher score indicating greater disability. It is measured every 3 days for 3 weeks from baseline.

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

Effects on Occupational Performance Through Dorsal Application of Kinesio Tape for Musculoskeletal Disorder - Carpal Tunnel Syndrome

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 4, 2017
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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