Effects on Occupational Performance Through Dorsal Application of Kinesio Tape for Musculoskeletal Disorder - Carpal Tunnel Syndrome
Phase: NA
Conditions: Carpal Tunnel Syndrome, Susceptibility to
Sponsor: Loma Linda University

Official title: Non-surgical Intervention for Carpal Tunnel 
Syndrome
NCT number: 03360344
Statistical analysis plan is included.
IRB Approval Date: October 2, 2017

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1. PROTOCOL INFORMATION
Title:  Non-surgical Intervention for Carpal Tunnel Syndrome
Funding Source:  School of Allied Health Professions
Version Date of Protocol:  October 2, 2017
Phase of Study:  November 2017 – November 2018
2. PRINCIPAL INVESTIGATOR INFORMATION
PI:  Heather Javaherian-Dysinger, OTD, OTR/L, Loma Linda University School of Allied
Health Professions
Name & Address of Research Institution:
Loma Linda University
School of Allied Health Professions
Nichol Hall, A901
Loma Linda, CA 92350
Phone:  909-558-5828 (ext 47325)
Fax: 909-558-0239
Email:  hjavaherian@llu.edu
3. STUDY PERSONNEL
Donnamarie Krause, MS, OTR/L. PhD Candidate
Noha Daher, DrPH, Committee Member
Shawn Roll, PhD, Committee Member
Nicholas Cvjetkovic, OTS, ATC, BS, Student research assistant
Michael Bradley Galloway, OTS, BS, Student research assistant
Diane Ganev, OTS, BA, Student research assistant
Kristin Kolack, OTS, BS, Student research assistant
4. STUDY INFORMATION
The location of the research will take place on scheduled dates at the Loma Linda University
School of Allied Health Professions campus, 11139 Anderson Street, Loma Linda, California
and Stanbridge University campus on 2041 Business Center Drive in Irvine, California.
Expected start date is December 1, 2017 and expected end date of research is December 1,
2018.  The research consists of a mixed method design and includes a single blind
randomized control trial with a repeated measure design. A qualitative element includes
semi-structured interviews of participants.

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5.  INCLUSION/EXCLUSION CRITERIA 
 
      INCLUSION 
• 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 
• 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 
 
 
6.  SUBJECT RECRUITMENT & SCREENING 
 
     Based on a power analysis, 64 participants are needed with an expected attrition rate of 20% 
 
increasing the total number of participants to 78, with 26 in each of three groups.  
 
Participants will be fluent in English, males and females age18 years and older. The study 
 
will include participants from any race or ethnicity that meet eligibility criteria and 
 
demonstrate a positive Phalen’s Test or positive Tinel’s Test. The study population includes 
 
individuals who have symptoms of or have received a diagnosis of carpal tunnel syndrome, 
 
or experience forearm wrist hand pain and currently not receiving treatment. If participant 
 
has symptoms in both extremities, the researcher will use each extremity as a separate unit 
 
and apply corresponding intervention to both extremities.   
 
 
 
Participants will be recruited using snowballing and judgmental sampling via word-of-mouth, 
 
flyers, emails, and social media with a $5.00 gift card provided per visit for each of the five 
 
visits for the study.  Flyers will be distributed throughout the Southern California area due to 
 
proximity but participants may come from any region if satisfying inclusion criteria and time 
 
commitment.  Flyers will be placed in, but not limited to, common public places such as pet 
 
grooming places, community postings, manufacturing facilities, clinics, hair stylists, dental 
 
hygienists, sonographers, office buildings, and more.  The principal investigator or 
 
appropriate personnel for Loma Linda University, and by the student researcher or appropriate 
 
personnel for the Stanbridge University access will acquire email addresses of potential 
 
participants.  Specific social media outlets will include posting on but not limited to, 
 
Facebook, Instagram, and Twitter, with a website that will be accessed at: 
 
carpaltunnelstudy.wordpress.com for information.  The contact information of the principal 

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investigator and student researcher will be available on the flyer with an invitation to contact 
 
researchers with any questions about the study. 
 
 
7.  INFORMED CONSENT PROCESS 
 
 
A student researcher will facilitate the informed consent process with the eligible 
 
participants once participants have agreed to take part in the study.  The informed consent 
 
process will take place in a designated private room at Loma Linda University School of 
 
Allied Health Professions and in a private classroom at Stanbridge University with time 
 
allotted for questions from the participant.  HIPPA compliance forms will be included in the 
 
informed consent  process and a copy of the participants’ Bill of Rights.  All research records 
 
will be secured by placing them in a locked cabinet in a locked office of the principal 
 
investigator and/or student researcher. 
 
8.  STUDY DESIGN 
 
 
a.  Background or rational for this study 
 
 
Carpal tunnel syndrome, a common neuropathy of the median nerve may be caused from an 
 
increased pressure of the carpal tunnel, prolonged exposure to hand-arm vibrations, a 
 
combination of repetitive hand use or hand force, and in recent years has expanded to include 
 
the use of computers and similar devices (Ali, Battecha, & Mansour, 2013). It is believed 
 
chronic repetitive use of the fingers and wrist may generate a shearing  between the carpal 
 
tunnel, the median nerve, and the flexor tendons.  
 
 
Carpal tunnel syndrome is the most frequent type of injury and makes up 41% of all 
 
identified upper extremity musculoskeletal disorders (Roll, 2016; United States Department 
 
of Labor, 2015).  Annually $15 – 18 billion dollars are spent in costs related to upper 
 
extremity musculoskeletal disorder and carpal tunnel syndrome (United States Department of 
 
Labor, 2015).  Commonly related to repetitive work exposures, prevalence increases with age 
 
and is three to one more prevalent in females. The targeted population of carpal tunnel 
 
syndrome  is highly associated with overuse of the upper extremities (Thomsen, Gerr, & 
 
Atroshi, 2008). 
 
 
Individuals who work in highly repetitive work environments have a significant chance of 
 
being diagnosed with carpal tunnel syndrome.  Jobs in manufacturing, the service industry, 
 
and nursing are identified among this population.  However, evidence now includes office 
 
workers as Coggon et al. (2013) found individuals who use computers for four hours a 
 
day also experience a high incidence of carpal tunnel syndrome.  Goldfarb (2016) furthered 
 
the Coggon et al. (2013) study with findings that those who use computers and work 12-hour 
 
days over an eight-year span are primarily the at-risk population, putting students at the 
 
highest risk.   
 

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According to the Occupational Therapy Practice Framework, it is within Occupational 
 
Therapy’s domain to intervene in musculoskeletal disorders as it impairs body function.  
 
Established treatment strategies for carpal tunnel syndrome include surgical interventions and 
 
non-surgical interventions; however, in a systematic review, Roll & Hardison (2017) found 
 
no  standardized protocol exists for management and treatment of carpal tunnel syndrome.  
 
Both surgical and non-surgical interventions have been found to have similar results and 
 
governmental regulation, along with decreased reimbursement are putting demands on early 
 
worksite intervention (Lysaght et al., 2010).  The most common accepted non-surgical 
 
protocol for carpal tunnel syndrome include lumbrical stretching exercises and a general 
 
cock-up splint, with one study reporting symptom relief up to 24-weeks (Baker et al., 2012; 
 
Manente et al., 2012). None of the accepted protocols take into consideration new 
 
evidence that suggests the wrist positioned in neutral and fingers supported in extension, 
 
provides the best outcomes for individuals with carpal tunnel syndrome (Bulut et al., 2015), 
 
and leaves the issue of splint compliance unaddressed.  Clearly, a new intervention for carpal 
 
tunnel syndrome is needed. 
 
Kinesio Tape is transitioning from the sports arena into rehabilitation as a modality for pain, 
increased activation of the lymphatic system, as an endogenic analgesic, and to correct 
musculoskeletal alignment (Kase et al. 1998).  Fourteen peer-reviewed studies had been 
conducted for lower extremity pain and function, with few studies of Kinesio Tape on the 
upper extremities.  Common application protocol for carpal tunnel syndrome is on the flexor 
side of the wrist and hands.  The Kase accepted method of application to the flexor surface of 
the wrist has face validity only.  To the best of our knowledge there are no studies that exist 
on the dorsal application of Kinesio Tape to facilitate wrist neutral and finger extension.   
 
The primary purpose of this randomized controlled trial graduate student research study is to 
explore the effect of dorsal application of Kinesio Tape on occupational performance as 
measured by pain, strength, and function of individuals with carpal tunnel syndrome forearm 
wrist hand pain as compared to the usual and accepted most common non-surgical 
intervention of lumbrical stretching exercises and general cockup splint. The secondary 
purpose is to explore changes in occupational performance through semi-structured 
interviews in order to understand if Kinesio Tape contributed to results and if so, how. In 
order to help us understand how the participants perceived the interventions, the third 
purpose is to explore concepts of adherence to interventions with carpal tunnel syndrome. 
 
 
 
 
 
b.  Objectives 
 
 
 
1.  Determine if the dorsal application of Kinesio Tape applied to the wrist extensors  
 
 
 
for  individuals with carpal tunnel syndrome and forearm wrist hand pain makes a  
 
 
 
difference in occupational performance as measured by pain, strength, and function.  
 
 
 
2.  Explore the perspectives of participants to understand if Kinesio Tape   
 
 
 
 
contributed to changes in occupational performance, and if so, how. 
 

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3.  Explore concepts of adherence to interventions with carpal tunnel syndrome. 
 
 
  
 
c. Procedures involved (Research Interventions) 
 
The following procedures will be used for this multi-method study design that consists of a 
randomized control trial and descriptive qualitative study, upon IRB approval: 
 
 
1.  Recruit via snowballing, word-of-mouth, flyers, emails, and social media 
  
 
      (See Appendix A) 
 
 
 
2.  Respond to study interest via Phone Script to answer questions regarding the study  
 
(See Appendix B) and set up a meeting time to review consent and initiate study  
 
procedures. 
 
 
 
3.  Review Informed Consent, HIPPA documents, and  
 
Patient’s Bill of Rights and obtain consent from those interested in participating in 
 
study. 
 
 
 
4.  Screen participants for inclusion criteria by administering  
 
 
 
the Phalen’s Test or Tinel’s Test (Appendix C). 
 
 
 
5.  Administer Demographic questionnaire (Appendix D). 
 
 
 
6.  Administer baseline Week One Visit One Boston Carpal Tunnel Questionnaire,  
 
 
 
Numeric Pain Rating Scale, Visual Analogue Scale (Appendices E – F - G).  If  
 
 
 
participant has symptoms in both extremities, the researcher will use each extremity  
 
 
 
as a separate unit and apply corresponding intervention to both extremities.   
 
 
 
7.  Collect Week One Visit One Baseline Grip and Pinch measurements (Appendix H). 
 
 
 
8.   Randomly assign participants using a random number generator, to one of three  
 
 
 
groups:  
Intervention group, control group, or usual protocol group.  A script will be used to 
control for bias and ensure consistency between groups.   
 
 
 
 
 
 
Intervention group:   
 
The student researcher and/or student research assistants who have been trained in  
 
Kinesio Tape and application procedures will apply the baseline dorsal application of 
 
Kinesio Tape according to determined protocol.  The Kinesio Tape will be measured 
 
along the participant’s lateral epicondyle to metacarpophalanges, the Kinesio Tape 
 
then bifurcated.  Anchor Kinesio Tape on the dorsal side at the musculotendinous 
 
juncture to digits 1 and 5, just past the carpalmetacarpophalangeal joint of digit 1 and 
 
metacarpophalange of joint 5, wrist in flexion to stretch the skin, paper off tension 
 
(10%).  Kinesio Tape application to digits 1 and 5 with carpalmetacarpophalangeal 
 
and metacarpophalange flexion during application.  Two space correction pieces 

 6
 
applied to both the extensor and flexor surface at 75% stretch, then radially deviate, 
 
smooth edges, ulnarly deviate, smooth edges, repeat.  
 
 
 
A handout with Kinesio Tape Removal Instructions will be provided (Appendix I).  
 
A symptom journal will be provided with instructions to complete daily (Appendix J). 
 
A script will be used with participants (Appendix K).  
 
 
 
 
 
 
Control group:   
 
The student researcher and/or student research assistants will apply the Sham   
 
application of Kinesio Tape, a four-inch strip of Kinesio Tape to the participants’  
 
shoulder (scapular spine).  A handout with Kinesio Tape Removal Instructions will be 
 
provided (Appendix I).  A symptom journal will be provided with instructions to 
 
complete daily (Appendix J). A script will be used with participants (Appendix K).  
 
 
 
 
 
 
Usual protocol group:  
 
 
The student researcher and/or student research assistants will provide a general wrist  
 
 
cock up splint with instructions to wear nightly and record compliance in a Splint  
 
 
and Exercise journal (Appendix L).  Wrist Lumbrical exercises will be demonstrated  
 
 
by the student researcher or student research assistants and a handout with  
 
 
 
instructions provided (Appendix M). A symptom journal will be provided with  
 
 
instructions to complete daily (Appendix J). A script will be used with participants  
 
 
(Appendix K). 
 
 
 
9.  Week One Visit Two a student researcher and/or student research assistants will  
 
 
 
remove Kinesio Tape, check splints, and collect symptom journals and the Usual  
 
 
 
protocol group Splint-wearing and Exercise journal.  Participants will complete  
 
 
 
Boston Carpal Tunnel Questionnaire, Numeric Pain Rating Scale, Visual Analogue  
 
 
 
Scale.  Grip and Pinch measurements will be recorded. 
 
 
 
 
Student researcher and/or student research assistants will re-apply Kinesio Tape and 
check splint and exercises resumed with the Usual protocol group.  
 
 
 
 
 
Total exposure to application and removal of Kinesio Tape is four times as  
 
 
 
participants return every third day of Weeks One and Two. 
 
 
 
10. Week Two Visit Three a student researcher and/or student research assistants will  
 
 
 
remove Kinesio Tape, check splints, and collect symptom journals and the Usual  
 
 
 
protocol group Splint-wearing and Exercise journal.  Participants will complete  
 
 
 
Boston Carpal Tunnel Questionnaire, Numeric Pain Rating Scale, Visual Analogue  
 
 
 
Scale.  Grip and Pinch measurements will be recorded. 
 
 
 
 
 
 
 
Student researcher and/or student research assistants will re-apply Kinesio Tape and 
 
 
 
check splint and exercises resumed with the Usual protocol group.  
 
 
 
11. Week Two Visit Four a student researcher and/or student research assistants will  
 
 
 
remove Kinesio Tape, check splints, and collect symptom journals and the Usual  

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protocol group Splint-wearing and Exercise journal.  Participants will   
 
 
 
 
complete Boston Carpal Tunnel Questionnaire, Numeric Pain Rating Scale, Visual  
 
 
 
Analogue Scale.  Grip and Pinch measurements will be recorded. 
 
 
 
 
Student researcher and/or student research assistants will re-apply Kinesio Tape and 
 
 
 
check splint and exercises resumed with the Accepted protocol group.  
 
 
 
12. Week Three Visit Five a student researcher and/or student research assistants will  
 
 
 
remove Kinesio Tape, check splints, and collect symptom journals and the Usual  
 
 
 
protocol group Splint-wearing and Exercise journal.  Participants  
 
 
 
 
 
will complete Boston Carpal Tunnel Questionnaire, Numeric Pain Rating Scale,  
 
 
 
Visual Analogue Scale.  Grip and Pinch measurements will be recorded.  
 
 
 
13. Up to 26 participants from the Intervention group will be invited to participate in a 
30-minute semi-structured audio-recorded interview with student researcher 
(Appendix N).  
 
 
 
14. Email Reminder Script regarding study date (Appendix O) 
 
 
 
15.  See Timeline (Appendix P) 
 
 
 
d.  Concise review of literature that supports the rationale, objectives, and methodology of  
 
 
the proposed study. 
 
An upper extremity musculoskeletal disorder affect working populations worldwide with 
evidence indicating 20% - 30% experience symptoms, and is considered the second most 
common cause of worldwide disability (Luckhaupt et al., 2013; Murray et al., 2012; 2013).  
In the United States alone, upper extremity musculoskeletal disorders are the second most 
common diagnosis, just behind low back injury for missed days of work, and accounted for 
34% of all work-related injuries in 2015, according to the U.S. Bureau of Labor Statistics 
(2015), but less than 2% of the national Institute for Heath budget is allocated to 
musculoskeletal disorders (Weinstein, 2016).  Occupational performance is the process of 
assisting clients in becoming actively engaged in their life activities while developing healthy 
behaviors and minimizing costs (Baum & Law, 1997).  An upper extremity musculoskeletal 
disorder impairs an individual’s ability to work, complete daily self-care tasks of both gross 
and fine motor (United States Bureau of Labor Statistics, 2015).   
 
The most common musculoskeletal disorder of the upper extremity is Carpal Tunnel 
Syndrome and is 41% all off upper extremity repetitive movement disorders (Roll, 2016). 
Occupational therapists historically have had a role in treating upper extremity 
musculoskeletal disorder conditions and holistically address the link between reductions in 
impairment to functional tasks (Roll, 2017).  According to Roll (2017) studies of the upper 
extremity have evaluated orthosis and modalities to increase body structure and occupation 
as specific interventions for upper extremity musculoskeletal disorder of carpal tunnel 
syndrome; however, there is a lack of homogeneity within publications. Musculoskeletal 
disorders and carpal tunnel syndrome are often treated by occupational therapists but in 

 8
separate departments (Roll, 2017), which cause problems for researchers and injured 
individuals alike. Traditionally Occupational Health Occupational Therapists provide 
interventions to individuals injured at work, often pre-surgically while Hand Occupational 
Therapists report treating individuals with carpal tunnel syndrome post-surgically.  These 
distinctions carry over into publications and research, though interventions and outcomes are 
the same.   
 
Diagnosis of carpal tunnel syndrome is confirmed through electromyography; however, 
medical personnel including Occupational Therapists assess carpal tunnel syndrome based on 
signs and symptoms and through an orthopedic special test known as the Wrist Flexion Test 
or the Phalen’s Test.  Evidence suggests Phalen’s Test and Tinel’s Test to be valid with high 
specificity, validity, and reliability. Denham et al. (2015) reported that specificity of the 
Phalen’s Test was 80% with confirmed diagnosis of carpal tunnel syndrome. Other studies 
indicate that the sensitivity of the Phalen Test and electromyography between 68% and 85% 
and 73% to 89% . Kotevoglu & Gulbahce-Saglam  (2005) found that there was a correlation 
of (r = 0.80, p<0.001) for the Phalen Test using diagnostic ultrasound and Tinel’s Test 
correlation factor of (r = 0.70, p<0.001). No standardized protocol for management and 
treatment of carpal tunnel syndrome exists; however, common established strategies consist 
of surgical or non-surgical interventions.  Surgical interventions are mostly positive but a 
recent study by Nanavati, Walker-Bone, Stanworth and Williams (2013) found almost one-
third reported difficulty completing activities of daily living or experienced a return of 
symptoms 28 days or more following surgery.   
 
Non-surgical interventions lack established uniform protocol according to a systematic 
review by Amini (2011), and Oiyun and MacDermid (2011) found an analysis of 
conservative approaches plateaued in effectiveness after three months.  The most common 
non-surgical intervention is splinting with evidence for either full-time or night depending on 
protocol and patient compliance with only mediocre effectiveness (Amini, 2011).  Recent 
evidence indicates finger position can influence properties of the median nerve with 
significant palmar bowing of the flexor retinaculum for finger extension and a flattening of 
the median nerve during the isometric squeeze grip (Nadar et al. (2013).  Bulut et al. (2015) 
found evidence that the wrist positioned in neutral and metacarpophalanges supported, 
provides the best outcomes, but is yet to be seen in clinical practice.  One non-surgical 
intervention transitioning from Sport Medicine into Rehabilitation is Kinesio Tape. 
 
Kinesio Tape is applied to the epidermis of the skin and by compression released on the 
nociceptors (pain receptors) provides input through the subcutaneous tissue layer to the 
body’s proprioceptive system according to Kase, Hashimoto and Okane (1998).  This 
hypodermic input influences pain, edema, and is able to provide musculoskeletal correction 
based on application (Kase et al, 1998).  Application ranges from injury management to 
muscle facilitation and include neurologic impairment interventions as well.  Brateanu (2009) 
elaborated on Kinesio Tape’s ability to be worn for several days, three to five, without 
reapplication and evidence of common applications for patellar pain syndrome, low back 
pain, and shoulder instability.  Few studies exist on upper extremity use of Kinesio Tape on 
forearm, wrist, hand pain and function, such as with carpal tunnel syndrome.  The Kase 
accepted method of Kinesio Tape application is on the flexor surface for musculoskeletal 

 9
disorder of carpal tunnel syndrome symptoms but has face validity only.  Kocjan (2016) in a 
randomized control trial of Kinesio Tape on the flexor side for carpal tunnel syndrome using 
a non-Kase method of application concluded no statistical significant results.  To the best of 
our knowledge no literature exists on the dorsal application of Kinesio tape for positioning 
the wrist in neutral, with the finger supported. The process of exploring the effects of Kinesio 
Tape on musculoskeletal disorders includes understanding participant’s issues of compliance 
as it relates to pain and non-surgical interventions. 
 
 
 
9.   DATA COLLECTION 
 
 
Data collection procedures on the affected extremity include psychometric assessments of 
 
pain, using the Numeric Pain Rating Scale and Visual Analogue Scale. Occupational 
 
performance will be measured using the Boston Carpal Tunnel Questionnaire completed by 
 
the participants and grip and pinch from each participant will recorded by the student
 
research assistants.   
 
At the final visit, the student researcher and/or student research assistants will conduct a 30-
minute 6-item semi-structured interview exploring the intervention group participant’s 
perception of wearing Kinesio tape and its impact on the participant’s occupational 
performance.  
 
 
Study intervention will be held at the beginning of the week and the end of the week during 
 
various times of day to account for sign and symptoms related to occupation and activities 
 
of daily living.  The researchers know which intervention is being studied; however, the 
 
participants will not know which intervention is being studied to increase accuracy of 
 
findings.  The benefit of blinding participants in this graduate student randomized controlled 
 
trial to the objective of the study is to determine if there is indeed a benefit of the 
 
intervention of dorsal application of Kinesio Tape versus the usual protocol or current care 
 
of splint and lumbrical exercises for carpal tunnel syndrome forearm wrist hand pain.  There 
 
Kinesio Tape application on the shoulder is to determine if there is an intervention effect 
 
is evidence to suggest even that application site could be beneficial.  All participants will be 
 
emailed the results of the study. 
 
Participants will complete a demographic questionnaire at baseline, which will include age, 
gender, ethnicity, current occupation and duration in that position. The demographic 
information will be used during data analysis to determine the influence of these variables 
on study outcomes.  Participants will complete the Numeric Pain Rating Scale and Visual 
Analogue Scale to allow a subjective measure of participants experiencing mild to moderate 
carpal tunnel syndrome forearm wrist hand pain, which will be completed at baseline, weeks 
one, two, and three.  These assessment tools are self-report measures using ordinal data with 
superior sensitivity, test retest reliability (r = 0.96 and 0.95) as well as construct validity (r = 
0.86) (Hawker, Mian, Kendzerska, & French, 2011; Hjermstad et al., 2011). The student 
researcher and/or student research assistants at baseline will record functional grip at weeks 
one, two, and three using a calibrated Jamar Dynamometer and standardized protocol and 
position.  The dynamometer is the only available tool to objectively measure functional grip 

 10
strength necessary to complete occupations of work, activities of daily living, household, 
and work tasks and demonstrates high test-retest reliability (r > 0.80), inter-rater reliability 
(r = 0.98) and concurrent validity (Roberts et al., 2011).  Pinch strength will be collected by 
the student researcher or student research assistants at baseline, weeks one, two, and three 
using a calibrated pinch meter with standardized protocol and position as it  is a commonly 
available tool to objectively measure functional pinch strength necessary for  fine motor 
control, hand use for occupations and tasks of daily living skills.  The pinch meter 
demonstrates high inter-rater reliability (r = 0.97) and test re-test reliability (r = 0.80) 
(Mathiowetz et al., 1985). 
 
  
Participants will also complete an 11-question standardized Boston Carpal Tunnel 
 
Questionnaire a commonly accepted subjective measure of function and severity as it relates 
 
to carpal tunnel syndrome and efficacy related to functional activities using an ordinal scale. 
 
The Symptom Severity Scale demonstrates high test-retest reliability (r = 0.91), with 
 
internal consistency of 0.80 – 0.90, and the Functional Status Scale also demonstrates high 
 
test-retest reliability (r = 0.93) with internal consistency of 0.88 – 0.93 (Carvalho Leite, 
 
Jerosch-Herold, & Song, 2006). 
 
 
 
 
See attached appendices D - O:  Boston Carpal Tunnel Questionnaire, Demographic 
 
Questionnaire, Numeric Pain Rating Scale Questionnaire, Visual Analogue Scale, Splint and 
 
Exercise Compliance Log, Symptom Log, Kinesio Tape Removal Instructions, Interview 
 
Guide, Scripts. 
 
 
 
 
 
10.  LABELING & STORAGE OF DATA & SPECIMENS 
 
 
Informed consents, HIPPA documents, and research records of functional grip and pinch 
 
measurements, occupational performance scales, and interviews will be stored in a locked 
 
cabinet in a locked office of the Principal Investigator.  Any electronic research records of 
 
functional grip and pinch measurements, occupational performance scales, interviews and 
 
other research information will be stored on a secured and password protected computer. 
 
Data will be secured in a locked cabinet for a period of three years and then destroyed. 
 
11.  DATA ANALYSIS 
 
 
 
The research analysis plan will include a repeated measures multi-factorial analysis of 
 
variance to analyze continuous data for the functional grip and pinch measurements, with an 
 
analysis of covariance to rule out any confounding variables between groups.  For Objective 
 
1 of the randomized controlled trial of the study continuous data will be analyzed with 
 
change score analysis from baseline to end of study.  To compare groups post-hoc 
 
Bonferroni will be used.  Non-parametric statistics using the Friedman’s Test will be used 
 
with the Numeric Pain Rating Scale, Visual Analogue Scale, and Boston Carpal Tunnel 
 
Questionnaire.  
 

 11
For Objective 2, qualitative data will be analyzed for thematic coding. Transcripts will be 
individually read and coded for emerging themes by the research team and then analyzed as 
a group to increase rigor.  For Objective 3 to explore concepts of adherence to interventions 
with carpal tunnel syndrome, triangulation will be used with data obtained through 
interviews and with journals using a deductive approach to explore Kinesio Tape on 
performance.  Data will be analyzed until redundancy is achieved.  
 
12.  RISK AND INJURY 
 
 
 
Participants may experience discomfort or skin irritation from wearing the tape, splint or 
 
completing the exercises.  Participants may also experience fear and/or anxiety, and/or 
 
hyperventilation before during, or after application of Kinesio Tape, and/or splint, and/or 
 
exercises. Under these circumstances the Kinesio Tape will be removed from the 
 
participant’s forearm wrist hand and provide first aid and seek medical care as needed. To 
 
minimize the potential of risks to participants the student researcher and student research 
 
assistants will ask if any known allergies to adhesives. Participants with a history or current 
 
allergy to adhesives will be excluded from the study.  Risks may also include a participant 
 
may feel uncomfortable answering questions during interviewing. Loss of confidentiality 
 
may occur if two participants know each other.  In order to protect confidentiality a number 
 
will be assigned to each participant.  The master list and Informed Consent will be kept 
 
separate in the Principal Investigator’s office. 
 
13.  BENEFIT (S) 
 
 
The benefit of this study may help determine the validity of a non-surgical cost effective 
 
intervention that can be applied at the work site and allow for increased participation in 
 
occupations of daily living for carpal tunnel syndrome forearm wrist hand pain.  Results of 
 
the study could provide insights to practitioners and researchers working with carpal tunnel 
 
syndrome forearm wrist hand pain and the influence of Kinesio Tape on occupational 
 
performance. Improving the understanding of terminology and inherent factors in current 
 
accepted protocols for carpal tunnel syndrome may be an additional benefit. 
 
 
 
14.  COMPENSATION 
 
Participants will receive a $5.00 gift card per visit for each of the five visits for the study. 
 
 
15.  CONFIDENTIALITY 
 
Numbers will be used to identify participants and a coding sheet known only to the 
researcher will be kept in a locked office.  All identifying information will be removed. Any 
published document resulting from this  study will not disclose participant identity without 
written permission. All data will be secured in a locked cabinet in a locked office. 
 
16.  LITERATURE REVIEW 

 12
 
Musculoskeletal disorders are consistently considered sprains, strains, tears resulting from 
over exertion of the muscles during an activity and result in an injury to muscles, joints, 
ligaments, tendons, cartilage, or nerve (Lysaght, Donnelly, & Luong, 2010; United States 
Bureau of Labor, 2015). Upper extremity musculoskeletal injuries account for the second 
most common musculoskeletal disorder according to the United States Department of Labor 
(2015) with carpal tunnel syndrome the most frequently identified (41%) of all upper 
extremity repetitive movement disorders (Roll, 2016; United States Department of labor, 
2015).   
 
Carpal tunnel syndrome is a common neuropathy of the median nerve of the wrist with 
progressive intermittent signs and symptoms leading to impaired function and even muscle 
atrophy with nocturnal pain and paresthesia, decreased tactile sensation, and numbness in the 
first three fingers, as well as pain in the upper extremity, weakness of the hand and wrist 
(Ozgen et al., 2011).  Carpal tunnel syndrome increases with age and three to one females to 
males experience symptoms with co-morbidities of diabetes and even pregnancy can be 
found to be contributing factors (Ozgen et al., 2011).  Ali and colleagues (2013) concluded 
carpal tunnel syndrome may be caused from an increased pressure of the carpal tunnel, 
prolonged exposure to hand-arm vibrations, a combination of repetitive hand use and the use 
of hand force, and in recent years has expanded to include the use of computers and similar 
devices. It is believed that chronic repetitive use of the fingers and wrist may generate a 
shearing between the carpal tunnel, the median nerve, and the flexor tendons, which results 
in a restricted hyperplasia and fibrosis of the tenosynovitis of the flexor tendons and the 
median nerve in the tunnel (Ali et al., 2013).  
 
Walker and colleagues (2000) identified individuals who work in highly repetitive 
environments have a significant chance of being diagnosed with carpal tunnel syndrome, for 
example individuals in manufacturing, service industry personnel such as hairdressers, 
massage therapists, gardeners, pet groomers, chefs, construction workers, and nurses are 
identified among this population.  However, office workers are now included as Coggon and 
colleagues (2013) found workers who use the PC for 4-hours a day experience a high 
incidence of this disabling upper extremity musculoskeletal disorder of carpal tunnel 
syndrome. Goldfarb in (2016) furthered Coggon and colleagues (2013) study with findings 
that those  who use computers and work 12 hour days over an 8-year span are primarily the 
at-risk population and could now include students.  Common interventions for this disorder 
lack protocol, homogeneity, and consistency of results.  Passive interventions are a patient’s 
first choice, and at times a physician’s but evidence based practice governmental regulation, 
as well as cost containment needs are pushing for increased and early worksite interventions, 
according to Lysaght and colleagues (2010).  Accepted protocols include combining 
intervention modalities such as splinting and lumbrical exercises, with varied mediocre 
effectives and high issues surrounding patient compliance (Amini, 2011). In a systematic 
review Roll and Hardison (2016) found splinting type and position remain unstandardized.    
 
One study using a combination of lumbrical stretching exercises and a general cock-up splint 
provided symptom relief up to 24 weeks, longer than any combination of conservative 
intervention (Baker et al., 2012; Manente et al., 2012).  New evidence by Nadar et al. (2013) 

 13
found finger position can influence properties of the median nerve and Bulut et al. (2015) 
found the wrist positioned in neutral and metacarpophalanges supported provides the best 
outcomes.  Kase et al. (1998) identified four principles of Kinesio Tape, that it supports 
muscles by improving muscle contraction, increases flow of body fluids, activates the 
endogenous analgesic system resulting in decreased pain, and corrects joint alignment based 
on application.  Fourteen peer review studies between 2004 – 2014 provide evidence of KT 
for lower extremity pain and edema.  Few and poor studies exist on upper extremity use of 
KT, such as with carpal tunnel syndrome and the Kase accepted method of Kinesio Tape 
application for carpal tunnel syndrome is on the flexor surface (palm of the hand and wrist) 
but has face validity only.  However, if Kinesio Tape is to support or facilitate muscles based 
on application, as well as provide musculoskeletal re-positioning, and influence sub-acute 
pain, then using Kinesio Tape on the flexor surface would seemingly only increase 
compression on the median nerve by pulling the wrist and fingers into flexion/grip position. 
The application of Kinesio Tape on the extensor surface may reposition the wrist into neutral 
and open the carpal tunnel while supporting the metacarpophalanges. Thus, the purpose of 
this study is to determine if the dorsal application of Kinesio Tape applied to the wrist 
extensors for individuals with carpal tunnel syndrome, makes a difference in occupational 
performance of pain, strength, and function and to explore the perspectives of participants to 
understand if Kinesio Tape contributed to changes in occupational performance and 
compliance and if so, how.   
 
 
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