The Effectiveness of Conservative Treatment With Added Kinesio Taping in Decreasing Pain and Improving Hand Function and Grip Strength Among Individuals With Lacertus Syndrome: A Pilot Randomized Controlled Trial
Phase: NA
Conditions: Lacertus Syndrome
Sponsor: Arab American University (Palestine)

STUDY PROTOCOL
Official Title:
The Effectiveness of Conservative Treatment with
Added Kinesio Taping in Decreasing Pain and
Improving Hand Function and Grip Strength among
Individuals with Lacertus Syndrome: A Pilot
Randomized Controlled Trial
NCT Number: Pending
Version: 1.0
Date: 1 February 2026
Principal Investigator: Husam Taha
Program: PhD in Rehabilitation Sciences
Institution: Arab American University Palestine

The Effectiveness of Conservative Treatment with Added 
Kinesio Taping in Decreasing Pain and Improving Hand 
Function  and  Grip  Strength  among  Individuals  with 
Lacertus Syndrome: A Pilot Randomized Controlled Trial
A PhD Dissertation Proposal
Submitted by: Husam Taha
Program: PhD in Rehabilitation Sciences
Institution: Arab American University Palestine
1

1. Introduction
1.1. Problem Statement
Lacertus syndrome is also a dynamic compression of the median nerve at the lacertus fibrosus, 
which is becoming an increasingly recognized, but often not considered cause of forearm pain, 
paresthesia, and functional disability  (Hagert, 2013). It has been confused with carpal tunnel 
syndrome or other nerve entrapment neuropathies and is uncommonly diagnosed, with up to 20% 
of patients having signs of median nerve involvement (Spinner & Amadio, 2003). The diagnostic 
issue is that this condition needs to be distinguished out of other similar syndromes and this has 
been facilitated recently with the introduction of more specific clinical tests including the 
Orthogonal Kinesiotaping Test (OKT) (Apard et al., 2025).  
Surgical decompression is the current standard of care of lacertus syndrome and it has reported 
high levels of success (Puntillo & Bertini, 2018). Surgery is not however always a viable and 
desirable option especially in resource constrained healthcare systems like in Palestine. Effective, 
evidence-based options of conservative treatments are thus an urgent clinical and community 
health concern. Lacertus syndrome is currently being treated in a conservative manner that is not 
well defined and there is no high quality evidence to inform clinical practice. This PhD proposal is 
going to fill this critical gap in the literature with a promising, non-invasive, and low-cost 
intervention: Kinesio Taping.
1.2. Rationale for Kinesio Taping
Kinesio Taping (KT) is a treatment method which has gained prominence within the region of 
rehabilitation; and a growing body of evidence on the application of this method in a broad range of 
musculoskeletal  and  neurological  problems  continues  to  increase  (Kase,  2003).  The  KT 
mechanism  of  action  as  postulated  is  multifactorial  in  nature  and  consists  of  cutaneous 
mechanoreceptor  excitation,  fascial  decompression,  proprioceptive  improvement  and 
neuromuscular re-education (Williams et al., 2012). A recent systematic review and meta-analysis 
demonstrated that KT can be a useful tool to alleviate pain and functional output syndrome such as 
2

carpal tunnel syndrome that is also a median nerve entrapment neuropathy (Ahn et al., 2019; 
Tomás‐Escolar et al., 2023). These findings indicate that concepts applied to inform the application 
of KT can be applied to other peripheral nerve entrapment syndromes like the lacertus syndrome.
1.3. Significance of the Research
The Palestinian healthcare system is characterized by certain special challenges, such as the 
shortage of resources and the lack of access to specialized surgery services (Eker & Imam, 2025). 
As a result, the need to develop cost-effective conservative treatment methods that may be applied 
in the primary care setting has become acute. Kinesio Taping is the perfect intervention in this 
situation because it is non-invasive, comparatively cheap and can be implemented in the patients so 
that they can administer it themselves. Also, the cultural background of Palestinian community, 
where  non-surgical  procedures  are  often  preferred,  suits  the  creation  of  evidence-based 
conservative  treatment  regimens  quite  well  (Giacaman,  2018).  This  study  can,  therefore, 
profoundly influence clinical practice in Palestine and other health care settings with lack of an 
evidence-based and culturally-sensitive treatment option to lacertus syndrome.
2. Literature Review
2.1. Lacertus Syndrome: An Evolving Understanding
2.1.1. Historical Perspective and Diagnostic Evolution
The development of lacertus syndrome as an independent clinical condition has taken its time and 
is changing with time. It has been initially characterized as a form of pronator syndrome but it is 
currently perceived as a form of median nerve entrapment in the lacertus fibrosus (Johnson et al., 
1979). The lacertus fibrosus or bicipital aponeurosis is a connective tissue emerging out of the 
tendon of the biceps brachii up to the deep fascia of the forearm which forms a potential location of 
the median nerve compression. The Hagert studies have also played a major role in establishing the 
clinical features and diagnostic criteria of lacertus syndrome that comprises forearm pain, 
3

paresthesias of the median nerve distribution, and pain on resisted pronation and flexor-pronator 
loading (Puntillo & Bertini, 2018).  In more recent times, the clinical tests have been developed to 
improve the diagnostic process. The lacertus compression test has proved to be very sensitive and 
specific to the condition. One of these is the Orthogonal Kinesiotaping Test (OKT) that was 
designed by Apard et al. (2025) and proved to be sensitive (95 percent) and specific (89 
percent)(Apard et al., 2025) . The OKT is an adaptation of the lacertus antagonist test (LAT), 
except that the examiner places Kinesio tape that mimics the hand action of LAT and can then 
examine the upper limb in detail. This new diagnostic technique does not just enhance the accuracy 
of the diagnosis but also enhances the knowledge of the condition just as it is in the patients.
2.1.2. Current Treatment Paradigms and Their Limitations
The current standard of care for lacertus syndrome is surgical release of the lacertus fibrosus, a 
procedure that has consistently demonstrated positive clinical outcomes (Hagert, 2013; Puntillo & 
Bertini, 2018). However, surgery is not without limitations. Some patients experience persistent or 
incomplete symptom resolution, and the procedure requires specialized expertise that may not be 
available in all clinical settings—particularly those with limited resources. These challenges 
underscore the need for effective conservative management strategies.
Despite this need, the literature shows a significant gap: very few studies have been conducted in 
the area of non-surgical treatment options for lacertus syndrome (Neal & Fields, 2010). Existing 
conservative  approaches  will  usually  encompass  activity  modification,  the  use  of  anti-
inflammatory medication and general physical therapy techniques. However, these interventions 
are not specific to the pathophysiological features of lacertus syndrome. Brutus et al. (2025) , 
highlight the important role of hand therapists in the management as well as diagnosis of this 
condition, and recommend a comprehensive intervention that includes therapist-led exercises in 
nerve gliding exercises, muscle stretching and ergonomic education. Corticosteroid injection (CSI) 
has also been tried as a conservative treatment; one trial found that 75% of patients had short-term 
benefit from this treatment  (Frees & Ward, 2025). Nonetheless, the study also found that a third of 
patients initially treated with CSI eventually needed surgery as a result of the symptoms returning, 
suggesting that CSI may only provide temporary benefit rather than one that is definitive. 
4

Lacertus syndrome is a very specific and relatively uncommon syndrome of dynamic compression 
of the median nerve at the lacertus fibrosus. Because there is a dearth of good quality research in the 
specific context of conservative care for the condition, the current study utilises the wider body of 
evidence for conservative management of other median nerve entrapment syndromes - most 
notably carpal tunnel syndrome (CTS). This approach makes sense given the common underlying 
mechanism of median nerve compression and the applicability of peripheral nerve entrapment 
principles of different anatomical regions  (Currie et al., 2022; Del Barrio et al., 2018).
Systematic reviews of CTS management reliably advocate for a multimodal conservative approach 
to mild to moderate nerve entrapment before resorting to surgery  (Currie et al., 2022; Del Barrio et 
al., 2018). Although lacertus syndrome involves the proximal forearm and not the wrist, the goals 
of treatment are similar: decreased mechanical compression, increased nerve mobility and relief of 
symptoms. Key elements of Evidence Based Conservative Management are:
Splinting: Neutral wrist splinting, especially at night, is a cornerstone of CTS care, and this reduces 
the pressure on the median nerve by keeping the wrist in a neutral position (Currie et al., 2022). 
Nerve-Gliding Exercises (Neuromobilization): There is mounting evidence for the use of nerve-
gliding  techniques  for  optimal  nerve  excursion  and  symptom  reduction  in  median  nerve 
entrapment.  A  systematic  review  conducted  by  Ballestero-Pérez  et  al.  (2017)  showed 
improvements in pain and function of patients with CTS (Ballestero-Perez et al., 2017), and 
another clinical trial showed additional improvements when neuromobilization was used with 
routine physical therapy (Ijaz et al., 2022). As these exercises work on the whole of the median 
nerve pathway, they have direct application to the lacertus syndrome.
Activity Modification and Patient Education: Ergonomic teaching, avoidance of symptom-
provoking postures (e.g. repetitive pronation especially seen in lacertus syndrome), and self-
management strategies are essential components of conservative care (Del Barrio et al., 2018).
Corticosteroid  Injections:  Although  these  injections  offer  short-term  relief,  corticosteroid 
injections are still a known option in the treatment of median nerve entrapment (Currie et al., 
2022). The recent evidence specific to lacertus syndrome is promising in terms of short-term 
outcomes (Frees & Ward, 2025).
5

Given the limited research dedicated exclusively to conservative treatment of lacertus syndrome, 
this study applies well-supported conservative principles established for CTS and related median 
nerve entrapment disorders. This evidence-based foundation provides a strong rationale for 
developing a standardized usual-care protocol within the proposed study, against which the 
additional benefit of Kinesio Taping can be systematically evaluated.
2.2. The Research Gap: A Need for Evidence-Based Conservative Treatments
It is evident that there is a critical gap in evidence base of conservative management of lacertus 
syndrome in existing literature. The study is extremely biased when it comes to surgical 
interventions, where there is a lack of quality research on non-invasive, therapist-led research. This 
is especially troublesome in the healthcare systems that lack resources, like in Palestine, where 
surgery might not be an easily available and desired procedure. This PhD proposal bridges this gap 
directly through the proposal of a thorough assessment of a promising conservative intervention 
Kinesio Taping.
3.   Theoretical  Framework:  The  International  Classification  of 
Functioning, Disability and Health (ICF) Model
Using the ICF model especially the hand core set (Kus et al., 2012, 2017), lacertus syndrome is 
understood not just as a nerve compression issue, but as a condition that impacts multiple levels of 
a person’s life. The Kinesio Taping intervention is conceptualized as a facilitator within this 
framework, aiming to improve body functions, which in turn enhances activities and participation.
Within the ICF framework, lacertus syndrome is identified as the Health Condition , representing a 
dynamic median nerve entrapment confirmed through clinical diagnosis using Hagert’s Triad and 
the Orthogonal Kinesiotaping Test (OKT). This condition leads to impairments in Body Functions 
& Structures , which will be the primary focus of the intervention. Specifically, this study will 
measure impairments such as b280 Sensation of pain using the Numeric Pain Rating Scale (NRS), 
b730 Muscle power functions (weakness) with a hand dynamometer and pinch gauge, and b265 
Touch function (paresthesia). The relevant body structure is s730 Structure of the upper extremity, 
6

specifically the lacertus fibrosus. 
The impact of these impairments on a patient’s daily life is captured under the Activities & 
Participation domain. This study will assess limitations and restrictions in areas such as d440 Fine 
hand use, d445 Hand and arm use, d5 Self-care, d6 Domestic life, and d8 Major life areas (e.g., 
work) using the QuickDASH questionnaire. 
Finally, the Environmental Factors domain includes the facilitators that are being investigated. 
These include the Kinesio Taping intervention itself, the standardized conservative treatment 
protocol (including education and exercise), and the support from health professionals ( e355 ), 
which will be documented through the intervention and conservative treatment  protocols. 
This framework provides a comprehensive and structured approach to: 
1. Holistic Assessment: It ensures that the study evaluates not just pain and strength (Body 
Functions), but also the real-world impact on a patient’s ability to perform daily tasks (Activities 
and Participation), as captured by the QuickDASH. 
2. Clear Intervention Target: It positions the Kinesio Taping intervention as a targeted therapy 
aimed at reducing impairments in Body Functions (e.g., pain, weakness) with the ultimate goal of 
improving Activities and Participation. 
3. Standardized Language: It uses a common, internationally accepted language to describe the 
patient’s experience and the study’s outcomes, enhancing the comparability and generalizability of 
the findings. 
By adopting the ICF and the Brief ICF Core Set for Hand Conditions, this study aligns with modern 
clinical research standards, ensuring that the evaluation of the Kinesio Taping intervention is 
comprehensive, patient-centered, and systematically structured. 
4. Research Questions and Hypotheses
This pilot study is guided by primary feasibility questions and secondary effectiveness questions.
7

4.1. Primary Feasibility Research Questions
The primary feasibility research questions are as follows:
-
What are the recruitment and retention rates for a 4-week  Kinesio Taping intervention trial 
among adults with lacertus syndrome in the West Bank? 
-
 What is the adherence rate to the prescribed Kinesio Taping  protocol among participants 
in the intervention group?
4.2. Secondary Effectiveness Research Questions
●
Research Question 2a: What is the preliminary estimate of the treatment effect of  Kinesio 
Taping on pain intensity, as measured by the Numeric Pain Rating Scale (NRS)?
●
Research Question 2b: What is the preliminary estimate of the treatment effect of  Kinesio 
Taping on upper extremity function, as measured by the QuickDASH questionnaire?
●
Research Question 2c: What is the preliminary estimate of the treatment effect of  Kinesio 
Taping on grip strength, as measured by a hydraulic hand dynamometer?
●
Research Question 2d: What is the preliminary estimate of the treatment effect of  Kinesio 
Taping on pinch grip strength, as measured by a calibrated pinch gauge?
5. Methodology
5.1. Study Design
A pilot, single-blind, parallel-group randomized controlled trial (RCT) will be used in this study. It 
will be a 1:1 allocation ratio where a group of therapeutic Kinesio Taping (KT plus Conservative 
treatment) will be compared to a control group (Conservative treatment alone). It will be a single-
blinded study and the outcome assessor is going to be blinded in terms of group assignment. 
Clinical trials registry (e.g., ClinicalTrials.gov) registration of the study protocol will take place 
before the recruitment starts.
5.2. Participants and Recruitment
8

5.2.1. Sample Size Justification
The sample size for this pilot study is set at 30 participants (15 per group). This number is 
consistent with established guidelines for pilot and feasibility studies, which recommend a sample 
size of 24 to 50 participants to reliably estimate the standard deviation for a future, larger-scale 
RCT (Julious, 2005; Whitehead et al., 2016). A sample size of 30 will provide sufficient data to:
●
Estimate Key Feasibility Parameters: With 15 participants per group, we can obtain 
reasonably precise estimates of recruitment rates, retention rates, and adherence to the 
intervention.
●
Obtain Preliminary Estimates of Treatment Effect: While this pilot study is not 
powered to detect statistically significant differences between the groups, it will provide 
preliminary estimates of the treatment effect size (Cohen, 2013) .
●
Assess the Variance of Outcome Measures: The data collected from this pilot study will 
allow us to estimate the variance of the primary outcome measures (Numeric Pain Rating 
Scale [NRS], Quick Disabilities of the Arm, Shoulder and Hand [QuickDASH], grip 
strength and pinch strength), which is essential for calculating the sample size for a future, 
definitive RCT.
5.2.2. Inclusion and Exclusion Criteria
Participants will be eligible for inclusion if they are adults between 18 and 65 years of age 
with  a  confirmed  clinical  diagnosis  of  lacertus  syndrome.  This  diagnosis  must  be 
established by a physician specializing in orthopedics, physical medicine, or neurology and 
must follow a standardized, multi-modal diagnostic protocol. Following this protocol, a 
comprehensive clinical examination will be administered to each of the participants and 
that will begin with a detailed medical history that will rule out other potential causes of 
forearm pain or neuropathy. The positive Hagert three criterion to be fulfilled in diagnosis 
will be positive palpation of lacertus fibrosus, recreation of symptoms during resisted 
forearm rotation, and recreation of symptoms during resisted elbow flexion. Besides these, 
9

the participants are also required to demonstrate a positive Orthogonal Kinesiotaping Test 
(OKT) - a very specific diagnostic test of the lacertus syndrome - to be conducted by a 
certified examiner (Apard et al., 2025). A thorough neurological assessment will also be 
done to eliminate other forms of median nerve entrapment syndrome, including carpal 
tunnel syndrome. To be able to provide a greater diagnostic accuracy, electrodiagnostic 
analysis (electromyography [EMG]/nerve conduction study [NCS]) will be performed, 
which  shall  identify  the  functionality  of  the  median  nerve,  the  presence  of  nerve 
compression  and  exclude  other  causes  of  neural  compromise,  including  cervical 
radiculopathy. In order to obtain a relatively homogenous sample with subacute to chronic 
presentations will be included only those people who have had their symptoms not less than 
four weeks.
Participants will be excluded from the study if they have had surgery for lacertus syndrome 
or any other condition that trapped the median nerve in the affected arm. Additional 
exclusion criteria include a known allergy to Kinesio tape or adhesive materials, the 
presence of any dermatological condition at the intended site of tape application, and any 
neurological or musculoskeletal disorder that could confound the assessment of lacertus 
syndrome symptoms. Pregnant individuals will also be excluded from participation.
5.2.3. Recruitment Strategy
Recruitment will take place at multiple private clinics, medical centers and hospitals from middle 
and north governorate in the West Bank. Potential participants will be identified by the treating 
clinicians and provided with information about the study. If they express interest, they will be 
contacted by the primary researcher (Husam Taha) to be screened for eligibility.
5.3. Randomization and Allocation Concealment
5.3.1. Randomization Procedure
Following enrollment and baseline assessment, participants will be allocated to treatment groups 
using a sophisticated covariate-adaptive minimization procedure designed to ensure balanced 
10

group characteristics and minimize the risk of confounding  (Lin et al., 2015). This approach 
represents a significant methodological advancement over simple randomization or fixed block 
randomization methods.
Covariate-Adaptive Minimization: The Pocock and Simon covariate-adaptive randomization 
method will be used in the study, which aims to dynamically balance treatment groups based on 
several prognostic factors over the recruitment period (Pocock & Simon, 1975). Unlike fixed block 
randomization, this approach does not depend on the number of participants; instead, the 
participant is randomized as soon as he or she joins the trial but group balance is maintained 
dynamically. The minimization algorithm will balance the following key prognostic variables: age 
(≤40 years vs. >40 years), gender (male vs. female), symptom duration (4-12 weeks vs. >12 
weeks), baseline pain intensity (NRS ≤5 vs. NRS >5), and recruitment site .
Methodological  Advantages:  Covariate-adaptive  minimization  has  a  few  advantages  over 
conventional randomization techniques, which are relevant to this pilot study with a moderate 
sample size  (Coart et al., 2023). Simulation studies show that minimization yields superior 
balanced treatment groups compared to restricted or unrestricted randomization, especially if the 
analysis takes several covariates into account  (Scott et al., 2002). The presence of the probabilistic 
element in the Pocock and Simon method adds randomness while more emphasis is placed on 
balance, thus minimising the risk of selection bias and confounding  (Zhao et al., 2015). 
Minimization is of particular value in trials with moderate sample sizes where chance imbalances 
are more likely to occur and have greater impact on validity of the study (Pandis, 2011).
5.3.2. Implementation Protocol
The minimization procedure will be implemented using validated randomization software that 
incorporates the Pocock and Simon algorithm with probabilistic treatment assignment (Saghaei, 
2011). The system will use a biased coin probability of 0.75 for assignment to the treatment that 
minimizes imbalance, with 0.25 probability for the alternative treatment. This approach maintains 
adequate randomness while achieving superior balance compared to deterministic minimization 
11

(Saghaei,  2011).  The  randomization  system  will  operate  in  real-time,  allowing  immediate 
treatment allocation upon completion of baseline assessments.
5.3.3. Allocation Concealment and Blinding
The randomization sequence will be generated and maintained by an independent statistician not 
involved in participant recruitment or assessment. Treatment allocation will be concealed through 
a secure, password-protected web-based system (Schulz & Grimes, 2002). The study will employ 
single-blind design with the outcome assessor blinded to group allocation. To maintain assessor 
blinding, outcome assessments will be conducted by a research assistant not involved in treatment 
delivery, and participants will be instructed not to discuss their treatment with the assessor (Bang et 
al., 2004).
5.4. Interventions
5.4.1. Experimental Group: Therapeutic Kinesio Taping
Participants in the experimental group will receive therapeutic Kinesio Taping applied with 25–
50% stretch over the lacertus fibrosus, in addition to Conservative treatment. The intervention 
protocol will be standardized and will include:
●
Materials: 5 cm width elastic therapeutic tape, alcohol swabs for skin preparation, and an 
optional barrier film.
●
Landmarks: Biceps tendon/lacertus fibrosus region, proximal pronator teres, and medial 
forearm fascia.
●
Technique: The tape will be applied with 25–50% stretch across the symptomatic area, 
following standardized landmarks.
●
Training  and  Home  Application: The  treating  therapist  will  perform  the  initial 
application in the clinic and will provide a structured training session for the participant 
and/or a caregiver. This will include a hands-on demonstration and return-demonstration 
until  competency  is  achieved,  printed  step-by-step  instructions,  and  access  to  an 
12

instructional video. Participants will be provided with a tape application log to record 
application and removal dates and any skin reactions. Telephone or messaging support will 
be available for troubleshooting.
●
Frequency/Dose: Participants will be instructed to reapply the tape every 2-3 days for a 
total of 4 weeks.
5.4.2. Control Group: Standardized Conservative treatment 
The control group will receive a standardized usual care protocol adapted from evidence-based 
conservative management for other median nerve entrapment syndromes, particularly carpal 
tunnel syndrome (CTS) (Ballestero-Perez et al., 2017; Del Barrio et al., 2018; Ijaz et al., 2022). 
This adaptation is necessary due to the lack of specific high-quality evidence for lacertus syndrome 
conservative care. This protocol will consist of a 4-week intervention including:
Educational Component: All participants will receive a standardized 30-minute educational 
session about lacertus syndrome, including anatomy and pathophysiology explanation using 
standardized  diagrams,  activity  modification  guidelines  with  specific  examples,  ergonomic 
principles for workplace and daily activities, and written educational materials in Arabic.
Standardized Exercise Program: A structured home exercise program consisting of median 
nerve gliding exercises (3 sets of 10 repetitions, twice daily), tendon gliding exercises for flexor 
tendons (3 sets of 10 repetitions, twice daily), gentle stretching exercises for forearm muscles (30-
second holds, 3 repetitions, twice daily), and progressive strengthening exercises using resistance 
bands during weeks 3-4.
Activity Modification Guidelines: Specific, standardized recommendations including avoidance 
of repetitive pronation activities for more than 30 minutes continuously, use of ergonomic tools 
when possible, regular breaks every 30 minutes during repetitive activities, and specific workplace 
modifications based on occupation.
Follow-up Protocol: Standardized follow-up will include weekly telephone check-ins to monitor 
compliance  and  address  questions,  standardized  exercise  logs  for  tracking  adherence,  and 
13

consistent messaging about expectations and timeline for improvement. This standardized usual 
care will be provided to both the control group and the experimental group to ensure that any 
observed differences can be attributed to the Kinesio Taping intervention.
5.5. Outcome Measures
Outcomes will be assessed at baseline, at the end of the 4-week intervention period.
5.5.1. Feasibility Outcomes
●
Recruitment rate: The number of participants recruited per month.
●
Retention rate: The proportion of participants who complete the 4-week intervention .
●
Adherence rate: The proportion of participants who adhere to the Kinesio Taping 
protocol, as assessed by the tape application logs.
5.5.2. Effectiveness Outcomes
Pain Intensity - Numeric Pain Rating Scale (NRS): The NRS is an 11-point scale ranging from 0 
(no pain) to 10 (worst imaginable pain). The NRS demonstrates excellent psychometric properties 
with strong construct validity (r = 0.86-0.95 with Visual Analog Scale [VAS]) and criterion 
validity (r = 0.63 with standardized pain measures) (Jensen, 2003; Nugent et al., 2021). Test-retest 
reliability is excellent (Intraclass Correlation Coefficient [ICC] = 0.95-0.98), and the instrument 
shows good responsiveness with a minimal clinically important difference (MCID) of 2 points 
(Modarresi et al., 2022; Young et al., 2025). The NRS is widely recommended for pain assessment 
in clinical trials due to its simplicity, validity, and sensitivity to change (Jt, 2001).
Upper  Extremity  Function  -  Quick  Disabilities  of  the  Arm,  Shoulder  and  Hand 
(QuickDASH): The QuickDASH is an 11-item questionnaire that measures physical function and 
symptoms  in  individuals  with  upper  extremity  musculoskeletal  disorders.  The  instrument 
demonstrates excellent construct validity with strong correlation to the full DASH questionnaire (r 
= 0.96) and good convergent validity with other upper extremity measures (Beaton et al., 2005). 
Internal consistency is excellent (Cronbach's α = 0.89-0.94), and test-retest reliability is excellent 
(ICC = 0.90-0.97) (Mintken et al., 2009). The QuickDASH shows good responsiveness to change 
14

with effect sizes of 0.6-1.2 and an MCID of 8-16 points (Sorensen et al., 2013). The Arabic version 
has demonstrated excellent psychometric properties (Cronbach's α = 0.90, ICC = 0.91), making it 
appropriate for use in the Palestinian population(Alnahdi, 2021).
Grip Strength - Hydraulic Hand Dynamometer: Hand grip strength will be measured using a 
calibrated hydraulic hand dynamometer following standardized protocols established by the 
American Society of Hand Therapists (ASHT). Hydraulic dynamometers demonstrate excellent 
concurrent validity (r = 0.97-0.99 between different brands) and construct validity with overall 
muscle strength measures (Sartorio et al., 2025). Reliability is excellent with intra-rater reliability 
(ICC = 0.95-0.98), inter-rater reliability (ICC = 0.90-0.97), and within-day reliability (ICC = 0.98) 
(Biasini et al., 2023; Bobos et al., 2020). The standard error of measurement is 2-3 kg with a 
minimal detectable change of 5-6 kg (Reuter et al., 2011). Three trials will be performed for each 
hand with 30-second rest intervals, and the average will be recorded as recommended by 
standardized protocols (Fess, 1992).
Pinch Grip Strength - Pinch Gauge: Pinch grip strength will be measured using a calibrated 
mechanical or digital pinch gauge (e.g., B&L Engineering or Jamar). The pinch gauge is a reliable 
and valid instrument for measuring pinch strength, with excellent test-retest reliability (Intraclass 
Correlation Coefficients [ICCs] > 0.90) for all three standard pinch positions (Mathiowetz et al., 
1984; MacDermid et al., 2001). The assessment will measure three standard pinch positions: tip 
pinch, key (lateral) pinch, and palmar (three-jaw chuck) pinch, following the standardized 
procedures of the ASHT. Pinch strength assessment has demonstrated good to excellent reliability 
(ICC > 0.80) and strong correlation with grip strength and hand function. For each pinch type, the 
average of three trials will be recorded for each hand, with a 30-second rest interval between trials.
5.5.3 Outcome Measures and International Classification of Functioning, Disability and Health 
(ICF) Alignment 
This study will utilize the Brief ICF Core Set for Hand Conditions as a framework for assessing 
outcomes, ensuring a comprehensive and patient-centered evaluation (Kus et al., 2012, 2017). The 
selected outcome measures are explicitly mapped to the ICF domains as follows:
Outcome Measure 
ICF Domain 
ICF Code 
Description
15

Numeric Pain 
Rating Scale 
(NRS)
Body Functions 
b280 
Sensation of pain
Hand 
Dynamometer 
(Grip Strength)
Body Functions 
b730 
Muscle power functions
Pinch Gauge 
(Pinch Strength)
Body Functions 
b730 
Muscle power functions
QuickDASH 
Questionnaire
Activities & 
Participation
d440 , 
d445 , d5 , 
d6 , d8
Fine hand use, hand and 
arm use, self-care, domestic 
life, major life areas
This alignment with the ICF framework ensures that the study evaluates not just impairments in 
body functions but also their impact on real-world activities and participation, consistent with 
modern clinical research standards. 
5.6. Data Collection and Management
All data will be collected by the primary researcher. Data will be entered into a secure, password-
protected database. To ensure data quality, a random 10% of the data will be double-checked for 
accuracy.
5.7. Data Analysis
Version 28 of the International Business Machines (IBM) Statistical Package for the Social 
Sciences (SPSS) will be used in data analysis. The findings of the feasibility outcomes and the 
nature of the participants will be summarized using descriptive statistics. In the case of the 
secondary  effectiveness  outcomes,  an  intention  to  treat  (ITT)  analysis  will  be  used.  The 
independent t-tests or Mann-Whitney U tests will be used to compare the differences in outcome 
16

scores between baseline and 4-week time point between the two groups, as the data will prove to be 
distributed differently. The effect size (Cohen d) will be produced, as an approximation of the size 
of the treatment effect. The p-value of less than 0.05 will be considered statistically significant.
5.8. Missing Data Management
Missing  Data  Prevention: Primary  strategies  to  minimize  missing  data  include  flexible 
scheduling  for  outcome  assessments,  multiple  contact  methods  for  follow-up  reminders, 
compensation for time and travel expenses, and clear explanation of study importance and 
participant commitment.
Primary Analysis Strategy: The  primary analysis will follow the intention-to-treat (ITT) 
principle, including all randomized participants in their originally assigned groups regardless of 
adherence or completion status (Armijo-Olivo et al., 2009). For missing outcome data, multiple 
imputation will be used as the primary method, creating 20 imputed datasets using predictive mean 
matching for continuous variables (Groenwold et al., 2014).
Sensitivity Analyses: Multiple sensitivity analyses will be conducted to assess the robustness of 
findings,  including  complete  case  analysis,  per-protocol  analysis,  worst-case  and  best-case 
scenario  imputations,  and  pattern  mixture  models  to  explore  different  missing  data 
mechanisms(Khan et al., 2021) . All missing data will be reported according to Consolidated 
Standards  of  Reporting  Trials  (CONSORT)  guidelines,  including  flow  diagrams  showing 
participant disposition and reasons for missing data by treatment group.
5.9. Safety Monitoring and Adverse Events
Skin Reaction Risk Assessment: While Kinesio Taping is generally considered safe, skin 
reactions can occur in 2-5% of users, particularly with prolonged application (Hofman et al., 2023). 
Before initial tape application, all participants will undergo skin integrity assessment, allergy 
17

history  questionnaire,  and  patch  testing  with  a  small  piece  of  Kinesio  tape  with  24-hour 
observation.
Monitoring Protocol: Systematic monitoring for adverse skin reactions will include daily self-
monitoring by participants using a standardized skin reaction scale, weekly clinical assessment by 
research staff, and immediate reporting system with 24-hour contact availability. Adverse skin 
reactions will be classified using a standardized four-grade scale from mild erythema to severe 
ulceration or systemic allergic reaction (Hamnerius et al., 2023).
Management Protocol: Standardized management procedures range from continued monitoring 
for mild reactions to immediate discontinuation and urgent medical evaluation for severe reactions. 
All adverse events will be documented according to Good Clinical Practice guidelines with 
detailed forms, photographic documentation when appropriate, and timely reporting to the 
institutional review board (Guideline, 2015).
5.10. Study Limitations
Pilot Study Limitations: It is important to recognize that this pilot study, although allowing for 
good feasibility information, has its own intrinsic limitations that must be taken into consideration 
when interpreting results. As emphasised by  Leon et al. (2011), pilot studies do not give 
meaningful effect size estimates for planning subsequent studies due to the imprecision inherent in 
small sample data . The confidence intervals around effect size estimates from this 30-subject-pilot 
will be large and could lead to misleading results for future sample size calculations.
Effect Size Interpretation: Any treatment effects seen in this pilot study should be interpreted 
with extreme caution and should not be used as primary basis for sample size calculation in a future 
definitive trial(Sim, 2019). The primary purpose of this pilot is to evaluate feasibility parameters 
rather than to show efficacy. Effect size estimates will be reported with appropriate confidence 
intervals and clear statements about their limitations for inferential purposes. The variance 
estimates generated from this pilot study will enable a much more reliable estimate than the effect 
size estimates for planning a future definitive trial.
18

5.11. Ethical Considerations
This study will be performed in compliance with the ethical principles of the Declaration of 
Helsinki. Ethical approval will be obtained from the Institutional Review Board, ethics committee 
(IRB) of the Arab American University Palestine. All participants will give written, informed 
consent before they are included in the study. Participants will be told that they can withdraw from 
participation in the study at any time without consequences. All information will be anonymized to 
ensure confidentiality of the participants.
6. Timeline
The proposed research will be conducted over a period of 12 months. The timeline for the study is 
as follows:
Month 
Task
1 
Finalize proposal, obtain ethical approval, register clinical trial
2 
Finalize recruitment materials, train outcome assessor
3-8 
Recruitment and Intervention Period (6 months)
9 
Complete data collection and begin data entry and cleaning
10 
Complete data analysis and begin writing dissertation
11 
Continue writing dissertation
12 
Finalize and submit dissertation
7. References
Alnahdi, A. H. (2021). Validity and reliability of the Arabic quick disabilities of the arm, Shoulder and Hand 
(QuickDASH-Arabic). Musculoskeletal Science and Practice, 53, 102372.
Apard, T., Ferembach, B., & Martinel, V. (2025). Lacertus Syndrome Diagnosis With the Orthogonal 
Kinesiotaping Test. Plastic and Reconstructive Surgery - Global Open, 13(4), e6728. 
https://doi.org/10.1097/GOX.0000000000006728
19

Armijo-Olivo, S., Warren, S., & Magee, D. (2009). Intention to treat analysis, compliance, drop-outs and how 
to deal with missing data in clinical research: a review. Physical Therapy Reviews, 14(1), 36–49. 
https://doi.org/10.1179/174328809X405928
Ballestero-Perez, R., Plaza-Manzano, G., Urraca-Gesto, A., Romo-Romo, F., de los Ángeles Atín-Arratibel, 
M., Pecos-Martín, D., Gallego-Izquierdo, T., & Romero-Franco, N. (2017). Effectiveness of nerve gliding 
exercises on carpal tunnel syndrome: a systematic review. Journal of Manipulative and Physiological 
Therapeutics, 40(1), 50–59.
Bang, H., Ni, L., & Davis, C. E. (2004). Assessment of blinding in clinical trials. Controlled Clinical Trials, 
25(2), 143–156. https://doi.org/10.1016/j.cct.2003.10.016
Beaton, D. E., Wright, J. G., Katz, J. N., & Group, U. E. C. (2005). Development of the QuickDASH: 
comparison of three item-reduction approaches. JBJS, 87(5), 1038–1046.
Biasini, N. R., Bannon, B., Pellegrino, M., Qaderi, A., Trinh, W., Switzer-McIntyre, S., Reid, W. D., & 
Kasawara, K. T. (2023). Reliability and validity of shoulder and handgrip strength testing. Physiotherapy 
Canada, 75(1), 65–71.
Bobos, P., Nazari, G., Lu, Z., & MacDermid, J. C. (2020). Measurement properties of the hand grip strength 
assessment: a systematic review with meta-analysis. Archives of Physical Medicine and Rehabilitation, 
101(3), 553–565.
Coart, E., Bamps, P., Quinaux, E., Sturbois, G., Saad, E. D., Burzykowski, T., & Buyse, M. (2023). 
Minimization in randomized clinical trials. Statistics in Medicine, 42(28), 5285–5311.
Cohen, J. (2013). Statistical power analysis for the behavioral sciences. routledge.
Currie, K. B., Tadisina, K. K., & Mackinnon, S. E. (2022). Common hand conditions: a review. Jama, 327(24), 
2434–2445.
Del Barrio, S. J., Gracia, E. B., García, C. H., de Miguel, E. E., Moreno, J. M. T., Marco, S. R., & Laita, L. C. 
(2018). Conservative treatment in patients with mild to moderate carpal tunnel syndrome: A systematic 
review. Neurología (English Edition), 33(9), 590–601.
Eker, O. Al, & Imam, A. (2025). Equity in the distribution of health resources and services in the West Bank, 
Palestine: a focus on hospitals and primary healthcare centers. International Journal for Equity in Health, 
24(1), 106.
Fess, F. E. (1992). Grip strength. Casanova JS Clinical Assessment Recommendations, 41–45.
Giacaman, R. (2018). The health of Palestinians. The Lancet, 392(10161), 2268.
Groenwold, R. H. H., Moons, K. G. M., & Vandenbroucke, J. P. (2014). Randomized trials with missing 
outcome data: how to analyze and what to report. Canadian Medical Association Journal, 186(15), 1153–
1157. https://doi.org/10.1503/cmaj.131353
Guideline, I. C. H. H. (2015). Integrated addendum to ICH E6 (R1): guideline for good clinical practice E6 
(R2). Current Step, 2, 1–60.
Hagert, E. (2013). Clinical Diagnosis and Wide-Awake Surgical Treatment of Proximal Median Nerve 
Entrapment at the Elbow: A Prospective Study. HAND, 8(1), 41–46. https://doi.org/10.1007/s11552-012-
9483-4
Hamnerius, N., Dahlin, J., Bruze, M., Nilsson, K., Sukakul, T., & Svedman, C. (2023). Colophonium-related 
Allergic Contact Dermatitis Caused by Medical Adhesive Tape Used to Prevent Skin Lesions in Soldiers. 
Acta Dermato-Venereologica, 103, adv18428. https://doi.org/10.2340/actadv.v103.18428
Hofman, H., Beeckman, D., Duljic, T., Al Gilani, S., Johansson, S., Kottner, J., Kinnaer, L.-M., & Eriksson, M. 
(2023). Patients’ experiences with the application of medical adhesives to the skin: a qualitative 
systematic review protocol. BMJ Open, 13(6), e073546. https://doi.org/10.1136/bmjopen-2023-073546
20

Ijaz, M. J., Karimi, H., Ahmad, A., Gillani, S. A., Anwar, N., & Chaudhary, M. A. (2022). Comparative 
efficacy of routine physical therapy with and without neuromobilization in the treatment of patients with 
mild to moderate carpal tunnel syndrome. BioMed Research International, 2022(1), 2155765.
Jensen, M. P. (2003). The validity and reliability of pain measures in adults with cancer. The Journal of Pain, 
4(1), 2–21.
Johnson, R. K., Spinner, M., & Shrewsbury, M. M. (1979). Median nerve entrapment syndrome in the 
proximal forearm. The Journal of Hand Surgery, 4(1), 48–51.
Jt, F. (2001). Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain 
rating scale. Pain, 94, 149–158.
Julious, S. A. (2005). Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics: 
The Journal of Applied Statistics in the Pharmaceutical Industry, 4(4), 287–291.
Khan, N. A., Torralba, K. D., & Aslam, F. (2021). Missing data in randomised controlled trials of rheumatoid 
arthritis drug therapy are substantial and handled inappropriately. RMD Open, 7(2), e001708. 
https://doi.org/10.1136/rmdopen-2021-001708
Kus, S., Dereskewitz, C., Coenen, M., Rauch, A., Rudolf, K.-D., & Hand, C. L. P. (2017). International 
Classification of Functioning, Disability and Health: development of an assessment set to evaluate 
functioning based on the Brief ICF Core Set for Hand Conditions–ICF HandA. Journal of Hand Surgery 
(European Volume), 42(7), 731–741.
Kus, S., Oberhauser, C., & Cieza, A. (2012). Validation of the brief International Classification of Functioning, 
Disability, and Health (ICF) core set for hand conditions. Journal of Hand Therapy, 25(3), 274–287.
Leon, A. C., Davis, L. L., & Kraemer, H. C. (2011). The role and interpretation of pilot studies in clinical 
research. Journal of Psychiatric Research, 45(5), 626–629. 
https://doi.org/10.1016/j.jpsychires.2010.10.008
Lin, Y., Zhu, M., & Su, Z. (2015). The pursuit of balance: an overview of covariate-adaptive randomization 
techniques in clinical trials. Contemporary Clinical Trials, 45, 21–25.
Mintken, P. E., Glynn, P., & Cleland, J. A. (2009). Psychometric properties of the shortened disabilities of the 
Arm, Shoulder, and Hand Questionnaire (QuickDASH) and Numeric Pain Rating Scale in patients with 
shoulder pain. Journal of Shoulder and Elbow Surgery, 18(6), 920–926.
Modarresi, S., Lukacs, M. J., Ghodrati, M., Salim, S., MacDermid, J. C., & Walton, D. M. (2022). A 
systematic review and synthesis of psychometric properties of the numeric pain rating scale and the visual 
analog scale for use in people with neck pain. The Clinical Journal of Pain, 38(2), 132–148.
Nugent, S. M., Lovejoy, T. I., Shull, S., Dobscha, S. K., & Morasco, B. J. (2021). Associations of pain numeric 
rating scale scores collected during usual care with research administered patient reported pain outcomes. 
Pain Medicine, 22(10), 2235–2241.
Pandis, N. (2011). Randomization. part 2: minimization. American Journal of Orthodontics and Dentofacial 
Orthopedics, 140(6), 902–904.
Pocock, S. J., & Simon, R. (1975). Sequential treatment assignment with balancing for prognostic factors in the 
controlled clinical trial. Biometrics, 103–115.
Puntillo, F., & Bertini, L. (2018). Nerve Entrapment Syndromes. In Ultrasound-Guided Peripheral Nerve 
Blocks (pp. 85–103). Springer International Publishing. https://doi.org/10.1007/978-3-319-71020-4_4
Reuter, S. E., Massy‐Westropp, N., & Evans, A. M. (2011). Reliability and validity of indices of hand‐grip 
strength and endurance. Australian Occupational Therapy Journal, 58(2), 82–87.
Saghaei, M. (2011). An overview of randomization and minimization programs for randomized clinical trials. 
Journal of Medical Signals & Sensors, 1(1), 55–61.
21

Sartorio, F., Lippi, L., Vercelli, S., Gallo, F., Zanin, D., Bergesio, S., de Sire, A., & Invernizzi, M. (2025). 
Reliability and validity of the hand-held dynamometer “NOD”: a new instrument for assessment of 
isometric grip strength. BMC Musculoskeletal Disorders, 26(1), 5.
Schulz, K. F., & Grimes, D. A. (2002). Allocation concealment in randomised trials: defending against 
deciphering. The Lancet, 359(9306), 614–618. https://doi.org/10.1016/S0140-6736(02)07750-4
Scott, N. W., McPherson, G. C., Ramsay, C. R., & Campbell, M. K. (2002). The method of minimization for 
allocation to clinical trials: a review. Controlled Clinical Trials, 23(6), 662–674.
Sim, J. (2019). Should treatment effects be estimated in pilot and feasibility studies? Pilot and Feasibility 
Studies, 5(1), 107. https://doi.org/10.1186/s40814-019-0493-7
Sorensen, A. A., Howard, D., Tan, W. H., Ketchersid, J., & Calfee, R. P. (2013). Minimal clinically important 
differences of 3 patient-rated outcomes instruments. The Journal of Hand Surgery, 38(4), 641–649.
Spinner, R. J., & Amadio, P. C. (2003). Compressive neuropathies of the upper extremity. Clinics in Plastic 
Surgery, 30(2), 155–173. https://doi.org/10.1016/S0094-1298(02)00103-7
Whitehead, A. L., Julious, S. A., Cooper, C. L., & Campbell, M. J. (2016). Estimating the sample size for a 
pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a 
continuous outcome variable. Statistical Methods in Medical Research, 25(3), 1057–1073.
Young, I., Dunning, J., Escaloni, J., Maselli, F., Prall, J., Mourad, F., & Fernández-de-Las-Peñas, C. (2025). 
Reliability, construct validity, responsiveness and minimum clinically important difference of the numeric 
pain rating scale and shoulder pain and disability index in patients with subacromial pain syndrome. 
Musculoskeletal Science and Practice, 103372.
Zhao, W., Hill, M. D., & Palesch, Y. (2015). Minimal sufficient balance—a new strategy to balance baseline 
covariates and preserve randomness of treatment allocation. Statistical Methods in Medical Research, 
24(6), 989–1002.
 
22