Comparison of Kinesiotaping and Graded Exposure Therapy on Kinesiophobia in Post-Mastectomy Patients

The aim of this research is to compare the effect of Comparison of Kinesiotaping and Graded exposure therapy on Kinesiophobia in Post-Mastectomy patients. The sample size was 30. The subjects were divided in two groups, 15 subjects in kinesiotaping group and 15 in graded exposure therapy group. Study duration was of 1 year. Sampling technique applied was nonprobability Convenience sampling technique. Patients had recently undergone mastectomy procedure age between 30 to 60 years and mean Tempa- 11 score of >23 were included. Tools used in the study are Tempa -11 for kinesiophobia, NPRS for Pain, SPADI for Functional outcome measure. Data was be analyzed through SPSS 26.

Study Overview

• Status: Completed
• Conditions: Post-mastectomy Pain Syndrome
• Intervention / Treatment: Other: Experimental interventional group 1(Kinesiotaping); Other: Experimental interventional group II (Graded exposure therapy)

Detailed Description

Mastectomy is a procedure performed as a part of treatment for breast cancer, which entails removal of entire breast tissue. Breast cancer is a condition where abnormal cells in the breasts proliferate and eventually develop tumor. It is the most prevalent form of cancer accounting for 23% of all the newly diagnosed cancers. There are several types of mastectomy procedures including complete mastectomy, radical mastectomy and modified radical mastectomy. After mastectomy, many possible complications and side effects can occur including seroma, lymphedema, pain, restricted range of motion, kinesiophobia, infection etc. and all these complications required special care and treatment to improve patient's quality of life. Breast cancer survivor often develop fear of movement called kinesiophobia either due to pain or other psychological factors. It is the excessive, irrational, and debilitating fear of movement or physical activity. This fear of movement is linked to a feeling of susceptibility to injury from movement. As a result of using the painful area less due to the fear of increased pain from movement, acute pain can develop into persistent and chronic pain that in return increase hospital stay and decrease quality of life which increase the financial burden on individual. According to the recent studies kinesiophobia is one of the parameters found in post-mastectomy patients with mean Tempa -11 score of 24 in Pakistani populations.

Post mastectomy complications are mostly manageable, and studies show significant improvement in patient's symptoms. Shoulder disability, pain and ROM are addressed in many studies but managing kinesiophobia in early stages after mastectomy still needs to be further discussed

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan
      • Fauji Foundation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Females
• Age between 30-60 years.
• Post-Mastectomy patients (not more than 4 weeks).
• Tempa -11 score >23.

Exclusion Criteria:

• Any shoulder dislocations/fracture.
• Any known neurological impairments i.e. radiculopathy
• Bilateral mastectomy
• Known Cardiac issues
• Patients undergoing chemotherapy
• Any known allergies to kinesiotaping

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Experimental: interventional group 1(Kinesiotaping); Kinesiotape will be applied by using two I-bands application technique. It will be applied once a week for 3 to 5 days and total time period of 3 weeks.	Other: Experimental interventional group 1(Kinesiotaping); Kinesiotape will be applied by using two I-bands application technique: Short band: to apply this ask the patient to move your arm behind her back as much as possible, then apply kinesiotape at the anterior glenohumeral joint. Longer band: to apply this ask the patient to horizontal adduct her arm as much as possible, than apply kinesiotape targeting the posterior side of glenohumeral joint. Apply both these band with paper-off stretch for 3-5 days or as depending upon skin sensitivity and tape adherence. Kinesiotape will be applied once a week for total time period of 3 weeks.
Experimental: Experimental :interventional group II (Graded exposure therapy); Graded exposure therapy consists of set of exercises, performed for 3 weeks with 3 sessions per week. Each exercise protocol has 5 to 10 repetitions per day.	Other: Experimental interventional group II (Graded exposure therapy); First week: gentle arm raises with 10 repetitions/day, slow and controlled stretch 25 to 50% force with 5 repetitions, passive internal and external rotations (with towel) with 5 repetitions each/day. Second week: overhead arm raises (wall climbing) with 10 repetitions/day, pendulum exercises 10 repetitions/day, cross arm stretches 5 repetitions/day, active internal and external rotations with 5 repetitions each/day. Third week: resistance exercises (initially with minimum weight or manual resistance), scapular squeezes 10 repetitions/day, gentle chest stretches 5 repetitions/day and gentle stretch with 75 to 100 % force 5 repetitions each/day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tempa-11 Scale	Tempa-11 Scale is used to measure Kinesiophobia. This questionnaire has 11 items with the total score of 44, 11 being the lowest possible score and 44 being the highest	Kinesiophobia will be assessed at baseline to 3rd week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Pain Rating Scale	Numeric pain rating scale is used to assess pain. Numeric pain rating scale is a 11-item scale comprising usually of horizonal or vertical line with 0 to 10 ratings between the two extremes.	Pain will be assessed at baseline to 3rd week
SPADI	The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two main items, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual face during various activities of daily living that require upper-extremity use.	it will be assessed at baseline to 3rd week

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Aisha Razzaq, PHD*, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Actual): June 15, 2025
• Study Completion (Actual): June 19, 2025

Study Registration Dates

• First Submitted: October 24, 2024
• First Submitted That Met QC Criteria: October 24, 2024
• First Posted (Actual): October 26, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: July 2, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Kinesiotaping; Kinesiophobia; Graded exposure therapy; Post-mastectomy patients
• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Kinesiophobia
• Other Study ID Numbers: RiphahIU Madiha Bashir

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No