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

NCT ID: NCT06658314

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-06-19

Brief Summary

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.

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

Conditions

Post-mastectomy Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Experimental interventional group 1(Kinesiotaping)

Intervention Type: OTHER

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 :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.

Group Type: EXPERIMENTAL

Experimental interventional group II (Graded exposure therapy)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aisha Razzaq, PhD*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Fauji Foundation Hospital

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

RiphahIU Madiha Bashir

Identifier Type: -

Identifier Source: org_study_id