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

Not Applicable

Not yet recruiting

• Conditions: Post-mastectomy Pain Syndrome

• Registration Number: NCT06658314
• Lead Sponsor: Riphah International University

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

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-24
• Study First Submitted QC: 2024-10-24
• Last Update Submitted: 2024-10-24
• Study First Posted: 2024-10-26
• Last Update Posted: 2024-10-26
• Study Start: 2024-11-01
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Tempa-11 Scale	Kinesiophobia will be assessed at baseline to 3rd week	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

Secondary Outcome Measures

Name	Time	Method
Numeric Pain Rating Scale	Pain will be assessed at baseline to 3rd week	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.
SPADI	it will be assessed at baseline to 3rd week	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.

Trial Locations

Locations (1)

Fauji Foundation Hospital; 🇵🇰 Rawalpindi, Punjab, Pakistan