Clinical trial NCT06658314: Comparison of Kinesiotaping and Graded Exposure Therapy on Kinesiophobia in Post-Mastectomy Patients
Official title: Comparison of Kinesiotaping and Graded Exposure Therapy on Kinesiophobia in Post-Mastectomy Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-mastectomy Pain Syndrome
Keywords: Kinesiophobia
Kinesiotaping
Graded exposure therapy
Post-mastectomy patients
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 30
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Tempa-11 Scale
timeFrame: Kinesiophobia will be assessed at baseline to 3rd week
Secondary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: Pain will be assessed at baseline to 3rd week
measure: SPADI
timeFrame: it will be assessed at baseline to 3rd week
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Fauji Foundation Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Aisha Razzaq, PhD*
role: PRINCIPAL_INVESTIGATOR
References: