NCT06658314

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2025

Completed
Last Updated

July 3, 2025

Status Verified

July 1, 2025

Enrollment Period

8 months

First QC Date

October 24, 2024

Last Update Submit

July 2, 2025

Conditions

Keywords

KinesiophobiaKinesiotapingGraded exposure therapyPost-mastectomy patients

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Numeric Pain Rating Scale

    Pain will be assessed at baseline to 3rd week

  • SPADI

    it will be assessed at baseline to 3rd week

Study Arms (2)

Experimental: interventional group 1(Kinesiotaping)

ACTIVE COMPARATOR

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)

Experimental :interventional group II (Graded exposure therapy)

EXPERIMENTAL

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)

Interventions

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 1(Kinesiotaping)

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.

Experimental :interventional group II (Graded exposure therapy)

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fauji Foundation Hospital

Rawalpindi, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Kinesiophobia

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Aisha Razzaq, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2024

First Posted

October 26, 2024

Study Start

November 1, 2024

Primary Completion

June 15, 2025

Study Completion

June 19, 2025

Last Updated

July 3, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations