NCT02749539

Brief Summary

Applications of new treatment modality which is Kinesio tape in post mastectomy shoulder problems.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2015

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 25, 2016

Completed
Last Updated

April 25, 2016

Status Verified

April 1, 2016

Enrollment Period

11 months

First QC Date

April 17, 2016

Last Update Submit

April 22, 2016

Conditions

Keywords

MastectomyShoulder PainROMKinesio Tape

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale (VAS)

    It is a perpendicular line on the scale that corresponded to their perceived pain intensity.

    2 weeks change from the baseline scores

Secondary Outcomes (1)

  • The Shoulder Pain and Disability Index (SPADI)

    2 weeks change from the baseline scores

Study Arms (2)

Kinesio tape

EXPERIMENTAL

The first 3 kinesio tape application was inhibition technique for supraspinatus, deltoid and teres minor muscles. the fourth Kinesio tape was mechanical correction for the shoulder joint. in addition to active-assistive range of motion exercises (AAROME), active stretching exercises and strengthening exercises for the shoulder joint. Likewise, patients also received postural correction exercises

Device: Kinesio tapeProcedure: physiotherapy program

Physiotherapy program

ACTIVE COMPARATOR

active-assistive range of motion exercises (AAROME), active stretching exercises and strengthening exercises for the shoulder joint. Likewise, patients also received postural correction exercises

Procedure: physiotherapy program

Interventions

Standard 2 -inches ( 5-m) Kinesio TexR tape was used for application in the experimental group

Also known as: Kinesio TexR tape
Kinesio tape

active-assistive range of motion exercises (AAROME), active stretching exercises and strengthening exercises for the shoulder joint. Likewise, patients also received postural correction exercises

Also known as: exercises
Kinesio tapePhysiotherapy program

Eligibility Criteria

Age35 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Underwent modified radical mastectomy for at least 2 weeks and taking chemotherapy and radiation therapy for stage 1 or II breast cancer.
  • Presence of shoulder pain with associated limitation of motion of the shoulder.
  • Good compliance and willingness to participate in kinesio taping sessions with a written consent

You may not qualify if:

  • Still diagnosed with active breast CA at the time of the study.
  • Presence of skin hypersensitivity to kinesio tape material.
  • Presence of treatment contraindications including the presence of a pacemaker, heart disease, pregnancy, infectious disease, epilepsy thrombophlebitis, arterial hypertension or metastatic cancer .
  • Presence of mental disturbances of the sensorium or language problems which can make communication and cooperation problematic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Shoulder Pain

Interventions

Athletic TapeExercise

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical EquipmentMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Physical Therapy

Study Record Dates

First Submitted

April 17, 2016

First Posted

April 25, 2016

Study Start

February 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

April 25, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will share

publication in a refereed journal