Post Mastectomy Shoulder Problems and Kinesio Taping

Investigating the Effect of Kinesio Tape Over the Conventional Physical Therapy Management of Shoulder Related Complications in Post-mastectomy Peri-menopausal Females: A Randomized Control Trial

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

Study Overview

• Status: Completed
• Conditions: Post Mastectomy Complications
• Intervention / Treatment: Device: Kinesio tape; Procedure: physiotherapy program

Detailed Description

Post-mastectomy complications are often noted and complaints by breast cancer survivors. It often involves the development of chronic arm pain with accompanying limitation of shoulder motion. Aim of the study was to investigate the effect of the kinesio tape (KT) on the shoulder pain and range of motion (ROM).

Method: 74 female patients underwent modified radical mastectomy were involved in this study. They were randomly divided into two groups, experimental who received KT for shoulder joint in addition to conventional physiotherapy program while, the control group received the physiotherapy program only. Outcome measures were visual analogues scale, shoulder ROM and shoulder Pain and Disability Index.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kinesio tape; 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 tape; Standard 2 -inches ( 5-m) Kinesio TexR tape was used for application in the experimental group; Other Names: Kinesio TexR tape; Procedure: physiotherapy program; active-assistive range of motion exercises (AAROME), active stretching exercises and strengthening exercises for the shoulder joint. Likewise, patients also received postural correction exercises; Other Names: exercises
Active Comparator: Physiotherapy program; 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; active-assistive range of motion exercises (AAROME), active stretching exercises and strengthening exercises for the shoulder joint. Likewise, patients also received postural correction exercises; Other Names: exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Shoulder Pain and Disability Index (SPADI)	It consists of 13 items that assess two domains; a 5-item subscale which measures pain and an 8-item subscale which measures disability. Total score is calculated by averaging the pain and disability subscale scores.	2 weeks change from the baseline scores

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: April 17, 2016
• First Submitted That Met QC Criteria: April 22, 2016
• First Posted (Estimate): April 25, 2016

Study Record Updates

• Last Update Posted (Estimate): April 25, 2016
• Last Update Submitted That Met QC Criteria: April 22, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Shoulder Pain; Mastectomy; ROM; Kinesio Tape
• Other Study ID Numbers: P.T.REC/012/001249

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: publication in a refereed journal

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No