Effect of Thera Band Exercises on Adhesive Capsulitis Post Mastectomy (Mastectomy)

Combined Effect of Graded Thera Band and Scapular Stabilization Exercises on Shoulder Adhesive Capsulitis Post Mastectomy

Breast cancer surgeries particularly mastectomy results in limited shoulder movement which can lead to arm, shoulder pain and stiffness. Females who underwent mastectomy have reported a significantly higher incidence of shoulder morbidity

Study Overview

• Status: Completed
• Conditions: Adhesive Capsulitis of Shoulder
• Intervention / Treatment: Other: Exercise; Other: Thera band

Detailed Description

Exercise therapy might help in reduction of pain and restoration of the range, coordination and control of movement in patients with adhesive capsulitis. Graded resistance exercises are effective in decreasing fatigue levels, enhancing functional capacity and muscle strength. Rehabilitation exercises which strengthen the scapular stability can be extremely beneficial in rehabilitation treatment of patients with shoulder pain and problems

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

Contacts and Locations

Study Locations

• Egypt
  • Dokki
    • Giza, Dokki, Egypt, 11432
      • Faculty of physical therapy, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Age ranged from 40-60 years.
• 2nd stage of adhesive capsulitis,
• Shoulder pain and stiffness for at least 3 months.
• Restriction in shoulder flexion, abduction, internal and external rotation ROM less than 50% when compared to the other shoulder.

Exclusion Criteria:

• Shoulder or acromioclavicular joint osteoarthritis.
• Bone diseases.
• Infection.
• Severe osteoporosis.
• Tumors or metastasis.
• History of previous shoulder trauma or accidental injuries.
• Previous history of dislocation.
• Previous history of surgery on the specific shoulder.
• Any other shoulder problems.

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: Thera band exercises group; received graded Thera band exercises for 5 days per week for eight weeks in addition to the conventional physical therapy program.	Other: Exercise; Hot packs, active range of motion exercises, pendular exercises, wall climb exercises, mobilization exercises, and shoulder capsular stretching; Other Names: conventional physical therapy program; Other: Thera band; graded Thera band exercises for shoulder flexion, abduction, internal, and external rotation; Other Names: graded Thera band exercises and scapular stabilization exercises
Experimental: conventional physiotherapy program group; received a conventional physical therapy program.	Other: Exercise; Hot packs, active range of motion exercises, pendular exercises, wall climb exercises, mobilization exercises, and shoulder capsular stretching; Other Names: conventional physical therapy program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder range of motion	A digital goniometer flexion and abduction, internal and external rotation range of motion	at baseline
Shoulder range of motion	A digital goniometer flexion and abduction, internal and external rotation range of motion	after 8 weeks
physical function	the Disability of the Arm, Shoulder, and Hand questionnaire [DASH] is used to measure physical function	at baseline
physical function	the Disability of the Arm, Shoulder, and Hand questionnaire [DASH] is used to measure physical function	after 8weeks
Health-related quality of life	assessed using the Medical Outcomes Study short-form (SF-36).	at baseline
Health-related quality of life	assessed using the Medical Outcomes Study short-form (SF-36).	after 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle strength	A handheld dynamometer (J Tech Commender Muscle Tester, Salt Lake City, Utah, USA)	at baseline
Muscle strength	A handheld dynamometer (J Tech Commender Muscle Tester, Salt Lake City, Utah, USA)	after 8 weeks
Visual analogue scale	used to assess the intensity of shoulder pain. consists of 10-cm line, and was utilized to quantify the pain severity within shoulder, where the score of zero means no pain, while a score of ten means significant pain	at baseline
Visual analogue scale	used to assess the intensity of shoulder pain.consists of 10-cm line, and was utilized to quantify the pain severity within shoulder, where the score of zero means no pain, while a score of ten means significant pain	after 8 weeks

Collaborators and Investigators

• Sponsor: Maged Basha
• Collaborators: Cairo University
• Investigators: Principal Investigator: Noha Kamel, PhD, Cairo University; Study Chair: Nancy Aboelnour, PhD, Cairo University

Publications and helpful links

General Publications

• Cheing GL, So EM, Chao CY. Effectiveness of electroacupuncture and interferential eloctrotherapy in the management of frozen shoulder. J Rehabil Med. 2008 Mar;40(3):166-70. doi: 10.2340/16501977-0142.
• Dilaveri CA, Sandhu NP, Neal L, Neben-Wittich MA, Hieken TJ, Mac Bride MB, Wahner-Roedler DL, Ghosh K. Medical factors influencing decision making regarding radiation therapy for breast cancer. Int J Womens Health. 2014 Nov 19;6:945-54. doi: 10.2147/IJWH.S71591. eCollection 2014. Review.
• Sabari JS, Maltzev I, Lubarsky D, Liszkay E, Homel P. Goniometric assessment of shoulder range of motion: comparison of testing in supine and sitting positions. Arch Phys Med Rehabil. 1998 Jun;79(6):647-51.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2021
• Primary Completion (Actual): December 25, 2021
• Study Completion (Actual): January 5, 2022

Study Registration Dates

• First Submitted: March 26, 2022
• First Submitted That Met QC Criteria: March 26, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Actual): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis
• Other Study ID Numbers: PT3465

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
• IPD Sharing Time Frame: 6 months after publication
• IPD Sharing Access Criteria: relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.
• IPD Sharing Supporting Information Type: Study Protocol

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