Effect of Thera Band Exercises on Adhesive Capsulitis Post Mastectomy

Adhesive Capsulitis of Shoulder Clinical Trial

— Mastectomy  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05311839
• Other study ID #: PT3465
• Status: Completed
• Phase: N/A
• Start date: January 10, 2021
• Est. completion date: January 5, 2022

Study information

• Verified date: April 2022
• Source: Qassim University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 5, 2022
• Est. primary completion date: December 25, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adhesive Capsulitis of Shoulder
• Bursitis

Intervention

Other:
• Exercise
Hot packs, active range of motion exercises, pendular exercises, wall climb exercises, mobilization exercises, and shoulder capsular stretching
• Thera band
graded Thera band exercises for shoulder flexion, abduction, internal, and external rotation

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy, Cairo University	Giza	Dokki

Sponsors (2)

Lead Sponsor	Collaborator
Maged Basha	Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder range of motion	A digital goniometer flexion and abduction, internal and external rotation range of motion	at baseline
Primary	Shoulder range of motion	A digital goniometer flexion and abduction, internal and external rotation range of motion	after 8 weeks
Primary	physical function	the Disability of the Arm, Shoulder, and Hand questionnaire [DASH] is used to measure physical function	at baseline
Primary	physical function	the Disability of the Arm, Shoulder, and Hand questionnaire [DASH] is used to measure physical function	after 8weeks
Primary	Health-related quality of life	assessed using the Medical Outcomes Study short-form (SF-36).	at baseline
Primary	Health-related quality of life	assessed using the Medical Outcomes Study short-form (SF-36).	after 8 weeks
Secondary	Muscle strength	A handheld dynamometer (J Tech Commender Muscle Tester, Salt Lake City, Utah, USA)	at baseline
Secondary	Muscle strength	A handheld dynamometer (J Tech Commender Muscle Tester, Salt Lake City, Utah, USA)	after 8 weeks
Secondary	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
Secondary	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