Effect of Thera Band Exercises on Adhesive Capsulitis Post Mastectomy

NCT05311839 | Completed

• 1 other identifier: PT3465
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Adhesive Capsulitis of Shoulder

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Muscle strength

  at baseline

• Muscle strength

  after 8 weeks

• Visual analogue scale

  at baseline

• Visual analogue scale

  after 8 weeks

Study Arms (2)

Thera band exercises group

EXPERIMENTAL

received graded Thera band exercises for 5 days per week for eight weeks in addition to the conventional physical therapy program.

Other: Exercise; Other: Thera band

conventional physiotherapy program group

EXPERIMENTAL

received a conventional physical therapy program.

Other: Exercise

Interventions

Exercise OTHER

Hot packs, active range of motion exercises, pendular exercises, wall climb exercises, mobilization exercises, and shoulder capsular stretching

Also known as: conventional physical therapy program

Thera band exercises group; conventional physiotherapy program group

Thera band OTHER

graded Thera band exercises for shoulder flexion, abduction, internal, and external rotation

Also known as: graded Thera band exercises and scapular stabilization exercises

Thera band exercises group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Gender Eligibility Details: Breast Cancer, post-mastectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age ranged from 40-60 years.
• nd 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maged Basha: lead
• Cairo University: collaborator

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Giza, Dokki, 11432, Egypt

Location

Related Publications (4)

• 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.

  PMID: 18292916 BACKGROUND

• 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.

  PMID: 25429241 RESULT

• 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. doi: 10.1016/s0003-9993(98)90038-7.

  PMID: 9630143 RESULT

• Aboelnour NH, Kamel FH, Basha MA, Azab AR, Hewidy IM, Ezzat M, Kamel NM. Combined effect of graded Thera-Band and scapular stabilization exercises on shoulder adhesive capsulitis post-mastectomy. Support Care Cancer. 2023 Mar 16;31(4):215. doi: 10.1007/s00520-023-07641-6.

  PMID: 36922413 DERIVED

MeSH Terms

Conditions

Bursitis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Noha Kamel, PhD

  Cairo University

  PRINCIPAL INVESTIGATOR

• Nancy Aboelnour, PhD

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, College of Medical Rehabilitation, Qassim University, Saudi Arabia, Qassim, Buraidah. Consultant Physical Therapist, El-Sahel Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Cairo, Egypt.

Study Record Dates

• First Submitted: March 26, 2022
• First Posted: April 5, 2022
• Study Start: January 10, 2021
• Primary Completion: December 25, 2021
• Study Completion: January 5, 2022
• Last Updated: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months after publication
• Access Criteria: relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

Locations

EG (1)