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

Primary Purpose

Adhesive Capsulitis of Shoulder

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Exercise
Thera band
Sponsored by
Maged Basha
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis of Shoulder

Eligibility Criteria

40 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Physical Therapy, Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Thera band exercises group

conventional physiotherapy program group

Arm Description

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

received a conventional physical therapy program.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Muscle strength
A handheld dynamometer (J Tech Commender Muscle Tester, Salt Lake City, Utah, USA)
Muscle strength
A handheld dynamometer (J Tech Commender Muscle Tester, Salt Lake City, Utah, USA)
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
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

Full Information

First Posted
March 26, 2022
Last Updated
April 19, 2022
Sponsor
Maged Basha
Collaborators
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05311839
Brief Title
Effect of Thera Band Exercises on Adhesive Capsulitis Post Mastectomy
Acronym
Mastectomy
Official Title
Combined Effect of Graded Thera Band and Scapular Stabilization Exercises on Shoulder Adhesive Capsulitis Post Mastectomy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 10, 2021 (Actual)
Primary Completion Date
December 25, 2021 (Actual)
Study Completion Date
January 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Maged Basha
Collaborators
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis of Shoulder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thera band exercises group
Arm Type
Experimental
Arm Description
received graded Thera band exercises for 5 days per week for eight weeks in addition to the conventional physical therapy program.
Arm Title
conventional physiotherapy program group
Arm Type
Experimental
Arm Description
received a conventional physical therapy program.
Intervention Type
Other
Intervention Name(s)
Exercise
Other Intervention Name(s)
conventional physical therapy program
Intervention Description
Hot packs, active range of motion exercises, pendular exercises, wall climb exercises, mobilization exercises, and shoulder capsular stretching
Intervention Type
Other
Intervention Name(s)
Thera band
Other Intervention Name(s)
graded Thera band exercises and scapular stabilization exercises
Intervention Description
graded Thera band exercises for shoulder flexion, abduction, internal, and external rotation
Primary Outcome Measure Information:
Title
Shoulder range of motion
Description
A digital goniometer flexion and abduction, internal and external rotation range of motion
Time Frame
at baseline
Title
Shoulder range of motion
Description
A digital goniometer flexion and abduction, internal and external rotation range of motion
Time Frame
after 8 weeks
Title
physical function
Description
the Disability of the Arm, Shoulder, and Hand questionnaire [DASH] is used to measure physical function
Time Frame
at baseline
Title
physical function
Description
the Disability of the Arm, Shoulder, and Hand questionnaire [DASH] is used to measure physical function
Time Frame
after 8weeks
Title
Health-related quality of life
Description
assessed using the Medical Outcomes Study short-form (SF-36).
Time Frame
at baseline
Title
Health-related quality of life
Description
assessed using the Medical Outcomes Study short-form (SF-36).
Time Frame
after 8 weeks
Secondary Outcome Measure Information:
Title
Muscle strength
Description
A handheld dynamometer (J Tech Commender Muscle Tester, Salt Lake City, Utah, USA)
Time Frame
at baseline
Title
Muscle strength
Description
A handheld dynamometer (J Tech Commender Muscle Tester, Salt Lake City, Utah, USA)
Time Frame
after 8 weeks
Title
Visual analogue scale
Description
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
Time Frame
at baseline
Title
Visual analogue scale
Description
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
Time Frame
after 8 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Breast Cancer, post-mastectomy
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noha Kamel, PhD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nancy Aboelnour, PhD
Organizational Affiliation
Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Physical Therapy, Cairo University
City
Giza
State/Province
Dokki
ZIP/Postal Code
11432
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
18292916
Citation
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.
Results Reference
background
PubMed Identifier
25429241
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.S71591. eCollection 2014.
Results Reference
result
PubMed Identifier
9630143
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. doi: 10.1016/s0003-9993(98)90038-7.
Results Reference
result

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Effect of Thera Band Exercises on Adhesive Capsulitis Post Mastectomy

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