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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05311839
Other study ID # PT3465
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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