Adhesive Capsulitis of Shoulder Clinical Trial
— MastectomyOfficial title:
Combined Effect of Graded Thera Band and Scapular Stabilization Exercises on Shoulder Adhesive Capsulitis Post Mastectomy
| 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 |
| Verified date | April 2022 |
| Source | Qassim University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| 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. |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Faculty of Physical Therapy, Cairo University | Giza | Dokki |
| Lead Sponsor | Collaborator |
|---|---|
| Maged Basha | Cairo University |
Egypt,
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
| 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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