Clinical trial NCT05311839: Effect of Thera Band Exercises on Adhesive Capsulitis Post Mastectomy
Official title: Combined Effect of Graded Thera Band and Scapular Stabilization Exercises on Shoulder Adhesive Capsulitis Post Mastectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adhesive Capsulitis of Shoulder
Lead sponsor: Qassim University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2022-04-05
Enrollment: 70
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Shoulder range of motion
timeFrame: at baseline
measure: Shoulder range of motion
timeFrame: after 8 weeks
measure: physical function
timeFrame: at baseline
measure: physical function
timeFrame: after 8weeks
measure: Health-related quality of life
timeFrame: at baseline
measure: Health-related quality of life
timeFrame: after 8 weeks
Secondary outcomes:
measure: Muscle strength
timeFrame: at baseline
measure: Muscle strength
timeFrame: after 8 weeks
measure: Visual analogue scale
timeFrame: at baseline
measure: Visual analogue scale
timeFrame: after 8 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy, Cairo University
state: Dokki
Study officials:
affiliation: Cairo University
name: Noha Kamel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Nancy Aboelnour, PhD
role: STUDY_CHAIR
References:
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.
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.
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.