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OpenTrials
Completed

NCT Number: NCT05311839

Effect of Thera Band Exercises on Adhesive Capsulitis Post Mastectomy

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

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Key information

Age range

40 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy, Cairo University

Giza, Dokki, 11432, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Other

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

Other names: conventional physical therapy program

Thera band

Other

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

Other names: graded Thera band exercises and scapular stabilization exercises

Primary outcomes

  1. Shoulder range of motion

    Time frame: at baseline

    A digital goniometer flexion and abduction, internal and external rotation range of motion

  2. Shoulder range of motion

    Time frame: after 8 weeks

    A digital goniometer flexion and abduction, internal and external rotation range of motion

  3. physical function

    Time frame: at baseline

    the Disability of the Arm, Shoulder, and Hand questionnaire [DASH] is used to measure physical function

  4. physical function

    Time frame: after 8weeks

    the Disability of the Arm, Shoulder, and Hand questionnaire [DASH] is used to measure physical function

  5. Health-related quality of life

    Time frame: at baseline

    assessed using the Medical Outcomes Study short-form (SF-36).

  6. Health-related quality of life

    Time frame: after 8 weeks

    assessed using the Medical Outcomes Study short-form (SF-36).

Secondary outcomes

  1. Muscle strength

    Time frame: at baseline

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

  2. Muscle strength

    Time frame: after 8 weeks

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

  3. Visual analogue scale

    Time frame: at baseline

    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

  4. Visual analogue scale

    Time frame: after 8 weeks

    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

Sponsors and collaborators

Lead sponsor

Maged Basha

Other

Collaborators

  • Cairo University

Registry information

Official study title

Combined Effect of Graded Thera Band and Scapular Stabilization Exercises on Shoulder Adhesive Capsulitis Post Mastectomy

Acronym: Mastectomy

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Apr 5, 2022
Registry last updated
Apr 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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