Adhesive Capsulitis of ShoulderMastectomyNCT05311839
Effect of Thera Band Exercises on Adhesive Capsulitis Post Mastectomy
A study testing Exercise and Thera band in people with Adhesive Capsulitis of Shoulder, run by Maged Basha at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Adhesive Capsulitis of Shoulder
- What is being tested?
- Exercise and Thera band
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2021to 5 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Shoulder or acromioclavicular joint osteoarthritis.
- Bone diseases.
- Infection.
- Severe osteoporosis.
- Tumors or metastasis.
- History of previous shoulder trauma or accidental injuries.
Show all 9Show fewer
- Previous history of dislocation.
- Previous history of surgery on the specific shoulder.
- Any other shoulder problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Effect of Graded Thera Band and Scapular Stabilization Exercises on Shoulder 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
Read the 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
- Conditions
- Adhesive Capsulitis of Shoulder
- Being tested
- Exercise, Thera band
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called conventional physical therapy program
Hot packs, active range of motion exercises, pendular exercises, wall climb exercises, mobilization exercises, and shoulder capsular stretching
Thera bandOther
Also called graded Thera band exercises and scapular stabilization exercises
graded Thera band exercises for shoulder flexion, abduction, internal, and external rotation
| Study group | Role | What they receive |
|---|---|---|
| Thera band exercises group | Experimental | received graded Thera band exercises for 5 days per week for eight weeks in addition to the conventional physical therapy program. Receives: Other: Exercise; Other: Thera band |
| conventional physiotherapy program group | Experimental | received a conventional physical therapy program. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder range of motion
A digital goniometer flexion and abduction, internal and external rotation range of motion
Measured: at baseline
Shoulder range of motion
A digital goniometer flexion and abduction, internal and external rotation range of motion
Measured: after 8 weeks
physical function
the Disability of the Arm, Shoulder, and Hand questionnaire [DASH] is used to measure physical function
Measured: at baseline
physical function
the Disability of the Arm, Shoulder, and Hand questionnaire [DASH] is used to measure physical function
Measured: after 8weeks
Health-related quality of life
assessed using the Medical Outcomes Study short-form (SF-36).
Measured: at baseline
Health-related quality of life
assessed using the Medical Outcomes Study short-form (SF-36).
Measured: after 8 weeks
Secondary outcomes (4)
Muscle strength
A handheld dynamometer (J Tech Commender Muscle Tester, Salt Lake City, Utah, USA)
Measured: at baseline
Muscle strength
A handheld dynamometer (J Tech Commender Muscle Tester, Salt Lake City, Utah, USA)
Measured: after 8 weeks
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
Measured: at baseline
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
Measured: after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start10 Jan 2021
- Primary completion25 Dec 2021
- Study completion5 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Adhesive Capsulitis of ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maged Basha
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Maged Basha, Qassim University
- Investigators
- Noha Kamel, PhD, Principal investigator, Cairo UniversityNancy Aboelnour, PhD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311839
- Sponsor's protocol ID
- PT3465
- Acronym
- Mastectomy
- Status last verified
- Apr 2022
- First submitted
- 26 Mar 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Publications
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.
PubMed 18292916Dilaveri 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.
PubMed 25429241Sabari 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.
PubMed 9630143Aboelnour NH, Kamel FH, Basha MA, Azab AR, Hewidy IM, Ezzat M, Kamel NM. Combined effect of graded Thera-Band and scapular stabilization exercises on shoulder adhesive capsulitis post-mastectomy. Support Care Cancer. 2023 Mar 16;31(4):215. doi: 10.1007/s00520-023-07641-6.
PubMed 36922413
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effect of Graded Thera Band and Scapular Stabilization Exercises on Shoulder Adhesive Capsulitis Post Mastectomy
- ClinicalTrials.gov ID
- NCT05311839
- Acronym / sponsor ID
- Mastectomy / PT3465
- Conditions
- Adhesive Capsulitis of Shoulder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Maged BashaUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 25 Dec 2021 (actual)
- Study completion
- 5 Jan 2022 (actual)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thera band exercises group | Experimental | Other: Exercise, Other: Thera bandreceived graded Thera band exercises for 5 days per week for eight weeks in addition to the conventional physical therapy program. |
| conventional physiotherapy program group | Experimental | Other: Exercisereceived a conventional physical therapy program. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- Shoulder or acromioclavicular joint osteoarthritis.
- Bone diseases.
- Infection.
- Severe osteoporosis.
- Tumors or metastasis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: conventional physical therapy programHot packs, active range of motion exercises, pendular exercises, wall climb exercises, mobilization exercises, and shoulder capsular stretching | Other | Thera band exercises group, conventional physiotherapy program group |
| Thera bandAlso: graded Thera band exercises and scapular stabilization exercisesgraded Thera band exercises for shoulder flexion, abduction, internal, and external rotation | Other | Thera band exercises group |
Primary outcome
Shoulder range of motion
Time frame: at baseline
A digital goniometer flexion and abduction, internal and external rotation range of motion
Shoulder range of motion
Time frame: after 8 weeks
A digital goniometer flexion and abduction, internal and external rotation range of motion
physical function
Time frame: at baseline
the Disability of the Arm, Shoulder, and Hand questionnaire [DASH] is used to measure physical function
physical function
Time frame: after 8weeks
the Disability of the Arm, Shoulder, and Hand questionnaire [DASH] is used to measure physical function
Health-related quality of life
Time frame: at baseline
assessed using the Medical Outcomes Study short-form (SF-36).
Health-related quality of life
Time frame: after 8 weeks
assessed using the Medical Outcomes Study short-form (SF-36).
4 secondary outcomes
Muscle strength
Time frame: at baseline
Muscle strength
Time frame: after 8 weeks
Visual analogue scale
Time frame: at baseline
Visual analogue scale
Time frame: after 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Background: PubMed 18292916Cheing 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 publication: PubMed 25429241Dilaveri 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 publication: PubMed 9630143Sabari 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.
- Derived from this study: PubMed 36922413Aboelnour NH, Kamel FH, Basha MA, Azab AR, Hewidy IM, Ezzat M, Kamel NM. Combined effect of graded Thera-Band and scapular stabilization exercises on shoulder adhesive capsulitis post-mastectomy. Support Care Cancer. 2023 Mar 16;31(4):215. doi: 10.1007/s00520-023-07641-6.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noha Kamel, PhD principal investigator
Cairo University
Nancy Aboelnour, PhD study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Thera band in people with Adhesive Capsulitis of Shoulder, run by Maged Basha at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder range of motion (time frame: at baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05311839, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.