Thyroiditis, ChronicNCT06954220
Baduanjin Exercises on Shoulder Dysfunction Post Thyroidectomy
A study testing Baduanjin exercises in people with Thyroiditis, Chronic, run by MTI University at 1 site in Egypt.
Trial summary
This study will be carried out at the outpatient clinic of the faculty of physical therapy, Cairo university, El Galaa general hosbital after referral from endocrine surgeon. Participants will perform these exercises in a room supervisor physiotherapist. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Thyroiditis, Chronic
- What is being tested?
- Baduanjin exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Apr 2025to 29 Jul 2025
- 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- They have the development of the shoulder dysfunction (Range of motion limitation and shoulder pain) (limitation of 20 ≥ ROM in shoulder flexion, abduction, external or internal rotation) after thyroidectomy.
- Patients who were 6 months to 1 year post unilateral neck dissection
- Aged 30- 50 years (at the time of surgery)
Who cannot join
- they had severe cardiac disease, uncontrolled hypertension and upper extremity problems started Before treatment of thyroid cancer surgery.
- Patients with neurological disease, rheumatologically disease, communication problems, recurrent infections, and history of head or neck malignancy, history of > 1 neck dissection, history of bilateral neck dissection,
- open wounds or incision presence in the region and patients proceeding with chemotherapy (CT) or radiotherapy (RT) were barred
Trial locations and contacts
1 site in 1 country.
About this study
This study will be carried out at the outpatient clinic of the faculty of physical therapy, Cairo university, El Galaa general hosbital after referral from endocrine surgeon. Participants will perform these exercises in a room supervisor physiotherapist.
All participants will sign a written consent form after receiving full information about the purpose of the study, procedure, possible benefits, privacy, and use of data.
Read the detailed description
This study will investigate the effects of Baduanjin exercises on shoulder dysfunction post thyroidectomy. To assign patients to different treatment groups, a table of random numbers generated by a computer was used. Patients were allocated randomly into two groups using this method. This study will be carried out at the outpatient clinic of the faculty of physical therapy, Cairo University, El Galaa general hospital and National Cancer Institute in Cairo to be treated in the outpatient clinic after referral from endocrine surgeon. Participants will perform these exercises in a room supervisor physiotherapist.
All participants will sign a written consent form after receiving full information about the purpose of the study, procedure, possible benefits, privacy, and use of data.
- Conditions
- Thyroiditis, Chronic
- Being tested
- Baduanjin exercises
- Medical subject headings
- Thyroiditis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baduanjin exercisesOther
Baduanjin has 8 movement forms, which are relatively less demanding. Assistive equipment is also not necessary during Baduanjin. These advantages make Baduanjin a suitable form of exercise training for post thyroidectomy patients. The movements involved in Baduanjin require the individual to reach beyond the base of support, change the base of support between bilateral and unilateral stance, and perform movements in a sustained squatting posture. These maneuvers challenge balance and require muscle strength to be executed successfully. In 8 movement forms of Baduanjin all include shoulder joint function exercises, thus making Baduanjin a potentially useful method for improving activity level and arm strength.
| Study group | Role | What they receive |
|---|---|---|
| Baduanjin exercises | Experimental | This group included 40 participants post thyroidectomy; they will receive Baduanjin exercises and conservative shoulder care Receives: Other: Baduanjin exercises |
| control group | No intervention | This group included 40 participants post thyroidectomy; they will receive conservative shoulder care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain and disability index (SPADI)
It was used to determine the shoulder pain and disability. It comprises of 13 items: a 5 item subscale to evaluate the pain and an 8 item subscale to evaluate the disability. The total score is determined by averaging the pain and disability subscale scores. The SPADI exhibits great construct validity, associating admirably with other district explicit shoulder questionnaires. The translated version of the SPADI in the Arabic language showed excellent internal consistency, with a Cronbach's α values of 0.98, and test retest reliability.the SPADI score ranges from 0 to 100, with higher scores indicating greater shoulder pain and disability
Measured: at baseline and at 12 weeks
Secondary outcomes (2)
Shoulder range of motion :( active range of motion (ROM)) using Image J
The ImageJ, a photograph-based goniometry tool, can measure the angle using images or videos during these exercises. Measurement method using ImageJ during active ROM exercises.Three-dimensional motion capture systems, such as Vicon, have been widely used with increased accuracy . However, as these technologies can be costly and are unavailable in many clinical settings , the ImageJ open-source software is considered particularly for measuring the ROM of the upper limbs during exercise
Measured: at baseline and at 12 weeks
Total calcium concentration
Measured: at baseline and at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start25 Apr 2025
- Primary completion25 Jul 2025
- Study completion29 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroiditis, ChronicStudies 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
- Model description
- Prospective Randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Ahmed Abd El hady El Fahl,ph.d, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954220
- Sponsor's protocol ID
- P.T.REC/012/005743
- Status last verified
- Aug 2025
- First submitted
- 24 Apr 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baduanjin Exercises on Shoulder Dysfunction Post Thyroidectomy
- ClinicalTrials.gov ID
- NCT06954220
- Acronym / sponsor ID
- P.T.REC/012/005743
- Conditions
- Thyroiditis, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Study start
- 25 Apr 2025 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- 29 Jul 2025 (actual)
- First posted
- 1 May 2025 (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.
This study will be carried out at the outpatient clinic of the faculty of physical therapy, Cairo university, El Galaa general hosbital after referral from endocrine surgeon. Participants will perform these exercises in a room supervisor physiotherapist.
All participants will sign a written consent form after receiving full information about the purpose of the study, procedure, possible benefits, privacy, and use of data.
Detailed description
This study will investigate the effects of Baduanjin exercises on shoulder dysfunction post thyroidectomy. To assign patients to different treatment groups, a table of random numbers generated by a computer was used. Patients were allocated randomly into two groups using this method. This study will be carried out at the outpatient clinic of the faculty of physical therapy, Cairo University, El Galaa general hospital and National Cancer Institute in Cairo to be treated in the outpatient clinic after referral from endocrine surgeon. Participants will perform these exercises in a room supervisor physiotherapist.
All participants will sign a written consent form after receiving full information about the purpose of the study, procedure, possible benefits, privacy, and use of data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Baduanjin exercises | Experimental | Other: Baduanjin exercisesThis group included 40 participants post thyroidectomy; they will receive Baduanjin exercises and conservative shoulder care |
| control group | No intervention | –This group included 40 participants post thyroidectomy; they will receive conservative shoulder care |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- They have the development of the shoulder dysfunction (Range of motion limitation and shoulder pain) (limitation of 20 ≥ ROM in shoulder flexion, abduction, external or internal rotation) after thyroidectomy.
- Patients who were 6 months to 1 year post unilateral neck dissection
- Aged 30- 50 years (at the time of surgery)
Key exclusion criteria (3 listed)
- they had severe cardiac disease, uncontrolled hypertension and upper extremity problems started Before treatment of thyroid cancer surgery.
- Patients with neurological disease, rheumatologically disease, communication problems, recurrent infections, and history of head or neck malignancy, history of > 1 neck dissection, history of bilateral neck dissection,
- open wounds or incision presence in the region and patients proceeding with chemotherapy (CT) or radiotherapy (RT) were barred
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 |
|---|---|---|
| Baduanjin exercisesBaduanjin has 8 movement forms, which are relatively less demanding. Assistive equipment is also not necessary during Baduanjin. These advantages make Baduanjin a suitable form of exercise training for post thyroidectomy patients. The movements involved in Baduanjin require the individual to reach beyond the base of support, change the base of support between bilateral and unilateral stance, and perform movements in a sustained squatting posture. These maneuvers challenge balance and require muscle strength to be executed successfully. In 8 movement forms of Baduanjin all include shoulder joint function exercises, thus making Baduanjin a potentially useful method for improving activity level and arm strength. | Other | Baduanjin exercises |
Primary outcome
Shoulder Pain and disability index (SPADI)
Time frame: at baseline and at 12 weeks
It was used to determine the shoulder pain and disability. It comprises of 13 items: a 5 item subscale to evaluate the pain and an 8 item subscale to evaluate the disability. The total score is determined by averaging the pain and disability subscale scores. The SPADI exhibits great construct validity, associating admirably with other district explicit shoulder questionnaires. The translated version of the SPADI in the Arabic language showed excellent internal consistency, with a Cronbach's α values of 0.98, and test retest reliability.the SPADI score ranges from 0 to 100, with higher scores indicating greater shoulder pain and disability
2 secondary outcomes
Shoulder range of motion :( active range of motion (ROM)) using Image J
Time frame: at baseline and at 12 weeks
Total calcium concentration
Time frame: at baseline and at 12 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 6 Aug 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baduanjin exercises in people with Thyroiditis, Chronic, run by MTI University 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 3 inclusion and 3 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 6 Aug 2025. 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 Pain and disability index (SPADI) (time frame: at baseline and at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2025.