Head and Neck CancerNCT06555913
Maitland Mobilization and Scapular Stabilization Shoulder Dysfunction
A study testing Maitland Mobilization, Scapular Stabilization and Traditional Physical Therapy in people with Head and Neck Cancer, run by Cairo University at 1 site in Egypt.
Trial summary
Sixty patients from both genders suffering from shoulder disability post unilateral NDS (modified radical, selective) will participate in this study. Their ages will be ranged from 30 to 50 years. They will be selected randomly from Damanhur Oncology center, El-Behira, Egypt. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Maitland Mobilization, Scapular Stabilization and Traditional Physical Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 1 Jul 2024
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients' age will be ranged between 30-50 years.
- Both genders will participate in this study.
- All patients suffering from shoulder pain and disability following unilateral modified radical NDS or selective NDS.
- All patients will begin the treatment program from 1 to 3 months after NDS.
- All patients will have limited ROM of shoulder flexion, abduction, external rotation.
- All patients enrolled to the study will have their informed consent.
Who cannot join
- Subjects with rotator cuff tears or other •shoulder ligament injuries.
- Adhesive capsulitis secondary to Diabetes mellitus or fractures.
- Recurrent shoulder dislocation.
- Recent fracture or surgery to the shoulder.
- Reflex sympathetic dystrophy.
- Neurological disorder.
- Epilepsy or any psychological disorders.
- The presence of residual local-regional cancer or distant metastases to other regions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maitland Mobilization and Scapular Stabilization Exercises on Shoulder Dysfunction Post Neck Dissection Surgeries
Sixty patients from both genders suffering from shoulder disability post unilateral NDS (modified radical, selective) will participate in this study. Their ages will be ranged from 30 to 50 years. They will be selected randomly from Damanhur Oncology center, El-Behira, Egypt. They will be randomly distributed into three equal groups (each group 20 patients).
Read the detailed description
Design of the study:
In this study the patients were randomly assigned into three equal groups (twenty patients for each group).
Group (A) :
This group included twenty patients suffering from shoulder disability following NDS (modified radical, selective). They received Maitland mobilization Technique and scapular stabilization exercises in addition to the traditional physical therapy program which included (ROM exercises, stretching exercises and strengthening exercises for shoulder muscles) 3 sessions per week, for 2 months.
Group (B):
This group included twenty patients suffering from shoulder disability following NDS (modified radical, selective). They received Maitland mobilization Technique in addition to the traditional physical therapy program which included (ROM exercises, stretching exercises and strengthening exercises for shoulder muscles) 3 sessions per week, for 2 months.
Group (C) :
This group included twenty patients suffering from shoulder disability following NDS (modified radical, selective). They received scapular stabilization exercises in addition to the traditional physical therapy program which include (ROM exercises, stretching exercises and strengthening exercises for shoulder muscles) 3 sessions per week, for 2 months.
- Conditions
- Head and Neck Cancer
- Being tested
- Maitland Mobilization, Scapular Stabilization, Traditional Physical Therapy
- Keywords
- Maitland Mobilization, Scapular Stabilization, Shoulder Dysfunction, Neck Dissection Surgeries
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maitland MobilizationOther
MM applies a passive oscillatory technique, classified from Grade I-IV with respect to intensity, to the shoulder in order to treat pain and stiffness.
Grade I refers to an intensity of small amplitude that is applied at the beginning of the joint ROM, where there is no loading on connective tissue; it is often used in cases of severe pain
Scapular StabilizationOther
Scapular stabilization exercises are thought to have an important role in improving pain and dysfunction in the shoulder. The concept that an unstable
scapula is associated with pathology and dysfunction of the shoulder is well accepted. The predominant theory emphasizes that for optimal function of the glenohumeral joint, the scapula must provide a stable base upon which upper extremity tasks are completed. Impaired scapular stability increases the risk for pathologies such as impingement or rotator cuff tears
Traditional Physical TherapyOther
ROM exercises, stretching exercises and strengthening exercises for shoulder muscles
| Study group | Role | What they receive |
|---|---|---|
| Maitland Mobilization and Scapular Stabilization | Experimental | This group included twenty patients suffering from shoulder disability following NDS (modified radical, selective). They received Maitland mobilization Technique and scapular stabilization exercises in addition to the traditional physical therapy program which included (ROM exercises, stretching exercises and strengthening exercises for shoulder muscles) 3 sessions per week, for 2 months. Receives: Other: Maitland Mobilization; Other: Scapular Stabilization; Other: Traditional Physical Therapy |
| Maitland Mobilization | Experimental | This group included twenty patients suffering from shoulder disability following NDS (modified radical, selective). They received Maitland mobilization Technique in addition to the traditional physical therapy program which included (ROM exercises, stretching exercises and strengthening exercises for shoulder muscles) 3 sessions per week, for 2 months. Receives: Other: Maitland Mobilization; Other: Traditional Physical Therapy |
| Scapular Stabilization | Experimental | This group included twenty patients suffering from shoulder disability following NDS (modified radical, selective). They received scapular stabilization exercises in addition to the traditional physical therapy program which include (ROM exercises, stretching exercises and strengthening exercises for shoulder muscles) 3 sessions per week, for 2 months. Receives: Other: Scapular Stabilization; Other: Traditional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital Goniometer
Digital goniometer is a device which measures joint ranges, together with velocity and acceleration variables, with a high level of precision and at a relatively low-cost, practically similar to current analogical tools. The digital goniometer is a device specifically designed for the measurement of angles of movement of the human body with a resolution of 1°, representing an ideal substitute to traditional goniometers, which are usually based on a scale of 5° increments
Measured: 2 months
Secondary outcomes (1)
Shoulder Pain and Disability Index
The shoulder pain and disability index (SPADI) is a self-report questionnaire developed to measure the pain and disability associated with shoulder pathology. The SPADI consists of 13 items in two subscales: pain (5 items) and disability (8 items), the original version has each item scored on a visual analogue scale (VAS) and a second version has items scored on a numerical rating scale (NRS)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start1 Nov 2023
- Primary completion1 Jun 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Mamdouh Abd-Elsalam Shaaban, Cairo University
- Investigators
- Research Ethical Committee Faculty of Physical Therapy, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555913
- Sponsor's protocol ID
- 81893
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maitland Mobilization and Scapular Stabilization Exercises on Shoulder Dysfunction Post Neck Dissection Surgeries
- ClinicalTrials.gov ID
- NCT06555913
- Acronym / sponsor ID
- 81893
- Conditions
- Head and Neck Cancer
- Keywords
- Maitland Mobilization, Scapular Stabilization, Shoulder Dysfunction, Neck Dissection Surgeries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 15 Aug 2024 (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.
Sixty patients from both genders suffering from shoulder disability post unilateral NDS (modified radical, selective) will participate in this study. Their ages will be ranged from 30 to 50 years. They will be selected randomly from Damanhur Oncology center, El-Behira, Egypt. They will be randomly distributed into three equal groups (each group 20 patients).
Detailed description
Design of the study:
In this study the patients were randomly assigned into three equal groups (twenty patients for each group).
Group (A) :
This group included twenty patients suffering from shoulder disability following NDS (modified radical, selective). They received Maitland mobilization Technique and scapular stabilization exercises in addition to the traditional physical therapy program which included (ROM exercises, stretching exercises and strengthening exercises for shoulder muscles) 3 sessions per week, for 2 months.
Group (B):
This group included twenty patients suffering from shoulder disability following NDS (modified radical, selective). They received Maitland mobilization Technique in addition to the traditional physical therapy program which included (ROM exercises, stretching exercises and strengthening exercises for shoulder muscles) 3 sessions per week, for 2 months.
Group (C) :
This group included twenty patients suffering from shoulder disability following NDS (modified radical, selective). They received scapular stabilization exercises in addition to the traditional physical therapy program which include (ROM exercises, stretching exercises and strengthening exercises for shoulder muscles) 3 sessions per week, for 2 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Maitland Mobilization and Scapular Stabilization | Experimental | Other: Maitland Mobilization, Other: Scapular Stabilization, Other: Traditional Physical TherapyThis group included twenty patients suffering from shoulder disability following NDS (modified radical, selective). They received Maitland mobilization Technique and scapular stabilization exercises in addition to the traditional physical therapy program which included (ROM exercises, stretching exercises and strengthening exercises for shoulder muscles) 3 sessions per week, for 2 months. |
| Maitland Mobilization | Experimental | Other: Maitland Mobilization, Other: Traditional Physical TherapyThis group included twenty patients suffering from shoulder disability following NDS (modified radical, selective). They received Maitland mobilization Technique in addition to the traditional physical therapy program which included (ROM exercises, stretching exercises and strengthening exercises for shoulder muscles) 3 sessions per week, for 2 months. |
| Scapular Stabilization | Experimental | Other: Scapular Stabilization, Other: Traditional Physical TherapyThis group included twenty patients suffering from shoulder disability following NDS (modified radical, selective). They received scapular stabilization exercises in addition to the traditional physical therapy program which include (ROM exercises, stretching exercises and strengthening exercises for shoulder muscles) 3 sessions per week, for 2 months. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients' age will be ranged between 30-50 years.
- Both genders will participate in this study.
- All patients suffering from shoulder pain and disability following unilateral modified radical NDS or selective NDS.
- All patients will begin the treatment program from 1 to 3 months after NDS.
- All patients will have limited ROM of shoulder flexion, abduction, external rotation.
Key exclusion criteria (8 listed)
- Subjects with rotator cuff tears or other •shoulder ligament injuries.
- Adhesive capsulitis secondary to Diabetes mellitus or fractures.
- Recurrent shoulder dislocation.
- Recent fracture or surgery to the shoulder.
- Reflex sympathetic dystrophy.
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 |
|---|---|---|
| Maitland MobilizationMM applies a passive oscillatory technique, classified from Grade I-IV with respect to intensity, to the shoulder in order to treat pain and stiffness. Grade I refers to an intensity of small amplitude that is applied at the beginning of the joint ROM, where there is no loading on connective tissue; it is often used in cases of severe pain | Other | Maitland Mobilization, Maitland Mobilization and Scapular Stabilization |
| Scapular StabilizationScapular stabilization exercises are thought to have an important role in improving pain and dysfunction in the shoulder. The concept that an unstable scapula is associated with pathology and dysfunction of the shoulder is well accepted. The predominant theory emphasizes that for optimal function of the glenohumeral joint, the scapula must provide a stable base upon which upper extremity tasks are completed. Impaired scapular stability increases the risk for pathologies such as impingement or rotator cuff tears | Other | Maitland Mobilization and Scapular Stabilization, Scapular Stabilization |
| Traditional Physical TherapyROM exercises, stretching exercises and strengthening exercises for shoulder muscles | Other | Maitland Mobilization, Maitland Mobilization and Scapular Stabilization, Scapular Stabilization |
Primary outcome
Digital Goniometer
Time frame: 2 months
Digital goniometer is a device which measures joint ranges, together with velocity and acceleration variables, with a high level of precision and at a relatively low-cost, practically similar to current analogical tools. The digital goniometer is a device specifically designed for the measurement of angles of movement of the human body with a resolution of 1°, representing an ideal substitute to traditional goniometers, which are usually based on a scale of 5° increments
1 secondary outcome
Shoulder Pain and Disability Index
Time frame: 2 months
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 20 Aug 2024.
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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.
Research Ethical Committee Faculty of Physical Therapy principal investigator
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 Maitland Mobilization, Scapular Stabilization and Traditional Physical Therapy in people with Head and Neck Cancer, run by Cairo 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 6 inclusion and 8 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 20 Aug 2024. 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?
Digital Goniometer (time frame: 2 months). 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 20 Aug 2024.