Frozen ShoulderNCT06201468
Frozen Shoulder (Scapular Mobilization Versus Scapular PNF)
A study testing Group A SCAPULAR MOBILIZATION in people with Frozen Shoulder and Scapular Mobilization, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to examine and compare the effects of SM versus SPNF on shoulder pain, ROM and functional disabilities in patients with frozen shoulder. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Frozen Shoulder, Scapular Mobilization, Scapular Proprioceptive Neuromuscular Facilitation
- What is being tested?
- Group A SCAPULAR MOBILIZATION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2024to 1 Dec 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All the patients refferd from orthopaedic surgeon with diagnosis of adhesive capsulitis. Patients will be included in this study if they fulfil the following criteria
- Case diagnosed with adhesive capsulitis, both primary and secondary.
- Both males and females of the age group 40 to 60 years.
- Limited active and passive movement of the shoulder joint movements, as well as difficulties with ADLs.
- 4- The onset of symptoms between 3 to 12 months. 5. Unilateral adhesive capsulitis.
Who cannot join
- 1. History of shoulder surgery or manipulation under anaesthesia, local corticosteroid injection administration to the affected shoulder within the last 6 months, 2. Neurological deficit affecting the shoulder function during daily activities, 3. Pathology of the shoulder joint other than adhesive capsulitis including rotator cuff tear, tendonitis at the shoulder and neck region, malignancies, history of trauma or accidental injuries of the upper limb.
- 4- Other pathological conditions including, a history of stroke, history of mastectomy and coronary artery bypass grafting (CABG).
- 5. Rheumatoid arthritis, osteoporosis, or disorders of the cervical spine, elbow, wrist or hand.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SCAPULAR MOBILIZATION VERSUS SCAPULAR PROPRIOCEPTIVE NEURO MUSCULAR FACILITATION ON FROZEN SHOUDER
This study will be conducted to examine and compare the effects of SM versus SPNF on shoulder pain, ROM and functional disabilities in patients with frozen shoulder.
Read the detailed description
This study will be conducted to examine and compare the effects of SM versus SPNF on shoulder pain, ROM and functional disabilities in patients with frozen shoulder.
- Conditions
- Frozen Shoulder, Scapular Mobilization, Scapular Proprioceptive Neuromuscular Facilitation
- Being tested
- Group A SCAPULAR MOBILIZATION
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A SCAPULAR MOBILIZATIONOther
Also called GROUP B SCAPULAR PNF
Two treatment groups will receive interventions as follows:
Group A (n = 21): will receive scapular mobilization combined with mobilization with movement (MWM) and capsular stretch for 4 weeks.
Group B (n = 21): will receive scapular proprioceptive neuromuscular facilitation combined with (MWM) and capsular stretch for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | Group A (n = 21): will receive scapular mobilization combined with mobilization with movement (MWM) and capsular stretch for 4 weeks.
Mulligan Mobilization with Movement for peripheral joints combines sustained manual application of 'gliding' force to a joint, with the aim of repositioning the positional faults with concurrent physiological motion of the joint, either performed actively by the subject or passively by the therapist Receives: Other: Group A SCAPULAR MOBILIZATION |
| group B | Experimental | Group B (n = 21): will receive scapular proprioceptive neuromuscular facilitation combined with (MWM) and capsular stretch for 4 weeks.
Scapular PNF incorporates functional or diagonal patterns (anterior elevation - posterior depression and posterior elevation - anterior depression) for performing the exercises and can be used to stretch or strengthen the muscles selectively. These techniques help the muscles to relearn the normal timing of recruitment and the amount of activation to sustain the balance between different groups of muscles Receives: Other: Group A SCAPULAR MOBILIZATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder disability
Shoulder Pain and Disability Index (SPADI)
The translated version of SPADI in the Arabic language showed excellent internal consistency and test-retest reliability. Validity was shown by substantial correlations between SPADI and Quick DASH, NRS, and active shoulder ROM. The Arabic SPADI is recommended for the evaluation of patients with shoulder dysfunction
Measured: 4 weeks
Shoulder range of motion
A goniometer is a device used to measure the range of motion (in degrees) of joints for either active or passive range. Shoulder flexion, extension, abduction adduction, internal rotation and external rotation will be assessed by Goniometer
Measured: 4 weeks
Secondary outcomes (2)
Scapular upward rotation
The Plurimeter-V gravity inclinometer will be used effectively and reliably for measuring upward rotation of the scapula in all ranges of shoulder abduction in the coronal plane
Measured: 4 weeks
Lateral scapular slide test
The three test positions will be used. For test position one (LSST-1), the subjects were instructed to keep their upper extremities relaxed at their sides. For test position two (LSST-2), the subjects were instructed to actively place both hands on the ipsilateral hips, and consequently, the humerus was positioned in medial rotation at 45° of abduction in the coronal plane. For test position three (LSST-3), the subjects were instructed to actively extend both elbows and to elevate both upper extremities to 90° in the coronal plane with maximal internal rotation. In this procedure, the distance between inferior aspect of the inferior angle of the scapula and the closest spinous process in the same horizontal plane was measured bilaterally with a tape measure for all three positions. A difference of 1.5 cm or more in any of the three positions was considered a positive result of the LSST
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start10 Jan 2024
- Primary completion10 Oct 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen ShoulderStudies 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
- Model description
- Two treatment groups will receive interventions as follows: Group A (n = 21): will receive scapular mobilization combined with mobilization with movement (MWM) and capsular stretch for 4 weeks. Group B (n = 21): will receive scapular proprioceptive neuromuscular facilitation combined with (MWM) and capsular stretch for 4 weeks.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mahmoud El morsy, Cairo University
- Investigators
- Mona M ibrahim, Study director, Cairo Universitymahmoud alsehemy, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201468
- Sponsor's protocol ID
- Frozen shoulder
- Status last verified
- Jul 2024
- First submitted
- 29 Dec 2023
- Last updated
- 3 Jul 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 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCAPULAR MOBILIZATION VERSUS SCAPULAR PROPRIOCEPTIVE NEURO MUSCULAR FACILITATION ON FROZEN SHOUDER
- ClinicalTrials.gov ID
- NCT06201468
- Acronym / sponsor ID
- Frozen shoulder
- Conditions
- Frozen Shoulder, Scapular Mobilization, Scapular Proprioceptive Neuromuscular Facilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 10 Oct 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 11 Jan 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.
This study will be conducted to examine and compare the effects of SM versus SPNF on shoulder pain, ROM and functional disabilities in patients with frozen shoulder.
Detailed description
This study will be conducted to examine and compare the effects of SM versus SPNF on shoulder pain, ROM and functional disabilities in patients with frozen shoulder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two treatment groups will receive interventions as follows: Group A (n = 21): will receive scapular mobilization combined with mobilization with movement (MWM) and capsular stretch for 4 weeks. Group B (n = 21): will receive scapular proprioceptive neuromuscular facilitation combined with (MWM) and capsular stretch for 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Other: Group A SCAPULAR MOBILIZATIONGroup A (n = 21): will receive scapular mobilization combined with mobilization with movement (MWM) and capsular stretch for 4 weeks. Mulligan Mobilization with Movement for peripheral joints combines sustained manual application of 'gliding' force to a joint, with the aim of repositioning the positional faults with concurrent physiological motion of the joint, either performed actively by the subject or passively by the therapist |
| group B | Experimental | Other: Group A SCAPULAR MOBILIZATIONGroup B (n = 21): will receive scapular proprioceptive neuromuscular facilitation combined with (MWM) and capsular stretch for 4 weeks. Scapular PNF incorporates functional or diagonal patterns (anterior elevation - posterior depression and posterior elevation - anterior depression) for performing the exercises and can be used to stretch or strengthen the muscles selectively. These techniques help the muscles to relearn the normal timing of recruitment and the amount of activation to sustain the balance between different groups of muscles |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- All the patients refferd from orthopaedic surgeon with diagnosis of adhesive capsulitis. Patients will be included in this study if they fulfil the following criteria
- Case diagnosed with adhesive capsulitis, both primary and secondary.
- Both males and females of the age group 40 to 60 years.
- Limited active and passive movement of the shoulder joint movements, as well as difficulties with ADLs.
- 4- The onset of symptoms between 3 to 12 months. 5. Unilateral adhesive capsulitis.
Key exclusion criteria (3 listed)
- 1. History of shoulder surgery or manipulation under anaesthesia, local corticosteroid injection administration to the affected shoulder within the last 6 months, 2. Neurological deficit affecting the shoulder function during daily activities, 3. Pathology of the shoulder joint other than adhesive capsulitis including rotator cuff tear, tendonitis at the shoulder and neck region, malignancies, history of trauma or accidental injuries of the upper limb.
- 4- Other pathological conditions including, a history of stroke, history of mastectomy and coronary artery bypass grafting (CABG).
- 5. Rheumatoid arthritis, osteoporosis, or disorders of the cervical spine, elbow, wrist or hand.
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 |
|---|---|---|
| Group A SCAPULAR MOBILIZATIONAlso: GROUP B SCAPULAR PNFTwo treatment groups will receive interventions as follows: Group A (n = 21): will receive scapular mobilization combined with mobilization with movement (MWM) and capsular stretch for 4 weeks. Group B (n = 21): will receive scapular proprioceptive neuromuscular facilitation combined with (MWM) and capsular stretch for 4 weeks. | Other | group A, group B |
Primary outcome
Shoulder disability
Time frame: 4 weeks
Shoulder Pain and Disability Index (SPADI) The translated version of SPADI in the Arabic language showed excellent internal consistency and test-retest reliability. Validity was shown by substantial correlations between SPADI and Quick DASH, NRS, and active shoulder ROM. The Arabic SPADI is recommended for the evaluation of patients with shoulder dysfunction
Shoulder range of motion
Time frame: 4 weeks
A goniometer is a device used to measure the range of motion (in degrees) of joints for either active or passive range. Shoulder flexion, extension, abduction adduction, internal rotation and external rotation will be assessed by Goniometer
2 secondary outcomes
Scapular upward rotation
Time frame: 4 weeks
Lateral scapular slide test
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
Related trials for Frozen Shoulder
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Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
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Ultrasound-Guided Intra-Articular vs Gluteal Intramuscular Corticosteroid Injection for Frozen Shoulder
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OMT for Adhesive Capsulitis
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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.
Mona M ibrahim study director
Cairo University
mahmoud alsehemy study director
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 Group A SCAPULAR MOBILIZATION in people with Frozen Shoulder and Scapular Mobilization, 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 5 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: status not confirmed, as of the sponsor's last update on 3 Jul 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?
Results are not available in the source record.
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 disability (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 3 Jul 2024.