NMTNCT05039138
EFFECT OF NEUROMUSCULAR TRAINING ON SHOULDER FUNCTION
A study testing NEUROMUSCULAR TRAINING EXERCISE and traditional training exerises in people with NMT, run by Cairo University.
Trial summary
This study will be conducted to compare the effect of neuromuscular training versus traditional strength training in terms of shoulder joint function, proprioception accuracy and isometric external and internal rotator muscles strength in patients with SIS, it will be conducted at the out-patient clinic of physical… Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- NMT
- What is being tested?
- NEUROMUSCULAR TRAINING EXERCISE and traditional training exerises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2021to 1 Dec 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 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient age from 25-40 with a clinical diagnosis of Neer's stage II SIS (Consigliere et al., 2018).
- Shoulder pain for at least three months (Heron et al., 2017) Painful arc of movement during flexion or abduction (Heron et al., 2017). Positive Neer's or Kennedy- Hawkins Test (Heron et al., 2017). Pain on resisted external rotation, abduction or Empty Can Test (Ager et al., 2019).
Who cannot join
- Symptoms of cervical radiculopathy. Diagnosed inflammatory disorder. Neurological disorder. Widespread pain condition. Evidence of complete RC tear (positive drop arm test). Previous surgery to the affected shoulder.
- :
Trial locations and contacts
No sites are listed yet.
About this study
Official title: EFFECT OF NEUROMUSCULAR TRAINING ON SHOULDER FUNCTION IN PATIENTS WITH SHOULDER IMPINGEMENT SYNDROME: A DOUBLE BLINDED RANDOMIZED CONTROLLED TRIAL
This study will be conducted to compare the effect of neuromuscular training versus traditional strength training in terms of shoulder joint function, proprioception accuracy and isometric external and internal rotator muscles strength in patients with SIS, it will be conducted at the out-patient clinic of physical therapy in Pharos University in Alexandria, Egypt
Read the detailed description
Double-blinded randomized controlled trial (patient and research assistant (the examiner of all patients) will be blinded).
Participants:
Thirty-four patients of both genders will be selected through non-probability sampling diagnosed as Neer's stage II SIS and their age range from 25-45 years will be randomly assigned to 1 of 2 groups. Each patient will sign an informed consent before starting the study (Appendix III).
Eligible patients will be recruited by physical therapist via referral from the treating orthopedic surgeon who will diagnose SIS based on clinical and radiological examination.
Group I (control): it includes 17 patients who will receive traditional strength training program.
Group II (experimental): it includes 17 patients who will receive upper extremity neuromuscular training exercises
- Conditions
- NMT
- Being tested
- NEUROMUSCULAR TRAINING EXERCISE, traditional training exerises
- Keywords
- NMT= NEUROMUSCULAR TRAINING
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEUROMUSCULAR TRAINING EXERCISEOther
patients will receive neuromuscular training exercises in group II
traditional training exerisesOther
traditional strength training exercises in group I
| Study group | Role | What they receive |
|---|---|---|
| Group I (control) | Experimental | : it includes 17 patients who will receive traditional strength training program. Receives: Other: traditional training exerises |
| Group II (experimental): | Experimental | it includes 17 patients who will receive upper extremity neuromuscular training exercises Receives: Other: NEUROMUSCULAR TRAINING EXERCISE |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPADI (The Shoulder Pain and Disability Index)
It is a self-report questionnaire for shoulder function
Measured: 6 weeks
Inclinometer
joint position sense
Measured: 6 weeks
Hand held dynamometer
isometric muscle strength
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start20 Dec 2021 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NMTStudies 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
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Ahmed Elnour Noaman Nada, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039138
- Sponsor's protocol ID
- shoulder neuromuscular
- Status last verified
- Dec 2021
- First submitted
- 1 Sep 2021
- Last updated
- 16 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF NEUROMUSCULAR TRAINING ON SHOULDER FUNCTION IN PATIENTS WITH SHOULDER IMPINGEMENT SYNDROME: A DOUBLE BLINDED RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT05039138
- Acronym / sponsor ID
- shoulder neuromuscular
- Conditions
- NMT
- Keywords
- NMT= NEUROMUSCULAR TRAINING
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Dec 2021 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 9 Sep 2021 (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 compare the effect of neuromuscular training versus traditional strength training in terms of shoulder joint function, proprioception accuracy and isometric external and internal rotator muscles strength in patients with SIS, it will be conducted at the out-patient clinic of physical therapy in Pharos University in Alexandria, Egypt
Detailed description
Double-blinded randomized controlled trial (patient and research assistant (the examiner of all patients) will be blinded).
Participants:
Thirty-four patients of both genders will be selected through non-probability sampling diagnosed as Neer's stage II SIS and their age range from 25-45 years will be randomly assigned to 1 of 2 groups. Each patient will sign an informed consent before starting the study (Appendix III).
Eligible patients will be recruited by physical therapist via referral from the treating orthopedic surgeon who will diagnose SIS based on clinical and radiological examination.
Group I (control): it includes 17 patients who will receive traditional strength training program.
Group II (experimental): it includes 17 patients who will receive upper extremity neuromuscular training exercises
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (control) | Experimental | Other: traditional training exerises: it includes 17 patients who will receive traditional strength training program. |
| Group II (experimental): | Experimental | Other: NEUROMUSCULAR TRAINING EXERCISEit includes 17 patients who will receive upper extremity neuromuscular training exercises |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patient age from 25-40 with a clinical diagnosis of Neer's stage II SIS (Consigliere et al., 2018).
- Shoulder pain for at least three months (Heron et al., 2017) Painful arc of movement during flexion or abduction (Heron et al., 2017). Positive Neer's or Kennedy- Hawkins Test (Heron et al., 2017). Pain on resisted external rotation, abduction or Empty Can Test (Ager et al., 2019).
Key exclusion criteria (2 listed)
- Symptoms of cervical radiculopathy. Diagnosed inflammatory disorder. Neurological disorder. Widespread pain condition. Evidence of complete RC tear (positive drop arm test). Previous surgery to the affected shoulder.
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 |
|---|---|---|
| NEUROMUSCULAR TRAINING EXERCISEpatients will receive neuromuscular training exercises in group II | Other | Group II (experimental): |
| traditional training exerisestraditional strength training exercises in group I | Other | Group I (control) |
Primary outcome
SPADI (The Shoulder Pain and Disability Index)
Time frame: 6 weeks
It is a self-report questionnaire for shoulder function
Inclinometer
Time frame: 6 weeks
joint position sense
Hand held dynamometer
Time frame: 6 weeks
isometric muscle strength
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing NEUROMUSCULAR TRAINING EXERCISE and traditional training exerises in people with NMT, run by Cairo University.
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 2 inclusion and 2 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 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact aya ahmed nada, master degree (+201285859034, elnour653@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SPADI (The Shoulder Pain and Disability Index) (time frame: 6 weeks). The study lists 3 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 16 Dec 2021.