Rotator Cuff TendinitisNCT04703660
Effect of Cervical Mobilization on Rotator Cuff Tendinitis
A study testing cervical mobilization in people with Rotator Cuff Tendinitis, run by Noha Elserty at 1 site in Egypt.
Trial summary
this study aimed to investigate the effect of 3 types of cervical mobilization on the strength of shoulder abductors, external rotators and pain level in patient with rotator cuff tendinitis. the measurement will be made immediately, 10 minutes, and 30 minutes after mobilization Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Rotator Cuff Tendinitis
- What is being tested?
- cervical mobilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 1 Jun 2021
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients will be included if they have rotator cuff tendinitis
Who cannot join
- Patients will be excluded if they had recent neck trauma or acute whiplash disorder ,any intra articular injection in the gleno-humeral joint during last three months, patients with musculoskeletal disorder (any type of fracture), any history of surgery on that shoulder and tendon calcification, cervical rib, rotator cuff tear.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate and Carry Over Effect of Different Cervical Mobilization Techniques on Rotator Cuff Tendinitis Patients
this study aimed to investigate the effect of 3 types of cervical mobilization on the strength of shoulder abductors, external rotators and pain level in patient with rotator cuff tendinitis. the measurement will be made immediately, 10 minutes, and 30 minutes after mobilization
Read the detailed description
subjects will be allocated according to the inclusion and exclusion criteria from outpatient clinic at El sahel teaching hospital. they will be assigned randomly into 3 groups, each group will receive certain type of cervical mobilization. the outcome measures will be measured before, immediate, 10 minutes, and 30 minutes after treatment
- Conditions
- Rotator Cuff Tendinitis
- Being tested
- cervical mobilization
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical mobilizationProcedure or surgery
3 types of cervical mobilization at the level of C 5- 6
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | This group will receive antero-posterior cervical mobilization at c5-6 grade III oscillation Receives: Procedure: cervical mobilization |
| group B | Active comparator | This group will receive lateral glide cervical mobilization at c5-6 grade III oscillation Receives: Procedure: cervical mobilization |
| group C | Active comparator | This group will receive postero-anterior cervical mobilization at c5-6 grade III oscillation Receives: Procedure: cervical mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in strength of shoulder abductors
strength testing with a hand-held dynamometer will be applied for 3 groups using Isometric contraction of shoulder abductors
Measured: before treatment, immediate, 10 minutes, and 30 minutes after cervical mobilization
change in strength of shoulder external rotators
strength testing with a hand-held dynamometer will be applied for 3 groups using Isometric contraction of shoulder external rotators
Measured: before treatment, immediate, 10 minutes, and 30 minutes after cervical mobilization
change in pain level
pain severity will be measured using visual analogue scale for 3 groups
Measured: before treatment, immediate, 10 minutes, and 30 minutes after cervical mobilization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start1 Feb 2021
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TendinitisStudies 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
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Noha Elserty
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Noha Elserty, Egyptian Chinese University
- Investigators
- Noha S Elserty, PhD, Principal investigator, Lecturer of physical therapy- Egyptian Chinese University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703660
- Sponsor's protocol ID
- interventional
- Status last verified
- May 2021
- First submitted
- 7 Jan 2021
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: supporting information that will be shared after publication of the study
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate and Carry Over Effect of Different Cervical Mobilization Techniques on Rotator Cuff Tendinitis Patients
- ClinicalTrials.gov ID
- NCT04703660
- Acronym / sponsor ID
- interventional
- Conditions
- Rotator Cuff Tendinitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Noha ElsertyUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 11 Jan 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 aimed to investigate the effect of 3 types of cervical mobilization on the strength of shoulder abductors, external rotators and pain level in patient with rotator cuff tendinitis. the measurement will be made immediately, 10 minutes, and 30 minutes after mobilization
Detailed description
subjects will be allocated according to the inclusion and exclusion criteria from outpatient clinic at El sahel teaching hospital. they will be assigned randomly into 3 groups, each group will receive certain type of cervical mobilization. the outcome measures will be measured before, immediate, 10 minutes, and 30 minutes after treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Procedure: cervical mobilizationThis group will receive antero-posterior cervical mobilization at c5-6 grade III oscillation |
| group B | Active comparator | Procedure: cervical mobilizationThis group will receive lateral glide cervical mobilization at c5-6 grade III oscillation |
| group C | Active comparator | Procedure: cervical mobilizationThis group will receive postero-anterior cervical mobilization at c5-6 grade III oscillation |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients will be included if they have rotator cuff tendinitis
Key exclusion criteria (1 listed)
- Patients will be excluded if they had recent neck trauma or acute whiplash disorder ,any intra articular injection in the gleno-humeral joint during last three months, patients with musculoskeletal disorder (any type of fracture), any history of surgery on that shoulder and tendon calcification, cervical rib, rotator cuff tear.
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 |
|---|---|---|
| cervical mobilization3 types of cervical mobilization at the level of C 5- 6 | Procedure or surgery | group A, group B, group C |
Primary outcome
change in strength of shoulder abductors
Time frame: before treatment, immediate, 10 minutes, and 30 minutes after cervical mobilization
strength testing with a hand-held dynamometer will be applied for 3 groups using Isometric contraction of shoulder abductors
change in strength of shoulder external rotators
Time frame: before treatment, immediate, 10 minutes, and 30 minutes after cervical mobilization
strength testing with a hand-held dynamometer will be applied for 3 groups using Isometric contraction of shoulder external rotators
change in pain level
Time frame: before treatment, immediate, 10 minutes, and 30 minutes after cervical mobilization
pain severity will be measured using visual analogue scale for 3 groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Individual participant dataSharing planned: Yes. supporting information that will be shared after publication of the study
Related trials for Rotator Cuff Tendinitis
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Ultrasound-Guided Extracorporeal Shock Wave Therapy for Calcific Tendinitis
Calcific Tendinitis of Shoulder
Recruiting
Electroacupuncture and Cupping for Shoulder Tendinitis
Shoulder Tendinopathy, Shoulder Tendinitis
Active, not recruiting
Eccentric Contraction Exercise For Shoulder Pain Syndrome
Shoulder Pain Syndrome, Rotator Cuff Syndrome
Recruiting
The Effect of Doppler Ultrasound on Calcified Tendinitis
Calcific Tendinitis of Shoulder
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 S Elserty, PhD principal investigator
Lecturer of physical therapy- Egyptian Chinese 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 cervical mobilization in people with Rotator Cuff Tendinitis, run by Noha Elserty 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 1 inclusion and 1 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 11 May 2021. 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?
Contact Noha S Elserty, PhD (+201006709648, noha_elserty@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in strength of shoulder abductors (time frame: before treatment, immediate, 10 minutes, and 30 minutes after cervical mobilization). 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 11 May 2021.