Paraplegia, IncompleteNCT06708962
Effect of Mulligan's Mobilization on Shoulder Joint Range of Motion and Subacromial Space in Paraplegic Patients
A study testing Mulligan's mobilization and corticosteroid injection for rotator cuff tendinopathy in people with Paraplegia, Incomplete, run by MTI University at 1 site in Egypt.
Trial summary
The aim of the study is to determine the effect of mulligan's mobilization on shoulder range of motion and subacromial joint space in paraplegic patients with subacromial impingement so, thirty patients will be randomly assigned to two groups group (A) and Group (B) Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Paraplegia, Incomplete
- What is being tested?
- Mulligan's mobilization and corticosteroid injection for rotator cuff tendinopathy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 10 Feb 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- More than one year after traumatic spinal cord injury
- The injury is at the second thoracic level or below.
- No cognitive impairment
- Relying on manual wheelchair for main movement.
Who cannot join
- No frozen shoulder
- No subluxation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Shoulder Joint Range of Motion and Subacromial Space Changes After Mulligan's Mobilization for Paraplegic Patients with Subacromial Impingement: a Randomized Controlled Trial
The aim of the study is to determine the effect of mulligan's mobilization on shoulder range of motion and subacromial joint space in paraplegic patients with subacromial impingement so, thirty patients will be randomly assigned to two groups group (A) and Group (B)
Read the detailed description
30 patients will be randomly assigned to two groups Group (A): will receive Mulligan's mobilization plus steroid injection for rotator cuff tendinopathy Group (B): will receive Steroid injection for rotator cuff tendinopathy only
Outcome measures will be:
- shoulder joint range of motion will be measured by laser goniometer
- Subacromial joint space will be measured by 3D ultrasonography
- Conditions
- Paraplegia, Incomplete
- Being tested
- Mulligan's mobilization, corticosteroid injection for rotator cuff tendinopathy
- Keywords
- Range of motion, subacromial impingement
- Medical subject headings
- Paraplegia, Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulligan's mobilizationOther
Mulligan mobilization isthe concurrent application of sustained accessory mobilization applied by a therapist and an active physiological movement to end range applied by the patient.
corticosteroid injection for rotator cuff tendinopathyOther
corticosteroid injection for rotator cuff helps resolving inflammation which occur for paraplegic patients from overuse of the crutches
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Will receive mulligan's mobilization plus corticosteroid injection for shoulder joint Receives: Other: Mulligan's mobilization; Other: corticosteroid injection for rotator cuff tendinopathy |
| corticosteroid injection for rotator cuff tendinopathy only | Sham comparator | patients will receive corticosteroid injection for rotator cuff muscle only which helps in resolving inflammation at the shoulder joint Receives: Other: corticosteroid injection for rotator cuff tendinopathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder joint range of motion
Shoulder joint ROM ( flexion - abduction- external and internal rotation will be measured by The laser goniometer HALO
Measured: Two months
Secondary outcomes (1)
Subacromial joint space
3D Ultrasonography enables the identification of common shoulder pathologies, and it will be utilized to assess the subacromial space as a kinematic indication of the shoulder.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start1 Dec 2024
- Primary completion30 Jan 2025
- Study completion10 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paraplegia, IncompleteStudies 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
- Randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Fayek Hammam, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708962
- Sponsor's protocol ID
- P.T.REC/012/003273
- Status last verified
- Feb 2025
- First submitted
- 25 Nov 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shoulder Joint Range of Motion and Subacromial Space Changes After Mulligan's Mobilization for Paraplegic Patients with Subacromial Impingement: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06708962
- Acronym / sponsor ID
- P.T.REC/012/003273
- Conditions
- Paraplegia, Incomplete
- Keywords
- Range of motion, subacromial impingement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 29 Nov 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.
The aim of the study is to determine the effect of mulligan's mobilization on shoulder range of motion and subacromial joint space in paraplegic patients with subacromial impingement so, thirty patients will be randomly assigned to two groups group (A) and Group (B)
Detailed description
30 patients will be randomly assigned to two groups Group (A): will receive Mulligan's mobilization plus steroid injection for rotator cuff tendinopathy Group (B): will receive Steroid injection for rotator cuff tendinopathy only
Outcome measures will be:
- shoulder joint range of motion will be measured by laser goniometer
- Subacromial joint space will be measured by 3D ultrasonography
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Mulligan's mobilization, Other: corticosteroid injection for rotator cuff tendinopathyWill receive mulligan's mobilization plus corticosteroid injection for shoulder joint |
| corticosteroid injection for rotator cuff tendinopathy only | Sham comparator | Other: corticosteroid injection for rotator cuff tendinopathypatients will receive corticosteroid injection for rotator cuff muscle only which helps in resolving inflammation at the shoulder joint |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- More than one year after traumatic spinal cord injury
- The injury is at the second thoracic level or below.
- No cognitive impairment
- Relying on manual wheelchair for main movement.
Key exclusion criteria (2 listed)
- No frozen shoulder
- No subluxation
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 |
|---|---|---|
| Mulligan's mobilizationMulligan mobilization isthe concurrent application of sustained accessory mobilization applied by a therapist and an active physiological movement to end range applied by the patient. | Other | Group A |
| corticosteroid injection for rotator cuff tendinopathycorticosteroid injection for rotator cuff helps resolving inflammation which occur for paraplegic patients from overuse of the crutches | Other | Group A, corticosteroid injection for rotator cuff tendinopathy only |
Primary outcome
Shoulder joint range of motion
Time frame: Two months
Shoulder joint ROM ( flexion - abduction- external and internal rotation will be measured by The laser goniometer HALO
1 secondary outcome
Subacromial joint space
Time frame: Two 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 12 Feb 2025.
- Related InfoLink provided by the sponsor.
- 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.
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 Mulligan's mobilization and corticosteroid injection for rotator cuff tendinopathy in people with Paraplegia, Incomplete, 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 4 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: finished, as of the sponsor's last update on 12 Feb 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. Some participants in this study may receive a placebo. 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 joint range of motion (time frame: Two 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 12 Feb 2025.