Shoulder Impingement SyndromeSAISNCT04801732

The Effect of Thoracic Mulligan Mobilization on Sub-acromial Impingement Syndrome

A study testing mulligan thoracic Sustained Natural Apophyseal Glides and traditional treatments in people with Shoulder Impingement Syndrome, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study was conducted to investigate the effect of mulligan thoracic sustained natural apophyseal glide on patients diagnosed as sub acromial impingement syndrome and its effect on shoulder range of motion, pain, function and disability of affected shoulder joint and size of sub acromial space, Half of the patients… Read more about this study

Who is it for?: Ages 25 to 40 years
Conditions the study is for: Shoulder Impingement Syndrome
What is being tested?: mulligan thoracic Sustained Natural Apophyseal Glides and traditional treatments
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 74 participants
Where: 1 siteEgypt
Study dates: 1 Aug 2022to 30 Nov 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 40 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Patients referred as sub-acromial impingement syndrome (stage 2) according to neer's classification.
Have +ve Neer's sign, +ve Hawkins and Kennedy test and +ve Empty and full can tests.
selected from both genders.
Aged from 25 to 40 years old.
Have restricted thoracic extension motion ( +ve occiput to wall test).

Who cannot join

History of shoulder adhesive capsulitis
Rotator cuff tendon tear/rupture (stage 3).
Shoulder dislocation, subluxation and fractures.
History of cervical, shoulder, upper back surgery.
Any spinal deformities such as scoliosis, kyphosis and rounded shoulder.
Diabetes mellitus.

Show all 10Show fewer

Radiculopathy.
History of breast cancer.
Previous stroke or Shoulder hand syndrome.
Ligamentous Laxity.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

faculty of physical therapy - Cairo university
Cairo

Other trials in Egypt

About this study

Official title: The Effect of Mulligan Thoracic Sustained Natural Apophyseal Glides on Sub-acromial Impingement Syndrome.

Read the detailed description

Forty patients with sub-acromial impingement syndrome will participate in this study. Intervention for the both group consisted of 12 session (3 times per week ) for one month. Subjects will be divided randomly and allocated into two groups , study group will received supervised exercise and mulligan thoracic SNAGS technique and the control group will received supervised exercise (stretching and strengthening exercises). both group will assessed by x ray to measure sub-acromial space , visual analogue scale for pain , The Shoulder Pain and Disability Index for shoulder function and goniometer for shoulder flexion, abduction ,external and internal rotation range of motion before and after treatment.

Conditions: Shoulder Impingement Syndrome
Being tested: mulligan thoracic Sustained Natural Apophyseal Glides, traditional treatments
Keywords: SUBACROMIAL IMPINGEMENT SYNDROME, mulligan thoracic sustained natural apophyseal glides, Acromiohumeral distance or subacromial space
Medical subject headings: Shoulder Impingement Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

mulligan thoracic Sustained Natural Apophyseal GlidesOther
Extension Thoracic Sustained Natural Apophyseal Glides :
Patient position: The patient sits astride the end of the table with hands placed behind the neck to protract the scapulae allowing access to the mid thoracic spine for the therapist's hand.
Therapist position: Therapist stands on their most efficient side for a centrally applied Sustained Natural Apophyseal Glides.
Therapist grasp: The therapist's mobilizing hand (ulnar border) will apply a cephalad glide in line with the facet joint plane of the involved spinal level and the other arm holds the thoracic wall above the level to be mobilized.
Traction is applied prior to glide, which is achieved by therapist knee extension
Repetitions: Three sets of ten repetitions will be done after a trial for the patient to be familial with the technique.
and traditional treatment.
traditional treatmentsOther
includes: Ice pack and Pendulum exercise and shoulder range of motion (elevation, depression, flexion, abduction, rotations).Stretching exercise for internal rotators and posterior capsule.
Strengthening exercise will be isometric in nature include external shoulder rotators, internal rotators, biceps, deltoid, and scapular stabilizers (rhomboids, trapezius, serratus anterior, Latissimus Dorsi , and pectoralis major muscles).

Study groups in NCT04801732
Study group	Role	What they receive
mulligan group	Experimental	Patients in the study group will treated with SNAGS techniques on thoracic spine with traditional treatment consist of ice application, supervised exercises (stretching and strengthening exercise) for 3 times/week for one month. Receives: Other: mulligan thoracic Sustained Natural Apophyseal Glides
exercising group	Active comparator	will receive only traditional treatment (ice application and supervised exercise ) for 3 times/week for one month. Receives: Other: traditional treatments

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain by Visual analogue scale
the patient asked to choose from scale from zero (no pain) to 10 (worst pain) to detect his/her intensity of pain.
Measured: changes from baseline to before treatment and changes before treatment to immediately after treatment
Range of motion of shoulder joint by universal goniometer.
for flexion stationary Arm of the goniometer was aligned with the lateral border of the scapula (mid axillary arm), and the moving arm was aligned with the humerus.
for abduction the fulcrum was placed at the mid point of the posterior aspect of the glenohumeral joint, stationary arm was parallel to the trunk, and the moving arm was parallel to the longitudinal axis of the humerus. for internal and external rotation patient was in supine with the hips and knees flexed approximately 45°.The tested arm was supported on the table in 90° of abduction, elbow flexed 90°, and the wrist in neutral position.
the fulcrum was placed on the olecranon, stationary arm Placed perpendicular to the floor, and the moving arm parallel with the forearm.
Measured: changes from baseline to before treatment and changes before treatment to immediately after treatment
Shoulder pain and disability index
the patients will asked to answer the questions on index . And then creating a percentage of pain and disability with higher scores indicating more severe limitation. The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).
Minimum Detectable Change (90% confidence) = 13 points
Measured: changes from baseline to before treatment and changes before treatment to immediately after treatment
The sub-acromial space by radiograph X ray
measure the size of sub-acromial space
Measured: changes from baseline to before treatment and changes before treatment to immediately after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202230 Nov 2022

First posted17 Mar 2021
Study start1 Aug 2022
Primary completion30 Nov 2022
Study completion30 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Shoulder Impingement SyndromeStudies 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: Randomized controlled study design were the recruited patients will randomly allocated into two groups control group and study group by Closed Envelope method of randomization. The treatment for all patients in both groups will conducted 3 times per week for one month .The study group (A): will receive SNAGS techniques on thoracic spine with traditional treatment consist of ice application, supervised exercises (stretching and strengthening exercise) and the study group(B) will receive only traditional treatment (ice or application and supervised exercise). All patients will be diagnosed as stage II according to Neer's classification recruited from orthopedic clinic from both sexes who met all the inclusion criteria and will be informed about the study procedure and signed the informed consent prepared for this study.
Masking: Single blind
Who is masked: Participant
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04801732
Sponsor's protocol ID: Basic Science PT
Other IDs: faculty of physical therapy
Acronym: SAIS
Status last verified: Mar 2023
First submitted: 7 Mar 2021
Last updated: 7 Mar 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: These data are case sensitive and considered confidential regarding my supervisors' and study directors' opinion, So, upon their request i prefer to not share individual participant data with other researchers

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Shoulder Impingement Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Mulligan Thoracic Sustained Natural Apophyseal Glides on Sub-acromial Impingement Syndrome.
ClinicalTrials.gov ID: NCT04801732
Acronym / sponsor ID: SAIS / Basic Science PT
Conditions: Shoulder Impingement Syndrome
Keywords: SUBACROMIAL IMPINGEMENT SYNDROME, mulligan thoracic sustained natural apophyseal glides, Acromiohumeral distance or subacromial space
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: Cairo UniversityUniversity, hospital or other
Study start: 1 Aug 2022 (actual)
Primary completion: 30 Nov 2022 (actual)
Study completion: 30 Nov 2022 (actual)
First posted: 17 Mar 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Randomized controlled study design were the recruited patients will randomly allocated into two groups control group and study group by Closed Envelope method of randomization. The treatment for all patients in both groups will conducted 3 times per week for one month .The study group (A): will receive SNAGS techniques on thoracic spine with traditional treatment consist of ice application, supervised exercises (stretching and strengthening exercise) and the study group(B) will receive only traditional treatment (ice or application and supervised exercise). All patients will be diagnosed as stage II according to Neer's classification recruited from orthopedic clinic from both sexes who met all the inclusion criteria and will be informed about the study procedure and signed the informed consent prepared for this study.

Arm	Type	Receives
mulligan group	Experimental	Other: mulligan thoracic Sustained Natural Apophyseal GlidesPatients in the study group will treated with SNAGS techniques on thoracic spine with traditional treatment consist of ice application, supervised exercises (stretching and strengthening exercise) for 3 times/week for one month.
exercising group	Active comparator	Other: traditional treatmentswill receive only traditional treatment (ice application and supervised exercise ) for 3 times/week for one month.

Who may qualify

Ages: 25 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Patients referred as sub-acromial impingement syndrome (stage 2) according to neer's classification.
Have +ve Neer's sign, +ve Hawkins and Kennedy test and +ve Empty and full can tests.
selected from both genders.
Aged from 25 to 40 years old.
Have restricted thoracic extension motion ( +ve occiput to wall test).

Key exclusion criteria (10 listed)

History of shoulder adhesive capsulitis
Rotator cuff tendon tear/rupture (stage 3).
Shoulder dislocation, subluxation and fractures.
History of cervical, shoulder, upper back surgery.
Any spinal deformities such as scoliosis, kyphosis and rounded 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
mulligan thoracic Sustained Natural Apophyseal GlidesExtension Thoracic Sustained Natural Apophyseal Glides : Patient position: The patient sits astride the end of the table with hands placed behind the neck to protract the scapulae allowing access to the mid thoracic spine for the therapist's hand. Therapist position: Therapist stands on their most efficient side for a centrally applied Sustained Natural Apophyseal Glides. Therapist grasp: The therapist's mobilizing hand (ulnar border) will apply a cephalad glide in line with the facet joint plane of the involved spinal level and the other arm holds the thoracic wall above the level to be mobilized. Traction is applied prior to glide, which is achieved by therapist knee extension Repetitions: Three sets of ten repetitions will be done after a trial for the patient to be familial with the technique. and traditional treatment.	Other	mulligan group
traditional treatmentsincludes: Ice pack and Pendulum exercise and shoulder range of motion (elevation, depression, flexion, abduction, rotations).Stretching exercise for internal rotators and posterior capsule. Strengthening exercise will be isometric in nature include external shoulder rotators, internal rotators, biceps, deltoid, and scapular stabilizers (rhomboids, trapezius, serratus anterior, Latissimus Dorsi , and pectoralis major muscles).	Other	exercising group

Primary outcome

Pain by Visual analogue scale
Time frame: changes from baseline to before treatment and changes before treatment to immediately after treatment
the patient asked to choose from scale from zero (no pain) to 10 (worst pain) to detect his/her intensity of pain.
Range of motion of shoulder joint by universal goniometer.
Time frame: changes from baseline to before treatment and changes before treatment to immediately after treatment
for flexion stationary Arm of the goniometer was aligned with the lateral border of the scapula (mid axillary arm), and the moving arm was aligned with the humerus. for abduction the fulcrum was placed at the mid point of the posterior aspect of the glenohumeral joint, stationary arm was parallel to the trunk, and the moving arm was parallel to the longitudinal axis of the humerus. for internal and external rotation patient was in supine with the hips and knees flexed approximately 45°.The tested arm was supported on the table in 90° of abduction, elbow flexed 90°, and the wrist in neutral position. the fulcrum was placed on the olecranon, stationary arm Placed perpendicular to the floor, and the moving arm parallel with the forearm.
Shoulder pain and disability index
Time frame: changes from baseline to before treatment and changes before treatment to immediately after treatment
the patients will asked to answer the questions on index . And then creating a percentage of pain and disability with higher scores indicating more severe limitation. The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst). Minimum Detectable Change (90% confidence) = 13 points
The sub-acromial space by radiograph X ray
Time frame: changes from baseline to before treatment and changes before treatment to immediately after treatment
measure the size of sub-acromial space

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 7 Mar 2023.
Individual participant dataSharing planned: No. These data are case sensitive and considered confidential regarding my supervisors' and study directors' opinion, So, upon their request i prefer to not share individual participant data with other researchers

Related trials for Shoulder Impingement Syndrome

Not yet recruiting
TECAR With Shoulder Chronic Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
Recruiting
Device-Assisted Balance Training for People With Shoulder Impingement
Shoulder
Not yet recruiting
"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
Subacromial Impingement Syndrome
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
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Not yet recruiting
Spencer vs Positional Release Techniques for Chronic Subacromial Impingement
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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.

Shimaa T Abu EL-Kasem, PhD 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 mulligan thoracic Sustained Natural Apophyseal Glides and traditional treatments in people with Shoulder Impingement Syndrome, 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 10 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 7 Mar 2023. 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?

Pain by Visual analogue scale (time frame: changes from baseline to before treatment and changes before treatment to immediately after treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04801732.

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 7 Mar 2023.