Shoulder ImpingementSISNCT05546177
Effect Of Instrumented Assisted Soft Tissue Mobilization On Pain, Function And Proprioception In Patients With Shoulder Impingement Syndrome
A study testing instrumented assisted soft tissue mobilization and traditional therapy in people with Shoulder Impingement, run by Cairo University.
Trial summary
this study will be conducted to investigate instrumented Assisted Soft Tissue Mobilization On Pain, Function And Proprioception In Patients With Shoulder Impingement Syndrome Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Shoulder Impingement
- What is being tested?
- instrumented assisted soft tissue mobilization and traditional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 25 Sep 2022to 30 Apr 2023
- 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 with impingement syndrome from both genders.
- Age range from 25-40 years
- Body mass index 18.5-24.9 kg/m2
- Subjects are non-smokers.
- Shoulder impingement symptoms lasting at least 6 weeks
Who cannot join
- Hand truma, present pain or other kinds of complaints in the hand area.
- History of deformities, fractures, or surgery of the tested upper extremity joints affecting hand grip strength within the last 6 months.
- Presence of cardiopulmonary, hormonal disorder, central or peripheral neurological deficits or any condition that can influence the results.
About this study
Official title: Effect Of Instrumented Assisted Soft Tissue Mobilization On Pain, Function And Proprioception In Patients With Shoulder Impingement Syndrome. A Randomised Controlled Trial
this study will be conducted to investigate instrumented Assisted Soft Tissue Mobilization On Pain, Function And Proprioception In Patients With Shoulder Impingement Syndrome
Read the detailed description
Shoulder impingement is a clinical syndrome in which soft tissues become painfully entrapped in the area of the shoulder joint. Patients present with pain on elevating the arm or when lying on the affected side. Shoulder pain is the third most common musculoskeletal complaint in orthopedic practice, and impingement syndrome is one of the more common underlying diagnoses. On the pathophysiological level, it can have various functional, degenerative, and mechanical causes. The impingement hypothesis assumes a pathophysiological mechanism in which different structures of the shoulder joint come into mechanical conflict. The decision to treat conservatively or surgically is generally made on the basis of the duration and severity of pain, the degree of functional disturbance, and the extent of structural damage. The goal of treatment is to restore pain-free and powerful movement of the shoulder joint.Instrument-assisted soft tissue mobilization (IASTM) is a popular treatment for myofascial restriction which is applied using specially designed instruments to provide a mobilizing effect to soft tissue (e.g., scar tissue and myofascial adhesion) to decrease pain and improve range of motion (ROM) and function. eighty patients will be allocated randomly into two equal groups; the experimental one will receive IASTM and the control will receive traditional therapy for eight weeks.
- Conditions
- Shoulder Impingement
- Being tested
- instrumented assisted soft tissue mobilization, traditional therapy
- Keywords
- instrumented assisted soft tissue mobilization, shoulder impingement syndrome
- 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.
instrumented assisted soft tissue mobilizationOther
The subject will be treated with instrumented assisted soft tissue mobilization, applied to the upper and lower fibers of Pectoral, Trapezius (upper, middle and lower), Rhomboids major , Rhomboids minor, Teres minor, Teres major, and Latissimus dorsi muscles. The IASTM technique was performed for 20 seconds parallel to the muscle fibers followed by 20 seconds perpendicular to the muscle fibers of each one of the selected muscle
traditional therapyOther
the patients will receive Transcutaneous electrical nerve stimulation (TENS) to manage the pain,Ultrasound , Exercise including (Range of motion exercises, stretching exercises, and strengthening exercises (Scapular stabilization exercises and rotator cuff strengthening exercises)
| Study group | Role | What they receive |
|---|---|---|
| instrumented assisted soft tissue mobilization | Experimental | the patients will receive instrumented assisted soft tissue mobilization three times a week for eight weeks Receives: Other: instrumented assisted soft tissue mobilization; Other: traditional therapy |
| traditional therapy | Active comparator | the patients will receive traditional therapy three times a week for eight weeks Receives: Other: traditional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
pain will be measured by visual analogue scale. It is a vertical or horizontal 100 mm line graduated by different levels of pain, starting from 0 (no pain) till 100 (worst pain)
Measured: up to eight weeks
shoulder disability
The Arabic version of Disabilities of arm, shoulder, and hand (DASH) will be used for assessing shoulder function. DASH questionnaire includes 30 items with score from 0 to 100. A score of 0 represents no disability, while a score of 100 represents the most sever.
Measured: up to eight weeks
Secondary outcomes (3)
shoulder range of motion
inclinometer will be used to assess shoulder range of motion.
Measured: up to eight weeks
shoulder proprioception
inclinometer will be used to assess shoulder proprioception
Measured: up to eight weeks
rounded shoulder
tape measure will be used to assess the rounded shoulder
Measured: up to eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start25 Sep 2022 (estimated)
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder ImpingementStudies 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
- instruments assisted soft tissue mobilization and traditional therapy
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nabil Mahmoud Ismail Abdel-Aal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546177
- Sponsor's protocol ID
- p.t.REC/012/002833
- Acronym
- SIS
- Status last verified
- Sep 2022
- First submitted
- 15 Sep 2022
- Last updated
- 19 Sep 2022
- 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 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Instrumented Assisted Soft Tissue Mobilization On Pain, Function And Proprioception In Patients With Shoulder Impingement Syndrome. A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05546177
- Acronym / sponsor ID
- SIS / p.t.REC/012/002833
- Conditions
- Shoulder Impingement
- Keywords
- instrumented assisted soft tissue mobilization, shoulder impingement syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Sep 2022 (estimated)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 19 Sep 2022 (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 investigate instrumented Assisted Soft Tissue Mobilization On Pain, Function And Proprioception In Patients With Shoulder Impingement Syndrome
Detailed description
Shoulder impingement is a clinical syndrome in which soft tissues become painfully entrapped in the area of the shoulder joint. Patients present with pain on elevating the arm or when lying on the affected side. Shoulder pain is the third most common musculoskeletal complaint in orthopedic practice, and impingement syndrome is one of the more common underlying diagnoses. On the pathophysiological level, it can have various functional, degenerative, and mechanical causes. The impingement hypothesis assumes a pathophysiological mechanism in which different structures of the shoulder joint come into mechanical conflict. The decision to treat conservatively or surgically is generally made on the basis of the duration and severity of pain, the degree of functional disturbance, and the extent of structural damage. The goal of treatment is to restore pain-free and powerful movement of the shoulder joint.Instrument-assisted soft tissue mobilization (IASTM) is a popular treatment for myofascial restriction which is applied using specially designed instruments to provide a mobilizing effect to soft tissue (e.g., scar tissue and myofascial adhesion) to decrease pain and improve range of motion (ROM) and function. eighty patients will be allocated randomly into two equal groups; the experimental one will receive IASTM and the control will receive traditional therapy for eight weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- instruments assisted soft tissue mobilization and traditional therapy
| Arm | Type | Receives |
|---|---|---|
| instrumented assisted soft tissue mobilization | Experimental | Other: instrumented assisted soft tissue mobilization, Other: traditional therapythe patients will receive instrumented assisted soft tissue mobilization three times a week for eight weeks |
| traditional therapy | Active comparator | Other: traditional therapythe patients will receive traditional therapy three times a week for eight weeks |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with impingement syndrome from both genders.
- Age range from 25-40 years
- Body mass index 18.5-24.9 kg/m2
- Subjects are non-smokers.
- Shoulder impingement symptoms lasting at least 6 weeks
Key exclusion criteria (3 listed)
- Hand truma, present pain or other kinds of complaints in the hand area.
- History of deformities, fractures, or surgery of the tested upper extremity joints affecting hand grip strength within the last 6 months.
- Presence of cardiopulmonary, hormonal disorder, central or peripheral neurological deficits or any condition that can influence the results.
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 |
|---|---|---|
| instrumented assisted soft tissue mobilizationThe subject will be treated with instrumented assisted soft tissue mobilization, applied to the upper and lower fibers of Pectoral, Trapezius (upper, middle and lower), Rhomboids major , Rhomboids minor, Teres minor, Teres major, and Latissimus dorsi muscles. The IASTM technique was performed for 20 seconds parallel to the muscle fibers followed by 20 seconds perpendicular to the muscle fibers of each one of the selected muscle | Other | instrumented assisted soft tissue mobilization |
| traditional therapythe patients will receive Transcutaneous electrical nerve stimulation (TENS) to manage the pain,Ultrasound , Exercise including (Range of motion exercises, stretching exercises, and strengthening exercises (Scapular stabilization exercises and rotator cuff strengthening exercises) | Other | instrumented assisted soft tissue mobilization, traditional therapy |
Primary outcome
pain intensity
Time frame: up to eight weeks
pain will be measured by visual analogue scale. It is a vertical or horizontal 100 mm line graduated by different levels of pain, starting from 0 (no pain) till 100 (worst pain)
shoulder disability
Time frame: up to eight weeks
The Arabic version of Disabilities of arm, shoulder, and hand (DASH) will be used for assessing shoulder function. DASH questionnaire includes 30 items with score from 0 to 100. A score of 0 represents no disability, while a score of 100 represents the most sever.
3 secondary outcomes
shoulder range of motion
Time frame: up to eight weeks
shoulder proprioception
Time frame: up to eight weeks
rounded shoulder
Time frame: up to eight weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing instrumented assisted soft tissue mobilization and traditional therapy in people with Shoulder Impingement, 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 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 19 Sep 2022. 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?
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 intensity (time frame: up to eight 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 19 Sep 2022.