Supraspinatus TendinopathyNCT03942640
Perineural Injection and Supraspinatus Tendenopathy
A study testing subctaneous perineural injection and deep prolotherapy in people with Supraspinatus Tendinopathy, run by Mansoura University at 1 site in Egypt.
Trial summary
Atotal of 150 consecutive patients with chronic supraspinatous tendinopathy were invited to participate in the study .patients were recruited from the out patient clinic of rheumatology and rehabilitation department,Mansoura university hospital a. Read more about this study
- Who is it for?
- Ages 18 to 20 years
- Conditions the study is for
- Supraspinatus Tendinopathy
- What is being tested?
- subctaneous perineural injection and deep prolotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2019to 1 Jan 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 18 to 20 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with supraspinatous tendinopathy
Who cannot join
- -Shoulder joint instability omplete rotator cuff tear Adhesive capsulitis Septic arthritis Malignancy Coagulopathy Connective tissue diseases Spondyloarthropathies Previous corticosteroid injection in the last six months. Previous other forms of regenerative injection therapy (e.g prp injection therapy) in the last six mo
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Reham Magdy Shaat
Al Mansurah, Dakahlia Provence, 050
Reham M. Shaat, associate professor, 01224082636, rehamshaat@gmail.com
About this study
Official title: Perineural Injection Therapy in Treatment of Chronic Supraspinatous Tendinopathy :A Randomized Clinical Trial Among Egyptian Patients .
Atotal of 150 consecutive patients with chronic supraspinatous tendinopathy were invited to participate in the study .patients were recruited from the out patient clinic of rheumatology and rehabilitation department,Mansoura university hospital
- perineural injection therapy group (subcutaneous prolotherapy) This group included 30 patients aged from 18 to 60 years Deep prolotherapy injection group The injection fluid contain 1 ml of 255 glucose and 1ml of lidocaine. The pathological area of the supraspinatous tendon was identified and graded using ultrasound pathology rating scale guided by ultrasonography (Simens Acuson p300 machine) Proper preparation with antiseptic solution of skin overlying the point of injection .
Read the detailed description
Baseline Evaluation
All patients were subjected to the following:
- Thorough History Taking
- Personal history: collected data include: age, sex, marital status, handedness, special habits and the current occupation.
- Complaint in the patient's own words.
- Present History he current symptoms, mode of onset, duration, , factors that may aggravate or relieve pain Characters of pain (dull aching,sharp pain ,burning sensation ,parasthesia). Distribution of pain . Review of systems: symptoms related to rheumatic conditions in particular conditions with predilection for shoulder joint affection. Symptoms suggestive of medical disorders e.g. diabetes mellitus or thyroid dysfunction.
- Past History Previous significant trauma(direct or occupational) orsugery to shoulder. Previous steroid injection to the shoulder. Previous injection of any type of regenerative medicine (as prp)
- Thorough General Examination
- General condition.
- Vital signs (pulse, blood pressure, respiratory rate, body temperature)
- Examination of systems (chest,cardiovascular,abdominal,neurological) to identify medical condition that may cause shoulder pain. 3-Muscloskeletal examination <!-- -->
- General muscloskeletal examination
Examination of all joints for :
I.deformity,visible swelling or muscle atrophy II.Palpation for tenderness,warmth,palpable swelling either bony enlargement or synovial effusion.
III.Abnormalities in range of motion. IV.Diffuse muscloskeletal pain. V.Abnormalities of gait.
- Conditions
- Supraspinatus Tendinopathy
- Being tested
- subctaneous perineural injection, deep prolotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subctaneous perineural injectionOther
Buffered glucose preparation :
2.4 ml of Na Bicarbonate 8.4% are mixed with 500ml dextrose 5%. Patients received 8 weekly injection
deep prolotherapyOther
The injection fluid contain 1 ml of 255 glucose and 1ml of lidocaine
| Study group | Role | What they receive |
|---|---|---|
| perineural injection group | Other | perineural injection therapy group (subcutaneous prolotherapy) This group included 30 patients aged from 18 to 60 years
Buffered glucose preparation :
2.4 ml of Na Bicarbonate 8.4% are mixed with 500ml dextrose 5%.
Patients received 8 weekly injection sessions at sites of chronic constriction injurey of the following nerves :
Suprascapular nerve.. Receives: Other: subctaneous perineural injection |
| deepprolotherapy group | Other | Deep prolotherapy injection group The injection fluid contain 1 ml of 255 glucose and 1ml of lidocaine. The pathological area of the supraspinatous tendon was identified and graded using ultrasound pathology rating scale guided by ultrasonography (Simens Acuson p300 machine) Proper preparation with antiseptic solution of skin overlying the point of injection . Receives: Other: deep prolotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of pain from baseline
The VAS-pain score is composed of a continuous horizontal line. This line is 100 mm in length. To measure the intensity of pain, the score is anchored by (0 score = no pain) at one end and (100 score = worst imaginable pain) on the other end. The patient places a mark to the VAS line at the point which represents the intensity of his pain
Measured: immediately before injection,2 monthes after injection,3 monthes after injection
change of range of motion from base line
III.Examination of passive and active range of motion using goniometer based on the description of norkin and white as following
- Abduction ;170
- Adduction :50
- Flexion :165
- Extension:60
- Internal rotation at 90 abduction :70
- External rotation at 90 abduction :100
Measured: immediately before injection,2 monthes after injection,3 monthes after injection
Secondary outcomes (1)
change of function from base line
Shoulder pain and disability index : a self -administered questionnaire that consists of 2 dimentions ,one for pain and the other for functional activities.
Measured: immediately before injection,2 monthes after injection,3 monthes after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start1 Jun 2019
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraspinatus TendinopathyStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942640
- Sponsor's protocol ID
- MS.17.10.127
- Status last verified
- May 2019
- First submitted
- 7 May 2019
- Last updated
- 14 Aug 2019
- 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 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perineural Injection Therapy in Treatment of Chronic Supraspinatous Tendinopathy :A Randomized Clinical Trial Among Egyptian Patients .
- ClinicalTrials.gov ID
- NCT03942640
- Acronym / sponsor ID
- MS.17.10.127
- Conditions
- Supraspinatus Tendinopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 8 May 2019 (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.
Atotal of 150 consecutive patients with chronic supraspinatous tendinopathy were invited to participate in the study .patients were recruited from the out patient clinic of rheumatology and rehabilitation department,Mansoura university hospital
- perineural injection therapy group (subcutaneous prolotherapy) This group included 30 patients aged from 18 to 60 years Deep prolotherapy injection group The injection fluid contain 1 ml of 255 glucose and 1ml of lidocaine. The pathological area of the supraspinatous tendon was identified and graded using ultrasound pathology rating scale guided by ultrasonography (Simens Acuson p300 machine) Proper preparation with antiseptic solution of skin overlying the point of injection .
Detailed description
Baseline Evaluation
All patients were subjected to the following:
- Thorough History Taking
- Personal history: collected data include: age, sex, marital status, handedness, special habits and the current occupation.
- Complaint in the patient's own words.
- Present History he current symptoms, mode of onset, duration, , factors that may aggravate or relieve pain Characters of pain (dull aching,sharp pain ,burning sensation ,parasthesia). Distribution of pain . Review of systems: symptoms related to rheumatic conditions in particular conditions with predilection for shoulder joint affection. Symptoms suggestive of medical disorders e.g. diabetes mellitus or thyroid dysfunction.
- Past History Previous significant trauma(direct or occupational) orsugery to shoulder. Previous steroid injection to the shoulder. Previous injection of any type of regenerative medicine (as prp)
- Thorough General Examination
- General condition.
- Vital signs (pulse, blood pressure, respiratory rate, body temperature)
- Examination of systems (chest,cardiovascular,abdominal,neurological) to identify medical condition that may cause shoulder pain. 3-Muscloskeletal examination <!-- -->
- General muscloskeletal examination
Examination of all joints for :
I.deformity,visible swelling or muscle atrophy II.Palpation for tenderness,warmth,palpable swelling either bony enlargement or synovial effusion.
III.Abnormalities in range of motion. IV.Diffuse muscloskeletal pain. V.Abnormalities of gait.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| perineural injection group | Other | Other: subctaneous perineural injectionperineural injection therapy group (subcutaneous prolotherapy) This group included 30 patients aged from 18 to 60 years Buffered glucose preparation : 2.4 ml of Na Bicarbonate 8.4% are mixed with 500ml dextrose 5%. Patients received 8 weekly injection sessions at sites of chronic constriction injurey of the following nerves : Suprascapular nerve.. |
| deepprolotherapy group | Other | Other: deep prolotherapyDeep prolotherapy injection group The injection fluid contain 1 ml of 255 glucose and 1ml of lidocaine. The pathological area of the supraspinatous tendon was identified and graded using ultrasound pathology rating scale guided by ultrasonography (Simens Acuson p300 machine) Proper preparation with antiseptic solution of skin overlying the point of injection . |
Who may qualify
- Ages
- 18 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with supraspinatous tendinopathy
Key exclusion criteria (1 listed)
- -Shoulder joint instability omplete rotator cuff tear Adhesive capsulitis Septic arthritis Malignancy Coagulopathy Connective tissue diseases Spondyloarthropathies Previous corticosteroid injection in the last six months. Previous other forms of regenerative injection therapy (e.g prp injection therapy) in the last six mo
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 |
|---|---|---|
| subctaneous perineural injectionBuffered glucose preparation : 2.4 ml of Na Bicarbonate 8.4% are mixed with 500ml dextrose 5%. Patients received 8 weekly injection | Other | perineural injection group |
| deep prolotherapyThe injection fluid contain 1 ml of 255 glucose and 1ml of lidocaine | Other | deepprolotherapy group |
Primary outcome
change of pain from baseline
Time frame: immediately before injection,2 monthes after injection,3 monthes after injection
The VAS-pain score is composed of a continuous horizontal line. This line is 100 mm in length. To measure the intensity of pain, the score is anchored by (0 score = no pain) at one end and (100 score = worst imaginable pain) on the other end. The patient places a mark to the VAS line at the point which represents the intensity of his pain
change of range of motion from base line
Time frame: immediately before injection,2 monthes after injection,3 monthes after injection
III.Examination of passive and active range of motion using goniometer based on the description of norkin and white as following * Abduction ;170 * Adduction :50 * Flexion :165 * Extension:60 * Internal rotation at 90 abduction :70 * External rotation at 90 abduction :100
1 secondary outcome
change of function from base line
Time frame: immediately before injection,2 monthes after injection,3 monthes after injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Supraspinatus Tendinopathy
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
High-intensity Laser Therapy Versus Extracorporeal Shock Wave on Tendon Thickness and Occupation Ratio In Patients With Chronic Supraspinatus Tendinopathy
Supraspinatus Tendinopathy
Active, not recruiting
Subacromial Corticosteroid Injection Combined With Exercise in Supraspinatus Tendinopathy
Supraspinatus Tendinopathy
Not yet recruiting
Effects of Aerobic Exercise on Shoulder Pain, Disability, and Ultrasonographic Outcomes in Patients With Type 2 Diabetes Mellitus With Supraspinatus Tendinopathy
Supraspinatus Tendinopathy, Type 2 Diabetes Mellitus (T2DM)
Not yet recruitingObservational study
Study on the Efficacy and Safety of Ultrasound-Guided Peritendinous Injection of Low-Molecular-Weight Hyaluronic Acid (Hyalotend®; 500-730 kDa) for Chronic Non-Calcific Supraspinatus Tendinopathy.
Supraespinatus Tendinopathy
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subctaneous perineural injection and deep prolotherapy in people with Supraspinatus Tendinopathy, run by Mansoura 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 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 14 Aug 2019. 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 Reham M. Shaat (01224082636, rehamshaat@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of pain from baseline (time frame: immediately before injection,2 monthes after injection,3 monthes after injection). 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 14 Aug 2019.