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. 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 .
Condition or disease | Intervention/treatment | Phase |
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Supraspinatus Tendinopathy | Other: subctaneous perineural injection Other: deep prolotherapy | Not Applicable |
Baseline Evaluation
All patients were subjected to the following:
Thorough History Taking
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.
Thorough General Examination
Examination of systems (chest,cardiovascular,abdominal,neurological) to identify medical condition that may cause shoulder pain.
3-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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Perineural Injection Therapy in Treatment of Chronic Supraspinatous Tendinopathy :A Randomized Clinical Trial Among Egyptian Patients . |
Actual Study Start Date : | June 1, 2019 |
Estimated Primary Completion Date : | October 1, 2020 |
Estimated Study Completion Date : | January 1, 2021 |
Arm | Intervention/treatment |
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perineural injection group
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.. |
Other: subctaneous perineural injection
Buffered glucose preparation : 2.4 ml of Na Bicarbonate 8.4% are mixed with 500ml dextrose 5%. Patients received 8 weekly injection |
deepprolotherapy group
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 .
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Other: deep prolotherapy
The injection fluid contain 1 ml of 255 glucose and 1ml of lidocaine
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III.Examination of passive and active range of motion using goniometer based on the description of norkin and white as following
Ages Eligible for Study: | 18 Years to 20 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with supraspinatous tendinopathy
Exclusion Criteria:
-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
Contact: Reham M. Shaat | 01224082636 | rehamshaat@gmail.com |
Egypt | |
Reham Magdy Shaat | Recruiting |
Mansoura, Dakahlia Provence, Egypt, 050 | |
Contact: Reham M. Shaat, associate professor 01224082636 rehamshaat@gmail.com |
Tracking Information | |||||
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First Submitted Date ICMJE | May 7, 2019 | ||||
First Posted Date ICMJE | May 8, 2019 | ||||
Last Update Posted Date | August 14, 2019 | ||||
Actual Study Start Date ICMJE | June 1, 2019 | ||||
Estimated Primary Completion Date | October 1, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
change of function from base line [ Time Frame: immediately before injection,2 monthes after injection,3 monthes after injection ] Shoulder pain and disability index : a self -administered questionnaire that consists of 2 dimentions ,one for pain and the other for functional activities.
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Perineural Injection and Supraspinatus Tendenopathy | ||||
Official Title ICMJE | Perineural Injection Therapy in Treatment of Chronic Supraspinatous Tendinopathy :A Randomized Clinical Trial Among Egyptian Patients . | ||||
Brief 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. 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 . |
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Detailed Description |
Baseline Evaluation All patients were subjected to the following:
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Supraspinatus Tendinopathy | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
60 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | January 1, 2021 | ||||
Estimated Primary Completion Date | October 1, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria: Patients with supraspinatous tendinopathy Exclusion Criteria: -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 |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 20 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Egypt | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03942640 | ||||
Other Study ID Numbers ICMJE | MS.17.10.127 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Mansoura University | ||||
Study Sponsor ICMJE | Mansoura University | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Mansoura University | ||||
Verification Date | May 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |