Clinical trial NCT03942640: Perineural Injection and Supraspinatus Tendenopathy
Official title: Perineural Injection Therapy in Treatment of Chronic Supraspinatous Tendinopathy :A Randomized Clinical Trial Among Egyptian Patients .
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Supraspinatus Tendinopathy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-05-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 20
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 .

Detailed description: Baseline Evaluation

All patients were subjected to the following:

1. Thorough History Taking

   1. Personal history: collected data include: age, sex, marital status, handedness, special habits and the current occupation.
   2. Complaint in the patient's own words.
   3. 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.
   4. 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)
2. Thorough General Examination

   1. General condition.
   2. Vital signs (pulse, blood pressure, respiratory rate, body temperature)
   3. Examination of systems (chest,cardiovascular,abdominal,neurological) to identify medical condition that may cause shoulder pain.

      3-Muscloskeletal examination

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   1. 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.

Eligibility criteria: 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

Primary outcomes:
measure: change of pain from baseline
timeFrame: immediately before injection,2 monthes after injection,3 monthes after injection
measure: change of range of motion from base line
timeFrame: immediately before injection,2 monthes after injection,3 monthes after injection
Secondary outcomes:
measure: change of function from base line
timeFrame: immediately before injection,2 monthes after injection,3 monthes after injection
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Reham Magdy Shaat
state: Dakahlia Provence
Study officials:
References: