Perineural Injection and Supraspinatus Tendenopathy

Not Applicable

• Conditions: Supraspinatus Tendinopathy
• Interventions: Other: subctaneous perineural injection; Other: deep prolotherapy

• Registration Number: NCT03942640
• Lead Sponsor: Mansoura University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2019-05
• Study First Submitted: 2019-05-07
• Study First Submitted QC: 2019-05-07
• Study First Posted: 2019-05-08
• Study Start: 2019-06-01
• Last Update Submitted: 2019-08-13
• Last Update Posted: 2019-08-14
• Primary Completion: 2020-10-01
• Study Completion: 2021-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients with supraspinatous tendinopathy

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
perineural injection group	subctaneous perineural injection	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..
deepprolotherapy group	deep prolotherapy	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 .

Primary Outcome Measures

Name	Time	Method
change of range of motion from base line	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
change of pain from baseline	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

Secondary Outcome Measures

Name	Time	Method
change of function from base line	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.

Trial Locations

Locations (1)

Reham Magdy Shaat; 🇪🇬 Mansoura, Dakahlia Provence, Egypt