Perineural Injection and Supraspinatus Tendenopathy

Mansoura University

Status: Unknown

Conditions: Supraspinatus Tendinopathy

Treatments: Other: deep prolotherapy; Other: subctaneous perineural injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03942640

MS.17.10.127

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 20 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

perineural injection group

Other group

Description:

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..

Treatment:

Other: subctaneous perineural injection

deepprolotherapy group

Other group

Description:

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 .

Treatment:

Other: deep prolotherapy