Perineural Injection and Supraspinatus Tendenopathy

NCT ID: NCT03942640

Last Updated: 2019-08-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2021-01-01

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

<!-- -->

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.

Conditions

Supraspinatus Tendinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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..

Group Type: OTHER

subctaneous perineural injection

Intervention Type: OTHER

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 .

Group Type: OTHER

deep prolotherapy

Intervention Type: OTHER

The injection fluid contain 1 ml of 255 glucose and 1ml of lidocaine

Interventions

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

Intervention Type: OTHER

deep prolotherapy

The injection fluid contain 1 ml of 255 glucose and 1ml of lidocaine

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Reham Magdy Shaat

Al Mansurah, Dakahlia Provence, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Reham M. Shaat

Role: CONTACT

rehamshaat@gmail.com

01224082636

Facility Contacts

Reham M. Shaat, associate professor

Role: primary

rehamshaat@gmail.com

01224082636

Other Identifiers

MS.17.10.127

Identifier Type: -

Identifier Source: org_study_id