Perineural Injection and Supraspinatus Tendenopathy

NCT03942640 | Unknown

• 1 other identifier: MS.17.10.127
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 .

Conditions

Supraspinatus Tendinopathy

Outcome Measures

Primary Outcomes (2)

• change of pain from baseline

  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

  immediately before injection,2 monthes after injection,3 monthes after injection

• change of range of motion from base line

  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

  immediately before injection,2 monthes after injection,3 monthes after injection

Secondary Outcomes (1)

• change of function from base line

  immediately before injection,2 monthes after injection,3 monthes after injection

Study Arms (2)

perineural injection group

OTHER

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

deepprolotherapy group

OTHER

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 .

Other: deep prolotherapy

Interventions

subctaneous perineural injection OTHER

Buffered glucose preparation : 2.4 ml of Na Bicarbonate 8.4% are mixed with 500ml dextrose 5%. Patients received 8 weekly injection

perineural injection group

deep prolotherapy OTHER

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

deepprolotherapy group

Eligibility Criteria

• Age: 18 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with supraspinatous tendinopathy

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Reham Magdy Shaat

Al Mansurah, Dakahlia Provence, 050, Egypt

RECRUITING

Central Study Contacts

Reham M. Shaat

CONTACT

01224082636; rehamshaat@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 8, 2019
• Study Start: June 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: January 1, 2021
• Last Updated: August 14, 2019

Record last verified: 2019-05

Locations

EG (1)