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Perineural Injection and Supraspinatus Tendenopathy

Primary Purpose

Supraspinatus Tendinopathy

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
subctaneous perineural injection
deep prolotherapy
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Supraspinatus Tendinopathy

Eligibility Criteria

18 Years - 20 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Reham Magdy ShaatRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

perineural injection group

deepprolotherapy group

Arm 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..

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 .

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

change of function from base line
Shoulder pain and disability index : a self -administered questionnaire that consists of 2 dimentions ,one for pain and the other for functional activities.

Full Information

First Posted
May 7, 2019
Last Updated
August 13, 2019
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT03942640
Brief Title
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

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
October 1, 2020 (Anticipated)
Study Completion Date
January 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: Thorough History Taking Personal history: collected data include: age, sex, marital status, handedness, special habits and the current occupation. Complaint in the patient's own words. 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. 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) Thorough General Examination General condition. Vital signs (pulse, blood pressure, respiratory rate, body temperature) Examination of systems (chest,cardiovascular,abdominal,neurological) to identify medical condition that may cause shoulder pain. 3-Muscloskeletal examination 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supraspinatus Tendinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
perineural injection group
Arm Type
Other
Arm 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..
Arm Title
deepprolotherapy group
Arm Type
Other
Arm 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 .
Intervention Type
Other
Intervention Name(s)
subctaneous perineural injection
Intervention Description
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
Intervention Name(s)
deep prolotherapy
Intervention Description
The injection fluid contain 1 ml of 255 glucose and 1ml of lidocaine
Primary Outcome Measure Information:
Title
change of pain from baseline
Description
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
Time Frame
immediately before injection,2 monthes after injection,3 monthes after injection
Title
change of range of motion from base line
Description
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
Time Frame
immediately before injection,2 monthes after injection,3 monthes after injection
Secondary Outcome Measure Information:
Title
change of function from base line
Description
Shoulder pain and disability index : a self -administered questionnaire that consists of 2 dimentions ,one for pain and the other for functional activities.
Time Frame
immediately before injection,2 monthes after injection,3 monthes after injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reham M. Shaat
Phone
01224082636
Email
rehamshaat@gmail.com
Facility Information:
Facility Name
Reham Magdy Shaat
City
Mansoura
State/Province
Dakahlia Provence
ZIP/Postal Code
050
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reham M. Shaat, associate professor
Phone
01224082636
Email
rehamshaat@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Perineural Injection and Supraspinatus Tendenopathy

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