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出境医 / 临床实验 / Perineural Injection and Supraspinatus Tendenopathy

Perineural Injection and Supraspinatus Tendenopathy

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 .


Condition or disease Intervention/treatment Phase
Supraspinatus Tendinopathy Other: subctaneous perineural injection Other: deep prolotherapy Not Applicable

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Perineural Injection Therapy in Treatment of Chronic Supraspinatous Tendinopathy :A Randomized Clinical Trial Among Egyptian Patients .
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : January 1, 2021
Arms and Interventions
Arm Intervention/treatment
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..

Other: 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


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 .
Other: deep prolotherapy
The injection fluid contain 1 ml of 255 glucose and 1ml of lidocaine

Outcome Measures
Primary Outcome Measures :
  1. change of pain from baseline [ Time Frame: 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

  2. change of range of motion from base line [ Time Frame: 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


Secondary Outcome Measures :
  1. change of function from base line [ Time Frame: 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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 20 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations

Contacts
Layout table for location contacts
Contact: Reham M. Shaat 01224082636 rehamshaat@gmail.com

Locations
Layout table for location information
Egypt
Reham Magdy Shaat Recruiting
Mansoura, Dakahlia Provence, Egypt, 050
Contact: Reham M. Shaat, associate professor    01224082636    rehamshaat@gmail.com   
Sponsors and Collaborators
Mansoura University
Tracking Information
First Submitted Date  ICMJE May 7, 2019
First Posted Date  ICMJE May 8, 2019
Last Update Posted Date August 14, 2019
Actual Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2019)
  • change of pain from baseline [ Time Frame: 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
  • change of range of motion from base line [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2019)
change of function from base line [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Perineural Injection and Supraspinatus Tendenopathy
Official Title  ICMJE Perineural Injection Therapy in Treatment of Chronic Supraspinatous Tendinopathy :A Randomized Clinical Trial Among Egyptian Patients .
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Supraspinatus Tendinopathy
Intervention  ICMJE
  • Other: 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

  • Other: deep prolotherapy
    The injection fluid contain 1 ml of 255 glucose and 1ml of lidocaine
Study Arms  ICMJE
  • 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..

    Intervention: Other: subctaneous perineural 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 .
    Intervention: Other: deep prolotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 7, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2021
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 20 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03942640
Other Study ID Numbers  ICMJE MS.17.10.127
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Mansoura University
Study Sponsor  ICMJE Mansoura University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mansoura University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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