Perineural Injection and Supraspinatus Tendenopathy

Perineural Injection Therapy in Treatment of Chronic Supraspinatous Tendinopathy :A Randomized Clinical Trial Among Egyptian Patients .

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 .

Study Overview

• Status: Unknown
• Conditions: Supraspinatus Tendinopathy
• Intervention / Treatment: Other: subctaneous perineural injection; Other: deep prolotherapy

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: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia Provence
    • Mansoura, Dakahlia Provence, Egypt, 050
      • Recruiting
      • Reham Magdy Shaat
      • Contact: Reham M. Shaat, associate professor; Phone Number: 01224082636; Email: rehamshaat@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 20 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	immediately before injection,2 monthes after injection,3 monthes after injection

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2019
• Primary Completion (ANTICIPATED): October 1, 2020
• Study Completion (ANTICIPATED): January 1, 2021

Study Registration Dates

• First Submitted: May 7, 2019
• First Submitted That Met QC Criteria: May 7, 2019
• First Posted (ACTUAL): May 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 13, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: MS.17.10.127

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No