Perineural Injection and Supraspinatus Tendenopathy

Sponsor
Mansoura University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03942640
Collaborator
(none)
60
1
2
19.1
3.1

Study Details

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

  1. 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
  • Other: subctaneous perineural injection
  • Other: deep prolotherapy
N/A

Detailed Description

Baseline Evaluation

All patients were subjected to the following:
  1. Thorough History Taking

  2. Personal history: collected data include: age, sex, marital status, handedness, special habits and the current occupation.

  3. Complaint in the patient's own words.

  4. 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.

  1. 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

  3. General condition.

  4. Vital signs (pulse, blood pressure, respiratory rate, body temperature)

  5. 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

Study Type:
Interventional
Anticipated 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 :
Jun 1, 2019
Anticipated Primary Completion Date :
Oct 1, 2020
Anticipated Study Completion Date :
Jan 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. change of pain from baseline [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 [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 [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

Criteria

Ages Eligible for Study:
18 Years to 20 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Reham Magdy Shaat Mansoura Dakahlia Provence Egypt 050

Sponsors and Collaborators

  • Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mansoura University
ClinicalTrials.gov Identifier:
NCT03942640
Other Study ID Numbers:
  • MS.17.10.127
First Posted:
May 8, 2019
Last Update Posted:
Aug 14, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 14, 2019