Comparative effectiveness of prolotherapy regenerative injection technique with conventional treatment to treat recalcitrant supraspinatus tendinosis in human subjects

Not Applicable

Completed

• Conditions: Recalcitrant supraspinatus tendinosis; Musculoskeletal Diseases; Enthesopathy, unspecified

• Registration Number: ISRCTN43520960
• Lead Sponsor: niversity of Malaya (Malaysia)

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30057849

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2012-09-01
• Study Start: 2013-02-05
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Age 18 to 65 years
2. Able to understand completely the study procedure
3. Symptomatic tendinopathy > 6 months
4. Failure of the following conservative modalities: relative rest, physiotherapy, non-steroidal anti-inflammatory drugs and two corticosteroid injection

Exclusion Criteria

1. Autoimmune Diseases such as Rheumatoid Arthritis etc
2. Patients on anticoagulant such as Warfarin, unless written consent is obtained from the attending physician
3. Congenital or Acquired Platelet Dysfunction abnormality/disorder e.g. von Willebrand Disease, Glanzmann Disease etc
4. Haemoglobin level less than 10G/L and/or Platelet count less than 100,000/uL
5. Diabetes
6. Corticosteroid injection within the past 6 weeks
7. Self-reported immuno-compromised status

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ltrasound changes such as :<br>1. Areas and site of hypoechoic tendinosis at area of maximal tendinosis on cross section scanning of the painful region (expressed in mm2)<br>2. The intensity of the area of tendinosis and also the ratio of area of tendinosis with normal tendon area (measured in decibels)<br>3. Number of focal area of tendinosis <br>4. Presence or absence of calcification and type of calcification (hard or soft)<br>5. Presence of tears within the tendon, bursal and articular. Length, site and height of tears are identified in cross section area with most and longest tears noted<br>6. Presence of periostitis <br>7. The percentage of Doppler flow within the area of tendinosis measured above: none, less than 50% and more than 50%<br>8. Presence of subacromial bursitis will also be assessed<br>9. Dynamic impingement test is also done with distance of between acromion and greater tuberosity at maximal abduction is also measured when impingement is positive

Secondary Outcome Measures

Name	Time	Method
1. Disabilities of the Arm, Shoulder and Hand (DASH) Score<br>2. Physical examination of the range of movement of the shoulder