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ISRCTN
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ISRCTN43520960
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DOI
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10.1186/ISRCTN43520960
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Comparative effectiveness of prolotherapy regenerative injection technique with conventional treatment to treat recalcitrant supraspinatus tendinosis in human subjects
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Scientific title
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Comparative effectiveness of prolotherapy regenerative injection technique with conventional treatment to treat recalcitrant supraspinatus tendinosis in human subjects: a randomised controlled trial
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Acronym
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N/A
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Serial number at source
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P1055/2010B
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Study hypothesis
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Prolotherapy injections is more effective than conventional therapy (physiotherapy and analagesic) for recalcitrant supraspinatus cuff tendinosis.
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Lay summary
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Lay summary under review 2
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Ethics approval
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Medical Ethics Committee, University Malaya Medical Center, 23 August 2010, ref.: 805.11
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Study design
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Randomised controlled trial
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Countries of recruitment
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Malaysia
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Disease/condition/study domain
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Recalcitrant supraspinatus tendinosis
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/09/2010
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Anticipated end date
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01/09/2012
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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20
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Interventions
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Two study arms which are the prolotherapy regenerative injection therapy group and control group.
The prolotherapy regenerative injection therapy group receives ultrasound guided prolotherapy injections which consist of a mixture of Dextrose 12% and 0.5% Lignocaine into the area of tendinosis and also standardised regime physiotherapy practiced by University Malaya Medical Center (UMMC).
The control group will continue conventional therapy of standardised regime physiotherapy practiced by UMMC physiotherapy and analgesics.
Patients from both groups will have ultrasound changes, Disabilities of the Arm, Shoulder and Hand (DASH) score and range of movement recorded at baseline and at 12 weeks.
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Primary outcome measure(s)
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Ultrasound changes such as :
1. Areas and site of hypoechoic tendinosis at area of maximal tendinosis on cross section scanning of the painful region (expressed in mm2)
2. The intensity of the area of tendinosis and also the ratio of area of tendinosis with normal tendon area (measured in decibels)
3. Number of focal area of tendinosis
4. Presence or absence of calcification and type of calcification (hard or soft)
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
6. Presence of periostitis
7. The percentage of Doppler flow within the area of tendinosis measured above: none, less than 50% and more than 50%
8. Presence of subacromial bursitis will also be assessed
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
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Secondary outcome measure(s)
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1. Disabilities of the Arm, Shoulder and Hand (DASH) Score
2. Physical examination of the range of movement of the shoulder
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Sources of funding
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Postgraduate Research Fund University of Malaya (Malaysia)
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Trial website
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Publications
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Contact name
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Dr
Li Shyan
Ch'ng
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Address
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Univeristy Malaya Medical Center
Biomedical Imaging
Lembah Pantai
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City/town
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Kuala Lumpur
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Zip/Postcode
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59100
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Country
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Malaysia
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Tel
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+603 79493930
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Fax
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+603 79494603
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Email
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lishyan@hotmail.com
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Sponsor
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University of Malaya (Malaysia)
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Address
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Institute of Research Management and Monitoring
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City/town
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Kuala Lumpur
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Zip/Postcode
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50603
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Country
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Malaysia
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Tel
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+603-79674522
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Fax
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+603-79674648
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Email
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um_research@um.edu.my
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Sponsor website:
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http://www.ippp.um.edu.my
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Date applied
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01/06/2012
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Last edited
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05/02/2013
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Date ISRCTN assigned
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05/02/2013
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