Contact information
Type
Scientific
Primary contact
Dr Li Shyan Ch'ng
ORCID ID
Contact details
Univeristy Malaya Medical Center
Biomedical Imaging
Lembah Pantai
Kuala Lumpur
59100
Malaysia
+603 79493930
lishyan@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
P1055/2010B
Study information
Scientific title
Comparative effectiveness of prolotherapy regenerative injection technique with conventional treatment to treat recalcitrant supraspinatus tendinosis in human subjects: a randomised controlled trial
Acronym
Study hypothesis
Prolotherapy injections is more effective than conventional therapy (physiotherapy and analagesic) for recalcitrant supraspinatus cuff tendinosis.
Ethics approval
Medical Ethics Committee, University Malaya Medical Center, 23 August 2010, ref.: 805.11
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Recalcitrant supraspinatus tendinosis
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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
Secondary outcome measures
1. Disabilities of the Arm, Shoulder and Hand (DASH) Score
2. Physical examination of the range of movement of the shoulder
Overall trial start date
01/09/2010
Overall trial end date
01/09/2012
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant 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
Recruitment start date
01/09/2010
Recruitment end date
01/09/2012
Locations
Countries of recruitment
Malaysia
Trial participating centre
Univeristy Malaya Medical Center
Kuala Lumpur
59100
Malaysia
Sponsor information
Organisation
University of Malaya (Malaysia)
Sponsor details
Institute of Research Management and Monitoring
Kuala Lumpur
50603
Malaysia
+603-79674522
um_research@um.edu.my
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Postgraduate Research Fund University of Malaya (Malaysia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary