Condition category
Musculoskeletal Diseases
Date applied
01/06/2012
Date assigned
05/02/2013
Last edited
05/02/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

Trial website

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

http://www.ippp.um.edu.my

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

Publication citations

Additional files

Editorial Notes