Condition category
Musculoskeletal Diseases
Date applied
01/06/2012
Date assigned
05/02/2013
Last edited
09/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Shoulder pain is a common complaint occurring in about 15 out of 1000 patients per year in the outpatient primary care setting. Rotator cuff disorders are one of the most common causes of shoulder pain. The treatment for rotator cuff disorders involves activity modification, physical therapy and anti-inflammatory or analgesic medication. If there is little improvement in pain and function, a corticosteroid injection may be used and physiotherapy continued. Prolotherapy is an injection-based treatment used in musculoskeletal conditions. The aim of this study is to assess the effectiveness of prolotherapy compared with conventional therapy of physiotherapy alone by assessing ultrasound changes, function and range of movement before and after treatment.

Who can participate?
Patients aged 18-65 with supraspinatus tendinosis (shoulder pain) that has not improved after 1 month of conservative treatment

What does the study involve?
Participants are randomly allocated into two groups. The control group continue conventional physiotherapy and the prolotherapy group receive ultrasound-guided injections and continue physiotherapy. Shoulder function, ultrasound changes and range of movement are assessed before and after treatment.

What are the possible benefits and risks of participating?
Participants may have faster recovery as a result of the prolotherapy injections. Participants also have close follow up. The injection of prolotherapy is more targeted and less painful as a smaller amount is needed for the injection. There will be some pain due to the injectables which would be similar to the corticosteroid injections which some patients may have received before. Shoulder joint infection is extremely rare and is comparable to the corticosteroid injections (1 in 17,000-50,000).

Where is the study run from?
University Malaya Medical Center (Malaysia)

When is the study starting and how long is it expected to run for?
September 2010 to September 2012

Who is funding the study?
University of Malaya (Malaysia)

Who is the main contact?
Dr Li Shyan Ch’ng
lishyan@hotmail.com

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 (0)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, 23/08/2010, 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 to request a patient information sheet

Condition

Recalcitrant supraspinatus tendinosis

Intervention

Two study arms which are the prolotherapy regenerative injection therapy group and the 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 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

University 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 (0)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

09/11/2017: Plain English summary added.