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

Comparative effectiveness of prolotherapy regenerative injection technique with conventional treatment to treat recalcitrant supraspinatus tendinosis in human subjects: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN43520960

Enrollment

Registered

2013-02-05

Start date

2010-09-01

Completion date

Unknown

Last updated

2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recalcitrant supraspinatus tendinosis Musculoskeletal Diseases Enthesopathy, unspecified

Interventions

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 inj

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
1. Disabilities of the Arm, Shoulder and Hand (DASH) Score 2. Physical examination of the range of movement of the shoulder	—

Countries

Malaysia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026