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Status unknownNCT04681937Updated Jun 1, 2021

Comparison of Hyaluronic Acid, PRP and Steroid Injections in Partial Rotator Cuff Tears: A Prospective Randomized Study

An interventional study of Subacromial Injection (hyaluronic acid) + Physical Therapy. and Subacromial Injection (Platelet-Rich-Plasma) + Physical Therapy. in Partial Tear of Rotator Cuff and Rotator Cuff Tears, sponsored by Bezmialem Vakif University. Status unknown at 2 sites in Turkey. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-06-01.

Sponsored by Bezmialem Vakif University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

There are many conservative treatment options available for partial rotator cuff tears. However, the superiority of a certain type of injection could not be demonstrated with the available data. Our aim is to compare the effectiveness of steroid, hyaluronic acid, prp and placebo (normal saline) injections in partial rotator cuff tears by applying the same physical therapy protocol after injection.

02

Conditions studied

  • Partial Tear of Rotator Cuff
  • Rotator Cuff Tears

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Keywords

  • partial rotator cuff tear
  • subacromial injection
  • plateled-rich-plasma
  • physical therapy
03

In context

Rotator Cuff Injuries

734 studies on the registry are indexed under Rotator Cuff Injuries; 161 are open to participants now.

This study's planned enrollment of 80 is above the median of 60 across 538 interventional studies indexed under Rotator Cuff Injuries.

Browse Rotator Cuff Injuries studies →

Lead sponsor

Bezmialem Vakif University is the lead sponsor of 345 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • persistent continous pain at least 3 months
  • partial thickness rotator cuff tear on MRI

Exclusion criteria

Exclusion Criteria:

  • inflammatory disease
  • pregnancy
  • known malignancy
  • bleeding disorder ( or \<10 g/dl Hb level, \<150.000 ul platelet)
  • previous shoulder injection
  • history of shoulder surgery
  • full-thickness tear
  • other shoulder problem (osteoarthritis, bony lesions, etc)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Hyaluronic Acid + Physical Therapy

    4 ml hyaluronic acid (subacromial)

    Combination Product: Subacromial Injection (hyaluronic acid) + Physical Therapy.

  • Experimental
    Platelet-Rich-Plasma (PRP) + Physical Therapy

    4 ml platelet-rich-plasma (subacromial)

    Combination Product: Subacromial Injection (Platelet-Rich-Plasma) + Physical Therapy.

  • Experimental
    Steroid + Physical Therapy

    methylprednisolone acetate (1ml methylprednisolone acetate + 3 ml serum saline) (subacromial)

    Combination Product: Subacromial Injection (methylprednisolone acetate) + Physical Therapy.

  • Experimental
    Placebo (serum saline) + Physical Therapy

    4 ml serum saline (subacromial)

    Combination Product: Subacromial Injection (Serum Saline) + Physical Therapy.

Interventions

  • Combination productSubacromial Injection (hyaluronic acid) + Physical Therapy.

    arm1: sodium hyaluronate (4ml) arm2: platelet-rich-plasma (4ml) arm3: methylprednisolone acetate (1ml methylprednisolone acetate + 3 ml serum saline) arm4: serum saline (4ml) The same physical therapy procedure will be applied to all arms after injection.

  • Combination productSubacromial Injection (Platelet-Rich-Plasma) + Physical Therapy.

    arm1: sodium hyaluronate (4ml) arm2: platelet-rich-plasma (4ml) arm3: methylprednisolone acetate (1ml methylprednisolone acetate + 3 ml serum saline) arm4: serum saline (4ml) The same physical therapy procedure will be applied to all arms after injection.

  • Combination productSubacromial Injection (methylprednisolone acetate) + Physical Therapy.

    arm1: sodium hyaluronate (4ml) arm2: platelet-rich-plasma (4ml) arm3: methylprednisolone acetate (1ml methylprednisolone acetate + 3 ml serum saline) arm4: serum saline (4ml) The same physical therapy procedure will be applied to all arms after injection.

  • Combination productSubacromial Injection (Serum Saline) + Physical Therapy.

    arm1: sodium hyaluronate (4ml) arm2: platelet-rich-plasma (4ml) arm3: methylprednisolone acetate (1ml methylprednisolone acetate + 3 ml serum saline) arm4: serum saline (4ml) The same physical therapy procedure will be applied to all arms after injection.

06

What researchers measure

Primary outcomes

  1. American Shoulder and Elbow Surgeons Shoulder Score (ASES)

    minimum score:0, maximum score:100, 100 is better function.

    Time frame: 12 months after injection

Secondary outcomes

  1. Constant-Murley Shoulder Outcome Score (CMS)

    minimum score:0, maximum score:100, 100 is better function.

    Time frame: 12 months after injection

  2. Visual analogue scale (VAS)

    minimum score:0, maximum score:10, 0 is better function

    Time frame: 12 months after injection

  3. Subjective Shoulder Value (SSV)

    minimum score:0, maximum score:100, 100 is better function.

    Time frame: 12 months after injection

  4. Range of Motion (ROM)

    Active Shoulder Range of Motion Measurements

    Time frame: 12 months after injection

07

Study locations

2 sites
  • Bezmialem Vakif University
    Istanbul, 34093, Turkey
  • Bezmialem Vakif University
    Istanbul, 34093, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04681937
Lead sponsor
Bezmialem Vakif University
Responsible party
Muzaffer Ağır (MD, Bezmialem Vakif University) — Principal investigator
First posted
Dec 23, 2020
Start date
Jun 1, 2021 (estimated)
Primary completion
Nov 15, 2021 (estimated)
Completion
Sep 15, 2022 (estimated)
Last update
Jun 1, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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