NCT04681937

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 23, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
Last Updated

June 1, 2021

Status Verified

May 1, 2021

Enrollment Period

6 months

First QC Date

December 13, 2020

Last Update Submit

May 28, 2021

Conditions

Partial Tear of Rotator CuffRotator Cuff Tears

Keywords

partial rotator cuff tearsubacromial injectionplateled-rich-plasmaphysical therapy

Outcome Measures

Primary Outcomes (1)

  • American Shoulder and Elbow Surgeons Shoulder Score (ASES)

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

    12 months after injection

Secondary Outcomes (4)

  • Constant-Murley Shoulder Outcome Score (CMS)

    12 months after injection

  • Visual analogue scale (VAS)

    12 months after injection

  • Subjective Shoulder Value (SSV)

    12 months after injection

  • Range of Motion (ROM)

    12 months after injection

Study Arms (4)

Hyaluronic Acid + Physical Therapy

EXPERIMENTAL

4 ml hyaluronic acid (subacromial)

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

Platelet-Rich-Plasma (PRP) + Physical Therapy

EXPERIMENTAL

4 ml platelet-rich-plasma (subacromial)

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

Steroid + Physical Therapy

EXPERIMENTAL

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

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

Placebo (serum saline) + Physical Therapy

EXPERIMENTAL

4 ml serum saline (subacromial)

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

Interventions

Subacromial Injection (hyaluronic acid) + Physical Therapy.COMBINATION_PRODUCT

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.

Hyaluronic Acid + Physical Therapy
Subacromial Injection (Platelet-Rich-Plasma) + Physical Therapy.COMBINATION_PRODUCT

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.

Platelet-Rich-Plasma (PRP) + Physical Therapy
Subacromial Injection (methylprednisolone acetate) + Physical Therapy.COMBINATION_PRODUCT

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.

Steroid + Physical Therapy
Subacromial Injection (Serum Saline) + Physical Therapy.COMBINATION_PRODUCT

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.

Placebo (serum saline) + Physical Therapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bezmialem Vakif University

Istanbul, 34093, Turkey (Türkiye)

Location

Bezmialem Vakif University

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Hyaluronic AcidPhysical Therapy ModalitiesMethylprednisolone Acetate

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydratesTherapeuticsRehabilitationMethylprednisolonePrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 13, 2020

First Posted

December 23, 2020

Study Start

June 1, 2021

Primary Completion

November 15, 2021

Study Completion

September 15, 2022

Last Updated

June 1, 2021

Record last verified: 2021-05

Locations

TU(2)