Clinical trial NCT05072899: Platelet Rich Plasm Versus Hyaluronic Acid Injection in Chronic Painful Shoulder
Official title: Platelet Rich Plasm Versus Hyaluronic Acid Injection in Chronic Painful Shoulder: Randomized Comparative Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Shoulder Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-10-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of This study is to compare between the effect of ultrasound-guided local injection of Platelet Rich Plasma (PRP)versus Hyaluronic (HA) for the treatment of chronic shoulder pain.

Detailed description: This study was prospective randomized comparative trial on patients with chronic shoulder pain presented at outpatient Clinic of Physical Medicine, Rheumatology and Rehabilitation Department at Assiut University Hospitals from June 2019 to December 2020. Our study started by 70 patient with chronic shoulder pain 20 of them were missed in follow up period, the range of age from 36 - 56 years, history, clinical examination, Laboratory investigation, and imaging (X-ray or MRI) done for all patient to complete the diagnosis, patient divided randomly into two groups, Group (A) included 25 patients were treated by PRP injection and group (B) included 25 patients were treated by HA injection, both injections were performed under ultrasound (US) guidance. Randomization by sealed envelopes technique, the follow up was at the baseline, 4 weeks and 6 months post injection.

Eligibility criteria: Inclusion Criteria:

* Adult patient age \>18 years.
* Patients with chronic shoulder pain more than 6 months not responding to medical treatment or physical therapy.
* Frozen shoulder.
* Rotator cuff disorders (partial tear).

Exclusion Criteria:

* Shoulder joint instability or traumatic shoulder pain.
* Patients with local infection at the shoulder, systemic infection, or inflammatory disease (e.g., rheumatoid arthritis and hepatitis)
* Patients with a history of diabetes mellitus and malignancy (either hematological or non-hematological).
* Pregnancy.
* Patients on anticoagulant therapy.
* Injection of shoulder with corticosteroids in the preceding 6 months.

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: 4weeks post injection follow up.
measure: Visual Analogue Scale (VAS)
timeFrame: 6 months post injection follow up
measure: Constant score (CS)
timeFrame: 4weeks post injection follow up.
measure: Constant score (CS)
timeFrame: 6 months post injection follow up
measure: Shoulder Pain and Disability Index (SPADI) questionnaire
timeFrame: 4weeks post injection follow up.
measure: Shoulder Pain and Disability Index (SPADI) questionnaire
timeFrame: 6 months post injection follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
affiliation: Assiut University-faculty of medicine
name: Eman H El-Hakeim, A.Professor
role: PRINCIPAL_INVESTIGATOR
References: