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Completed

NCT Number: NCT05072899

Platelet Rich Plasm Versus Hyaluronic Acid Injection in Chronic Painful Shoulder

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.

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Key information

Conditions

Chronic Shoulder Pain

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut university

Asyut, 71515, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

platelet rich plasm

Procedure

local injection of shoulder joint by platelet rich plasm

Hyaluronic acid

Procedure

local injection of shoulder joint by Hyaluronic acid

Primary outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: 4weeks post injection follow up.

    0-10 visual analogue scale of pain

  2. Visual Analogue Scale (VAS)

    Time frame: 6 months post injection follow up

    0-10 visual analogue scale of pain

  3. Constant score (CS)

    Time frame: 4weeks post injection follow up.

    This scoring system combines physical examination tests with subjective evaluations by the patients. The subjective assessment consists of 35 points and the remaining 65 points are assigned for the physical examination assessment. The subjective assessment includes a single item for pain (15 points) and 4 items for activities of daily living (20 points) (work 4, sport 4, sleep2 and positioning the hand in space 10 points). The objective assessment includes: range of motion (40 points) (forward elevation, 10 points; lateral elevation, 10 points; internal rotation, 10 points; external rotation, 10 points) and power (25 points) (scoring based on the number of pounds of pull the patient can resist in abduction to a maximum of 25 points). The total possible score is therefore 100 points.

  4. Constant score (CS)

    Time frame: 6 months post injection follow up

    This scoring system combines physical examination tests with subjective evaluations by the patients. The subjective assessment consists of 35 points and the remaining 65 points are assigned for the physical examination assessment. The subjective assessment includes a single item for pain (15 points) and 4 items for activities of daily living (20 points) (work 4, sport 4, sleep2 and positioning the hand in space 10 points). The objective assessment includes: range of motion (40 points) (forward elevation, 10 points; lateral elevation, 10 points; internal rotation, 10 points; external rotation, 10 points) and power (25 points) (scoring based on the number of pounds of pull the patient can resist in abduction to a maximum of 25 points). The total possible score is therefore 100 points.

  5. Shoulder Pain and Disability Index (SPADI) questionnaire

    Time frame: 4weeks post injection follow up.

    is a self-introduction administered index designed to measure the effects of different pathologic conditions on the functional status of the shoulder. All items are rated by using a visual analogue scale from "no pain" or "no difficulty" to "worst imaginable pain" or "so difficult it required help". A numerical value was obtained by dividing the scale into 11 segments from 0 to 10 for each item

  6. Shoulder Pain and Disability Index (SPADI) questionnaire

    Time frame: 6 months post injection follow up

    is a self-introduction administered index designed to measure the effects of different pathologic conditions on the functional status of the shoulder. All items are rated by using a visual analogue scale from "no pain" or "no difficulty" to "worst imaginable pain" or "so difficult it required help". A numerical value was obtained by dividing the scale into 11 segments from 0 to 10 for each item

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Platelet Rich Plasm Versus Hyaluronic Acid Injection in Chronic Painful Shoulder: Randomized Comparative Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 11, 2021
Registry last updated
Oct 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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