Chronic Shoulder PainNCT05072899
Platelet Rich Plasm Versus Hyaluronic Acid Injection in Chronic Painful Shoulder
A study testing platelet rich plasm and Hyaluronic acid in people with Chronic Shoulder Pain, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Shoulder Pain
- What is being tested?
- platelet rich plasm and Hyaluronic acid
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2019to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Platelet Rich Plasm Versus Hyaluronic Acid Injection in Chronic Painful Shoulder: Randomized Comparative Trial
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.
Read the 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.
- Conditions
- Chronic Shoulder Pain
- Being tested
- platelet rich plasm, Hyaluronic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet rich plasmProcedure or surgery
local injection of shoulder joint by platelet rich plasm
Hyaluronic acidProcedure or surgery
local injection of shoulder joint by Hyaluronic acid
| Study group | Role | What they receive |
|---|---|---|
| 25 patient with chronic shoulder pain injected with platelet rich plasm | Experimental | patients with chronic shoulder pain injected with platelet rich plasm ultrasound guided, assessment done on initial visit and follow up after 4weeks and 6month using (VAS, CS, SPADI) Receives: Procedure: platelet rich plasm |
| 25 patient with chronic shoulder pain injected with Hyaluronic acid | Experimental | patients with chronic shoulder pain injected with Hyaluronic acid ultrasound guided, assessment done on initial visit and follow up after 4weeks and 6month using (VAS, CS, SPADI) Receives: Procedure: Hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
0-10 visual analogue scale of pain
Measured: 4weeks post injection follow up.
Visual Analogue Scale (VAS)
0-10 visual analogue scale of pain
Measured: 6 months post injection follow up
Constant score (CS)
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.
Measured: 4weeks post injection follow up.
Constant score (CS)
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.
Measured: 6 months post injection follow up
Shoulder Pain and Disability Index (SPADI) questionnaire
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
Measured: 4weeks post injection follow up.
Shoulder Pain and Disability Index (SPADI) questionnaire
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
Measured: 6 months post injection follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start15 Jun 2019
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Shoulder PainStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mohamed H. ElHakeim, Assiut University
- Investigators
- Eman H El-Hakeim, A.Professor, Principal investigator, Assiut University-faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072899
- Sponsor's protocol ID
- Faculty of medicine Assiut uni
- Status last verified
- Oct 2021
- First submitted
- 18 Sep 2021
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Rich Plasm Versus Hyaluronic Acid Injection in Chronic Painful Shoulder: Randomized Comparative Trial
- ClinicalTrials.gov ID
- NCT05072899
- Acronym / sponsor ID
- Faculty of medicine Assiut uni
- Conditions
- Chronic Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 25 patient with chronic shoulder pain injected with platelet rich plasm | Experimental | Procedure: platelet rich plasmpatients with chronic shoulder pain injected with platelet rich plasm ultrasound guided, assessment done on initial visit and follow up after 4weeks and 6month using (VAS, CS, SPADI) |
| 25 patient with chronic shoulder pain injected with Hyaluronic acid | Experimental | Procedure: Hyaluronic acidpatients with chronic shoulder pain injected with Hyaluronic acid ultrasound guided, assessment done on initial visit and follow up after 4weeks and 6month using (VAS, CS, SPADI) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| platelet rich plasmlocal injection of shoulder joint by platelet rich plasm | Procedure or surgery | 25 patient with chronic shoulder pain injected with platelet rich plasm |
| Hyaluronic acidlocal injection of shoulder joint by Hyaluronic acid | Procedure or surgery | 25 patient with chronic shoulder pain injected with Hyaluronic acid |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: 4weeks post injection follow up.
0-10 visual analogue scale of pain
Visual Analogue Scale (VAS)
Time frame: 6 months post injection follow up
0-10 visual analogue scale of pain
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.
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.
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eman H El-Hakeim, A.Professor principal investigator
Assiut University-faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing platelet rich plasm and Hyaluronic acid in people with Chronic Shoulder Pain, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: 4weeks post injection follow up.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2021.