Shoulder PainNCT05882786
Corticosteroid Injection Versus Tendon Dry Needling for Subacromial Impingement Syndrome
A study testing Corticosteroid injection and Dry Needling in people with Shoulder Pain and Shoulder Impingement Syndrome, run by Uskudar State Hospital.
Trial summary
This randomized clinical trial aims to compare the efficacy of corticosteroid injection and tendon dry needling for the treatment of subacromial impingement syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder Pain, Shoulder Impingement Syndrome, Shoulder Impingement
- What is being tested?
- Corticosteroid injection and Dry Needling
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 1 Jan 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18-65 years old
- Diagnosis of subacromial impingement syndrome, confirmed by clinical examination and imaging (such as X-ray or MRI)
- Moderate to severe shoulder pain, with a score of at least 4 on a 0-10 visual analog scale (VAS) for pain
- Willingness to comply with the study protocol and attend all study visits and assessments
- Ability to provide informed consent to participate in the study.
Who cannot join
- Contraindications to corticosteroid injection or dry needling, such as local infection, bleeding disorders, or allergy to the injectate or needle
- Previous shoulder surgery on the affected shoulder
- Other active shoulder conditions, such as rotator cuff tear or adhesive capsulitis, that may confound the study results
- Systemic conditions, such as rheumatoid arthritis or osteoarthritis, that may affect the shoulder joint and its function
- History of shoulder dislocation or instability
- Pregnancy or breastfeeding
Show all 9Show fewer
- Current use of systemic corticosteroids or immunosuppressive drugs
- Injection to shoulder area in the past six months.
- Inability to complete the study assessments or follow the study protocol, such as due to cognitive impairment or language barrier.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparing the Efficacy of Corticosteroid Injection and Tendon Dry Needling for Subacromial Impingement Syndrome: A Randomized Clinical Trial
This randomized clinical trial aims to compare the efficacy of corticosteroid injection and tendon dry needling for the treatment of subacromial impingement syndrome.
Read the detailed description
This randomized clinical trial will compare the efficacy of corticosteroid injection and tendon dry needling for the treatment of subacromial impingement syndrome.Participants will be randomized to receive either a corticosteroid injection or tendon dry needling treatment. The corticosteroid injection group will receive a single subacromial injection of 40mg triamcinolone acetonide under ultrasound guidance. The tendon dry needling group will receive a total of 3 sessions of dry needling treatment to the supraspinatus, infraspinatus, and subscapularis muscle tendons. Patients will be assessed before treatment, after treatment, after three weeks and after three months with visual analog scale, Shoulder Pain and Disability Index (SPADI) and shoulder range of motion measurements.
- Conditions
- Shoulder Pain, Shoulder Impingement Syndrome, Shoulder Impingement, Subacromial Impingement Syndrome, Subacromial Impingement
- Being tested
- Corticosteroid injection, Dry Needling
- Medical subject headings
- Shoulder Pain, Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticosteroid injectionProcedure or surgery
Subacromial injection of 40mg triamcinolone acetonide.
Dry NeedlingProcedure or surgery
Dry needling treatment to the supraspinatus, infraspinatus, and subscapularis muscles tendons.
| Study group | Role | What they receive |
|---|---|---|
| The corticosteroid (Triamcinolone Acetonide) injection group | Active comparator | Participants in this group will receive a single subacromial injection of 40mg triamcinolone acetonide. Receives: Procedure: Corticosteroid injection |
| Tendon dry needling group | Active comparator | Participants in this group will receive a total of 3 sessions of dry needling treatment to the supraspinatus, infraspinatus, and subscapularis muscle tendons. Receives: Procedure: Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog Scale for Pain
A Visual Analog Scale (VAS) for pain is a commonly used tool to measure the intensity of pain experienced by a patient. It typically consists of a horizontal or vertical line, typically 10 centimeters long, with endpoints labeled as "no pain" and "worst possible pain." The patient is asked to mark on the line the point that best represents the intensity of their pain, with the distance from the "no pain" end of the line to the patient's mark representing the pain score.
Measured: First day, after three weeks, after three months
Change in The Shoulder Pain and Disability Index (SPADI)
The Shoulder Pain and Disability Index (SPADI) is a validated patient-reported outcome measure that is commonly used to assess pain and functional disability related to shoulder disorders. The SPADI consists of 13 items that assess pain and disability in two domains: 1) pain and 2) disability. The pain domain consists of five items that assess the intensity and frequency of shoulder pain, while the disability domain consists of eight items that assess the impact of shoulder pain on daily activities such as sleeping, dressing, and carrying objects.
Measured: First day, after three weeks, after three months
Change in Range Of Motion (ROM) Measurements
ROM of the shoulder joint is typically assessed using a goniometer, a device that measures joint angles. The goniometer is used to measure the degree of movement in different directions, including flexion, extension, abduction, adduction, internal rotation, and external rotation. The measurements obtained from the goniometer can then be used to determine the improvement or deterioration in ROM over time, which can be an indicator of treatment efficacy.
Measured: First day, after three weeks, after three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- 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
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uskudar State Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mustafa Hüseyin Temel, Uskudar State Hospital
- Investigators
- Mustafa H Temel, M.D., Principal investigator, Uskudar State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882786
- Sponsor's protocol ID
- ImpDn1
- Status last verified
- May 2023
- First submitted
- 7 May 2023
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be shared upon reasonable request by the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Corticosteroid Injection and Tendon Dry Needling for Subacromial Impingement Syndrome: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05882786
- Acronym / sponsor ID
- ImpDn1
- Conditions
- Shoulder Pain, Shoulder Impingement Syndrome, Shoulder Impingement, Subacromial Impingement Syndrome, Subacromial Impingement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Uskudar State HospitalOther government
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 31 May 2023 (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.
This randomized clinical trial aims to compare the efficacy of corticosteroid injection and tendon dry needling for the treatment of subacromial impingement syndrome.
Detailed description
This randomized clinical trial will compare the efficacy of corticosteroid injection and tendon dry needling for the treatment of subacromial impingement syndrome.Participants will be randomized to receive either a corticosteroid injection or tendon dry needling treatment. The corticosteroid injection group will receive a single subacromial injection of 40mg triamcinolone acetonide under ultrasound guidance. The tendon dry needling group will receive a total of 3 sessions of dry needling treatment to the supraspinatus, infraspinatus, and subscapularis muscle tendons. Patients will be assessed before treatment, after treatment, after three weeks and after three months with visual analog scale, Shoulder Pain and Disability Index (SPADI) and shoulder range of motion measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| The corticosteroid (Triamcinolone Acetonide) injection group | Active comparator | Procedure: Corticosteroid injectionParticipants in this group will receive a single subacromial injection of 40mg triamcinolone acetonide. |
| Tendon dry needling group | Active comparator | Procedure: Dry NeedlingParticipants in this group will receive a total of 3 sessions of dry needling treatment to the supraspinatus, infraspinatus, and subscapularis muscle tendons. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients aged 18-65 years old
- Diagnosis of subacromial impingement syndrome, confirmed by clinical examination and imaging (such as X-ray or MRI)
- Moderate to severe shoulder pain, with a score of at least 4 on a 0-10 visual analog scale (VAS) for pain
- Willingness to comply with the study protocol and attend all study visits and assessments
- Ability to provide informed consent to participate in the study.
Key exclusion criteria (9 listed)
- Contraindications to corticosteroid injection or dry needling, such as local infection, bleeding disorders, or allergy to the injectate or needle
- Previous shoulder surgery on the affected shoulder
- Other active shoulder conditions, such as rotator cuff tear or adhesive capsulitis, that may confound the study results
- Systemic conditions, such as rheumatoid arthritis or osteoarthritis, that may affect the shoulder joint and its function
- History of shoulder dislocation or instability
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 |
|---|---|---|
| Corticosteroid injectionSubacromial injection of 40mg triamcinolone acetonide. | Procedure or surgery | The corticosteroid (Triamcinolone Acetonide) injection group |
| Dry NeedlingDry needling treatment to the supraspinatus, infraspinatus, and subscapularis muscles tendons. | Procedure or surgery | Tendon dry needling group |
Primary outcome
Change in Visual Analog Scale for Pain
Time frame: First day, after three weeks, after three months
A Visual Analog Scale (VAS) for pain is a commonly used tool to measure the intensity of pain experienced by a patient. It typically consists of a horizontal or vertical line, typically 10 centimeters long, with endpoints labeled as "no pain" and "worst possible pain." The patient is asked to mark on the line the point that best represents the intensity of their pain, with the distance from the "no pain" end of the line to the patient's mark representing the pain score.
Change in The Shoulder Pain and Disability Index (SPADI)
Time frame: First day, after three weeks, after three months
The Shoulder Pain and Disability Index (SPADI) is a validated patient-reported outcome measure that is commonly used to assess pain and functional disability related to shoulder disorders. The SPADI consists of 13 items that assess pain and disability in two domains: 1) pain and 2) disability. The pain domain consists of five items that assess the intensity and frequency of shoulder pain, while the disability domain consists of eight items that assess the impact of shoulder pain on daily activities such as sleeping, dressing, and carrying objects.
Change in Range Of Motion (ROM) Measurements
Time frame: First day, after three weeks, after three months
ROM of the shoulder joint is typically assessed using a goniometer, a device that measures joint angles. The goniometer is used to measure the degree of movement in different directions, including flexion, extension, abduction, adduction, internal rotation, and external rotation. The measurements obtained from the goniometer can then be used to determine the improvement or deterioration in ROM over time, which can be an indicator of treatment efficacy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Individual participant dataSharing planned: Yes. Individual participant data will be shared upon reasonable request by the corresponding author.
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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.
Mustafa H Temel, M.D. principal investigator
Uskudar State Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Corticosteroid injection and Dry Needling in people with Shoulder Pain and Shoulder Impingement Syndrome, run by Uskudar State Hospital.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mustafa H Temel, M.D. (+905342714872, mhuseyintemel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analog Scale for Pain (time frame: First day, after three weeks, after three months). The study lists 3 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 31 May 2023.