AcupunctureNCT05794633
Acupuncture Therapy in Patients With Subacromial Impingement Syndrome
A study testing Acupuncture in people with Acupuncture and Subacromial Impingement Syndrome, run by Fatih Sultan Mehmet Training and Research Hospital.
Trial summary
Shoulder pain is highly prevalent within general population, and shoulder impingement syndrome (SIS) is a common cause of shoulder pain. A small number of clinical and methodologically diverse trials have been published recently which show little evidence to support or refute the use of acupuncture for shoulder pain. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acupuncture, Subacromial Impingement Syndrome
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 12 Sep 2023to 20 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Subacromial impingement syndrome
- Age range from 20-65 years
- Pain VAS ≥ 4
- Shoulder impingement symptoms lasting at least 6 weeks
Who cannot join
- Presence of other shoulder pathologies
- Previous applications of physiotherapy and injection of hyaluronic acid and/or corticosteroid during the preceding 3 months;
- Presence of cervical pain or other conditions such as fibromyalgia confusing the clinical picture
- Presence of malignancy, blood disorder, neurologic, motor, and/or sensory deficit in the upper extremity;
- Pregnancy,
- Local anesthetic allergy
- Previous acupuncture treatment
- History of deformities, fractures, or surgery of the shoulder
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of Acupuncture Therapy in Patients With Subacromial Impingement Syndrome, Randomized Placebo-controlled Trial
Shoulder pain is highly prevalent within general population, and shoulder impingement syndrome (SIS) is a common cause of shoulder pain. A small number of clinical and methodologically diverse trials have been published recently which show little evidence to support or refute the use of acupuncture for shoulder pain. Some researchers concluded, there is a need for further well-designed clinical trials. Our aim in this study is to investigate the effect of acupuncture treatment on pain, range of motion, functionality and quality of life in patients diagnosed with Subacromial Impingement Syndrome as a result of clinical and radiological tests.
Read the detailed description
A randomized, prospective, double-blinded, placebo-controlled trial will be conducted. Patients diagnosed with shoulder impingement syndrome will be divided into two groups (acupuncture and placebo acupuncture) The evaluation will be performed at treatment initiation and at the end of the treatment and 1 month after treatment initiation.All patients will be evaluated by the same physiatrist who are blinded to the randomization process and treatment protocols.Primary outcome is pain which will be evaulated with visual analogue scale (VAS) for rest, activity, and sleep-disturbing. Secondary outcomes are shoulder range of motion in all groups will be evaluated with goniometer, shoulder function which will be evaulated with the Shoulder Pain and Disability Index (SPADI) and The Disabilities of the Arm, Shoulder and Hand Score (QuickDash) and quality of life in all groups will be evaluated with The Western Ontario Rotator Cuff Index (WORC).
- Conditions
- Acupuncture, Subacromial Impingement Syndrome
- Being tested
- Acupuncture, Placebo acupuncture
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
The patients will be recieved two days a week for 8 sessions with sterile 25*40 mm needles.Selected points are as local points, 2 painful points (ahshi point) in the shoulder region, Large intestine 4, 15, Gallbladder 21, Triple warmer 5, 14 Small intestine 9; as distant points Gallbladder 34 and Stomach 38.
Patients will recieve also exercise treatment for 8 weeks and coldpack for 4 weeks
Placebo acupunctureOther
The patients will be recieved two days a week for 8 sessions with placebo needle. Selected points are Large intestine 15 Triple warmer 14 gallbladder 21 and small intestine 9. We will use the placebo needle (blunt needle, tip obtuse, when acupuncture the feeling is similar to acupuncture needles into the skin, but it retracts instead of piercing the skin) to conduct acupuncture treatment. The retention time will be the same as those in the acupuncture group. The specialist will give the subjects verbal cues before and during the acupuncture manipulation, which further reduces the subjects' doubts about the authenticity of acupuncture in the this group. To ensure the implementation of the blinding method, all patients will be treated independently and avoid contacting with each other.
Patients will recieve also exercise treatment for 8 weeks and coldpack for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture Group | Experimental | The patients will be recieved two days a week for 8 sessions with sterile 25*40 mm needles.Selected points are as local points, 2 painful points (ahshi point) in the shoulder region, Large intestine 4, 15, Gallbladder 21, Triple warmer 5, 14 Small intestine 9; as distant points Gallbladder 34 and Stomach 38.
Patients will recieve also exercise treatment for 8 weeks and coldpack for 4 weeks Receives: Other: Acupuncture |
| Placebo Acupuncture Group | Placebo comparator | The patients will be recieved two days a week for 8 sessions with placebo needle. Selected points are Large intestine 15 Triple warmer 14 gallbladder 21 and small intestine 9. We will use the Placebo needle (blunt needle, tip obtuse, when acupuncture the feeling is similar to acupuncture needles into the skin, but it retracts instead of piercing the skin) to conduct acupuncture treatment. The retention time will be the same as those in the acupuncture group. The specialist will give the subjects verbal cues before and during the acupuncture manipulation, which further reduces the subjects' doubts about the authenticity of acupuncture in the this group. To ensure the implementation of the blinding method, all patients will be treated independently and avoid contacting with each other.
Patients will recieve also exercise treatment for 8 weeks and coldpack for 4 weeks Receives: Other: Placebo acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
All groups will be evaluated for shoulder pain with visual analogue scale (VAS) for rest, activity, and sleep-disturbing.
Measured: 2 months
Shoulder Pain and Disability Index
All groups will be evaluated for shoulder function with the Shoulder Pain and Disability Index (SPADI). SPADI:The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. To answer the questions, patients place a mark on a 10cm visual analogue scale for each question. Higher results indicate worse function.
Measured: 2 months
The Disabilities of the Arm, Shoulder and Hand Score
All groups will be evaluated for shoulder function with The Disabilities of the Arm, Shoulder and Hand Score (QuickDash). The QuickDASH only contains 11 items. It is a questionnaire that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms. The QuickDASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to his/her severity/function level. Higher results indicate worse function.
Measured: 2 months
Secondary outcomes (2)
Shoulder range of motion
All groups will be evaluated for shoulder range of motion with goniometer.
Measured: 2 months
Quality of life index
Quality of life: All groups will be evaluated for quality of life with The Western Ontario Rotator Cuff Index (WORC). Each item in WORC has a possible score from 0-100 (100mm VAS). Scores can be computed for individual subscales and summated for a total score, which can range from 0-2100, with a higher score representing lower quality of life.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start12 Sep 2023 (estimated)
- Primary completion20 Nov 2023 (estimated)
- Study completion20 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AcupunctureStudies 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 placebo-controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu Karamanlıoğlu, Fatih Sultan Mehmet Training and Research Hospital
- Investigators
- Duygu Silte Karamanlioglu, Principal investigator, Fatih Sultan Mehmet Traning and Research HospitalMeryem Yilmaz Kaysin, Study chair, Fatih Sultan Mehmet Traning and Research HospitalFeyza Akan Begoglu, Study chair, Fatih Sultan Mehmet Traning and Research HospitalPinar Akpinar, Study chair, Fatih Sultan Mehmet Traning and Research HospitalFeyza Unlu Ozkan, Study chair, Fatih Sultan Mehmet Traning and Research HospitalIlknur Aktas, Study chair, Fatih Sultan Mehmet Traning and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794633
- Sponsor's protocol ID
- KAEK-2012-70
- Status last verified
- Sep 2023
- First submitted
- 6 Mar 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karamanlioglu DS, Kaysin MY, Begoglu FA, Akpinar P, Ozkan FU, Aktas I. Effects of acupuncture on pain and function in patients with subacromial impingement syndrome: A randomized sham-controlled trial. Integr Med Res. 2024 Jun;13(2):101049. doi: 10.1016/j.imr.2024.101049. Epub 2024 May 25.
PubMed 38948487
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Acupuncture Therapy in Patients With Subacromial Impingement Syndrome, Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05794633
- Acronym / sponsor ID
- KAEK-2012-70
- Conditions
- Acupuncture, Subacromial Impingement Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 12 Sep 2023 (estimated)
- Primary completion
- 20 Nov 2023 (estimated)
- Study completion
- 20 Jan 2024 (estimated)
- First posted
- 3 Apr 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.
Shoulder pain is highly prevalent within general population, and shoulder impingement syndrome (SIS) is a common cause of shoulder pain. A small number of clinical and methodologically diverse trials have been published recently which show little evidence to support or refute the use of acupuncture for shoulder pain. Some researchers concluded, there is a need for further well-designed clinical trials. Our aim in this study is to investigate the effect of acupuncture treatment on pain, range of motion, functionality and quality of life in patients diagnosed with Subacromial Impingement Syndrome as a result of clinical and radiological tests.
Detailed description
A randomized, prospective, double-blinded, placebo-controlled trial will be conducted. Patients diagnosed with shoulder impingement syndrome will be divided into two groups (acupuncture and placebo acupuncture) The evaluation will be performed at treatment initiation and at the end of the treatment and 1 month after treatment initiation.All patients will be evaluated by the same physiatrist who are blinded to the randomization process and treatment protocols.Primary outcome is pain which will be evaulated with visual analogue scale (VAS) for rest, activity, and sleep-disturbing. Secondary outcomes are shoulder range of motion in all groups will be evaluated with goniometer, shoulder function which will be evaulated with the Shoulder Pain and Disability Index (SPADI) and The Disabilities of the Arm, Shoulder and Hand Score (QuickDash) and quality of life in all groups will be evaluated with The Western Ontario Rotator Cuff Index (WORC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Acupuncture Group | Experimental | Other: AcupunctureThe patients will be recieved two days a week for 8 sessions with sterile 25*40 mm needles.Selected points are as local points, 2 painful points (ahshi point) in the shoulder region, Large intestine 4, 15, Gallbladder 21, Triple warmer 5, 14 Small intestine 9; as distant points Gallbladder 34 and Stomach 38. Patients will recieve also exercise treatment for 8 weeks and coldpack for 4 weeks |
| Placebo Acupuncture Group | Placebo comparator | Other: Placebo acupunctureThe patients will be recieved two days a week for 8 sessions with placebo needle. Selected points are Large intestine 15 Triple warmer 14 gallbladder 21 and small intestine 9. We will use the Placebo needle (blunt needle, tip obtuse, when acupuncture the feeling is similar to acupuncture needles into the skin, but it retracts instead of piercing the skin) to conduct acupuncture treatment. The retention time will be the same as those in the acupuncture group. The specialist will give the subjects verbal cues before and during the acupuncture manipulation, which further reduces the subjects' doubts about the authenticity of acupuncture in the this group. To ensure the implementation of the blinding method, all patients will be treated independently and avoid contacting with each other. Patients will recieve also exercise treatment for 8 weeks and coldpack for 4 weeks |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of Subacromial impingement syndrome
- Age range from 20-65 years
- Pain VAS ≥ 4
- Shoulder impingement symptoms lasting at least 6 weeks
Key exclusion criteria (8 listed)
- Presence of other shoulder pathologies
- Previous applications of physiotherapy and injection of hyaluronic acid and/or corticosteroid during the preceding 3 months;
- Presence of cervical pain or other conditions such as fibromyalgia confusing the clinical picture
- Presence of malignancy, blood disorder, neurologic, motor, and/or sensory deficit in the upper extremity;
- Pregnancy,
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 |
|---|---|---|
| AcupunctureThe patients will be recieved two days a week for 8 sessions with sterile 25*40 mm needles.Selected points are as local points, 2 painful points (ahshi point) in the shoulder region, Large intestine 4, 15, Gallbladder 21, Triple warmer 5, 14 Small intestine 9; as distant points Gallbladder 34 and Stomach 38. Patients will recieve also exercise treatment for 8 weeks and coldpack for 4 weeks | Other | Acupuncture Group |
| Placebo acupunctureThe patients will be recieved two days a week for 8 sessions with placebo needle. Selected points are Large intestine 15 Triple warmer 14 gallbladder 21 and small intestine 9. We will use the placebo needle (blunt needle, tip obtuse, when acupuncture the feeling is similar to acupuncture needles into the skin, but it retracts instead of piercing the skin) to conduct acupuncture treatment. The retention time will be the same as those in the acupuncture group. The specialist will give the subjects verbal cues before and during the acupuncture manipulation, which further reduces the subjects' doubts about the authenticity of acupuncture in the this group. To ensure the implementation of the blinding method, all patients will be treated independently and avoid contacting with each other. Patients will recieve also exercise treatment for 8 weeks and coldpack for 4 weeks | Other | Placebo Acupuncture Group |
Primary outcome
Pain intensity
Time frame: 2 months
All groups will be evaluated for shoulder pain with visual analogue scale (VAS) for rest, activity, and sleep-disturbing.
Shoulder Pain and Disability Index
Time frame: 2 months
All groups will be evaluated for shoulder function with the Shoulder Pain and Disability Index (SPADI). SPADI:The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. To answer the questions, patients place a mark on a 10cm visual analogue scale for each question. Higher results indicate worse function.
The Disabilities of the Arm, Shoulder and Hand Score
Time frame: 2 months
All groups will be evaluated for shoulder function with The Disabilities of the Arm, Shoulder and Hand Score (QuickDash). The QuickDASH only contains 11 items. It is a questionnaire that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms. The QuickDASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to his/her severity/function level. Higher results indicate worse function.
2 secondary outcomes
Shoulder range of motion
Time frame: 2 months
Quality of life index
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Derived from this study: PubMed 38948487Karamanlioglu DS, Kaysin MY, Begoglu FA, Akpinar P, Ozkan FU, Aktas I. Effects of acupuncture on pain and function in patients with subacromial impingement syndrome: A randomized sham-controlled trial. Integr Med Res. 2024 Jun;13(2):101049. doi: 10.1016/j.imr.2024.101049. Epub 2024 May 25.
- Individual participant dataSharing planned: No
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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.
Duygu Silte Karamanlioglu principal investigator
Fatih Sultan Mehmet Traning and Research Hospital
Meryem Yilmaz Kaysin study chair
Fatih Sultan Mehmet Traning and Research Hospital
Feyza Akan Begoglu study chair
Fatih Sultan Mehmet Traning and Research Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Acupuncture and Subacromial Impingement Syndrome, run by Fatih Sultan Mehmet Training and Research 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 4 inclusion and 8 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 14 Sep 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. Some participants in this study may receive a placebo. 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 Duygu Silte Karamanlioglu (00905323074990, drduygusilte@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 2 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?
On the ClinicalTrials.gov record for NCT05794633, which also lists 1 linked publication.
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 14 Sep 2023.