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Acupuncture Therapy in Patients With Subacromial Impingement Syndrome

Primary Purpose

Acupuncture, Subacromial Impingement Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupuncture
Placebo acupuncture
Sponsored by
Fatih Sultan Mehmet Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acupuncture

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Clinical diagnosis of Subacromial impingement syndrome Age range from 20-65 years Pain VAS ≥ 4 Shoulder impingement symptoms lasting at least 6 weeks Exclusion Criteria: 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Acupuncture Group

    Placebo Acupuncture Group

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    Pain intensity
    All groups will be evaluated for shoulder pain with visual analogue scale (VAS) for rest, activity, and sleep-disturbing.
    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.
    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.

    Secondary Outcome Measures

    Shoulder range of motion
    All groups will be evaluated for shoulder range of motion with goniometer.
    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.

    Full Information

    First Posted
    March 6, 2023
    Last Updated
    September 12, 2023
    Sponsor
    Fatih Sultan Mehmet Training and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05794633
    Brief Title
    Acupuncture Therapy in Patients With Subacromial Impingement Syndrome
    Official Title
    Effectiveness of Acupuncture Therapy in Patients With Subacromial Impingement Syndrome, Randomized Placebo-controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 12, 2023 (Anticipated)
    Primary Completion Date
    November 20, 2023 (Anticipated)
    Study Completion Date
    January 20, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fatih Sultan Mehmet Training and Research Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acupuncture, Subacromial Impingement Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized placebo-controlled trial
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    All patients will be evaluated by the same physiatrist who are blinded to the randomization process and treatment protocols
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Acupuncture Group
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Placebo Acupuncture Group
    Arm Type
    Placebo Comparator
    Arm Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Acupuncture
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Placebo acupuncture
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Pain intensity
    Description
    All groups will be evaluated for shoulder pain with visual analogue scale (VAS) for rest, activity, and sleep-disturbing.
    Time Frame
    2 months
    Title
    Shoulder Pain and Disability Index
    Description
    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.
    Time Frame
    2 months
    Title
    The Disabilities of the Arm, Shoulder and Hand Score
    Description
    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.
    Time Frame
    2 months
    Secondary Outcome Measure Information:
    Title
    Shoulder range of motion
    Description
    All groups will be evaluated for shoulder range of motion with goniometer.
    Time Frame
    2 months
    Title
    Quality of life index
    Description
    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.
    Time Frame
    2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of Subacromial impingement syndrome Age range from 20-65 years Pain VAS ≥ 4 Shoulder impingement symptoms lasting at least 6 weeks Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Duygu Silte Karamanlioglu
    Phone
    00905323074990
    Email
    drduygusilte@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Duygu Silte Karamanlioglu
    Organizational Affiliation
    Fatih Sultan Mehmet Traning and Research Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Meryem Yilmaz Kaysin
    Organizational Affiliation
    Fatih Sultan Mehmet Traning and Research Hospital
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Feyza Akan Begoglu
    Organizational Affiliation
    Fatih Sultan Mehmet Traning and Research Hospital
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Pinar Akpinar
    Organizational Affiliation
    Fatih Sultan Mehmet Traning and Research Hospital
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Feyza Unlu Ozkan
    Organizational Affiliation
    Fatih Sultan Mehmet Traning and Research Hospital
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Ilknur Aktas
    Organizational Affiliation
    Fatih Sultan Mehmet Traning and Research Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Acupuncture Therapy in Patients With Subacromial Impingement Syndrome

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