Acupuncture Therapy in Patients With Subacromial Impingement Syndrome

• ClinicalTrials.gov Identifier: NCT05794633
• Recruitment Status: Not yet recruiting
• First Posted: April 3, 2023
• Last Update Posted: September 14, 2023
• Sponsor: Fatih Sultan Mehmet Training and Research Hospital
• Information provided by (Responsible Party): Duygu Karamanlıoğlu, Fatih Sultan Mehmet Training and Research Hospital

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.

Condition or disease	Intervention/treatment	Phase
Acupuncture; Subacromial Impingement Syndrome	Other: Acupuncture; Other: Placebo acupuncture	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized placebo-controlled trial
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: All patients will be evaluated by the same physiatrist who are blinded to the randomization process and treatment protocols
• Primary Purpose: Treatment
• Official Title: Effectiveness of Acupuncture Therapy in Patients With Subacromial Impingement Syndrome, Randomized Placebo-controlled Trial
• Estimated Study Start Date: September 12, 2023
• Estimated Primary Completion Date: November 20, 2023
• Estimated Study Completion Date: January 20, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Acupuncture Group; 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	Other: Acupuncture; 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 Comparator: Placebo Acupuncture Group; 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	Other: Placebo acupuncture; 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

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.

Secondary Outcome Measures :

1. Shoulder range of motion [ Time Frame: 2 months ]
   All groups will be evaluated for shoulder range of motion with goniometer.
2. Quality of life index [ Time Frame: 2 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Duygu Silte Karamanlioglu; 00905323074990; drduygusilte@hotmail.com

Sponsors and Collaborators

Fatih Sultan Mehmet Training and Research Hospital

Investigators

• Principal Investigator: Duygu Silte Karamanlioglu; Fatih Sultan Mehmet Traning and Research Hospital
• Study Chair: Meryem Yilmaz Kaysin; Fatih Sultan Mehmet Traning and Research Hospital
• Study Chair: Feyza Akan Begoglu; Fatih Sultan Mehmet Traning and Research Hospital
• Study Chair: Pinar Akpinar; Fatih Sultan Mehmet Traning and Research Hospital
• Study Chair: Feyza Unlu Ozkan; Fatih Sultan Mehmet Traning and Research Hospital
• Study Chair: Ilknur Aktas; Fatih Sultan Mehmet Traning and Research Hospital

More Information

• Responsible Party: Duygu Karamanlıoğlu, Principal investigator, Fatih Sultan Mehmet Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT05794633
• Other Study ID Numbers: KAEK-2012-70
• First Posted: April 3, 2023
• Last Update Posted: September 14, 2023
• Last Verified: September 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Shoulder Impingement Syndrome; Syndrome; Rotator Cuff Injuries; Disease; Pathologic Processes; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Joint Diseases; Musculoskeletal Diseases