Acupuncture Therapy in Patients With Subacromial Impingement Syndrome

NCT05794633 | Unknown

• 1 other identifier: KAEK-2012-70
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acupuncture; Subacromial Impingement Syndrome

Outcome Measures

Primary Outcomes (3)

• Pain intensity

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

  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.

  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.

  2 months

Secondary Outcomes (2)

• Shoulder range of motion

  2 months

• Quality of life index

  2 months

Study Arms (2)

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

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

Other: Placebo acupuncture

Interventions

Acupuncture OTHER

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

Acupuncture Group

Placebo acupuncture OTHER

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

Placebo Acupuncture Group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Related Publications (1)

• 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.

  PMID: 38948487 DERIVED

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Duygu Silte Karamanlioglu

  Fatih Sultan Mehmet Traning and Research Hospital

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Central Study Contacts

Duygu Silte Karamanlioglu

CONTACT

00905323074990; drduygusilte@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: All patients will be evaluated by the same physiatrist who are blinded to the randomization process and treatment protocols
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Randomized placebo-controlled trial

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: April 3, 2023
• Study Start: September 12, 2023
• Primary Completion: November 20, 2023
• Study Completion: January 20, 2024
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share