A Long Term Follow-Up of Rotator Cuff Tear Patients Treated With Integrated Complementary and Alternative Medicine

NCT04566939 | Completed

• 1 other identifier: JS-CT-2020-11
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective observational trial. Data of 4 hospitals will be used to find out the efficacy of conservative treatment in rotator cuff tear.

Conditions

Rotator Cuff Tear

Keywords

Rotator cuff tear, Korean medical treatment

Outcome Measures

Primary Outcomes (1)

• Shoulder Pain intensity scale: Numeric Rating Scale (NRS)

  The investigators will survey Shoulder Pain intensity scale: Numeric Rating Scale (NRS) before hospitalization and after discharging from 4 hospitals(Haeundae Jaseng Korean Medicine Hospital, Jaseng Korean Medicine Hospital, Bucheon Jaseng Korean Medicine Hospital, and Daejeon Jaseng Korean Medicine Hospital. The score ranges from 0 to 10. The higher scores mean a worse outcome, and the lower scores mean a better outcome.

  Finish survey by March 2021

Secondary Outcomes (3)

• Functional scale: Shoulder Pain and Disability Index (SPADI)

  Finish survey by March 2021

• 5-Level Quality of life: EuroQol 5-Dimension (EQ-5D-5L)

  Finish survey by March 2021

• Patient Global Impression of Change (PGIC)

  Finish survey by March 2021

Interventions

Herbal medicine DRUG

Herbal medicine will be administered in water-based decoction (120ml) and dried powder (2g) form (Ostericum koreanum,Eucommia ulmoides, canthopanax sessiliflorus, Achyranthes japonica, Psoralea corylifolia, aposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycinemax, Atractylodes japonica) at the physician's discretion.

Also known as: Traditional herbal medicine

Chuna manual medicine PROCEDURE

Chuna is a Korean manual therapy directed at the spine and joints that incorporates various spinal manual medicine techniques for joint mobilization involving high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement. Chuna manual medicine will be administered to the shoulder at the physician's discretion.

Also known as: Chuna manipulation

Pharmacopuncture PROCEDURE

Pharmacopuncture consisting of select herbal ingredients will be administered at Gyunwoo (LI15), Gyunryo(TE14), Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea) at the physician's discretion.

Acupuncture PROCEDURE

Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.

Electroacupuncture PROCEDURE

Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.

Cupping PROCEDURE

Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points.

Herbal hot pack PROCEDURE

Herbal hot pack treatment will be administered using mainly proximal acupuncture points and Ah-shi points.

Physical therapy PROCEDURE

The participants in the control group will be receive one or more physical therapy according to the physician's decision.

Other intervention(s) PROCEDURE

Patients will be allowed any other additional intervention(s) as deemed necessary regardless of type or dose, and patterns of use will be investigated and recorded as a pragmatic clinical study.

Eligibility Criteria

• Age: 17 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who ended up the hospitalization and treatment in Haeundae Jaseng Korean Medicine Hospital, Jaseng Korean Medicine Hospital, Bucheon Jaseng Korean Medicine Hospital, Daejeon Jaseng Korean Medicine Hospital

You may qualify if:

• Patients who had been hospitalized with symptoms of shoulder pain at Haeundae Jaseng Korean Medicine Hospital, Jaseng Korean Medicine Hospital, Bucheon Jaseng Korean Medicine Hospital and Daejeon Jaseng Korean Medicine Hospital from Jan 2015 to Mar 2020.
• Patients diagnosed with 'Rotation Cuff Tear' finding of the EMR imaging (T2-weighted MRI scan of Shoulder
• Patients who had been hospitalized more than 3 days
• Patients who are within age from 19 to 70

You may not qualify if:

• Patients who are hospitalized by traffic accident
• Patients who are diagnosed other serious shoulder injury that can cause shoulder pain(tumor of shoulder, acute fracture and dislocation of shoulder)
• Patients who had treated shoulder pain at Haeundae Jaseng Korean Medicine Hospital, Jaseng Korean Medicine Hospital, Bucheon Jaseng Korean Medicine Hospital and Daejeon Jaseng Korean Medicine Hospital in recent 6 months.
• Patients who are considered impossible to attend survey by investigators.

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (1)

Haeundae Jaseng Hospital of Korean Medicine

Busan, 48102, South Korea

Location

Related Publications (1)

• Yoo DH, Choi JY, Lee SG, Choi KW, Park HB, Kim H, Cho H, Kim SD, Kim D, Lee YJ, Park KS, Ha IH. Long-Term Follow-Up of Inpatients with Rotator Cuff Tear Who Received Integrative Korean Medicine Treatment: A Retrospective Analysis and Questionnaire Survey. Explore (NY). 2024 Mar-Apr;20(2):212-221. doi: 10.1016/j.explore.2023.08.005. Epub 2023 Aug 25.

  PMID: 37689574 DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Phytotherapy; Acupuncture Therapy; Electroacupuncture; Cupping Therapy; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Combined Modality Therapy; Electric Stimulation Therapy; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• HYUN WOO CHO, PhD

  Haeundae Jaseng Hospital of Korean Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: September 28, 2020
• Study Start: September 21, 2020
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

KR (1)