Effect of Ultrasound-guided Suprascapular Nerve Block Versus Intra-articular Corticosteroid Injection for Frozen Shoulder

NCT03515278 | Completed DMC

• 2 other identifiers: 20170915R2018SKHADR029
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to compare the effect of ultrasound-guided suprascapular nerve block and intra-articular corticosteroid injection for frozen shoulder in pain control, improvement of range of motion, quality of life, and function.

Conditions

Frozen Shoulder

Keywords

Frozen shoulder; adhesive capsulitis; ultrasound-guided intervention; suprascapular nerve block; intra-articular injection

Outcome Measures

Primary Outcomes (1)

• Change of scores of the Shoulder Pain and Disability Index (SPADI)

  The total SPADI score, which ranges between 0 and 100, is calculated by averaging the scores from the pain and disabilities subclasses.

  baseline and at 4 weeks and 12 weeks after the beginning of the treatment.

Secondary Outcomes (3)

• the active ROM

  baseline and at 4 weeks and 12 weeks after the beginning of the treatment.

• Change of the Shoulder Disability Questionnaire (SDQ)

  baseline and at 4 weeks and 12 weeks after the beginning of the treatment.

• Change of 36-item Short-Form Health Survey (SF-36)

  baseline and at 4 weeks and 12 weeks after the beginning of the treatment.

Study Arms (2)

suprascapular nerve block (SCNB) group

EXPERIMENTAL

SCNB with physiotherapy. Suprascapular nerve block: Ultrasound-guided SCNB by 3 c.c. 1% lidocaine with 20mg triamcinolone. Physiotherapy: The physiotherapy program includes physical modalities (heat therapy and electric therapy) and therapeutic exercise. (stretching, mobilization and ROM exercise, and strengthening)

Procedure: SCNB group

intra-articular corticosteroid injection (IACI) group

ACTIVE COMPARATOR

IACI with physiotherapy. Intra-articular steroid Injections: Receive intra-articular corticosteroid injection.Ultrasound-guided IACI with 3c.c. 1% lidocaine and 20mg triamcinolone. Physiotherapy: The physiotherapy program includes physical modalities (heat therapy and electric therapy) and therapeutic exercise. (stretching, mobilization and ROM exercise, and strengthening)

Procedure: IACI group

Interventions

SCNB group PROCEDURE

IACI can provide rapid effect in pain reliving, reducing inflammation and improving ROM that could increase the compliance of exercise therapy.

Also known as: IACI group

suprascapular nerve block (SCNB) group

IACI group PROCEDURE

SCNB is a new choice for treatment of frozen shoulder.As radiology techniques advance, ultrasound-guided SCNB becomes more popular. It provides a cost and time-effective way to infiltrate the nerve accurately without injury to the nerves or vessels.

Also known as: SCNB group

intra-articular corticosteroid injection (IACI) group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• unilateral side involvement.
• ≥50% loss of passive ROM (external rotation or abduction) in the glenohumeral joint comparing to the unaffected side.
• duration of symptoms ≥3 months.
• age≥ 20year old.

You may not qualify if:

• ever received manipulation of the affected shoulder with/without anesthesia.
• systemic disease, severe degeneration, or trauma involving the shoulder. (ie, rheumatoid arthritis, osteoarthritis, history of injury to the labrum or articular cartilage or malignancies in the shoulder region, etc.)
• neurologic diseases such as stroke or peripheral nerve neuropathy that have already affect the activity of shoulder.
• pain or disorders of the cervical spine, elbow, wrist, or hand.
• a history of drug allergy to local or corticosteroids.
• Pregnancy or lactation.
• Received corticosteroids, or hyaluronic acid intra-articular injection into the affected shoulder during the preceding 4 weeks.

Sponsors & Collaborators

• Shin Kong Wu Ho-Su Memorial Hospital: lead

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Lin-Fen Hsieh, M.D

  Shin Kong Wu Ho-Su Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: May 3, 2018
• Study Start: February 13, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: December 23, 2020

Record last verified: 2020-01

Locations

TW (1)