Effect of Ultrasound-guided Hyaluronic or Corticosteroid Injections in Patients With Chronic Subacromial Bursitis

NCT02702206 | Completed DMC

• 2 other identifiers: 20131202RMOST 103-2314-B-341 -003 -MY2
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized controlled trial to compare the effect of ultrasound-guided hyaluronic or corticosteroid injections in patients with chronic subacromial bursitis.

Conditions

Shoulder Pain; Subdeltoid Bursitis; Subacromial Bursitis

Keywords

Shoulder pain; subdeltoid bursitis; subacromial bursitis; intra-bursa injection

Outcome Measures

Primary Outcomes (1)

• Change from baseline VAS pain score

  The VAS scores for pain were obtained using a 100-mm-long horizontal line, with 0 mm on the left indicating no pain and 100 mm on the right indicating very severe pain.

  baseline and 2 weeks

Secondary Outcomes (4)

• the active ROM

  between these time points: baseline, 2 weeks, 4 weeks (end of the intervention), 8 weeks, and 16 weeks

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

  between these time points: baseline, 2 weeks, 4 weeks (end of the intervention), 8 weeks, and 16 weeks

• Change of the Shoulder Disability Questionnaire (SDQ)

  between these time points: baseline, 2 weeks, 4 weeks (end of the intervention), 8 weeks, and 16 weeks

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

  between these time points: baseline, 2 weeks, 4 weeks (end of the intervention), 8 weeks, and 16 weeks

Study Arms (3)

corticosteroids SASD injection

EXPERIMENTAL

under US guidance 2ml triamcinolone (1ml/10mg), 0.5ml distilled water and 1ml 1% lidocaine

Drug: corticosteroids

hyaluronic acid (ARTZ) SASD injection

EXPERIMENTAL

under US guidance 2.5ml HA (ARTZ, 1% sodium hyaluronate solution, 10mg/mL, molecular weight 0.9x106Da) and 1ml 1% lidocaine

Drug: hyaluronic acid

normal saline SASD injection

PLACEBO COMPARATOR

under US guidance 2.5ml normal saline and 0.5ml distilled water and 1ml 1% lidocaine

Drug: normal saline

Interventions

corticosteroids DRUG

under US guidance, 2ml triamcinolone (1ml/10mg), 0.5ml distilled water and 1ml 1% lidocaine

Also known as: triamcinolone

corticosteroids SASD injection

hyaluronic acid DRUG

under US guidance, 2.5ml HA (ARTZ, 1% sodium hyaluronate solution, 10mg/mL, molecular weight 0.9x106Da) and 1ml 1% lidocaine

Also known as: ARTZ

hyaluronic acid (ARTZ) SASD injection

normal saline DRUG

under US guidance, 2.5ml normal saline (placebo group). 0.5ml distilled water and 1ml 1% lidocaine

Also known as: placebo group

normal saline SASD injection

Eligibility Criteria

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

You may qualify if:

• shoulder pain for more than 1 month
• age ≥ 20 years old
• painful abduction or internal rotation with a visual analog scale (VAS) pain score ≥4
• the presence of a painful arc of motion or pain at the middle to terminal range of shoulder abduction or internal rotation with a soft end feel
• tenderness over the subacromial bursa
• a reduction in pain of ≥40% on active shoulder abduction or internal rotation at the terminal range after injection of 3ml of 1%lidocain into the SASD bursa under ultrasound (US) guidance.

You may not qualify if:

• a history of uncontrolled chronic diseases, e.g., malignant neoplasms, blood dyscrasia, and infection
• previous surgery of the affected shoulder
• any evidence of a rotator cuff tear or tendinopathy, demonstrated by positive resistive tests or sonographic findings
• calcification of the rotator cuff, demonstrated by x-ray or sonographic findings
• the presence of arthritis, such as inflammatory arthritis (e.g., rheumatoid arthritis, seronegative spondyloarthropathy, or crystal-related arthropathy), osteoarthritis, frozen shoulder, subacromial spurs, or deformity of the acromion
• the presence of instability of the affected shoulder
• a previous fracture near the shoulder region
• the presence of cervical radiculopathy or myelopathy
• having received a corticosteroid or hyaluronic acid subacromial or shoulder joint injection in the past 3 months

Sponsors & Collaborators

• Shin Kong Wu Ho-Su Memorial Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

Location

Related Publications (1)

• Hsieh LF, Lin YJ, Hsu WC, Kuo YC, Liu YC, Chiang YP, Wang CP. Comparison of the corticosteroid injection and hyaluronate in the treatment of chronic subacromial bursitis: A randomized controlled trial. Clin Rehabil. 2021 Sep;35(9):1305-1316. doi: 10.1177/02692155211007799. Epub 2021 Apr 15.

  PMID: 33858205 DERIVED

MeSH Terms

Conditions

Shoulder Pain

Interventions

Adrenal Cortex Hormones; Triamcinolone; Hyaluronic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Glycosaminoglycans; Polysaccharides; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2014
• First Posted: March 8, 2016
• Study Start: August 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 23, 2020

Record last verified: 2017-01

Locations

TW (1)