The Efficacy of Ultrasound-guided Hydrodilatation With Hyaluronic Acid for Patients With Adhesive Capsulitis

NCT02708706 | Completed

• 1 other identifier: 2014-10-009B
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted to compare the efficacy of hydrodilatation with hyaluronic acid under ultrasonographic guidance plus physical therapy (PT) with that of PT alone for treating adhesive capsulitis.

Conditions

Adhesive Capsulitis

Keywords

adhesive capsulitis; hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• change in constant shoulder score

  visual analog scale

  at 6, 12 wk

Secondary Outcomes (4)

• change in glenohumeral joint range of motion

  at 6, 12 wk

• change in Short Form-36

  at 6, 12 wk

• change in pain intensity

  at 6, 12 wk

• change in Shoulder Pain And disability index

  at 6, 12 wk

Study Arms (2)

physical therapy and hyaluronic acid

EXPERIMENTAL

patient received ultrasound-guided hydrodilatation with hyaluronic acid plus physical therapy

Drug: hyaluronic acid (hyruan); Other: physical therapy

physical therapy only

ACTIVE COMPARATOR

patient received physical therapy only

Other: physical therapy

Interventions

hyaluronic acid (hyruan) DRUG

2cc hyaluronic acid

Also known as: hyaluronate

physical therapy and hyaluronic acid

physical therapy OTHER

patient received traditional physical therapy, including therapeutic exercise and stretch exercise

Also known as: rehabilitation

physical therapy and hyaluronic acid; physical therapy only

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a duration of complaints more than 3 months
• a reduction in passive range of motion in at least 2 of the following: forward flexion, abduction, or external rotation of the affected shoulder of more than 30 degree compared with the other side.

You may not qualify if:

• prior manipulation of the affected shoulder under anesthesia;
• other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions, osteoarthritis, damage to the glenohumeral cartilage,osteoporosis, or malignancies in the shoulder region);
• neurologic deficits affecting shoulder function in normal daily activities;
• shoulder pain caused by cervical radiculopathy
• a history of drug allergy to hyaluronic acid;
• pregnancy or lactation;
• received injection into the affected shoulder during the preceding 3 months

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei veteran general hospital

Taipei, Taiwan

Location

Related Publications (1)

• Wu SY, Hsu PC, Tsai YY, Huang JR, Wang KA, Wang JC. Efficacy of combined ultrasound-guided hydrodilatation with hyaluronic acid and physical therapy in patients with adhesive capsulitis: A randomised controlled trial. Clin Rehabil. 2024 Feb;38(2):202-215. doi: 10.1177/02692155231200089. Epub 2023 Sep 11.

  PMID: 37697666 DERIVED

MeSH Terms

Conditions

Bursitis

Interventions

Hyaluronic Acid; Physical Therapy Modalities; Rehabilitation

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Therapeutics; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2016
• First Posted: March 15, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: May 17, 2022

Record last verified: 2022-05

Locations

TW (1)