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Steroid Injection for Adhesive Capsulitis

T

Taipei Veterans General Hospital

Status

Unknown

Conditions

Adhesive Capsulitis

Treatments

Drug: Normal saline
Drug: Triamcinolone Acetonide
Drug: lidocaine hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT04364425
2019-07-005C

Details and patient eligibility

About

This study was conducted to compare the efficacy of hydrodilatation with low dose steroid with high dose steroid for treating adhesive capsulitis.

Full description

Design: a prospective, double-blinded, randomized, clinical trial

Patient and methods:

Patients with adhesive capsulitis for at least 3 months were enrolled and randomly allocated into group 1 (hydrodilatation with low dose steroid ) and group 2 (hydrodilatation with high dose steroid). The patients were evaluated before treatment and were reevaluated 0, 6, and 12 weeks after the beginning of the treatment. Outcomes measures included a pain scale (visual analog scale), range of motion, Constant shoulder score, Shoulder Pain And Disability Index

Enrollment

80 estimated patients

Sex

All

Ages

35 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. clinical diagnosis of adhesive capsulitis
  2. a duration of complaints more than 3 months
  3. 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.

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

80 participants in 2 patient groups

low dose steroid
Experimental group
Description:
patient received ultrasound-guided 40mg triamcinolone + 4cc xylocaine + 12cc NS
Treatment:
Drug: lidocaine hydrochloride
Drug: Triamcinolone Acetonide
Drug: Normal saline
high dose steroid
Active Comparator group
Description:
patient received ultrasound-guided 10mg triamcinolone + 4cc xylocaine + 15cc NS
Treatment:
Drug: lidocaine hydrochloride
Drug: Triamcinolone Acetonide
Drug: Normal saline

Trial contacts and locations

1

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Central trial contact

Jia chi Wang

Data sourced from clinicaltrials.gov

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