Hyaluronic Acid Injection Combined With Rehabilitation for Frozen Shoulder (HA - AC)

Tri-Service General Hospital

Status: Completed

Conditions: Frozen Shoulder; Adhesive Capsulitis

Treatments: Other: Rehabilitation; Drug: Hyaluronic Acid (HA)

Study type: Interventional

Funder types: Other

Identifiers

NCT07570095

C202205160

Details and patient eligibility

About

This randomized controlled trial evaluates the clinical efficacy of ultrasound-guided intra-articular hyaluronic acid injection combined with rehabilitation in patients with adhesive capsulitis (frozen shoulder).

Participants were randomly assigned to either an injection plus rehabilitation group or a rehabilitation-only group. The injection group received ultrasound-guided intra-articular hyaluronic acid once weekly for three weeks, along with a standardized rehabilitation program for six weeks. The control group received the same rehabilitation program without injection.

Clinical outcomes were assessed at multiple time points, including baseline, 4, 6, 8, and 12 weeks. The primary outcome was the change in the Shoulder Pain and Disability Index (SPADI) total score. Secondary outcomes included SPADI pain and disability subscales, as well as shoulder range of motion.

This study was registered retrospectively after study initiation due to administrative oversight.

Full description

Adhesive capsulitis is a common musculoskeletal disorder characterized by progressive pain and restricted range of motion of the shoulder joint, leading to significant functional impairment. Although rehabilitation remains the cornerstone of treatment, the additional benefit of intra-articular hyaluronic acid injection remains controversial.

This randomized controlled trial aimed to evaluate the clinical efficacy of ultrasound-guided intra-articular injection of non-cross-linked hyaluronic acid combined with a structured rehabilitation program in patients with adhesive capsulitis.

Participants were randomly assigned to two groups: an injection plus rehabilitation group and a rehabilitation-only group. The injection group received ultrasound-guided intra-articular hyaluronic acid injections once weekly for three consecutive weeks. Both groups underwent a standardized rehabilitation program twice weekly for six weeks, including range of motion exercises, stretching, and strengthening under the supervision of a physical therapist.

Clinical outcomes were assessed at multiple time points, including baseline, 4, 6, 8, and 12 weeks. The primary outcome measure was the change in the Shoulder Pain and Disability Index (SPADI) total score over time. Secondary outcomes included SPADI pain and disability subscales, as well as shoulder external rotation range of motion.

This study was conducted in accordance with institutional ethical standards and approved by the Institutional Review Board. The trial was registered retrospectively following study initiation due to administrative oversight.

Enrollment: 60 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged 20 to 80 years.
• Clinical diagnosis of adhesive capsulitis (frozen shoulder) characterized by shoulder pain and restricted range of motion for at least 1 month.
• Limitation of both active and passive shoulder range of motion, particularly in external rotation.
• Ability to understand the study procedures and provide informed consent.

Exclusion criteria

• Prior shoulder surgery or fracture on the affected side.
• Rotator cuff tear confirmed by imaging.
• Glenohumeral osteoarthritis or inflammatory joint disease.
• Neurological disorders affecting shoulder function.
• Previous intra-articular injection within the past 3 months.
• Contraindications to hyaluronic acid injection.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Hyaluronic Acid Injection + Rehabilitation

Experimental group

Description:

Participants receive ultrasound-guided intra-articular injection of non-cross-linked hyaluronic acid (10 mg/mL, once weekly for 3 consecutive weeks) combined with a standardized rehabilitation program consisting of joint mobilization, stretching, and strengthening exercises, performed twice weekly for 6 weeks.

Treatment:

Drug: Hyaluronic Acid (HA)

Other: Rehabilitation

Rehabilitation Alone

Active Comparator group

Description:

Participants receive a standardized rehabilitation program including joint mobilization, stretching, and strengthening exercises, performed twice weekly for 6 weeks without hyaluronic acid injection.

Treatment:

Other: Rehabilitation