CClinicalTrials.gg
CompletedNCT05983081Updated Mar 11, 2026

Efficacy of Intra-articular Hyaluronate Injection for Adhesive Capsulitis

An interventional study of hyaluronic acid and Physical Therapy in Adhesive Capsulitis, sponsored by Tri-Service General Hospital (TSGH). Completed at 1 site in Taiwan. Open to participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-11.

Sponsored by Tri-Service General Hospital (TSGH) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
01

Study summary

Objective: To evaluate the efficacy of intra-articular hyaluronic acid (HA) injections for the treatment of adhesive capsulitis (AC) of the shoulder.

Design: Prospective, randomized, parallel-group interventional trial Setting: Rehabilitation department of a medical center hospital. Participants: Participants: Patients with frozen-phase primary adhesive capsulitis Interventions: The patients received intra-articular glenohumeral joint injections of HA, 60mg, once per week for 3 consecutive weeks.

Main Outcome Measures: Active and passive range of motion (ROM) of the affected shoulder; Shoulder pain and disability were measured using 2 questionnaires: the SPADI.

The patients were evaluated before treatment and were reevaluated 4, 6, 8, and 26 weeks after the beginning of the treatment.

02

Conditions studied

  • Adhesive Capsulitis

Browse trials for

Keywords

  • frozen shoulder
  • hyaluronic acid
03

In context

Bursitis

411 studies on the registry are indexed under Bursitis; 112 are open to participants now.

This study's enrollment of 46 is close to the median of 45 across 371 interventional studies indexed under Bursitis.

Browse Bursitis studies →

Lead sponsor

Tri-Service General Hospital (TSGH) is the lead sponsor of 32 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients diagnosed with frozen shoulder by a clinical physician based on the patient's medical history, physical examination, X-ray, and ultrasound or magnetic resonance imaging reports.
  • Clinical course: Patients must have a pain score of less than 3, no nighttime shoulder pain, and be in the post-freezing stage, primarily presenting restricted shoulder joint range of motion.
  • The affected shoulder joint must have at least two angles of shoulder joint movement reduced by at least 30% compared to the healthy side: shoulder flexion, abduction, and external rotation, or a single affected side abduction angle reduced by 50% relative to the healthy side.
  • Age between 40 to 70 years old.

Exclusion criteria

Exclusion Criteria:

  • full-thickness tear or massive tear of the rotator cuff tendons or calcific tendinitis.
  • Presence of systemic rheumatic disease.
  • History of shoulder fracture or previous shoulder surgery.
  • Received shoulder injections for treatment within the last 3 months.
  • Acute cervical nerve root compression.
  • Current pregnancy or lactation.
  • Patients with shoulder instability or cancer.
  • Patients with cognitive impairment, unable to follow simple instructions, or unable to comply with the study procedures.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    Intra-articular Hyaluronic Acid Injection

    A- Experimental Group: Intra-articular Hyaluronic Acid Injection Treatment Regimen Patients in the experimental group received ultrasound-guided intra-articular injections of hyaluronic acid (Artibest, 60 mg/3 ml, 2%, manufactured by Kang Stem Biotech, Taiwan) into the affected shoulder joint. The injections were administered once a week for three consecutive weeks, totaling three injections per patient. The subjects were evaluated for shoulder function using the Shoulder Pain and Disability Index (SPADI) and Range of Motion (ROM) assessment at the following time points: before the treatment, 4 weeks after the treatment, 6 weeks after the treatment, and 8 weeks and 26 weeks after the treatment.

    Drug: hyaluronic acid

  • Active comparator
    Physical Therapy

    B- Control Group: Physical Therapy Patients in the control group underwent a 6-week physical therapy program, consisting of two sessions per week, with each session lasting approximately 30 minutes. The physical therapy program was conducted under the guidance and supervision of a physical therapist and included joint exercises, stretching, and muscle strengthening exercises. The subjects were evaluated for shoulder function using the Shoulder Pain and Disability Index (SPADI) and Range of Motion (ROM) assessment at the following time points: before the treatment, 4 weeks after the treatment, 6 weeks after the treatment, and 8 weeks and 26 weeks after the treatment.

    Other: Physical Therapy

Interventions

  • Drughyaluronic acid

    patients receives intra-articular injections of Hyaluronic acid. the injections were administered once a week for three consecutive weeks, total three injections per patients

  • OtherPhysical Therapy

    a week physical therapy program, consist of two sessions per week, (30 minutes each), including joint exercises, stretch and etc..

06

What researchers measure

Primary outcomes

  1. Shoulder Pain and Disability Index

    The SPADI consists of two subscales, pain, and disability, comprising a total of 13 items. Each item is rated on a scale from 0 (no pain/disability) to 10 (most severe pain/disability). Higher scores indicate greater functional impairment. The total score on the SPADI is used to determine the percentage of functional disability

    Time frame: baseline, 4, 6, 8, and 26 weeks after treatment initiation

Secondary outcomes

  1. Range of Motion

    The ROM is assessed using a standardized goniometer in the standard position to measure the angles of shoulder joint movement on the affected side. It includes flexion, extension, abduction, external rotation, and internal rotation.

    Time frame: baseline, 4, 6, 8, and 26 weeks after treatment initiation

07

Study locations

1 site
  • Tri-Service General Hospital
    Taipei, Alberta 114, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05983081
Lead sponsor
Tri-Service General Hospital (TSGH)
Responsible party
Chih-Ya Chang (Attending Physician, Tri-Service General Hospital (TSGH)) — Principal investigator
First posted
Aug 9, 2023
Start date
Aug 1, 2023
Primary completion
Aug 14, 2024
Completion
Aug 14, 2024
Last update
Mar 11, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion