Adhesive CapsulitisNCT05983081
Efficacy of Intra-articular Hyaluronate Injection for Adhesive Capsulitis
A study testing hyaluronic acid and Physical Therapy in people with Adhesive Capsulitis, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- hyaluronic acid and Physical Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2023to 14 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Adhesive Capsulitis
- Being tested
- hyaluronic acid, Physical Therapy
- Keywords
- frozen shoulder, hyaluronic acid
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyaluronic acidDrug
patients receives intra-articular injections of Hyaluronic acid. the injections were administered once a week for three consecutive weeks, total three injections per patients
Physical TherapyOther
a week physical therapy program, consist of two sessions per week, (30 minutes each), including joint exercises, stretch and etc..
| Study group | Role | What they receive |
|---|---|---|
| Intra-articular Hyaluronic Acid Injection | Experimental | 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. Receives: Drug: hyaluronic acid |
| Physical Therapy | Active comparator | 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. Receives: Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: baseline, 4, 6, 8, and 26 weeks after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start1 Aug 2023
- Primary completion14 Aug 2024
- Study completion14 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive CapsulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- group A: intra-articular glenohumeral joint injections with HA, 60mg, once per week for 3 consecutive weeks. group B: physical therapy
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chih-Ya Chang, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983081
- Sponsor's protocol ID
- C202205161
- Status last verified
- Mar 2026
- First submitted
- 1 Aug 2023
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intra-articular Hyaluronate Injection for Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT05983081
- Acronym / sponsor ID
- C202205161
- Conditions
- Adhesive Capsulitis
- Keywords
- frozen shoulder, hyaluronic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 14 Aug 2024 (actual)
- Study completion
- 14 Aug 2024 (actual)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- group A: intra-articular glenohumeral joint injections with HA, 60mg, once per week for 3 consecutive weeks. group B: physical therapy
| Arm | Type | Receives |
|---|---|---|
| Intra-articular Hyaluronic Acid Injection | Experimental | Drug: hyaluronic acidA- 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. |
| Physical Therapy | Active comparator | Other: Physical TherapyB- 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyaluronic acidpatients receives intra-articular injections of Hyaluronic acid. the injections were administered once a week for three consecutive weeks, total three injections per patients | Drug | Intra-articular Hyaluronic Acid Injection |
| Physical Therapya week physical therapy program, consist of two sessions per week, (30 minutes each), including joint exercises, stretch and etc.. | Other | Physical Therapy |
Primary outcome
Shoulder Pain and Disability Index
Time frame: baseline, 4, 6, 8, and 26 weeks after treatment initiation
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
1 secondary outcome
Range of Motion
Time frame: baseline, 4, 6, 8, and 26 weeks after treatment initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Adhesive Capsulitis
Not yet recruiting
Effects of Clinic Versus mHealth Application-Based Shoulder Rehabilitation in Patients With Adhesive Capsulitis
Adhesive Capsulitis
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
Not yet recruiting
Effects of Posterior Capsular Stretching With and Without Dynamic Neuromuscular Stabilization Exercises in Frozen Shoulder
Frozen Shoulder
Active, not recruiting
Spencer vs. Ola Grimsby Techniques With Scapular Motor Training in Idiopathic Adhesive Capsulitis
Idiopathic Adhesive Capsulitis
Not yet recruitingPhase 4
OMT for Adhesive Capsulitis
Adhesive Capsulitis of the Shoulder, Frozen Shoulder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hyaluronic acid and Physical Therapy in people with Adhesive Capsulitis, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Pain and Disability Index (time frame: baseline, 4, 6, 8, and 26 weeks after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.