Adhesive Capsulitis of the ShoulderPhase 3NCT07183436
Intra-articular Corticosteroids Are Widely Used for Adhesive Capsulitis, But Alternatives Are Required for Patients With Contraindications. Hyaluronic Acid (HA) and Ketorolac Have Shown Individual Benefits. However, Evidence on Their Combination Remains Limited.
A Phase 3 study testing Intra-articular Hyaluronic Acid and Ketorolac and Intra-articular Ketorolac in people with Adhesive Capsulitis of the Shoulder, run by Mahidol University at 1 site in Thailand.
Trial summary
This randomized, double-blind trial compared a single intra-articular injection of moderate-molecular-weight hyaluronic acid (HA) plus ketorolac with ketorolac alone in patients with adhesive capsulitis. Fifty-six participants were randomized into two equal groups and followed for 24 weeks. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Adhesive Capsulitis of the Shoulder
- What is being tested?
- Intra-articular Hyaluronic Acid and Ketorolac and Intra-articular Ketorolac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteThailand
- Study dates
- 1 Nov 2023to 1 Jul 2025
- Phase
- Phase 3
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-70 years
- Symptom duration of 1-12 months
- Provision of informed consent.
Who cannot join
- History of trauma or prior surgery to the affected shoulder
- Bilateral adhesive capsulitis
- Uncontrolled diabetes (HbA1C > 7%)
- Abnormal thyroid function
- Prior intra-articular injection in the affected shoulder
- Full-thickness rotator cuff tear on imaging
Show all 10Show fewer
- History of gastrointestinal bleeding
- Known allergy to hyaluronic acid or NSAIDs
- Systemic conditions affecting joint pain (e.g., SLE, rheumatoid arthritis, osteoarthritis)
- Neurological disorders affecting muscle strength or sensation coagulopathy or bleeding disorders withdrawal or refusal of consent at any time
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Bangkok, 10400
About this study
Official title: Efficacy of Combined Intra-Articular Hyaluronic Acid and Ketorolac Versus Ketorolac Alone in the Treatment of Adhesive Capsulitis: A Randomized Controlled Trial
This randomized, double-blind trial compared a single intra-articular injection of moderate-molecular-weight hyaluronic acid (HA) plus ketorolac with ketorolac alone in patients with adhesive capsulitis. Fifty-six participants were randomized into two equal groups and followed for 24 weeks. The primary outcome was shoulder function measured by the Thai Shoulder Pain and Disability Index (SPADI). Secondary outcomes included pain (VAS), passive range of motion (PROM), analgesic use, and adverse events. Both groups showed significant improvement in pain and function with no between-group difference in SPADI or VAS. The HA+ketorolac group demonstrated small but significant gains in external rotation and adduction. Both treatments were safe and well tolerated.
Read the detailed description
Adhesive capsulitis, or frozen shoulder, is characterized by pain and stiffness due to capsular inflammation and fibrosis. Corticosteroid injections are commonly used but may be contraindicated in some patients. Hyaluronic acid (HA) and ketorolac each have shown benefit, yet evidence on their combined use is limited.
This randomized, double-blind, controlled trial enrolled 56 adults with adhesive capsulitis. Participants were randomized 1:1 to receive either HA plus ketorolac or ketorolac alone as a single intra-articular injection, followed by standardized rehabilitation. Follow-up assessments were conducted at 2, 6, 12, and 24 weeks.
The primary outcome was functional outcome measured by the Thai SPADI. Secondary outcomes included pain (VAS), PROM, analgesic use, and adverse events. Both groups improved significantly in function and pain, without significant between-group differences. However, the HA+ketorolac group showed modest but significant improvements in external rotation and adduction range of motion. Safety outcomes were favorable in both groups, with only one mild adverse event reported.
This study demonstrates that intra-articular HA combined with ketorolac and ketorolac alone are safe and effective alternatives to corticosteroid injection for adhesive capsulitis. The combination may provide additional benefit in range of motion recovery and can be considered in patients for whom corticosteroids are unsuitable.
- Conditions
- Adhesive Capsulitis of the Shoulder
- Being tested
- Intra-articular Hyaluronic Acid and Ketorolac, Intra-articular Ketorolac
- Keywords
- Adhesive capsulitis, Frozen shoulder, Shoulder pain, Hyaluronic acid, Ketorolac, Intra-articular injection, Randomized controlled trial, Range of motion
- Medical subject headings
- Bursitis, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular Hyaluronic Acid and KetorolacDrug
Also called Hyaluronic Acid and Ketorolac injection
Single intra-articular injection containing 2 mL moderate-molecular-weight hyaluronic acid (20 mg/2 mL), 1 mL ketorolac (30 mg/mL), and 2 mL lidocaine (10 mg/mL), total volume 5 mL. Administered under aseptic technique (ultrasound-guided or landmark-based) followed by standardized rehabilitation program.
Intra-articular KetorolacDrug
Also called Ketorolac injection
single intra-articular injection containing 1 mL ketorolac (30 mg/mL), 2 mL lidocaine (10 mg/mL), and 2 mL normal saline, total volume 5 mL. Administered under aseptic technique (ultrasound-guided or landmark-based) followed by standardized rehabilitation program.
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic Acid and Ketorolac injection | Experimental | Participants received a single intra-articular injection of Hyaluronic Acid and Ketorolac Receives: Drug: Intra-articular Hyaluronic Acid and Ketorolac |
| Ketorolac injection | Active comparator | Participants received a single intra-articular injection of ketorolac Receives: Drug: Intra-articular Ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder function (Thai SPADI score)
Shoulder Pain and Disability Index (Thai version), patient-reported outcome measure, score range 0-100 (higher score = worse disability)
Measured: Baseline, 2, 6, 12, and 24 weeks post-injection
Secondary outcomes (3)
Pain intensity (VAS score)
Visual Analog Scale for shoulder pain, 0-10 (higher score = worse pain)
Measured: Baseline, 2, 6, 12, and 24 weeks post-injection
Passive range of motion (PROM)
Passive range of motion of the affected shoulder (flexion, extension, abduction, adduction, internal and external rotation) measured with goniometer in degrees
Measured: Baseline, 2, 6, 12, and 24 weeks post-injection
Adverse events
Number and type of treatment-related adverse events (mild, moderate, or severe) reported by participants or observed by investigators
Measured: 0-24 weeks post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start1 Nov 2023
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Adhesive Capsulitis of the ShoulderStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants randomized in a 1:1 ratio to receive either intra-articular HA+ketorolac or ketorolac alone, each followed by standardized rehabilitation
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pratantat Charoenchaipong, MD, Principal investigator, Ramathibodi HospitalSorawut Thamyongkit, MD, Study director, Chakri Naruebodindra Medical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183436
- Sponsor's protocol ID
- MURA2023/497
- Status last verified
- Sep 2025
- First submitted
- 14 Sep 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee SC, Rha DW, Chang WH. Rapid analgesic onset of intra-articular hyaluronic acid with ketorolac in osteoarthritis of the knee. J Back Musculoskelet Rehabil. 2011;24(1):31-8. doi: 10.3233/BMR-2011-0272.
PubMed 21248398Taheri P, Dehghan F, Mousavi S, Solouki R. Comparison of Subacromial Ketorolac Injection versus Corticosteroid Injection in the Treatment of Shoulder Impingement Syndrome. J Res Pharm Pract. 2017 Oct-Dec;6(4):223-227. doi: 10.4103/jrpp.JRPP_17_57.
PubMed 29417082Xu J, Qu Y, Li H, Zhu A, Jiang T, Chong Z, Wang B, Shen P, Xie Z. Effect of Intra-articular Ketorolac Versus Corticosteroid Injection for Knee Osteoarthritis: A Retrospective Comparative Study. Orthop J Sports Med. 2020 Apr 10;8(4):2325967120911126. doi: 10.1177/2325967120911126. eCollection 2020 Apr.
PubMed 32313809Mao B, Peng R, Zhang Z, Zhang K, Li J, Fu W. The Effect of Intra-articular Injection of Hyaluronic Acid in Frozen Shoulder: a Systematic Review and Meta-analysis of Randomized Controlled Trials. J Orthop Surg Res. 2022 Mar 3;17(1):128. doi: 10.1186/s13018-022-03017-4.
PubMed 35241100Uhm KE, Chang MC. Comparison of Effectiveness of Intraarticular Hyaluronate and Corticosteroid injections in Adhesive Capsulitis: A Systematic Review and Meta-analysis. Pain Physician. 2024 Sep;27(7):387-400.
PubMed 39353107
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Combined Intra-Articular Hyaluronic Acid and Ketorolac Versus Ketorolac Alone in the Treatment of Adhesive Capsulitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07183436
- Acronym / sponsor ID
- MURA2023/497
- Conditions
- Adhesive Capsulitis of the Shoulder
- Keywords
- Adhesive capsulitis, Frozen shoulder, Shoulder pain, Hyaluronic acid, Ketorolac, Intra-articular injection, Randomized controlled trial, Range of motion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 19 Sep 2025 (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.
This randomized, double-blind trial compared a single intra-articular injection of moderate-molecular-weight hyaluronic acid (HA) plus ketorolac with ketorolac alone in patients with adhesive capsulitis. Fifty-six participants were randomized into two equal groups and followed for 24 weeks. The primary outcome was shoulder function measured by the Thai Shoulder Pain and Disability Index (SPADI). Secondary outcomes included pain (VAS), passive range of motion (PROM), analgesic use, and adverse events. Both groups showed significant improvement in pain and function with no between-group difference in SPADI or VAS. The HA+ketorolac group demonstrated small but significant gains in external rotation and adduction. Both treatments were safe and well tolerated.
Detailed description
Adhesive capsulitis, or frozen shoulder, is characterized by pain and stiffness due to capsular inflammation and fibrosis. Corticosteroid injections are commonly used but may be contraindicated in some patients. Hyaluronic acid (HA) and ketorolac each have shown benefit, yet evidence on their combined use is limited.
This randomized, double-blind, controlled trial enrolled 56 adults with adhesive capsulitis. Participants were randomized 1:1 to receive either HA plus ketorolac or ketorolac alone as a single intra-articular injection, followed by standardized rehabilitation. Follow-up assessments were conducted at 2, 6, 12, and 24 weeks.
The primary outcome was functional outcome measured by the Thai SPADI. Secondary outcomes included pain (VAS), PROM, analgesic use, and adverse events. Both groups improved significantly in function and pain, without significant between-group differences. However, the HA+ketorolac group showed modest but significant improvements in external rotation and adduction range of motion. Safety outcomes were favorable in both groups, with only one mild adverse event reported.
This study demonstrates that intra-articular HA combined with ketorolac and ketorolac alone are safe and effective alternatives to corticosteroid injection for adhesive capsulitis. The combination may provide additional benefit in range of motion recovery and can be considered in patients for whom corticosteroids are unsuitable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants randomized in a 1:1 ratio to receive either intra-articular HA+ketorolac or ketorolac alone, each followed by standardized rehabilitation
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic Acid and Ketorolac injection | Experimental | Drug: Intra-articular Hyaluronic Acid and KetorolacParticipants received a single intra-articular injection of Hyaluronic Acid and Ketorolac |
| Ketorolac injection | Active comparator | Drug: Intra-articular KetorolacParticipants received a single intra-articular injection of ketorolac |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18-70 years
- Symptom duration of 1-12 months
- Provision of informed consent.
Key exclusion criteria (10 listed)
- History of trauma or prior surgery to the affected shoulder
- Bilateral adhesive capsulitis
- Uncontrolled diabetes (HbA1C > 7%)
- Abnormal thyroid function
- Prior intra-articular injection in the affected shoulder
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 |
|---|---|---|
| Intra-articular Hyaluronic Acid and KetorolacAlso: Hyaluronic Acid and Ketorolac injectionSingle intra-articular injection containing 2 mL moderate-molecular-weight hyaluronic acid (20 mg/2 mL), 1 mL ketorolac (30 mg/mL), and 2 mL lidocaine (10 mg/mL), total volume 5 mL. Administered under aseptic technique (ultrasound-guided or landmark-based) followed by standardized rehabilitation program. | Drug | Hyaluronic Acid and Ketorolac injection |
| Intra-articular KetorolacAlso: Ketorolac injectionsingle intra-articular injection containing 1 mL ketorolac (30 mg/mL), 2 mL lidocaine (10 mg/mL), and 2 mL normal saline, total volume 5 mL. Administered under aseptic technique (ultrasound-guided or landmark-based) followed by standardized rehabilitation program. | Drug | Ketorolac injection |
Primary outcome
Shoulder function (Thai SPADI score)
Time frame: Baseline, 2, 6, 12, and 24 weeks post-injection
Shoulder Pain and Disability Index (Thai version), patient-reported outcome measure, score range 0-100 (higher score = worse disability)
3 secondary outcomes
Pain intensity (VAS score)
Time frame: Baseline, 2, 6, 12, and 24 weeks post-injection
Passive range of motion (PROM)
Time frame: Baseline, 2, 6, 12, and 24 weeks post-injection
Adverse events
Time frame: 0-24 weeks post-injection
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 25 Sep 2025.
- Results publication: PubMed 21248398Lee SC, Rha DW, Chang WH. Rapid analgesic onset of intra-articular hyaluronic acid with ketorolac in osteoarthritis of the knee. J Back Musculoskelet Rehabil. 2011;24(1):31-8. doi: 10.3233/BMR-2011-0272.
- Results publication: PubMed 29417082Taheri P, Dehghan F, Mousavi S, Solouki R. Comparison of Subacromial Ketorolac Injection versus Corticosteroid Injection in the Treatment of Shoulder Impingement Syndrome. J Res Pharm Pract. 2017 Oct-Dec;6(4):223-227. doi: 10.4103/jrpp.JRPP_17_57.
- Results publication: PubMed 32313809Xu J, Qu Y, Li H, Zhu A, Jiang T, Chong Z, Wang B, Shen P, Xie Z. Effect of Intra-articular Ketorolac Versus Corticosteroid Injection for Knee Osteoarthritis: A Retrospective Comparative Study. Orthop J Sports Med. 2020 Apr 10;8(4):2325967120911126. doi: 10.1177/2325967120911126. eCollection 2020 Apr.
- Results publication: PubMed 35241100Mao B, Peng R, Zhang Z, Zhang K, Li J, Fu W. The Effect of Intra-articular Injection of Hyaluronic Acid in Frozen Shoulder: a Systematic Review and Meta-analysis of Randomized Controlled Trials. J Orthop Surg Res. 2022 Mar 3;17(1):128. doi: 10.1186/s13018-022-03017-4.
- Results publication: PubMed 39353107Uhm KE, Chang MC. Comparison of Effectiveness of Intraarticular Hyaluronate and Corticosteroid injections in Adhesive Capsulitis: A Systematic Review and Meta-analysis. Pain Physician. 2024 Sep;27(7):387-400.
- Randomized, double-blind, placebo-controlled trial of 60 patients with adhesive capsulitis. Participants were randomized into four arms (saline, corticosteroid, hyaluronic acid, corticosteroid + hyaluronic acid)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Pratantat Charoenchaipong, MD principal investigator
Ramathibodi Hospital
Sorawut Thamyongkit, MD study director
Chakri Naruebodindra Medical Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intra-articular Hyaluronic Acid and Ketorolac and Intra-articular Ketorolac in people with Adhesive Capsulitis of the Shoulder, run by Mahidol University at 1 site in Thailand.
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 3 inclusion and 10 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 25 Sep 2025. 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 Thailand. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 function (Thai SPADI score) (time frame: Baseline, 2, 6, 12, and 24 weeks post-injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07183436, which also lists 5 linked publications.
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 25 Sep 2025.