Frozen ShoulderNCT07731646
Local Anesthesia While Awake Versus General Anesthesia for Frozen Shoulder Manipulation
A study testing Ultrasound-Guided WALANT-Based Shoulder Manipulation and Shoulder Manipulation Under General Anesthesia in people with Frozen Shoulder and Adhesive Capsulitis of the Shoulder, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
This study compared two anesthesia approaches for shoulder manipulation in adults with primary frozen shoulder that had not improved after at least 6 months of conservative treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frozen Shoulder, Adhesive Capsulitis of the Shoulder
- What is being tested?
- Ultrasound-Guided WALANT-Based Shoulder Manipulation and Shoulder Manipulation Under General Anesthesia
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Feb 2025to 15 Sep 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Diagnosis of primary frozen shoulder.
- Persistent symptoms despite at least 6 months of conservative treatment.
- Frozen shoulder defined by at least one of the following: forward flexion less than 100 degrees, external rotation less than 60 degrees, internal rotation limited such that the dorsum of the hand could not reach above the L5 vertebral level, or at least a 50% reduction in shoulder motion in any plane compared with the unaffected shoulder.
- Willingness to provide written informed consent and comply with the study procedures and follow-up schedule.
Who cannot join
- Secondary frozen shoulder.
- Known allergy to any medication planned for use in the study.
- Pregnancy or breastfeeding.
- Severe osteoporosis.
- Unstable systemic medical condition.
- Active infection at the planned intervention site.
- Hemiplegia or hemiparesis affecting the involved extremity.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Katip Celebi University Ataturk Training and Research Hospital
Izmir, İzmir, 35360
About this study
Official title: WALANT Technique Versus General Anesthesia in Frozen Shoulder Manipulation: A Prospective Randomized Controlled Trial
This study compared two anesthesia approaches for shoulder manipulation in adults with primary frozen shoulder that had not improved after at least 6 months of conservative treatment. A total of 72 participants were randomly assigned to undergo manipulation either with ultrasound-guided wide-awake local anesthesia no tourniquet (WALANT) in an outpatient setting or under general anesthesia in the operating room.
The main outcome was shoulder forward flexion 4 weeks after the procedure. Other outcomes included shoulder abduction, external rotation, internal rotation, pain, shoulder function, anxiety before the procedure, and early procedure-related complications. Participants were evaluated before the procedure and during the first 4 weeks after treatment. The study aimed to determine whether outpatient manipulation under WALANT could provide short-term clinical outcomes comparable to those of manipulation under general anesthesia.
Read the detailed description
This was a single-center, prospective, randomized, parallel-group controlled trial comparing an ultrasound-guided wide-awake local anesthesia no tourniquet (WALANT)-based outpatient protocol with manipulation under general anesthesia in adults with primary frozen shoulder. Participants had persistent symptoms despite at least 6 months of conservative treatment.
A total of 72 participants were randomly assigned in a 1:1 ratio using a computer-generated randomization sequence. Allocation concealment was maintained using sequentially numbered, opaque, sealed envelopes. In the WALANT group, a 25-mL solution containing 12 mL of 2% lidocaine, 0.5 mL of 1:1,000 epinephrine, 2.5 mL of 8.4% sodium bicarbonate, and 10 mL of 0.9% sodium chloride was administered under ultrasound guidance into the glenohumeral joint, anterior capsule, and coracohumeral ligament region in an outpatient setting. After a 30-minute waiting period, shoulder manipulation was performed.
Participants in the general anesthesia group underwent manipulation in the operating room after general anesthesia was induced with intravenous propofol. The same orthopaedic surgeon performed the manipulation procedure in both groups using a standardized sequence of forward flexion, extension, abduction, adduction, internal rotation, and external rotation. Both groups received the same postprocedural analgesia and standardized rehabilitation program. No intra-articular corticosteroid or additional injection therapy was administered.
The primary outcome was shoulder forward flexion at 4 weeks after the procedure. Secondary outcomes included shoulder abduction, external rotation, internal rotation, pain intensity, shoulder function, preprocedural anxiety, and early procedure-related complications. Clinical assessments were performed before the procedure and during the first 4 weeks after treatment by an independent orthopaedic surgeon who was blinded to group allocation.
- Being tested
- Ultrasound-Guided WALANT-Based Shoulder Manipulation, Shoulder Manipulation Under General Anesthesia
- Keywords
- Adhesive capsulitis, frozen shoulder, manipulation, WALANT, general anesthesia, outpatient procedure, shoulder range of motion
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided WALANT-Based Shoulder ManipulationProcedure or surgery
Ultrasound-guided administration of a 25-mL WALANT solution followed by standardized shoulder manipulation after a 30-minute waiting period in an outpatient setting.
Shoulder Manipulation Under General AnesthesiaProcedure or surgery
Standardized shoulder manipulation performed in the operating room under general anesthesia induced with intravenous propofol.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-Guided WALANT-Based Manipulation | Experimental | Participants received ultrasound-guided administration of a 25-mL WALANT solution containing 12 mL of 2% lidocaine, 0.5 mL of 1:1,000 epinephrine, 2.5 mL of 8.4% sodium bicarbonate, and 10 mL of 0.9% sodium chloride into the glenohumeral joint, anterior capsule, and coracohumeral ligament region. After a 30-minute waiting period, standardized shoulder manipulation was performed in an outpatient setting. Receives: Procedure: Ultrasound-Guided WALANT-Based Shoulder Manipulation |
| Manipulation Under General Anesthesia | Active comparator | Participants underwent standard preoperative preparation and shoulder manipulation in the operating room. General anesthesia was induced with intravenous propofol with mask ventilation provided throughout the procedure. The same standardized shoulder manipulation sequence was used as in the WALANT group. Receives: Procedure: Shoulder Manipulation Under General Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Shoulder Forward Flexion at 4 Weeks
Shoulder forward flexion was measured in degrees using a goniometer. Higher values indicate greater shoulder range of motion. The mean forward flexion value was compared between the two study arms.
Measured: 4 weeks after the procedure
Secondary outcomes (10)
Mean Shoulder Abduction
Shoulder abduction was measured in degrees using a goniometer. Higher values indicate greater range of motion.
Measured: Baseline and 1, 2, 3, and 4 weeks after the procedure
Mean Shoulder External Rotation
Shoulder external rotation was measured in degrees using a goniometer. Higher values indicate greater range of motion.
Measured: Baseline and 1, 2, 3, and 4 weeks after the procedure
Distribution of Shoulder Internal Rotation Categories
Internal rotation was categorized according to the highest anatomical level reached by the dorsum of the hand: 1, lateral hip; 2, sacrum; 3, lumbar region; and 4, thoracic region. Higher categories indicate better internal rotation.
Measured: Baseline and 1, 2, 3, and 4 weeks after the procedure
Mean Visual Analog Scale Pain Score
Pain was evaluated on a 0-to-10 Visual Analog Scale, with higher scores indicating greater pain intensity.
Measured: Baseline and 1, 2, 3, and 4 weeks after the procedure
Mean Modified UCLA Shoulder Score
Shoulder function was evaluated using the Modified University of California, Los Angeles Shoulder Score. Scores range from 0 to 35, with higher scores indicating better shoulder function.
Measured: Baseline and 1, 2, 3, and 4 weeks after the procedure
Mean DASH Score
Upper-extremity disability was evaluated using the Disabilities of the Arm, Shoulder and Hand questionnaire. Scores range from 0 to 100, with higher scores indicating greater disability.
Measured: Baseline and 1, 2, 3, and 4 weeks after the procedure
Mean Constant-Murley Score
Shoulder function was evaluated using the Constant-Murley Score. Scores range from 0 to 100, with higher scores indicating better shoulder function.
Measured: Baseline and 1, 2, 3, and 4 weeks after the procedure
Mean Preprocedural STAI-6 Score
Anxiety was evaluated using the six-item short form of the State-Trait Anxiety Inventory-State subscale. Raw scores range from 6 to 24, with higher scores indicating greater anxiety.
Measured: Immediately before the procedure
Number of Participants With Early Procedure-Related Complications
The number of participants who experienced procedure-related complications, infections, early recurrence, or need for reintervention was recorded.
Measured: From the procedure through 4 weeks after the procedure
Mean Shoulder Forward Flexion at Early Follow-up Time Points
Shoulder forward flexion was measured in degrees using a goniometer. Higher values indicate greater shoulder range of motion.
Measured: Baseline and 1, 2, and 3 weeks after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start24 Feb 2025
- Primary completion25 Aug 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen ShoulderStudies 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
- randomized controlled
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tolgacan Kurtulus, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731646
- Sponsor's protocol ID
- IKCU-WALANT-2025-21
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the publication will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WALANT Technique Versus General Anesthesia in Frozen Shoulder Manipulation: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07731646
- Acronym / sponsor ID
- IKCU-WALANT-2025-21
- Keywords
- Adhesive capsulitis, frozen shoulder, manipulation, WALANT, general anesthesia, outpatient procedure, shoulder range of motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 25 Aug 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 28 Jul 2026 (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 study compared two anesthesia approaches for shoulder manipulation in adults with primary frozen shoulder that had not improved after at least 6 months of conservative treatment. A total of 72 participants were randomly assigned to undergo manipulation either with ultrasound-guided wide-awake local anesthesia no tourniquet (WALANT) in an outpatient setting or under general anesthesia in the operating room.
The main outcome was shoulder forward flexion 4 weeks after the procedure. Other outcomes included shoulder abduction, external rotation, internal rotation, pain, shoulder function, anxiety before the procedure, and early procedure-related complications. Participants were evaluated before the procedure and during the first 4 weeks after treatment. The study aimed to determine whether outpatient manipulation under WALANT could provide short-term clinical outcomes comparable to those of manipulation under general anesthesia.
Detailed description
This was a single-center, prospective, randomized, parallel-group controlled trial comparing an ultrasound-guided wide-awake local anesthesia no tourniquet (WALANT)-based outpatient protocol with manipulation under general anesthesia in adults with primary frozen shoulder. Participants had persistent symptoms despite at least 6 months of conservative treatment.
A total of 72 participants were randomly assigned in a 1:1 ratio using a computer-generated randomization sequence. Allocation concealment was maintained using sequentially numbered, opaque, sealed envelopes. In the WALANT group, a 25-mL solution containing 12 mL of 2% lidocaine, 0.5 mL of 1:1,000 epinephrine, 2.5 mL of 8.4% sodium bicarbonate, and 10 mL of 0.9% sodium chloride was administered under ultrasound guidance into the glenohumeral joint, anterior capsule, and coracohumeral ligament region in an outpatient setting. After a 30-minute waiting period, shoulder manipulation was performed.
Participants in the general anesthesia group underwent manipulation in the operating room after general anesthesia was induced with intravenous propofol. The same orthopaedic surgeon performed the manipulation procedure in both groups using a standardized sequence of forward flexion, extension, abduction, adduction, internal rotation, and external rotation. Both groups received the same postprocedural analgesia and standardized rehabilitation program. No intra-articular corticosteroid or additional injection therapy was administered.
The primary outcome was shoulder forward flexion at 4 weeks after the procedure. Secondary outcomes included shoulder abduction, external rotation, internal rotation, pain intensity, shoulder function, preprocedural anxiety, and early procedure-related complications. Clinical assessments were performed before the procedure and during the first 4 weeks after treatment by an independent orthopaedic surgeon who was blinded to group allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-Guided WALANT-Based Manipulation | Experimental | Procedure: Ultrasound-Guided WALANT-Based Shoulder ManipulationParticipants received ultrasound-guided administration of a 25-mL WALANT solution containing 12 mL of 2% lidocaine, 0.5 mL of 1:1,000 epinephrine, 2.5 mL of 8.4% sodium bicarbonate, and 10 mL of 0.9% sodium chloride into the glenohumeral joint, anterior capsule, and coracohumeral ligament region. After a 30-minute waiting period, standardized shoulder manipulation was performed in an outpatient setting. |
| Manipulation Under General Anesthesia | Active comparator | Procedure: Shoulder Manipulation Under General AnesthesiaParticipants underwent standard preoperative preparation and shoulder manipulation in the operating room. General anesthesia was induced with intravenous propofol with mask ventilation provided throughout the procedure. The same standardized shoulder manipulation sequence was used as in the WALANT group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years or older.
- Diagnosis of primary frozen shoulder.
- Persistent symptoms despite at least 6 months of conservative treatment.
- Frozen shoulder defined by at least one of the following: forward flexion less than 100 degrees, external rotation less than 60 degrees, internal rotation limited such that the dorsum of the hand could not reach above the L5 vertebral level, or at least a 50% reduction in shoulder motion in any plane compared with the unaffected shoulder.
- Willingness to provide written informed consent and comply with the study procedures and follow-up schedule.
Key exclusion criteria (7 listed)
- Secondary frozen shoulder.
- Known allergy to any medication planned for use in the study.
- Pregnancy or breastfeeding.
- Severe osteoporosis.
- Unstable systemic medical condition.
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 |
|---|---|---|
| Ultrasound-Guided WALANT-Based Shoulder ManipulationUltrasound-guided administration of a 25-mL WALANT solution followed by standardized shoulder manipulation after a 30-minute waiting period in an outpatient setting. | Procedure or surgery | Ultrasound-Guided WALANT-Based Manipulation |
| Shoulder Manipulation Under General AnesthesiaStandardized shoulder manipulation performed in the operating room under general anesthesia induced with intravenous propofol. | Procedure or surgery | Manipulation Under General Anesthesia |
Primary outcome
Mean Shoulder Forward Flexion at 4 Weeks
Time frame: 4 weeks after the procedure
Shoulder forward flexion was measured in degrees using a goniometer. Higher values indicate greater shoulder range of motion. The mean forward flexion value was compared between the two study arms.
10 secondary outcomes
Mean Shoulder Abduction
Time frame: Baseline and 1, 2, 3, and 4 weeks after the procedure
Mean Shoulder External Rotation
Time frame: Baseline and 1, 2, 3, and 4 weeks after the procedure
Distribution of Shoulder Internal Rotation Categories
Time frame: Baseline and 1, 2, 3, and 4 weeks after the procedure
Mean Visual Analog Scale Pain Score
Time frame: Baseline and 1, 2, 3, and 4 weeks after the procedure
Mean Modified UCLA Shoulder Score
Time frame: Baseline and 1, 2, 3, and 4 weeks after the procedure
Mean DASH Score
Time frame: Baseline and 1, 2, 3, and 4 weeks after the procedure
Mean Constant-Murley Score
Time frame: Baseline and 1, 2, 3, and 4 weeks after the procedure
Mean Preprocedural STAI-6 Score
Time frame: Immediately before the procedure
Number of Participants With Early Procedure-Related Complications
Time frame: From the procedure through 4 weeks after the procedure
Mean Shoulder Forward Flexion at Early Follow-up Time Points
Time frame: Baseline and 1, 2, and 3 weeks after the procedure
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 29 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the publication will be shared.
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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.
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 Ultrasound-Guided WALANT-Based Shoulder Manipulation and Shoulder Manipulation Under General Anesthesia in people with Frozen Shoulder and Adhesive Capsulitis of the Shoulder, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
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 5 inclusion and 7 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 29 Jul 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 Turkey (Türkiye). 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?
Mean Shoulder Forward Flexion at 4 Weeks (time frame: 4 weeks after the procedure). 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 29 Jul 2026; AzTrials last refreshed its copy on 31 Oct 2026.