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Completed

NCT Number: NCT07731646

Local Anesthesia While Awake Versus General Anesthesia for Frozen Shoulder Manipulation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Izmir Katip Celebi University Ataturk Training and Research Hospital

Izmir, İzmir, 35360, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Ultrasound-Guided WALANT-Based Shoulder Manipulation

Procedure

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 Anesthesia

Procedure

Standardized shoulder manipulation performed in the operating room under general anesthesia induced with intravenous propofol.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Mean Shoulder Abduction

    Time frame: Baseline and 1, 2, 3, and 4 weeks after the procedure

    Shoulder abduction was measured in degrees using a goniometer. Higher values indicate greater range of motion.

  2. Mean Shoulder External Rotation

    Time frame: Baseline and 1, 2, 3, and 4 weeks after the procedure

    Shoulder external rotation was measured in degrees using a goniometer. Higher values indicate greater range of motion.

  3. Distribution of Shoulder Internal Rotation Categories

    Time frame: Baseline and 1, 2, 3, and 4 weeks after the procedure

    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.

  4. Mean Visual Analog Scale Pain Score

    Time frame: Baseline and 1, 2, 3, and 4 weeks after the procedure

    Pain was evaluated on a 0-to-10 Visual Analog Scale, with higher scores indicating greater pain intensity.

  5. Mean Modified UCLA Shoulder Score

    Time frame: Baseline and 1, 2, 3, and 4 weeks after the procedure

    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.

  6. Mean DASH Score

    Time frame: Baseline and 1, 2, 3, and 4 weeks after the procedure

    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.

  7. Mean Constant-Murley Score

    Time frame: Baseline and 1, 2, 3, and 4 weeks after the procedure

    Shoulder function was evaluated using the Constant-Murley Score. Scores range from 0 to 100, with higher scores indicating better shoulder function.

  8. Mean Preprocedural STAI-6 Score

    Time frame: Immediately before the procedure

    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.

  9. Number of Participants With Early Procedure-Related Complications

    Time frame: From the procedure through 4 weeks after the procedure

    The number of participants who experienced procedure-related complications, infections, early recurrence, or need for reintervention was recorded.

  10. Mean Shoulder Forward Flexion at Early Follow-up Time Points

    Time frame: Baseline and 1, 2, and 3 weeks after the procedure

    Shoulder forward flexion was measured in degrees using a goniometer. Higher values indicate greater shoulder range of motion.

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Registry information

Official study title

WALANT Technique Versus General Anesthesia in Frozen Shoulder Manipulation: A Prospective Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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