An interventional study of Ultrasound-guided injection of sodium hyaluronate, ropivacaine hydrochloride, and compound betamethasone and spencer in Frozen Shoulder, sponsored by Zichao Zhang. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Zichao Zhang · Not applicable, Interventional, and Treatment
### What is this study about?
This study compared whether adding the **Spencer muscle energy technique (MET)** versus conventional rehabilitation, following identical ultrasound-guided intra-articular corticosteroid-hyaluronate injection, improves shoulder outcomes for patients with painful-phase frozen shoulder (adhesive capsulitis).
### Why does it matter?
Frozen shoulder causes shoulder pain and marked loss of range of motion, greatly impairing daily function and quality of life. The painful "freezing" phase is dominated by inflammation and pain-driven muscle guarding. Intra-articular injection can deliver short-term pain relief but cannot mechanically stretch contracted joint capsules; it therefore works best as a platform for subsequent rehabilitation.
Although the Spencer muscle energy technique is widely used clinically for frozen-shoulder rehabilitation, prior trials often combined it with variable injection protocols and lacked direct comparison against standard rehabilitation. It remained unclear whether any observed benefits came from the injection itself or from the manual therapy technique. This trial fixed the injection and pain neuroscience education for both groups, isolating the effect of the manual therapy approach.
### What did the researchers do?
Patients with unilateral painful-phase primary frozen shoulder were randomised into two groups. All participants received one ultrasound-guided glenohumeral and subacromial bursa injection (corticosteroid, hyaluronate, ropivacaine and normal saline), plus standardised pain neuroscience education.
417 studies on the registry are indexed under Bursitis; 112 are open to participants now.
This study's enrollment of 64 is above the median of 45 across 376 interventional studies indexed under Bursitis.
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Exclusion Criteria:
The Spencer group received physiotherapist-administered standardized Spencer muscle energy technique (MET) on the same schedule as controls. This sequential manual therapy uses targeted shoulder positioning, gentle voluntary sub-maximal isometric contraction and post-isometric relaxation to reduce muscle spasm and improve shoulder range of motion. All participants across both arms obtained the same ultrasound-guided injection and standardized pain neuroscience education.
Drug: Ultrasound-guided injection of sodium hyaluronate, ropivacaine hydrochloride, and compound betamethasone · Procedure: spencer
Participants in the control group received conventional rehabilitation on the same schedule, including conventional manual therapy, joint mobilization, and stretching exercises, delivered by physiotherapists according to standardized protocols. The two groups therefore differed in the manual-therapy modality (Spencer MET versus conventional manual therapy), while sharing the injection, the pain neuroscience education, and the home-exercise schedule.
Drug: Ultrasound-guided injection of sodium hyaluronate, ropivacaine hydrochloride, and compound betamethasone · Procedure: conventional rehabilitation
All participants received a single ultrasound-guided injection administered by the same qualified rehabilitation physician after baseline assessment. The injectate comprised 10 mL of 0.9% sodium chloride solution, sodium hyaluronate injection (25 mg; ARTZDispo), ropivacaine hydrochloride (100 mg; Naropin), and compound betamethasone injection (7 mg; Diprospan), with a total volume of 20 mL. Of this volume, 15 mL was injected into the glenohumeral joint and 5 mL into the subacromial bursa. No repeat injections were administered. Both groups received the same pain neuroscience education and completed an 8-week treatment period, with follow-up through 24 weeks.
The technique comprises a sequence of specific positioning, gentle voluntary isometric contraction, and post-isometric relaxation applied to the shoulder in a defined order, aimed at lengthening shortened muscle and fascia, normalizing joint range, and reducing muscle spasm. Treatment frequency and duration followed the standardized operating protocol of the department.
participants received standardized physiotherapist-led conventional rehabilitation with the same schedule as the intervention group, including: (1) conventional manual therapy: soft-tissue massage and trigger-point release for perishoulder muscle spasm; (2) Maitland-grade glenohumeral joint mobilization (traction, glides) to enhance capsular mobility; (3) static stretching exercises of shoulder girdle muscles to lengthen tight soft tissues and preserve range of motion. All subjects received identical ultrasound-guided injection and pain neuroscience education.
Constant-Murley score
Constant-Murley score, full name Constant-Murley Shoulder Score, ranges from 0 to 100, and a higher score indicates better overall shoulder function.
Time frame: CMS was administered at baseline, 8 weeks, 24 weeks.
Numerical Rating Scale
NRS, full name Numeric Rating Scale, ranges from 0 to 10, and a higher score indicates greater pain intensity.
Time frame: at baseline, 8 weeks, 24 weeks
the 17-item Tampa Scale for Kinesiophobia
TSK-17, full name Tampa Scale of Kinesiophobia-17, ranges from 17 to 68, and a higher score indicates worse kinesiophobia.
Time frame: TSK-17 was administered at baseline, 8 weeks, 24 weeks.
Mental health-related quality
SF-36 MCS, full name 36-Item Short-Form Health Survey Mental Component Summary, ranges from 0 to 100, and a higher score indicates better mental-health-related quality of life.
Time frame: SF-36 was administered at baseline, 8 weeks, 24 weeks.
Active shoulder ROM
Active shoulder ROM, full name active shoulder range of motion (including flexion, abduction, external rotation, internal rotation), measured in degrees, and a higher value indicates greater shoulder mobility.
Time frame: ROM was administered at baseline, 8 weeks, 24 weeks.
the coracohumeral ligament (CHL)
CHL, full name coracohumeral ligament, measured in millimetres, and a higher thickness value indicates more severe soft-tissue fibrosis.
Time frame: CHL was administered at baseline, 8 weeks, 24 weeks.
the inferior glenohumeral capsule
IGHC, full name inferior glenohumeral capsule, measured in millimetres, and a higher thickness value indicates more severe capsular fibrosis.
Time frame: IGHC was administered at baseline, 8 weeks, 24 weeks.
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jun 2025 to primary completion in Aug 2026, 14 months.
Of 233 non-industry interventional studies with no phase under Bursitis, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 16. This study's 14 months is above that.
Counting every sponsor, half of 233 studies reached it within 10 months; a quarter within 5 and three quarters within 16.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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