Frozen ShoulderJoint InjectioNCT07879625
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
A study testing Ultrasound-guided injection of sodium hyaluronate, ropivacaine hydrochloride, and compound betamethasone, spencer and conventional rehabilitation in people with Frozen Shoulder, run by Zichao Zhang at 1 site in China.
Trial summary
### 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Frozen Shoulder
- What is being tested?
- Ultrasound-guided injection of sodium hyaluronate, ropivacaine hydrochloride, and compound betamethasone, spencer and conventional rehabilitation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 3 Jun 2025to 26 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Aged 18-70 years
- Willing to undergo randomization
- Diagnosis of primary idiopathic frozen shoulder; diagnosis confirmed by the primary author, defined as limited active and passive shoulder range of motion, with characteristic restricted passive external rotation (<50%) at both 0° and 90° elbow flexion relative to the contralateral shoulder
Who cannot join
- - Secondary frozen-shoulder (e.g., post-traumatic, secondary to prolonged immobilization)
- Pregnancy
- Previous surgical treatment for frozen shoulder
- Cervical-origin shoulder symptoms (screened via comprehensive cervical assessment including Spurling's test, cervical distraction test, neurologic examination: reflexes, sensory assessment, muscle strength testing, evaluation for muscle wasting; imaging performed when clinically indicated)
- Other shoulder pathologies ruled out by plain radiography (true anteroposterior [Grashey view], lateral scapular Y-view, axillary view) and shoulder magnetic resonance imaging as clinically indicated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Short- and Long-term Effects of Joint Cavity Injection Combined With Spencer Technique on Shoulder Function and Pain in Frozen Shoulder During the Pain Stage
### 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).
Read more
### 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.
- Spencer group (n=33): 8-week programme of Spencer muscle energy technique
- Control group (n=31): 8-week conventional rehabilitation (joint mobilisation, manual therapy and stretching)
- Outcomes were assessed at baseline, 8-weeks (end-of-treatment), and 24-week follow-up
- Primary outcome: shoulder function measured by the Constant-Murley score
- Secondary measures: pain (NRS), kinesiophobia (TSK-17), mental quality-of-life (SF-36 MCS), active shoulder range of motion, and ultrasound thickness of the coracohumeral ligament and inferior glenohumeral capsule
- Outcome assessors and data analysts were blinded to group allocation; safety and adverse events were monitored throughout the trial.
- Conditions
- Frozen Shoulder
- Being tested
- Ultrasound-guided injection of sodium hyaluronate, ropivacaine hydrochloride, and compound betamethasone, spencer, conventional rehabilitation
- Keywords
- frozen shoulder
- 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 injection of sodium hyaluronate, ropivacaine hydrochloride, and compound betamethasoneDrug
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.
spencerProcedure or surgery
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.
conventional rehabilitationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| spencer group | Experimental | 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. Receives: Drug: Ultrasound-guided injection of sodium hyaluronate, ropivacaine hydrochloride, and compound betamethasone; Procedure: spencer |
| Control group | Active comparator | 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. Receives: Drug: Ultrasound-guided injection of sodium hyaluronate, ropivacaine hydrochloride, and compound betamethasone; Procedure: conventional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: CMS was administered at baseline, 8 weeks, 24 weeks.
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: IGHC was administered at baseline, 8 weeks, 24 weeks.
numeric rating scale
NRS, full name Numerical Rating Scale, rated from 0 to 10, and a higher score value indicates greater pain intensity.
Measured: NRS was administered at baseline, 8 weeks, 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start3 Jun 2025
- Primary completion14 Aug 2026
- Study completion26 Oct 2026 (estimated)
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zichao Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zichao Zhang, Qingdao Municipal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879625
- Sponsor's protocol ID
- 2026-KY-026
- Acronym
- Joint Injectio
- Status last verified
- Nov 2026
- First submitted
- 5 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Short- and Long-term Effects of Joint Cavity Injection Combined With Spencer Technique on Shoulder Function and Pain in Frozen Shoulder During the Pain Stage
- ClinicalTrials.gov ID
- NCT07879625
- Acronym / sponsor ID
- Joint Injectio / 2026-KY-026
- Conditions
- Frozen Shoulder
- Keywords
- frozen shoulder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Zichao ZhangUniversity, hospital or other
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- 14 Aug 2026 (actual)
- Study completion
- 26 Oct 2026 (estimated)
- First posted
- 19 Oct 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.
### 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.
- Spencer group (n=33): 8-week programme of Spencer muscle energy technique
- Control group (n=31): 8-week conventional rehabilitation (joint mobilisation, manual therapy and stretching)
- Outcomes were assessed at baseline, 8-weeks (end-of-treatment), and 24-week follow-up
- Primary outcome: shoulder function measured by the Constant-Murley score
- Secondary measures: pain (NRS), kinesiophobia (TSK-17), mental quality-of-life (SF-36 MCS), active shoulder range of motion, and ultrasound thickness of the coracohumeral ligament and inferior glenohumeral capsule
- Outcome assessors and data analysts were blinded to group allocation; safety and adverse events were monitored throughout the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spencer group | Experimental | Drug: Ultrasound-guided injection of sodium hyaluronate, ropivacaine hydrochloride, and compound betamethasone, Procedure: spencerThe 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. |
| Control group | Active comparator | Drug: Ultrasound-guided injection of sodium hyaluronate, ropivacaine hydrochloride, and compound betamethasone, Procedure: conventional rehabilitationParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18-70 years
- Willing to undergo randomization
- Diagnosis of primary idiopathic frozen shoulder; diagnosis confirmed by the primary author, defined as limited active and passive shoulder range of motion, with characteristic restricted passive external rotation (<50%) at both 0° and 90° elbow flexion relative to the contralateral shoulder
Key exclusion criteria (5 listed)
- - Secondary frozen-shoulder (e.g., post-traumatic, secondary to prolonged immobilization)
- Pregnancy
- Previous surgical treatment for frozen shoulder
- Cervical-origin shoulder symptoms (screened via comprehensive cervical assessment including Spurling's test, cervical distraction test, neurologic examination: reflexes, sensory assessment, muscle strength testing, evaluation for muscle wasting; imaging performed when clinically indicated)
- Other shoulder pathologies ruled out by plain radiography (true anteroposterior [Grashey view], lateral scapular Y-view, axillary view) and shoulder magnetic resonance imaging as clinically indicated
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 injection of sodium hyaluronate, ropivacaine hydrochloride, and compound betamethasoneAll 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. | Drug | Control group, spencer group |
| spencerThe 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. | Procedure or surgery | spencer group |
| conventional rehabilitationparticipants 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. | Procedure or surgery | Control group |
Primary outcome
Constant-Murley score
Time frame: CMS was administered at baseline, 8 weeks, 24 weeks.
Constant-Murley score, full name Constant-Murley Shoulder Score, ranges from 0 to 100, and a higher score indicates better overall shoulder function.
6 secondary outcomes
the 17-item Tampa Scale for Kinesiophobia
Time frame: TSK-17 was administered at baseline, 8 weeks, 24 weeks.
Mental health-related quality
Time frame: SF-36 was administered at baseline, 8 weeks, 24 weeks.
Active shoulder ROM
Time frame: ROM was administered at baseline, 8 weeks, 24 weeks.
the coracohumeral ligament (CHL)
Time frame: CHL was administered at baseline, 8 weeks, 24 weeks.
the inferior glenohumeral capsule
Time frame: IGHC was administered at baseline, 8 weeks, 24 weeks.
numeric rating scale
Time frame: NRS was administered at baseline, 8 weeks, 24 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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 injection of sodium hyaluronate, ropivacaine hydrochloride, and compound betamethasone, spencer and conventional rehabilitation in people with Frozen Shoulder, run by Zichao Zhang at 1 site in China.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 5 Nov 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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?
Constant-Murley score (time frame: CMS was administered at baseline, 8 weeks, 24 weeks.). 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 5 Nov 2026.