Adhesive CapsulitisNCT06041282
Conservative Treatment of Early Adhesive Capsulitis
A study testing manipulation under anesthesia and supervised home rehabilitation in people with Adhesive Capsulitis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
A prospective, multicentre, randomized controlled study comparing the efficacy of conservative treatment for early adhesive capsulitis Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- manipulation under anesthesia and supervised home rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in our hospital who need manual release of periarthritis of shoulder or home rehabilitation treatment;
- Unilateral and primary periarthritis of shoulder
- Age ≥40 years old and ≤80 years old, regardless of gender.
- Forward flexion movement is more than 50% limited compared with the contralateral.
- Duration of disease ≤3 months
Who cannot join
- Patients with a previous history of shoulder joint surgery
- Patients who did not complete the follow-up within the specified time
- Patients with other shoulder diseases.
- Patient with systemic immune disease.
- Patients who have participated in clinical trials or are conducting other clinical trials within 3 months before screening
- Patients with serious primary cardiovascular diseases, lung diseases, endocrine and metabolic diseases, or serious diseases affecting their survival, such as tumor or AIDS, are considered not suitable for admission.
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- Patients with serious liver diseases, kidney diseases, hematological diseases, such as kidney function (BUN, Cr) more than the upper limit of normal, liver function (ALT, AST, TBIL) more than 2 times the upper limit of normal.
- Patients with viral hepatitis, infectious diseases, abnormal blood coagulation mechanism and other diseases that researchers consider inappropriate for surgery.
- Pregnant or lactating women, or those planning to get pregnant during the test, with positive urine HCG test results before the test; Menstruating women should wait until their period is over before undergoing surgery.
- Patients with severe neurological and mental diseases.
- Suspected or true history of alcohol and drug abuse.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310058
weiliang shen, Doctor, 86-0571-86995513, wlshen@zju.edu.cn
About this study
Official title: A Multicentre Randomized Controlled Trial of Manipulation Under Anesthesia and Supervised Home Rehabilitation in the Treatment of Early Adhesive Capsulitis
A prospective, multicentre, randomized controlled study comparing the efficacy of conservative treatment for early adhesive capsulitis
Read the detailed description
This clinical trial evaluated the most common protocols for the treatment of adhesive capsulitis in secondary hospitals. To compare the efficacy of manipulation under anesthesia and supervised home conservative treatment of early adhesive capsulitis.
- Conditions
- Adhesive Capsulitis
- Being tested
- manipulation under anesthesia, supervised home rehabilitation
- Keywords
- manipulation under anesthesia, supervised home rehabilitation
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manipulation under anesthesiaProcedure or surgery
After the anesthesia took effect, the patient was placed in the supine position, and the experienced surgeon stood at the head of the bed to release the affected limb by four angles of forward flexion, abduction, external rotation and internal rotation. After the operation is completed, 1ml de Bosson (MSD) +2.5ml sodium hyaluronate (Biochemical Industries Co., LTD.) is injected once.
supervised home rehabilitationProcedure or surgery
The doctor instructs the patient in exercise training at the outpatient clinic. At each clinic visit, the doctor will guide the different stages of the movement. At the first visit, the doctor guides the patient through the first phase of the rehabilitation program to improve the patient's basic mobility. At the first month of follow-up, the second phase of rehabilitation program was guided, and the recovery of mobility was accompanied by muscle training, including wall climbing and muscle resistance exercises. 1ml Debossone (MSD) +2.5ml sodium hyaluronate (Biochemical Industries Co., LTD.) was injected once at the clinic. All the training required patients to do their best at home to complete 3 sets of 5 each. At the end of each day, the patient will upload a video to the platform, and the doctor will evaluate whether the patient's recovery is in place.
| Study group | Role | What they receive |
|---|---|---|
| manipulation under anesthesia group | Experimental | The patient underwent manipulation under anesthesia Receives: Procedure: manipulation under anesthesia |
| Supervised home rehabilitation group | Active comparator | The patient underwent supervised home rehabilitation Receives: Procedure: supervised home rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant-Murley Score (CMS)
The Constant-Mulery score mainly includes 8 aspects related to your shoulder in the past 4 weeks.
The proportion of subjective and objective components in the Constant-Mulery score is 35 points/65 points. A total of 100 points.The subjective part of the score includes the score of pain degree and the score of impact on daily life. 35 points in total.The objective part of the score includes the score of shoulder range of motion and strength. 65 points in total.
Measured: 6months after intervention
Secondary outcomes (8)
Constant-Murley Score (CMS)
The Constant-Mulery score mainly includes 8 aspects related to your shoulder in the past 4 weeks.
The proportion of subjective and objective components in the Constant-Mulery score is 35 points/65 points. A total of 100 points.The subjective part of the score includes the score of pain degree and the score of impact on daily life. 35 points in total.The objective part of the score includes the score of shoulder range of motion and strength. 65 points in total.
Measured: 1 months, 3months, and 1year after intervention
Oxford Shoulder Score (OSS)
The Oxford Shoulder Score (OSS) consists of 12 questions with five options each. The light to heavy lines were assigned 1, 2, 3, 4 and 5 points respectively. So the total score is between 12 and 60. A score of 12 represents perfectly normal shoulder function and a score of 60 represents the most severe difficulty in shoulder function.
Measured: 1 months, 3months, 6 months and 1year after intervention
Fear-avoidance belief questionnaire(FABQ)
The FABQ is a self-assessment scale with 16 options. Each option has 0~6 points and 7 grades (from extremely disagreeable to extremely agreed). "0" means completely disagreed, "6" means completely agreed, and "1~5" means not sure. The higher the score, the more inclined to fully agree
Measured: 1 months, 3months, 6 months and 1year after intervention
Insomnia Severity Index(ISI)
The scale is a simple tool for screening insomnia, including 7 items, which are used to evaluate the nature and symptoms of sleep disorders of subjects.
Measured: 1 months, 3months, 6 months and 1year after intervention
Hospital Anxiety and Depression Scale(HADS)
HADS is a self-assessment scale, including two subscales, HADS-A and HADS-D, with a total of 14 items, including 7 items for anxiety (A) and 7 items for depression (D). Each item is scored at four levels according to the frequency of symptoms in the past month. Each item is scored at 0-3 points in four levels. The higher the score, the more serious the anxiety or depression
Measured: 1 months, 3months, 6 months and 1year after intervention
SF-36
SF-36 is a concise health questionnaire developed by the Boston Institute of Health, which is widely used in the measurement of the quality of life of the general population, the evaluation of clinical trials and the evaluation of health policies. SF-36 is used to assess physiological function, physiological function, physical pain, general health, energy, social function, emotional function and mental health, which are classified into "physical health" and "mental health"
Measured: 1 months, 3months, 6 months and 1year after intervention
Visual analogue scale(VAS)
Draw a 10cm horizontal line on the paper. One end of the line is "0", indicating no pain; the other end is "10", indicating severe pain; The middle represents different degrees of pain; Let the patient draw a mark on the horizontal line according to their feelings to indicate the degree of pain.
Measured: 1 months, 3months, 6 months and 1year after intervention
range of motion
Measure the patient's flexion, abduction, internal rotation and external rotation angle
Measured: 1 months, 3months, 6 months and 1year after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start1 Jan 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive CapsulitisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041282
- Sponsor's protocol ID
- 2023-0750
- Status last verified
- Dec 2025
- First submitted
- 11 Sep 2023
- Last updated
- 2 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Randomized Controlled Trial of Manipulation Under Anesthesia and Supervised Home Rehabilitation in the Treatment of Early Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT06041282
- Acronym / sponsor ID
- 2023-0750
- Conditions
- Adhesive Capsulitis
- Keywords
- manipulation under anesthesia, supervised home rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Sep 2023 (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.
A prospective, multicentre, randomized controlled study comparing the efficacy of conservative treatment for early adhesive capsulitis
Detailed description
This clinical trial evaluated the most common protocols for the treatment of adhesive capsulitis in secondary hospitals. To compare the efficacy of manipulation under anesthesia and supervised home conservative treatment of early adhesive capsulitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| manipulation under anesthesia group | Experimental | Procedure: manipulation under anesthesiaThe patient underwent manipulation under anesthesia |
| Supervised home rehabilitation group | Active comparator | Procedure: supervised home rehabilitationThe patient underwent supervised home rehabilitation |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients in our hospital who need manual release of periarthritis of shoulder or home rehabilitation treatment;
- Unilateral and primary periarthritis of shoulder
- Age ≥40 years old and ≤80 years old, regardless of gender.
- Forward flexion movement is more than 50% limited compared with the contralateral.
- Duration of disease ≤3 months
Key exclusion criteria (11 listed)
- Patients with a previous history of shoulder joint surgery
- Patients who did not complete the follow-up within the specified time
- Patients with other shoulder diseases.
- Patient with systemic immune disease.
- Patients who have participated in clinical trials or are conducting other clinical trials within 3 months before screening
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 |
|---|---|---|
| manipulation under anesthesiaAfter the anesthesia took effect, the patient was placed in the supine position, and the experienced surgeon stood at the head of the bed to release the affected limb by four angles of forward flexion, abduction, external rotation and internal rotation. After the operation is completed, 1ml de Bosson (MSD) +2.5ml sodium hyaluronate (Biochemical Industries Co., LTD.) is injected once. | Procedure or surgery | manipulation under anesthesia group |
| supervised home rehabilitationThe doctor instructs the patient in exercise training at the outpatient clinic. At each clinic visit, the doctor will guide the different stages of the movement. At the first visit, the doctor guides the patient through the first phase of the rehabilitation program to improve the patient's basic mobility. At the first month of follow-up, the second phase of rehabilitation program was guided, and the recovery of mobility was accompanied by muscle training, including wall climbing and muscle resistance exercises. 1ml Debossone (MSD) +2.5ml sodium hyaluronate (Biochemical Industries Co., LTD.) was injected once at the clinic. All the training required patients to do their best at home to complete 3 sets of 5 each. At the end of each day, the patient will upload a video to the platform, and the doctor will evaluate whether the patient's recovery is in place. | Procedure or surgery | Supervised home rehabilitation group |
Primary outcome
Constant-Murley Score (CMS)
Time frame: 6months after intervention
The Constant-Mulery score mainly includes 8 aspects related to your shoulder in the past 4 weeks. The proportion of subjective and objective components in the Constant-Mulery score is 35 points/65 points. A total of 100 points.The subjective part of the score includes the score of pain degree and the score of impact on daily life. 35 points in total.The objective part of the score includes the score of shoulder range of motion and strength. 65 points in total.
8 secondary outcomes
Constant-Murley Score (CMS)
Time frame: 1 months, 3months, and 1year after intervention
Oxford Shoulder Score (OSS)
Time frame: 1 months, 3months, 6 months and 1year after intervention
Fear-avoidance belief questionnaire(FABQ)
Time frame: 1 months, 3months, 6 months and 1year after intervention
Insomnia Severity Index(ISI)
Time frame: 1 months, 3months, 6 months and 1year after intervention
Hospital Anxiety and Depression Scale(HADS)
Time frame: 1 months, 3months, 6 months and 1year after intervention
SF-36
Time frame: 1 months, 3months, 6 months and 1year after intervention
Visual analogue scale(VAS)
Time frame: 1 months, 3months, 6 months and 1year after intervention
range of motion
Time frame: 1 months, 3months, 6 months and 1year after intervention
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 2 Jan 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manipulation under anesthesia and supervised home rehabilitation in people with Adhesive Capsulitis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 2 Jan 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?
Contact weiliang shen, doctor (+86 0571 87783759, wlshen@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant-Murley Score (CMS) (time frame: 6months after intervention). 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 2 Jan 2026.