An interventional study of SSNB + IACI and Sham SSNB + IACI in Frozen Shoulder and Adhesive Capsulitis, sponsored by Universitair Ziekenhuis Brussel. Recruiting at 1 site in Belgium. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by Universitair Ziekenhuis Brussel · Not applicable, Interventional, and Treatment
Frozen shoulder remains a challenging disease to treat as pain and loss of range of motion can persist for many months or even years. This loss of function can have a severe impact on the patient's activities, participation and overall quality of life.
The use of ultrasound-guided (USG) suprascapular nerve blocks (SSNB) and/or intra-articular corticoid injections (IACI) has been supported by many studies. However, double blinded randomized clinical trials using a combination of SSNB and IACI are rare.
The primary objective of this study is to compare the effectiveness of a glenohumeral IACI combined with a SSNB, compared to a glenohumeral IACI combined with a sham SSNB. Outcome measures of interest are shoulder-related disability reported by the patients, shoulder pain and shoulder stiffness. These outcome parameters will be compared between both treatment arms with an intention-to-treat analysis.
As key secondary objectives, the investigators aim to identify which physical examination tests, or combinations of those, are correlated with MRI diagnostic criteria and favor a more positive evolution. Finally, through predictive analysis the investigators will try to establish which patients benefit the most from the combined SSNB + IACI.
Frozen Shoulder (FS) is common disease affecting 2 to 5% of the general population, with a higher prevalence in patients suffering from diabetes and thyroid dysfunction.It remains frustrating for patients and treating health care professionals as severe shoulder pain and loss of function can last for up to two years. 5-7 In the early stage, most patients identify the following symptoms: strong component of night pain, pain with rapid or unguarded movements and aggravated by movement or lying on the affected shoulder.8 Combined with marked pain and limitation in all directions of shoulder range of motion, it is easy to understand that suffering from Frozen Shoulder will have a detrimental effect on quality of life and the ability to perform activities of daily living.
The overall treatment aim for this condition is to "improve pain and function" and treatment goals should be set individually in a shared decision-making process. Patient education on the clinical course and different possible therapeutic interventions, including self-management strategies, should always come first. Clinicians should promote activity modification to utilize pain-free, functional ROM and stretching of the shoulder capsule matching the patient's current level of irritability.
Intra-articular corticosteroid injections (IACI) into the gleno-humeral (GH) joint, combined with shoulder mobility and stretching exercises, have shown to be more effective in providing short-term (4-6weeks) pain relief and improved function compared to exercises alone.
A recent article by Rex et al. places the results of the UK FROST trial in the context of 8 other randomized controlled trials comparing intra-articular corticoid injections (IACI) to manipulation under anesthesia (MUA), arthroscopic capsular release (ACR) and hydrodilatation. These findings did not show clinical superiority of either IACI, MUA nor ACR and evidence for hydrodilatation was inconclusive.
Common sense, in accordance with the National Institute of Health and Care Excellence (NICE) guidelines, recommends that treatments should be offered in a stepped approach from least to most invasive. In their systematic review from 2020, Challoumas et al. show that in the early phase of Frozen Shoulder IA corticosteroid is associated with better short-term outcomes, with possible benefits extending in the mid-terms. These authors recommend to associate IACI to education for home-based exercises and physiotherapy to increase the chances of resolution of symptoms by 6 months.
Unfortunately, not all patients show sufficient improvement in pain and function with IACI and need other therapies. The suprascapular nerve (SSN) provides 60 tot 70% of sensory innervation of the shoulder and suprascapular nerve block (SSNB) has shown in meta-analysis to significantly improve pain and ROM in patients with Frozen Shoulder. This systematic review however has several limitations. Blinding was not always sufficient to rule out a placebo effect, different injections techniques and products (local anesthetics with or without corticosteroids) were used and only data for pain and ROM shoulder could be aggregated as shoulder function was not evaluated in enough trials.
In a rigorous triple blinded RCT, we demonstrated that three successive SSNB with local anesthetics did not improve shoulder pain and function more than three sham injections in patients suffering from subacute Frozen Shoulder. On the other hand, it has been hypothesized that the SSN may be involved in the pathogenesis of Frozen Shoulder and that therefore using optimal approach and drugs (combination of local anesthetics and corticosteroids) in SSNB should be further evaluated in high-quality RCTs.
Evidence suggests that 20mg of triamcinolone or methylprednisolone maybe as effective in frozen shoulder than 40mg but the dosage of 40mg remains most common in clinical and research practice and was chosen to be administered intra-articular in this trial. Trial simulation indicates that the equivalent of 20mg of methylprednisolone is sufficient to increase the mean duration of peripheral nerve blocks and this dosage will be used for SSNB in this study.
In a retrospective review of 102 patients, Jung et al. showed that the combination of an IACI with an SSNB further increased treatment efficacy compared to a single IACI in Frozen Shoulder patients; as pain, ROM and function scored significantly better at different time points (2weeks, 2months and 1 year).
To our knowledge, there has been no previous prospective RCT investigating the added value of an SSNB in combination with an IACI, delivering under ultra-sound guidance the same total amount of corticosteroids in both treatment arms and assuring quadruple blinding (participant, care provider, investigator and outcomes assessor).
The aim of this study is to determine if there is any difference in pain relief and function, as measured by the Shoulder Pain and Disability Index (SPADI), in patients with Frozen Shoulder when given an GH IACI with a SSNB compared to an GH IACI with a sham SSNB. Furthermore, we want to identify which patients will benefit most from GH IACI or the combination of GH IACI and SSNB. The results of this trial will help to guide clinical practice treating patients with FS and improve resource allocation.
383 studies on the registry are indexed under Bursitis; 111 are open to participants now.
This study's planned enrollment of 110 is above the median of 44 across 346 interventional studies indexed under Bursitis.
Browse Bursitis studies →Universitair Ziekenhuis Brussel is the lead sponsor of 375 studies on the registry; 107 are open to participants now.
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Inclusion Criteria:
Exclusion Criteria:
Control subjects for the diagnostic accuracy part of the study protocol
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients randomized to this arm will receive a SSNB (20-mg methylprednisolone acetate and 5-mL Ropivacaine 2mg/ml) than a IACI (40-mg methylprednisolone acetate and 1-mL Ropivacaine 2mg/ml). Rehabilitation/physiotherapy is considered standard of care.
Other: SSNB + IACI
Patients randomized to this arm will receive a SSNB (5-mL Linisol 10mg/ml) than a IACI (40-mg methylprednisolone acetate and 1-mL Ropivacaine 2mg/ml) Rehabilitation/physiotherapy is considered standard of care.
Other: Sham SSNB + IACI
Usual care: All patients complete rehabilitation under supervision of their own physiotherapist. The investigators will provide some guidelines and criteria but is the physiotherapist's choice how to implement these guidelines in clinical practice. Patient education on home-exercises Monitoring of peak pain, at rest/night and after rehabilitation sessions using a Numeric-Pain-Rating-Scale (0-10) (NPRS) to evaluate tissue irritability and guide physiotherapy and rehabilitation. Use of passive physiotherapy (cold, heat or electric therapies) to treat pain. Active and passive mobilization of the shoulder under the pain threshold, Maitland mobilization, stretch exercises such as: table slides, wall climbers. Use of affected upper limb in pain free Range-of-Motion (ROM) is tolerated and stimulated. Progressively increase time and frequency of Total-End-Range-Time (TERT) positions to increase ROM
Also known as: Usual care
Usual care: All patients complete rehabilitation under supervision of their own physiotherapist. The investigators will provide some guidelines and criteria but is the physiotherapist's choice how to implement these guidelines in clinical practice. Patient education on home-exercises Monitoring of peak pain, at rest/night and after rehabilitation sessions using a Numeric-Pain-Rating-Scale (0-10) (NPRS) to evaluate tissue irritability and guide physiotherapy and rehabilitation. Use of passive physiotherapy (cold, heat or electric therapies) to treat pain. Active and passive mobilization of the shoulder under the pain threshold, Maitland mobilization, stretch exercises such as: table slides, wall climbers. Use of affected upper limb in pain free Range-of-Motion (ROM) is tolerated and stimulated. Progressively increase time and frequency of Total-End-Range-Time (TERT) positions to increase ROM
Also known as: Usual care
Shoulder Pain and Disability Index (SPADI)
The Shoulder Pain and Disability Index (SPADI) is a self-administered index consisting of 13 items, divided into two subscales: 5 items for pain and 8 items for disability. It can be completed by patients in less than 5 min and has shown good reliability and construct validity in the assessment of shoulder impairments and in particular frozen shoulder. The score for each subscale is obtained by adding up all the individual subscale scores and dividing the result by the maximum subscale score. The normalized score is converted to a scale from 0 to 100, with 100 indicating no problems and 0 indicating serious problems.
Time frame: 3 months
Pain - Numeric Pain Rating Scale (NPRS)
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). It is the simplest and most commonly used pain rating scale and offers numerous advantages, including ease of administration and scoring, multiple response options, and no reported age-related difficulties in its use.
Time frame: 4 weeks - 3 months - 6 months - 12months after the intervention
Shoulder Pain and Disability Index (SPADI)
The Shoulder Pain and Disability Index (SPADI) is a self-administered index consisting of 13 items, divided into two subscales: 5 items for pain and 8 items for disability. It can be completed by patients in less than 5 min and has shown good reliability and construct validity in the assessment of shoulder impairments and in particular frozen shoulder. The score for each subscale is obtained by adding up all the individual subscale scores and dividing the result by the maximum subscale score. The normalized score is converted to a scale from 0 to 100, with 100 indicating no problems and 0 indicating serious problems.
Time frame: 4 weeks- 6 months - 12months after the intervention
Constant- Murley score (CMS)
The CMS is a composite scale divided into four sections: pain (15 points), activities of daily living (20 points), ROM (40 points) and strength (25 points) with a total score ranging from 0 (worst possible) to 100 (best possible). Patients were asked to verbally rate each parameter.
Time frame: 4weeks - 3 months - 6 months - 12 months after the intervention
Health related quality of life, evaluated with the EuroQol
The EQ-5D 3L is a generic measure of health-related quality of life developed by the EuroQol Group. It is a validated measurement of quality of life widely used in different pathologies. The questionnaire is made up of two parts. The first part is descriptive and uses five different dimensions to score quality of life. These five dimensions are mobility, self-care, activities of the daily life, pain/discomfort and anxiety/depression. There are five different answer possibilities within each dimension, i.e. "no problem", "slight problem", "moderate problem", "severe problem" and "unable to". This renders 3125 different answer possibilities. The second part uses a visual analogue scale (VAS) to score the current health status of the patient, ranging from zero to one hundred. Zero corresponds to death and one hundred corresponds to a (subjective) perfect health status.
Time frame: 4weeks - 3 months - 6 months - 12 months after the intervention
PROMIS-29 Upper Extremity v2.0
The nine-item Patient-Reported Outcomes Measurement Information System (PROMIS)- Upper Extremity short form has been validated against different legacy PROM and general health scores. Item-levels are scored numerically for an individual's response to each question. PROMIS instruments are always expressed as a score relative to the mean of a group (T-score). The mean score in a population is assigned the value 50. The standard deviation is equal to 10 points. Higher scores (above the mean score) means more of the concept being measured.
Time frame: 4weeks - 3 months - 6 months - 12 months after the intervention
Shoulder ROM in abduction, anteflexion, external rotation
Active and passive ROM in anterior elevation, abduction and external rotation are measured using an adapted (large, total length 50cm) goniometer, as described by Riddle et al. and Sabari et al., and values were expressed in degrees °.
Time frame: 4weeks - 3 months - 6 months - 12 months after the intervention
Tampa Scale for Kinesiophobia (TSK-11):
A shortened version of the original 17-item TSK, that measures the extent to which a person believes that physical activity or movement may lead to (re)-injury. Patients rate each item on a four-point Likert scale, with scoring alternatives ranging from "strongly disagree" to "strongly agree". Scores range from 11 to 44 with a higher score reflecting greater pain-related fear.
Time frame: 4weeks - 3 months - 6 months - 12 months after the intervention
Pain Self-Efficacy Questionnaire (PSEQ)
The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item scale which assesses a person's confidence in the ability to perform a task or activity, despite the pain. Each item is scored on a seven-point Likert scale (from "not at all confident" to "completely confident"). The total score ranges from 0 to 60 with a higher score representing greater pain self-efficacy beliefs.
Time frame: 4weeks - 3months - 6 months - 12 months after the intervention
Global Rating of Change Score (GRoC)
The Global Rating of Change Score (GRoC) is a frequently used outcome measure that is used independently to measure improvements in a patient's condition or as an anchor for other outcomes measures. On 11-point Likert scale participants rate the clinical course of their condition since the start of the treatment: from -5 "a great deal worse" to +5 "a great deal better" with 0 being "no change".
Time frame: 4weeks - 3months - 6 months - 12 months after the intervention
Work Ability Index (WAI)
The Work Ability Index (WAI) measures the work ability considering physical and mental parts of work as well as different diseases and their impact on work ability. It's a 10 items questionnaire concerning current work ability compared with the lifetime best, work ability in relation to the job demands, number of current diseases diagnosed by a physician, estimated work impairment due to diseases, sick leave, self-prognosis of work ability and mental resources. A given answer to a question earns points. The sum of all these points results in the WAI score, which ranges from 7 to 49 points. The score indicates the extent to which the individual's capabilities and the job requirements are consistent with each other, a higher score indicating a better match between capabilities and job requirements.
Time frame: 4weeks - 3months - 6 months - 12 months after the intervention
Work Status
Work status: Health economic assessment: As the investigators expect subgroups of Frozen Shoulder to be unable to work, subjects will be questioned if they are incapacitated to work due to Frozen Shoulder during baseline assessments. Once the symptoms and function improve, the investigators expect patients to be able to return to work.
Time frame: 4weeks - 3months - 6 months - 12 months after the intervention
Health care service use
Patients will keep a diary to log usage of pain medication and physiotherapy visits
Time frame: 4weeks - 3months - 6 months - 12 months after the intervention
Adverse effects
At every patient study contact, the occurrence or not of adverse affects will be recorded.
Time frame: 4weeks - 3months - 6 months - 12 months after the intervention
Rescue therapy
As this is a pragmatic trial, patients will be offered rescue therapy, consisting of an USG SSNB + IACI in their affected shoulder, every 3 months after inclusion, with a maximum of 3 interventions in 12 months
Time frame: 3months - 6months - 12months after the intervention
Superiority analysis of shoulder-related disability, pain and shoulder stiffness at 6 months after start of enrolment.
An intermediary statistical analysis will be performed at 6 months after start of enrolment. In case all 3 outcomes (disability, pain, shoulder stiffness) show non-superiority at 6m, the study will not be extended to the 12-month time point.
Time frame: 6 months after start of enrolment
Exploratory prediction analysis: part 1
Through regression analysis the investigators want to find out which factors predict I) SPADI score at 3 -6- 12 months follow-up, II) pain NPR level at 3-6-12 months, III) shoulder ROM (°) at 3-6-12 months and IV) return to work and WAI score at 3-6-12 months. The initial set of predictor variables, baseline values, that will be considered is : 1. SPADI score 2. Presence of joint capsule enhancement on MRI: (yes/no) 3. Shoulder ROM (°) 4. Age (years) 5. Gender (male/female) 5\. Duration of symptoms to intervention (weeks) 6. Presence of diabetes (yes/no)
Time frame: 18 months after inclusion
Exploratory prediction analysis: part 2
Through regression analysis the investigators want to identify which physical examination tests, or which combinations of tests are correlated with MRI diagnostic criteria and a more positive evolution of SPADI score - NPR pain score - shoulder ROM (°)- Return to Work (RTW)/WAI score: The initial set of predictor variables, baseline values, that will be considered is : 1. SPADI score 2. Presence of joint capsule enhancement on MRI: (yes/no) 3. Shoulder ROM (°) 4. Age (years) 5. Gender (male/female) 5\. Duration of symptoms to intervention (weeks) 6. Presence of diabetes (yes/no)
Time frame: 18 months after inclusion
Exploratory prediction analysis: part 3
Through regression analysis the investigators want to identify patients that benefit the most from the combined SSNB + IACI The initial set of predictor variables, baseline values, that will be considered is : 1. SPADI score 2. Presence of joint capsule enhancement on MRI: (yes/no) 3. Shoulder ROM (°) 4. Age (years) 5. Gender (male/female) 5\. Duration of symptoms to intervention (weeks) 6. Presence of diabetes (yes/no)
Time frame: 18 months after inclusion
Plan to share: No — Data will be published in peer review journal on completion of the study.
Started Feb 2025 (actual). Primary completion is estimated for May 2027, 27 months after the start.
Of 217 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 17. This study's planned 27 months is above that.
Counting every sponsor, half of 217 studies reached it within 10 months; a quarter within 5 and three quarters within 17.
How these figures are worked out, and which studies are left out of them.
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