Adhesive CapsulitisBAC-ReimsNCT06176248
Evaluation of the Efficacy of Suprascapular Nerve Block in Adhesive Capsulitis
A study testing Triamcinolone Acetonide and saline solution in people with Adhesive Capsulitis, run by CHU de Reims at 1 site in France.
Trial summary
This is a double-blind interventional superiority study evaluating the efficacy of suprascapular nerve block in addition to conventional therapies for adhesive capsulitis. Adhesive capsulitis is a pathology that results in reduced shoulder mobility due to retraction of the periarticular capsule. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Triamcinolone Acetonide and saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 11 Oct 2024to 6 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient treated for adhesive capsulitis corresponding to a loss of passive amplitude of more than 20° in external rotation elbow to body and/or abduction in relation to the contralateral shoulder.
- Patient over 18 years of age
- Patient covered by a social security scheme
- Presence of an accompanying person on the day of the procedure for the return trip
- Patient having signed the consent form to participate in the study
Who cannot join
- Patient protected by law
- Pregnant women
- Patient who has had shoulder surgery less than six months old
- Patient unable to undergo rehabilitation within one month of surgery
- Allergy to one of the products used (anesthetic, iodinated contrast medium)
- Neuro-orthopedic disorder hampering clinical recovery
- Hemostasis disorder contraindicating block (no discontinuation of anticoagulants according to SFAR recommendations, congenital hemostasis disorder)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of Suprascapular Nerve Block in Adhesive Capsulitis: a Randomized Controlled Superiority Trial
This is a double-blind interventional superiority study evaluating the efficacy of suprascapular nerve block in addition to conventional therapies for adhesive capsulitis.
Adhesive capsulitis is a pathology that results in reduced shoulder mobility due to retraction of the periarticular capsule. It may be primary or secondary to traumatic or neurological events, or associated with diabetes in particular.
Read more
The usual treatment includes re-education sessions to improve joint amplitude and restore shoulder mobility. In persistent forms, intra-articular injection of cortisone is combined with distension of the capsule with a local anaesthetic under radiographic control.
In some countries, subscapular nerve block (reversible anaesthesia) is used to improve pain. The combination of arthrodistension and subscapular nerve block has never been performed to accelerate the healing process.
The aim of this study is to compare the performance of these two procedures together against the reference technique alone on time to improvement with the number of patients improved at one month according to the Constant score.
This score is used to assess shoulder pain and function, with a significant improvement above eight points.
Read the detailed description
The glenohumeral joint is a highly mobile joint involving abduction, anterior elevation, external rotation and internal rotation. It is composed of a capsule innervated by the suprascapular nerve. Retractile capsulitis is a frequent pathology, affecting 2 to 5% of the general population, and associating both pain and stiffening of the joint, leading to functional discomfort, particularly in abduction and external rotation movements. It is due to capsular retraction of the shoulder joint, which may be idiopathic or secondary to traumatic or neurological etiology, or associated with diabetes. In the majority of cases, this pathology leads to recovery, but the time to total recovery is variable, ranging from six months to one year. Some studies have even shown the persistence of symptoms, with an average follow-up time of four years in some patients. The majority of patients are off work due to the functional discomfort associated with shoulder stiffness.
Therapeutic management is currently poorly codified. Physiotherapy using active mobilization maneuvers has been shown to improve joint amplitudes, and is used as a first-line treatment. In the event of persistent symptoms, cortisone infiltration has been evaluated using a variety of protocols, including sub-acromial and intra-articular infiltration, as well as arthro-distension, which consists of dilating the capsule under radiological control using 1 intra-articular injection of xylocaine, corticoids and contrast medium. In France, arthrodistension has become the reference technique, as it is more effective than intra-articular infiltration of cortisone derivatives. In fact, several trials and meta-analyses have demonstrated short-term superiority in improving the pain associated with capsulitis and, above all, better progress in terms of joint amplitude, as assessed in particular by Constant's algo-functional scores.
If adhesive capsulitis persists despite these therapies, arthroscopic surgery is sometimes performed.
The suprascapular nerve is a mixed nerve whose sensitive component is the main sensitive branch innervating the shoulder. An anaesthetic block of this nerve provides a punctual reduction in painful sensations in the shoulder, enabling less painful arthrodistension and pain-free physiotherapy sessions for faster joint amplitude work. Several studies have compared suprascapular nerve block versus intra-articular infiltration in this condition, with conflicting results which nevertheless show a trend towards improved joint amplitudes and earlier onset of pain in the anesthetic block group. However, no study has compared suprascapular nerve block with arthrodistension, which remains the standard treatment in Europe. Moreover, no study has investigated the superiority of adding this therapy to arthrodistension. Our hypothesis is that suprascapular nerve block combined with arthrodistension may accelerate healing.
The main benefit expected for the patient is the shortening of the time to improvement (recovery of joint amplitudes, functional improvement and improvement in quality of life).
The expected benefits for society would be to improve therapeutic management and reduce healthcare consumption and indirect costs (time off work).
The foreseeable risks are low, with a risk of allergy to the anesthetic and a transient motor deficit (4h) in the supra-scapular nerve territory.
- Conditions
- Adhesive Capsulitis
- Being tested
- Triamcinolone Acetonide, saline solution
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone AcetonideDrug
1 injection of local anaesthetic (5 ml levobupivacaine 2.5 mg/mL) opposite the subscapular nerve, under ultrasound control, in a lateral decubitus or sitting position. Subsequently, they underwent Xray-controlled arthrodistension by injection of 1 ml of Triamcinolone Acetonide, combined with 10 ml of visipaque 270 contrast medium and 5 ml of Xylocaine.
saline solutionDrug
intramuscular injection of 1 ml saline under ultrasound control under the same conditions as the experimental group. Subsequently, they will undergo Xray-controlled arthrodistension under the same conditions as the experimental group
| Study group | Role | What they receive |
|---|---|---|
| Block and arthrodistension | Active comparator | Not described Receives: Drug: Triamcinolone Acetonide |
| Placebo and arthrodistension | Placebo comparator | Not described Receives: Drug: saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant score
The Constant score measured at inclusion and at 1 month in both groups. Calculation of the difference in score between the two times (minimum 0 - maxumum 100)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start11 Oct 2024
- Primary completion6 Jun 2026
- Study completion6 Jun 2026
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 CHU de ReimsThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176248
- Sponsor's protocol ID
- PA23085*
- Acronym
- BAC-Reims
- Status last verified
- Aug 2026
- First submitted
- 24 Jul 2023
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Suprascapular Nerve Block in Adhesive Capsulitis: a Randomized Controlled Superiority Trial
- ClinicalTrials.gov ID
- NCT06176248
- Acronym / sponsor ID
- BAC-Reims / PA23085*
- Conditions
- Adhesive Capsulitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 11 Oct 2024 (actual)
- Primary completion
- 6 Jun 2026 (actual)
- Study completion
- 6 Jun 2026 (actual)
- First posted
- 19 Dec 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.
This is a double-blind interventional superiority study evaluating the efficacy of suprascapular nerve block in addition to conventional therapies for adhesive capsulitis.
Adhesive capsulitis is a pathology that results in reduced shoulder mobility due to retraction of the periarticular capsule. It may be primary or secondary to traumatic or neurological events, or associated with diabetes in particular.
The usual treatment includes re-education sessions to improve joint amplitude and restore shoulder mobility. In persistent forms, intra-articular injection of cortisone is combined with distension of the capsule with a local anaesthetic under radiographic control.
In some countries, subscapular nerve block (reversible anaesthesia) is used to improve pain. The combination of arthrodistension and subscapular nerve block has never been performed to accelerate the healing process.
The aim of this study is to compare the performance of these two procedures together against the reference technique alone on time to improvement with the number of patients improved at one month according to the Constant score.
This score is used to assess shoulder pain and function, with a significant improvement above eight points.
Detailed description
The glenohumeral joint is a highly mobile joint involving abduction, anterior elevation, external rotation and internal rotation. It is composed of a capsule innervated by the suprascapular nerve. Retractile capsulitis is a frequent pathology, affecting 2 to 5% of the general population, and associating both pain and stiffening of the joint, leading to functional discomfort, particularly in abduction and external rotation movements. It is due to capsular retraction of the shoulder joint, which may be idiopathic or secondary to traumatic or neurological etiology, or associated with diabetes. In the majority of cases, this pathology leads to recovery, but the time to total recovery is variable, ranging from six months to one year. Some studies have even shown the persistence of symptoms, with an average follow-up time of four years in some patients. The majority of patients are off work due to the functional discomfort associated with shoulder stiffness.
Therapeutic management is currently poorly codified. Physiotherapy using active mobilization maneuvers has been shown to improve joint amplitudes, and is used as a first-line treatment. In the event of persistent symptoms, cortisone infiltration has been evaluated using a variety of protocols, including sub-acromial and intra-articular infiltration, as well as arthro-distension, which consists of dilating the capsule under radiological control using 1 intra-articular injection of xylocaine, corticoids and contrast medium. In France, arthrodistension has become the reference technique, as it is more effective than intra-articular infiltration of cortisone derivatives. In fact, several trials and meta-analyses have demonstrated short-term superiority in improving the pain associated with capsulitis and, above all, better progress in terms of joint amplitude, as assessed in particular by Constant's algo-functional scores.
If adhesive capsulitis persists despite these therapies, arthroscopic surgery is sometimes performed.
The suprascapular nerve is a mixed nerve whose sensitive component is the main sensitive branch innervating the shoulder. An anaesthetic block of this nerve provides a punctual reduction in painful sensations in the shoulder, enabling less painful arthrodistension and pain-free physiotherapy sessions for faster joint amplitude work. Several studies have compared suprascapular nerve block versus intra-articular infiltration in this condition, with conflicting results which nevertheless show a trend towards improved joint amplitudes and earlier onset of pain in the anesthetic block group. However, no study has compared suprascapular nerve block with arthrodistension, which remains the standard treatment in Europe. Moreover, no study has investigated the superiority of adding this therapy to arthrodistension. Our hypothesis is that suprascapular nerve block combined with arthrodistension may accelerate healing.
The main benefit expected for the patient is the shortening of the time to improvement (recovery of joint amplitudes, functional improvement and improvement in quality of life).
The expected benefits for society would be to improve therapeutic management and reduce healthcare consumption and indirect costs (time off work).
The foreseeable risks are low, with a risk of allergy to the anesthetic and a transient motor deficit (4h) in the supra-scapular nerve territory.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Block and arthrodistension | Active comparator | Drug: Triamcinolone Acetonide |
| Placebo and arthrodistension | Placebo comparator | Drug: saline solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient treated for adhesive capsulitis corresponding to a loss of passive amplitude of more than 20° in external rotation elbow to body and/or abduction in relation to the contralateral shoulder.
- Patient over 18 years of age
- Patient covered by a social security scheme
- Presence of an accompanying person on the day of the procedure for the return trip
- Patient having signed the consent form to participate in the study
Key exclusion criteria (7 listed)
- Patient protected by law
- Pregnant women
- Patient who has had shoulder surgery less than six months old
- Patient unable to undergo rehabilitation within one month of surgery
- Allergy to one of the products used (anesthetic, iodinated contrast medium)
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 |
|---|---|---|
| Triamcinolone Acetonide1 injection of local anaesthetic (5 ml levobupivacaine 2.5 mg/mL) opposite the subscapular nerve, under ultrasound control, in a lateral decubitus or sitting position. Subsequently, they underwent Xray-controlled arthrodistension by injection of 1 ml of Triamcinolone Acetonide, combined with 10 ml of visipaque 270 contrast medium and 5 ml of Xylocaine. | Drug | Block and arthrodistension |
| saline solutionintramuscular injection of 1 ml saline under ultrasound control under the same conditions as the experimental group. Subsequently, they will undergo Xray-controlled arthrodistension under the same conditions as the experimental group | Drug | Placebo and arthrodistension |
Primary outcome
Constant score
Time frame: 1 month
The Constant score measured at inclusion and at 1 month in both groups. Calculation of the difference in score between the two times (minimum 0 - maxumum 100)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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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 Triamcinolone Acetonide and saline solution in people with Adhesive Capsulitis, run by CHU de Reims at 1 site in France.
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 7 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: finished, as of the sponsor's last update on 24 Aug 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 France. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 score (time frame: 1 month). 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 24 Aug 2026.