Evaluation of the Efficacy of Suprascapular Nerve Block in Adhesive Capsulitis
ConditionAdhesive Capsulitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCHU de Reims
About this 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.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Triamcinolone Acetonide
Drug1 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 solution
Drugintramuscular 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
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: Block and arthrodistensionActive comparator 1 intervention
Group B: Placebo and arthrodistensionPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
1 monthSponsors and contacts
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Source ClinicalTrials.gov