Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06176248 |
| Other study ID # |
PA23085* |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 2024 |
| Est. completion date |
March 2025 |
Study information
| Verified date |
March 2024 |
| Source |
CHU de Reims |
| Contact |
Lois BOLKO |
| Phone |
03 26 78 80 80 |
| Email |
lbolko[@]chu-reims.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
