Clinical trial NCT04044196: Preoperative Psychological Risk Factors for the Retractable Capsulitis of the Shoulder After Shoulder Rotator Cuff Repair Surgery
Official title: Preoperative Psychological Risk Factors for the Retractable Capsulitis of the Shoulder After Shoulder Rotator Cuff Repair Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frozen Shoulder
Rotator Cuff Tears
Lead sponsor: Hospital Ambroise Paré Paris
Sponsor class: OTHER
First posted: 2019-08-05
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who undergo rotator cuff repair under arthroscopy

Brief summary: The main objective of our study is to determine whether preoperative anxiety, depression and kinesiophobia are risk factors for retractile capsulitis after arthroscopic rotator cuff repair to best support these patients. patients postoperatively.

Detailed description: The occurrence of a postoperative frozen shoulder after tendon repair of the rotator cuff of the shoulder is a devastating complication. It causes stiffness and slows down recovering. It associates a synovitis and a capsular retraction generating a transient but very incapacitating passive and active joint stiffness.

The evolution of capsulitis occurs in three phases:

* The first phase or cold phase is distinguished mainly by pain. The stiffness settles gradually. This phase lasts 2 to 9 months
* In the second phase or frozen phase lasting 4 to 12 months, the pain is less severe, but the rigidity is substantial.
* In the third phase, the function is gradually recovered and the pain disappears. This phase can last up to two years.

Some patients will get back full mobility of their shoulder in 12 to 18 months, while others may have persistent symptoms for several months.

The International Society of Arthroscopy, Knee Surgery and Orthopedic Sports Medicine recently codified the clinical diagnosis: active anterior elevation less than 100 °, external rotation elbow to body less than 10 °, internal rotation less than L5.

So if the diagnosis is better codified , prevention is the main concern. Some etiologies have been clearly identified. Systemic etiologies are reported: diabetes, thyroid pathologies, Dupuytren's disease and other factors such as ipsilateral breast surgery and myocardial infarction.

Psychological predispositions have long been suggested as risk factors for capsulitis, but a significant relationship has not been clearly established. The fear of having pain or an apathetic temperament could lead to a stay of the pains and curb the reeducation. In 1953, Coventry already evoked a "so called periarthritic personality" associating apathy, muscle contractures and a threshold of low pain. In 2014, De Beer investigated whether personality traits favored the occurrence of a retractable capsule primary or secondary to surgery but did not identify specific personality significantly more prone to stiffening of the shoulder.

Moreover, the fear of pain during movement or kinesiophobia and the avoidance behaviors generated are known factors in the persistence of pain and chronic limitations of function.

The main objective of our study is to determine whether preoperative anxiety, depression and kinesiophobia are risk factors for retractile capsulitis after arthroscopic rotator cuff repair to best support these patients. patients postoperatively.

Our hypothesis is that there is a psychological ground predisposing to the postoperative occurrence of a retractile capsulitis of the shoulder.

Eligibility criteria: Inclusion Criteria:

* Patient over 18 years old
* Patient with rotator cuff rupture or subacromial conflict.
* Free and enlightened non-opposition

Exclusion Criteria:

* Pregnancy and breast feeding
* Associated repair of the scapular tendon
* Risk factors for capsulitis: diabetes, thyroid pathology, hypercholesterolemia, dupuytren's disease, homolateral breast surgery, history of myocardial infarction
* Patient not affiliated to a social security scheme
* Refusal of the patient

Primary outcomes:
measure: retractile capsulitis
timeFrame: 6 months postoperatively
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: preoperatively and 6 months after surgery
measure: Tampa Scale for Kinesiophobia (TSK)
timeFrame: preoperatively and 6 months after surgery
measure: Numeric Pain Rating Scale
timeFrame: preoperatively and 6 months after surgery
measure: Constant shoulder score
timeFrame: preoperatively and 6 months after surgery
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Ambroise Paré Hospital
state: Ile De France
city: Paris
country: France
facility: Groupe Hospitalier Diaconesses Croix Saint-Simon
Study officials:
affiliation: Orthopaedic surgery department
name: Thomas Bauer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aim F, Chevallier R, Marion B, Klouche S, Bastard C, Bauer T. Psychological risk factors for the occurrence of frozen shoulder after rotator cuff repair. Orthop Traumatol Surg Res. 2022 Apr;108(2):103212. doi: 10.1016/j.otsr.2022.103212. Epub 2022 Jan 22.