Preoperative Psychological Risk Factors for the Retractable Capsulitis of the Shoulder After Shoulder Rotator Cuff Repair Surgery

Rotator Cuff Tears Clinical Trial

Official title:

Preoperative Psychological Risk Factors for the Retractable Capsulitis of the Shoulder After Shoulder Rotator Cuff Repair Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04044196
• Other study ID #: APR012018
• Secondary ID: 2018-A00148-47
• Status: Completed
• Start date: May 1, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: October 2020
• Source: Hospital Ambroise Paré Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bursitis
• Frozen Shoulder
• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

Procedure:
• Rotator cuff repair
Rotator cuff repair performed arthroscopically

Locations

Country	Name	City	State
France	Ambroise Paré Hospital	Boulogne-Billancourt	Ile De France
France	Groupe Hospitalier Diaconesses Croix Saint-Simon	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Ambroise Paré Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	retractile capsulitis	rate of patients with retractile capsulitis defined as active anterior elevation less than 100 °, external rotation elbow to body less than 10 °, internal rotation less than L5	6 months postoperatively
Secondary	Hospital Anxiety and Depression Scale (HADS)	self-questionnaire Scoring: Total score: Depression (D) and Anxiety (A) 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)	preoperatively and 6 months after surgery
Secondary	Tampa Scale for Kinesiophobia (TSK)	self-questionnaire The TSK consists of 17 questions. A score of 17 is the lowest possible score, and indicates no kinesiophobia or negligible. A score of 68 is the highest possible score and indicates extreme fear of pain with movement.	preoperatively and 6 months after surgery
Secondary	Numeric Pain Rating Scale	from "0" (no pain) to "10" (the worst pain)	preoperatively and 6 months after surgery
Secondary	Constant shoulder score	divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function	preoperatively and 6 months after surgery