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

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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tears; Frozen Shoulder
• Intervention / Treatment: Procedure: Rotator cuff repair

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.

• Study Type: Observational
• Enrollment (Actual): 77

Contacts and Locations

Study Locations

• France
  • Paris, France, 75020
    • Groupe Hospitalier Diaconesses Croix Saint-Simon
  • Ile De France
    • Boulogne-Billancourt, Ile De France, France, 92100
      • Ambroise Paré Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient who undergo rotator cuff repair under arthroscopy

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Numeric Pain Rating Scale	from "0" (no pain) to "10" (the worst pain)	preoperatively and 6 months after surgery
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

Collaborators and Investigators

• Sponsor: Hospital Ambroise Paré Paris
• Investigators: Principal Investigator: Thomas Bauer, MD, PhD, Orthopaedic surgery department

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2018
• Primary Completion (ACTUAL): March 1, 2020
• Study Completion (ACTUAL): March 1, 2020

Study Registration Dates

• First Submitted: July 31, 2019
• First Submitted That Met QC Criteria: July 31, 2019
• First Posted (ACTUAL): August 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 29, 2020
• Last Update Submitted That Met QC Criteria: October 28, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries; Bursitis
• Other Study ID Numbers: APR012018; 2018-A00148-47 (OTHER: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No