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

Sponsor
Hospital Ambroise Paré Paris (Other)
Overall Status
Completed
CT.gov ID
NCT04044196
Collaborator
(none)
77
2
22
38.5
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
77 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Preoperative Psychological Risk Factors for the Retractable Capsulitis of the Shoulder After Shoulder Rotator Cuff Repair Surgery
Actual Study Start Date :
May 1, 2018
Actual Primary Completion Date :
Mar 1, 2020
Actual Study Completion Date :
Mar 1, 2020

Outcome Measures

Primary Outcome Measures

  1. retractile capsulitis [6 months postoperatively]

    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

Secondary Outcome Measures

  1. Hospital Anxiety and Depression Scale (HADS) [preoperatively and 6 months after surgery]

    self-questionnaire Scoring: Total score: Depression (D) and Anxiety (A) 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)

  2. Tampa Scale for Kinesiophobia (TSK) [preoperatively and 6 months after surgery]

    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.

  3. Numeric Pain Rating Scale [preoperatively and 6 months after surgery]

    from "0" (no pain) to "10" (the worst pain)

  4. Constant shoulder score [preoperatively and 6 months after surgery]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ambroise Paré Hospital Boulogne-Billancourt Ile De France France 92100
2 Groupe Hospitalier Diaconesses Croix Saint-Simon Paris France 75020

Sponsors and Collaborators

  • Hospital Ambroise Paré Paris

Investigators

  • Principal Investigator: Thomas Bauer, MD, PhD, Orthopaedic surgery department

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shahnaz Klouche, MD, Clinical Research director, Hospital Ambroise Paré Paris
ClinicalTrials.gov Identifier:
NCT04044196
Other Study ID Numbers:
  • APR012018
  • 2018-A00148-47
First Posted:
Aug 5, 2019
Last Update Posted:
Oct 29, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 29, 2020