Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02924519
Other study ID # 1-10-72-103-14
Secondary ID
Status Active, not recruiting
Phase N/A
First received August 9, 2016
Last updated October 3, 2016
Start date May 2014
Est. completion date October 2018

Study information

Verified date August 2016
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Data Protection Agency
Study type Observational

Clinical Trial Summary

Shoulder disorders are frequent, often associated with pain and occur in 7-34% of the general population and in 21% of the elderly population.

Of particular interest is prediction of postoperative pain after outpatient arthroscopic shoulder surgery since the clinical experience is that surgery does not always provides pain relief and the interindividual variation in acute postoperative pain intensity is significant. In addition, a Swedish study has shown that shoulder operations are associated with longer convalescence than other orthopaedic outpatient surgeries.


Description:

This study is a prospective cohort with 6 months follow-up. Patients receive 5 questionnaires (preoperatively, 24 hours, 1 week, 3 months, 6 months, 1 and 2 years after surgery). The questionnaires contain questions about:

- Preoperative shoulder pain (type, intensity and duration)

- Preoperative pain in other areas besides the shoulder

- Brief Pain Inventory (BPI)

- Western Ontario Rotator Cuff Index (WORC)

- Single Assessment Numeric Evaluation (SANE)

- 3 validated physiological questionnaires:

- State Trait Anxiety (STAI)

- Pain Catastrophizing Scale (PCS)

- Hospital Anxiety and Depression Scale (HADS)

In addition a cold pressor test is performed on the day of surgery to test the patients' threshold and ability to repress pain.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 150
Est. completion date October 2018
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 110 Years
Eligibility Inclusion Criteria:

- Arthroscopic shoulder surgery (subacromial decompression and acromioclavicular joint resection).

Exclusion Criteria:

- • < 18 years

- mental disorders

- Unable to speak and/or read Danish

- Shoulder surgery within the last year

- Raynauds phenomenon

- Cuff suture

- Biceps tenodesis

- Labrum suture

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Aarhus Horsens Regional Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Chronic postoperative pain Measured on a numerical rating scale (NRS; 0=no pain and 10=worst possible pain. Chronic postoperative pain is defined as NRS>=3 with an impact on daily living 6 months after surgery No
Primary Acute postoperative pain Measured on a numerical rating scale (NRS; 0=no pain and 10=worst possible pain. NRS>3= acute postoperative pain 24 hours after surgery No
Secondary Acute postoperative pain Measured on a numerical rating scale (NRS; 0=no pain and 10=worst possible pain. NRS>3= acute postoperative pain 1 week after surgery No
Secondary Acute postoperative pain Measured on a numerical rating scale (NRS; 0=no pain and 10=worst possible pain. NRS>3= acute postoperative pain 3 month after surgery No
Secondary Preoperative psychological predictors for chronic pain Hospital Anxiety and Depression Scale (HADS) 6 months after surgery No
Secondary Preoperative psychological predictors for chronic pain State-Trait Anxiety 6 months after surgery No
Secondary Preoperative psychological predictors for chronic pain Pain Catastrophizing Scale (PCS) 6 months after surgery No
Secondary Preoperative physical predictors for chronic pain Cold pressure test 6 months after surgery No
Secondary Preoperative comorbidity Other places than the shoulder 6 months after surgery No
See also
  Status Clinical Trial Phase
Completed NCT02190682 - Data Collection for Prediction of Postoperative Chronic Pain for a Software
Completed NCT02630849 - Does a Multimodal no‐Compression Suture Technique of the Intercostal Space Reduce Chronic Post‐Thoracotomy Pain? N/A
Recruiting NCT05062356 - Pain Control Following Total Hip Arthroplasty Phase 1
Recruiting NCT06036979 - A Comparative Study Between the Effectiveness of Preoperative ESPB Versus Preoperative PVPB in Decreasing PMPS. A Randomized Controlled Study N/A
Completed NCT03529201 - QLB After Nephrectomy N/A
Completed NCT01388946 - Analgesia in Laparoscopic Cholecystectomy N/A
Completed NCT04280432 - Monocentric Observational Study: Postoperative Pain After Cesarean Section: Incidence and Risk Factors.
Enrolling by invitation NCT04508465 - Persistent Postoperative Pain After Major Emergency Abdominal Surgery
Withdrawn NCT04670042 - Using Peripheral Nerve Stimulation (PNS) to Treat Chronic Post-surgical Pain (CPSP) After Knee Surgery N/A
Recruiting NCT06281431 - A Comparative Effect of Echogenic Needle for Nerve Block on Acute and Chronic Postoperative Pain N/A
Completed NCT01467102 - euCPSP: European Observational Study on Chronic Post Surgical Pain,PAIN-OUT Study N/A
Recruiting NCT05920967 - PANDORA: Paravertebral AdjuNctive DexamethasOne Palmitate Reducing Chronic Pain After Caridiac Surgery N/A
Completed NCT01510496 - Transition From Acute to Chronic Pain After Inguinal Hernia, Hysterectomy and Thoracotomy: Analysis of Risk Factors and Association With Genetic Polymorphisms N/A
Not yet recruiting NCT03275207 - Dexmedetomidine for Prevention of Chronic Postoperative Pain Phase 4
Not yet recruiting NCT03363672 - Prevalence, Impact and Predictors of Chronic Postoperative Pain N/A
Not yet recruiting NCT02991287 - Validation of Predictive Scale of Chronic Postsurgical Pain N/A
Completed NCT02115945 - Femoral and Epidural Block After Total Knee Arthroplasty Phase 0
Completed NCT04313855 - Help With Early Detection of Postoperative Neuropathic Pain Using SMS After Ambulatory Surgery N/A
Active, not recruiting NCT04604847 - Postoperative Painful Chronicization After Knee Replacement Surgery : Exploratory Study of BDNF's Kinetics N/A
Enrolling by invitation NCT04735211 - Chronic Postsurgical Pediatric Pain. Evaluation Risk Factors to Develop Chronic Postsurgical Pain in Children and Adolescents Undergoing Surgery in a First Level Hospital