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Clinical Trials/NCT05328349
NCT05328349
Completed
Not Applicable

Do Psychosocial Factors Predict the Persistence of Shoulder Pain?

Laval University1 site in 1 country112 target enrollmentApril 1, 2022
ConditionsShoulder Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Shoulder Pain
Sponsor
Laval University
Enrollment
112
Locations
1
Primary Endpoint
QuickDASH at 6 months
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Several studies have shown that in chronic pain conditions, factors such as lack of positivity and resilience, pain catastrophizing, stress, anxiety and depression can contribute to the persistence and maintenance of pain. Thus, the present project will identify psychosocial risk factors that predict the persistence of shoulder pain. Individuals with shoulder pain (n=112) will be recruited. At baseline, the participants will fill a series of questionnaires evaluating different biopsychosocial constructs (resilience, perceived stress, anxiety, depression, pain, disability, pain catastrophizing, self-efficacy, social support, physical activity). After baseline evaluation, the participants will take part in an educational program aimed at promoting self-management of shoulder pain. At the end of the project (6 months), participants will only fill questionnaires evaluating pain and disability. Based on the scores on these questionnaires, the participants will be classified as having persistent shoulder pain or as recovered. Thereafter, statistical analyses will be performed to identify significant predictors for persistent shoulder pain. The primary hypothesis of the study is that low levels of resilience, self-efficacy, social support and physical activity, and high levels of stress, pain, disability, catastrophizing, anxiety and depression will negatively influence the pain response resulting in increased pain ratings and persistent symptoms over time.

Detailed Description

A prospective cohort study will be conducted. One hundred and twelve individuals with rotator cuff related shoulder pain (RCRSP) will be evaluated twice: baseline and 6-month after baseline. At baseline, participants will complete a questionnaire on sociodemographic and symptomatology. Then, the participants will be asked to fill questionnaires covering a biopsychosocial spectrum: Brief Resilience Scale (BRS), Perceived Stress Scale (PSS-10), Numeric Pain Rating Scale (NPRS), abbreviated version of the Disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH), Patient-Health Questionnaire - 9 (PHQ-9), General Anxiety Disorder - 7 (GAD-7), Pain Catastrophizing Scale (PCS), Pain Self-Efficacy Questionnaire (PSEQ), Multidimensional Scale of Perceived Social Support (MSPSS) and short version of the International Physical Activity Questionnaire (IPAQ). After the baseline evaluation, participants will take part in an educational program aimed at promoting self-management of shoulder pain. The program will include two one-on-one sessions (approximately 30-45 minutes) within 2 weeks with a physiotherapist. The main reasons to propose an education intervention is that it is usual to receive a rehabilitation intervention when a person presents shoulder pain. It was therefore difficult to expect that the participants would not seek treatment during the study period and therefore that the investigators could only have considered the effect of time (natural evolution of the injury). Finally, at 6-months, participants will only be asked to fill NPRS and QuickDASH. Based on the scores on these questionnaires, the participants will be classified as having persistent shoulder pain or as recovered.The follow-up evaluation will be performed online (6-month follow-up) using RedCap. For the statistical analysis, participants will be dichotomized into 2 subgroups according to whether their symptoms have resolved or not at 6-month, aiming to determine the baseline variables that predict the persistence of pain 6 months after baseline. All variables found to be significant on univariate analyses will be considered potential predictors. Thereafter, logistic regression analyses will be performed to identify significant predictors for persistent rotator cuff related shoulder pain.

Registry
clinicaltrials.gov
Start Date
April 1, 2022
End Date
June 30, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jean-Sébastien Roy

Professor

Laval University

Eligibility Criteria

Inclusion Criteria

  • Adults, aged between 18 and 60 years old;
  • English or French speakers;
  • Rotator cuff related shoulder pain symptoms - Rotator cuff related shoulder pain diagnosis will be based on the participant history and a clinical assessment performed by an experienced physiotherapist. Participants will have to present shoulder symptoms related to rotator cuff related shoulder pain, which is defined as:
  • pain over the deltoid and/or upper arm region;
  • pain associated with arm movement;
  • familiar pain reproduced with loading or resisted testing during abduction and/or external rotation of the arm.
  • Participants will also have to present at least one positive finding in each of the following categories:
  • painful arc of movement;
  • positive Neer's or Kennedy-Hawkins Test;
  • pain on resisted external rotation, resisted abduction or Empty Can Test. A positive cluster of these criteria represents a valid diagnostic cluster;

Exclusion Criteria

  • clinical signs of full thickness rotator cuff tears;
  • other shoulder disorders e.g. adhesive capsulitis (restriction of passive glenohumeral movement of at least 25% for 2 or more directions), severe osteoarthritis, fracture, dislocation, severe acromioclavicular joint pathology;
  • previous shoulder surgery;
  • presence of significant co-morbidity e.g. neurological disorders, rheumatoid arthritis;
  • current or past carcinoma;
  • unlikely to be able to perform required clinical assessment tasks or attend the required evaluation and intervention sessions;
  • symptomatic cervical spine pathology, defined as reproduction of symptoms with active physiological cervical spine movements;
  • corticosteroid injection in the last 6 weeks.

Outcomes

Primary Outcomes

QuickDASH at 6 months

Time Frame: 6 months

Shoulder pain and function will be evaluated using the abbreviated version of the Disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH) questionnaire. The questionnaire consists of 11 items covering 6 domains (daily activities, symptoms, social function, work function, sleep, and confidence) that are scored on a numeric rating scale between 1 (no difficulty) and 5 (unable). Participants will be dichotomized into 2 subgroups according to whether their symptoms have resolved or not at 6-month. To do this, the investigators will use the NPRS and QuickDASH scores from the 6-month follow-up. If patients present a score between 0 (no disability) and 11 (minimal clinically important difference - MCID) on the QuickDASH, their symptoms will be considered resolved. Conversely, if their score is greater than 11 on the QuickDASH , their symptoms will be considered unresolved.

NPRS at 6 months

Time Frame: 6 months

The NPRS will quantify the average pain over the last 7 days. This scale score ranges from 0 (no pain) to 10 (worst pain), and the scale is considered valid and with good reliability to assess individuals with shoulder pain. Participants will be dichotomized into 2 subgroups according to whether their symptoms have resolved or not at 6-month. To do this, the investigators will use the NPRS and QuickDASH scores from the 6-month follow-up. If patients present a score between 0 (no disability) and 2 (minimal clinically important difference - MCID) on the NPRS, their symptoms will be considered resolved. Conversely, if their score is greater than 2 on the NPRS, their symptoms will be considered unresolved

Secondary Outcomes

  • Sel-Efficacy at Baseline(Baseline)
  • Pain Catastrophizing at Baseline(Baseline)
  • Physical Activity Level at Baseline(Baseline)
  • QuickDASH at Baseline(Baseline)
  • NPRS at Baseline(Baseline)
  • Perceived Stress at Baseline(Baseline)
  • Resilience at Baseline(Baseline)
  • Social Support at Baseline(Baseline)
  • Depressive symptoms at Baseline(Baseline)
  • Level of Anxiety at Baseline(Baseline)

Study Sites (1)

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