Clinical trial NCT05328349: Psychosocial Factors of Persistent Shoulder Pain
Official title: Do Psychosocial Factors Predict the Persistence of Shoulder Pain?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Pain
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential participants will be recruited from a convenience sample through the electronic mailing lists of Université Laval (\>40,000 individuals), social media (mainly Facebook, Twitter and Instagram), the medical communities in Quebec City (advertisements in medical, physiotherapy, radiology clinics and pharmacies) and advertisement with patient advocacy or professional organizations and with unions of workers at risk for rotator cuff related shoulder pain.

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.

Eligibility criteria: Inclusion Criteria:

1. Adults, aged between 18 and 60 years old;
2. English or French speakers;
3. 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:
   1. painful arc of movement;
   2. positive Neer's or Kennedy-Hawkins Test;
   3. pain on resisted external rotation, resisted abduction or Empty Can Test. A positive cluster of these criteria represents a valid diagnostic cluster;
4. Minimal score of 12 points on the QuickDASH (based on its minimal clinically important difference \[MCID\]).

Exclusion Criteria:

1. clinical signs of full thickness rotator cuff tears;
2. 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;
3. previous shoulder surgery;
4. presence of significant co-morbidity e.g. neurological disorders, rheumatoid arthritis;
5. current or past carcinoma;
6. unlikely to be able to perform required clinical assessment tasks or attend the required evaluation and intervention sessions;
7. symptomatic cervical spine pathology, defined as reproduction of symptoms with active physiological cervical spine movements;
8. corticosteroid injection in the last 6 weeks.

Primary outcomes:
measure: QuickDASH at 6 months
timeFrame: 6 months
measure: NPRS at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: QuickDASH at Baseline
timeFrame: Baseline
measure: NPRS at Baseline
timeFrame: Baseline
measure: Resilience at Baseline
timeFrame: Baseline
measure: Perceived Stress at Baseline
timeFrame: Baseline
measure: Pain Catastrophizing at Baseline
timeFrame: Baseline
measure: Depressive symptoms at Baseline
timeFrame: Baseline
measure: Level of Anxiety at Baseline
timeFrame: Baseline
measure: Sel-Efficacy at Baseline
timeFrame: Baseline
measure: Social Support at Baseline
timeFrame: Baseline
measure: Physical Activity Level at Baseline
timeFrame: Baseline
Other outcomes:
Locations:
city: Québec city
country: Canada
facility: Dayana P Rosa
state: Quebec
Study officials:
affiliation: Laval University
name: Jean-Sébastien Roy, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: