Psychosocial Factors of Persistent Shoulder Pain

NCT ID: NCT05328349

Last Updated: 2023-10-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 112 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2023-06-30

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.

Conditions

Shoulder Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Education Program

All 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, and familiar pain reproduced with loading or resisted testing during abduction and/or external rotation of the arm.

Education Program

Intervention Type: BEHAVIORAL

After the baseline evaluation, all participants will take part in an education intervention, aiming at promoting self-management of shoulder pain, that will include two one-on-one sessions (approximately 30-45 minutes) within 2 weeks with a physiotherapist (1st session right after the baseline evaluation, 2nd session two weeks later). Participants will receive written information regarding shoulder (anatomy and function) and basic pain science and will be directed to watch a series of six educational videos on shoulder pain and function, persistent pain, physical activity, stress, sleep and eating habits. It should be noted that the objective of this study is not to assess the effectiveness of the intervention; the purpose of offering an intervention to participants is to control the intervention that will be received by them.

Interventions

Education Program

After the baseline evaluation, all participants will take part in an education intervention, aiming at promoting self-management of shoulder pain, that will include two one-on-one sessions (approximately 30-45 minutes) within 2 weeks with a physiotherapist (1st session right after the baseline evaluation, 2nd session two weeks later). Participants will receive written information regarding shoulder (anatomy and function) and basic pain science and will be directed to watch a series of six educational videos on shoulder pain and function, persistent pain, physical activity, stress, sleep and eating habits. It should be noted that the objective of this study is not to assess the effectiveness of the intervention; the purpose of offering an intervention to participants is to control the intervention that will be received by them.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Jean-Sébastien Roy

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jean-Sébastien Roy, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Laval University

Locations

Dayana P Rosa

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

#2022-2502

Identifier Type: -

Identifier Source: org_study_id