Psychosocial Factors of Persistent Shoulder Pain

NCT05328349 | Completed

• 1 other identifier: #2022-2502
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Pain

Outcome Measures

Primary Outcomes (2)

• QuickDASH at 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.

  6 months

• NPRS at 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

  6 months

Secondary Outcomes (10)

• QuickDASH at Baseline

  Baseline

• NPRS at Baseline

  Baseline

• Resilience at Baseline

  Baseline

• Perceived Stress at Baseline

  Baseline

• Pain Catastrophizing at Baseline

  Baseline

Study Arms (1)

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.

Behavioral: Education Program

Interventions

Education Program 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.

Education Program

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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;
• Minimal score of 12 points on the QuickDASH (based on its minimal clinically important difference \[MCID\]).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Dayana P Rosa

Québec, Quebec, Canada

Location

MeSH Terms

Conditions

Shoulder Pain

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Jean-Sébastien Roy, PT, PhD

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 14, 2022
• Study Start: April 1, 2022
• Primary Completion: May 31, 2023
• Study Completion: June 30, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-10

Locations

CA (1)