Shoulder PainNCT05328349
Psychosocial Factors of Persistent Shoulder Pain
An observational study of Shoulder Pain, run by Laval University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Education Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 112 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2022to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Show all 11Show fewer
- 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]).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do Psychosocial Factors Predict the Persistence of Shoulder Pain?
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.
Read the 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
- Being tested
- Education Program
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 6 months
Secondary outcomes (10)
QuickDASH at Baseline
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).
Measured: Baseline
NPRS at Baseline
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.
Measured: Baseline
Resilience at Baseline
The validated French version of Brief Resilience Scale (BRS) will be used to classify the groups into low or high resilience levels. The BRS aims to measure the individual's ability to recover from a trauma or stress situations. It is composed of 6 items, which negatively or positively assess the stressful situation. Each question presents 5 response options ranging from 1= "strongly disagree" to 5= "strongly agree". Higher scores represent high levels of resilience. Internal consistency of the scale showed Cronbach's alpha of 0.84.
Measured: Baseline
Perceived Stress at Baseline
The Perceived Stress Scale - 10 (PSS-10) translated and adapted to French will be applied to measure the individuals' perceived stress.66 The scale quantifies the extent of how individuals consider stressful situations experienced in the last month. It uses a 10-item scale with a 5-point Likert scale of response (0=never; to 4=always) and higher scores indicate greater perceived stress. The Cronbach alpha for the instrument is 0.83.66
Measured: Baseline
Pain Catastrophizing at Baseline
The Pain Catastrophizing Scale (PCS) translated and validated to French will be used to identify catastrophic thoughts about pain. The PCS is a 13-item scale aiming to quantify pain catastrophizing characterized by magnification, rumination, and helplessness of pain beliefs. Its score ranges from 0 to 52: 0 - best score and 52=worst score, where 52 means higher individual catastrophizing. High internal reliability has been reported in patients with chronic pain with adequate validity and test-retest reliability.
Measured: Baseline
Depressive symptoms at Baseline
The French version of Patient Health Questionnaire-9, a shorter version of the complete PHQ, will be used to self-report depressive symptoms. Each of the nine items can be scored from 0 (not at all) to 3 (nearly every day), and the total scale score ranges from 0-27, where higher scores mean more severity of symptoms. A Cronbach's alpha of 0.86 was demonstrated for the instrument.
Measured: Baseline
Level of Anxiety at Baseline
The French version of the General Anxiety Disorder (GAD-7) will be utilized to evaluate generalized anxiety. Each of the seven items are scored from 0 (not at all) to 3 (nearly every day). The total GAD-7 scale score ranges from 0-21 and higher scores means higher anxiety levels. The scale presents satisfactory internal consistency (Cronbach's alpha=0.89).
Measured: Baseline
Sel-Efficacy at Baseline
The Pain Self-Efficacy Questionnaire (PSEQ) consists of 10 items utilized to measure patient's confidence in performing daily activities despite of pain. Each item is rated on a scale ranging from 0 ("not at all confident") to 6 ("completely confident"), and the total score can range from 0 to 60, with higher scores indicating better self-efficacy. The questionnaire has shown excellent validity, reliability, and responsiveness in individuals with musculoskeletal disorders.
Measured: Baseline
Social Support at Baseline
The French version of the Multidimensional Scale of Perceived Social Support (MSPSS) will be used to evaluate individual perceived satisfaction with social support received from family, friends and significant others. It is a 12 Likert-type items questionnaire with 7 response options (from 1, 'completely disagree', to 7 'strongly agree'). Higher scores represent higher satisfaction with social support received. The scale presented satisfactory internal consistency with a Cronbach's alpha value of 0.92.
Measured: Baseline
Physical Activity Level at Baseline
The French short version of the International Physical Activity Questionnaire (IPAQ) will be used to assesses the frequency, duration, and intensity of physical activity. This short version includes 7 items and provides total activity scores expressed in metabolic equivalent (MET) minutes. A test-retest reliability of 0.81 (95% Confidence Interval 0.79 to 0.82) were previously determined.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start1 Apr 2022
- Primary completion31 May 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Sébastien Roy, Laval University
- Investigators
- Jean-Sébastien Roy, PT, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328349
- Sponsor's protocol ID
- #2022-2502
- Status last verified
- Oct 2023
- First submitted
- 7 Apr 2022
- Last updated
- 3 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Psychosocial Factors Predict the Persistence of Shoulder Pain?
- ClinicalTrials.gov ID
- NCT05328349
- Acronym / sponsor ID
- #2022-2502
- Conditions
- Shoulder Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Education Program | – | Behavioral: Education ProgramAll 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (11 listed)
- 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:
- Participants will also have to present at least one positive finding in each of the following categories:
- Minimal score of 12 points on the QuickDASH (based on its minimal clinically important difference [MCID]).
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education ProgramAfter 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. | Behavioural | Education Program |
Primary outcome
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
10 secondary outcomes
QuickDASH at Baseline
Time frame: Baseline
NPRS at Baseline
Time frame: Baseline
Resilience at Baseline
Time frame: Baseline
Perceived Stress at Baseline
Time frame: Baseline
Pain Catastrophizing at Baseline
Time frame: Baseline
Depressive symptoms at Baseline
Time frame: Baseline
Level of Anxiety at Baseline
Time frame: Baseline
Sel-Efficacy at Baseline
Time frame: Baseline
Social Support at Baseline
Time frame: Baseline
Physical Activity Level at Baseline
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Sébastien Roy, PT, PhD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Pain, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QuickDASH at 6 months (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.