Chronic Shoulder PainNCT02738372
Influence of Biopsychosocial Factors and Central Sensitization in Predicting the Recovery of Chronic Shoulder Pain
An observational study of Chronic Shoulder Pain, run by University of Malaga.
Trial summary
Background: Shoulder pain is the third most common musculoskeletal condition presenting to physicians or physiotherapists ) in primary healthcare after low back and neck pain being a significant cause of morbidity and functional disability in both working and general population. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Shoulder Pain
- What is being tested?
- Diagnosis/Prognosis
- Type of treatment
- Injection or infusion
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Mar 2020
- How long will I take part?
- 24 Months
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects between 18-70 years with chronic shoulder pain
Who may be able to join
- Men / women aged between 18 and 70 years.
- Patients suffering from shoulder pain, defined as pain presented or exacerbated by movements in the shoulder, pain intensity = 2 measured by a numerical scale with values from 0 to 10, meaning 0= no pain and 10= the worst pain, will be included in this study, among all these following shoulder pain conditions: (i) rotator cuff (RC) tendinopathy ; (ii) adhesive capsulitis (AC) ; (iii) glenohumeral instability ; (iv) SLAP lesion; (v) and/or acromioclavicular pathology. Subjects will not be required to undergo diagnostic imaging (i.e MRI) to diagnosis the pathology because of the recruitment will be carried out by clinical findings.
- Duration of symptoms: greater than 3 months.
Who cannot join
- Recent shoulder dislocation (1 year prior) and/or systemic diseases such as rheumatoid arthritis, osteoarthritis, fibromyalgia and/or polymyalgia rheumatica.
- Shoulder pain considered to be originated in the cervical region and other traumas or if there is a neurological dysfunction (i.e multiple sclerosis), osteoporosis, hemophilia and / or cancer.
- Inability to provide informed consent and/or complete written questionnaires.
About this study
Official title: The Influence of Biopsychosocial Factors and Peripheral and/or Central Sensitization in Predicting the Recovery of Chronic Shoulder Pain: a Prospective Cohort Study. Study Protocol
Background: Shoulder pain is the third most common musculoskeletal condition presenting to physicians or physiotherapists ) in primary healthcare after low back and neck pain being a significant cause of morbidity and functional disability in both working and general population. Despite the large group of individuals seeking for primary care services, about 50% of patients with shoulder pain still report persistent pain after 12-18 months. As a result, socio-economic burdens are considerable due to extensive use of heath care services, sickness absence, disability pension, and loss of productivity as well as, patient´s suffering.
Aims: the primary aim of this study was to evaluate what biopsychosocial factors predict a better and/or poor outcome in patients with Chronic shoulder pain. The secondary aim was to analyze the role of central sensitization in predicting a better and/or poor outcome in patients with Chronic shoulder pain.
Read more
Hypothesis:
- A high level of physical inactivity, kinesiophobia, fear avoidance and pain catastrophizing and low level of self-efficacy will ease the perpetuation of Chronic shoulder pain.
- The presence of central sensitization will predict a poor outcome in patients with chronic shoulder pain.
Read the detailed description
The present study will be a 24 months multi-center, double-blind, prospective, cohort study which will be carried out between April 2016 and March 2018. Subjects diagnosed of rotator cuff (RC) tendinopathy, adhesive capsulitis (AC), glenohumeral instability, superior labrum anterior to posterior (SLAP) lesion, and/or acromioclavicular pathology and fulfill the inclusion criteria will be asked for participating in the investigators study. Several questionnaires that will test the influence of different biopsychosocial factors and the presence of Central Sensitization will be administrated to these subjects. The outcomes will be assessed at baseline and 5 follow-ups (after 3, 6, 12, 18 and 24 months, t1-t6).
Subjects will attend for their routine clinical appointment. The examiners will carry out the clinical consultation according to usual practice. Subjects who fulfill the selection criteria will be asked whether they wish to be considered for trial participation. Examiners will inform subjects who are interested in participation. Ineligible subjects and those who do not wish to participate in the trial will receive normal clinical care delivered by clinicians according to the best clinical practice.
Anonymized age, gender and visual analogue scale (VAS)- verbal numeric rating scale (VNRS) for pain will be collected for those subjects who decline to take part in the project, in order to assess the external validity of the recruited sample of subjects.
Eligible patients who are interested in the trial will be asked to provide written informed consent to participate. The examiners will allocate the participants in an unique study group. Participants will then complete several questionnaires at baseline, 3, 6, 12, 18 and 24 months after the beginning of the study. A blinded examiner will deliver these questionnaires. Subsequent sessions will occur at the follow-up visits. Participants will be asked about any problems they had had during the previous months before following-up. There will be brief discussion about whether participants have subjected for any treatment (physical, pharmacological, injection and/or no treatment).
- Conditions
- Chronic Shoulder Pain
- Being tested
- Diagnosis/Prognosis
- Keywords
- Chronic Pain, Biopsychosocial Factors, Shoulder pain, Prognosis, Central Nervous System Sensitization
- Medical subject headings
- Chronic Pain, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis/PrognosisOther
The present study will be a 24 months multi-center, triple-blind, prospective, cohort study which will be carried out between April 2016 and March 2018. Subjects diagnosed of rotator cuff (RC) tendinopathy, adhesive capsulitis (AC), glenohumeral instability, SLAP lesion, and/or acromioclavicular pathology and fulfill the inclusion criteria will be asked for participating in our study. Several questionnaires that will test the influence of different biopsychosocial factors and the presence of Central Sensitization will be administrated to these subjects. The outcomes will be assessed at baseline and 5 follow-ups (after 3, 6, 12, 18 and 24 months, t1-t6).
| Study group | Role | What they receive |
|---|---|---|
| Chronic Shoulder Pain | 1. Men / women aged between 18 and 70 years.
2. Patients suffering from shoulder pain, defined as pain presented or exacerbated by movements in the shoulder, pain intensity ≥ 2 measured by a numerical scale with values from 0 to 10, meaning 0= no pain and 10= the worst pain, will be included in this study, among all these following shoulder pain conditions: (i) Rotator Cuff tendinopathy; (ii) Adhesive Capsulitis; (iii) glenohumeral instability; (iv) SLAP lesion; (v) and/or acromioclavicular pathology. Subjects will not be required to undergo diagnostic imaging (i.e. Magnetic Resonance Imaging) to diagnosis the pathology because of the recruitment will be carried out by clinical findings.
3. Duration of symptoms: greater than 3 months. Receives: Other: Diagnosis/Prognosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline The brief pain inventory short form (BIP-SF) at 3,6,12,18 and 24 months
Pain will be assessed with The brief pain inventory short form (BIP-SF). This will be used to assess how pain interferes with patient's functioning in addition to measuring the intensity and location of pain.
Measured: Pain will be evaluated at baseline and 5 follow-ups (3,6,12,18 and 24 months).
Secondary outcomes (5)
Change from baseline Pain catastrophizing at 3, 6, 12, 18 and 24 months assessed with The Pain Catastrophizing Scale (PSC)
The catastrophic thinking bout pain will be assessed with The Pain Catastrophizing Scale (PSC).
Measured: Pain catastrophizing will be evaluated at baseline and 5 follow-ups (3,6,12,18 and 24 months).
Change from baseline Kinesiophobia at 3,6,12,18 and 24 months assessed with Tampa Scale For Kinesiophobia (TSK)
The fear of movement (kinesiophobia) will be assessed with Tampa Scale For Kinesiophobia (TSK).
Measured: Kinesiophobia will be evaluated at baseline and 5 follow-ups (3,6,12,18 and 24 months).
Change from baseline Fear avoidance at 3,6,12,18 and 24 months assessed with Fear Avoidance Belief Questionnaire (FABQ)
Fear avoidance will be assessed with Fear Avoidance Belief Questionnaire (FABQ).
Measured: Fear avoidance will be measured at baseline at 5 follow-ups (3,6,12,18 and 24 months)
Change from baseline Self-efficacy at 3,6,12,18 and 24 months assessed with Pain Self-Efficacy Questionnaire (PSEQ)
Self-efficacy will be assessed with Pain Self-Efficacy Questionnaire (PSEQ)
Measured: Self-efficacy will be measured at baseline at 5 follo-ups (3,6,12,18 and 24 months)
Change from baseline Shoulder Function at 3,6,12,18 and 24 months assessed with Shoulder Pain and Disability Index (SPADI)
Function will be assessed with Shoulder Pain and Disability Index (SPADI)
Measured: Function will be measured at baseline and 5 follow-ups (3,6,12,18 and 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2019
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Shoulder PainStudies of the same condition, open and under way.
- 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
- 90 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandro Luque-Suarez, University of Malaga
- Investigators
- Alejandro Luque Suarez, PhD, Principal investigator, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02738372
- Sponsor's protocol ID
- UMalaga
- Status last verified
- Oct 2018
- First submitted
- 5 Apr 2016
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Martinez-Calderon J, Struyf F, Meeus M, Morales-Ascencio JM, Luque-Suarez A. Influence of psychological factors on the prognosis of chronic shoulder pain: protocol for a prospective cohort study. BMJ Open. 2017 Mar 6;7(3):e012822. doi: 10.1136/bmjopen-2016-012822.
PubMed 28264825
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Biopsychosocial Factors and Peripheral and/or Central Sensitization in Predicting the Recovery of Chronic Shoulder Pain: a Prospective Cohort Study. Study Protocol
- ClinicalTrials.gov ID
- NCT02738372
- Acronym / sponsor ID
- UMalaga
- Conditions
- Chronic Shoulder Pain
- Keywords
- Chronic Pain, Biopsychosocial Factors, Shoulder pain, Prognosis, Central Nervous System Sensitization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Nov 2019 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 14 Apr 2016 (estimated)
- 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.
Background: Shoulder pain is the third most common musculoskeletal condition presenting to physicians or physiotherapists ) in primary healthcare after low back and neck pain being a significant cause of morbidity and functional disability in both working and general population. Despite the large group of individuals seeking for primary care services, about 50% of patients with shoulder pain still report persistent pain after 12-18 months. As a result, socio-economic burdens are considerable due to extensive use of heath care services, sickness absence, disability pension, and loss of productivity as well as, patient´s suffering.
Aims: the primary aim of this study was to evaluate what biopsychosocial factors predict a better and/or poor outcome in patients with Chronic shoulder pain. The secondary aim was to analyze the role of central sensitization in predicting a better and/or poor outcome in patients with Chronic shoulder pain.
Hypothesis:
- A high level of physical inactivity, kinesiophobia, fear avoidance and pain catastrophizing and low level of self-efficacy will ease the perpetuation of Chronic shoulder pain.
- The presence of central sensitization will predict a poor outcome in patients with chronic shoulder pain.
Detailed description
The present study will be a 24 months multi-center, double-blind, prospective, cohort study which will be carried out between April 2016 and March 2018. Subjects diagnosed of rotator cuff (RC) tendinopathy, adhesive capsulitis (AC), glenohumeral instability, superior labrum anterior to posterior (SLAP) lesion, and/or acromioclavicular pathology and fulfill the inclusion criteria will be asked for participating in the investigators study. Several questionnaires that will test the influence of different biopsychosocial factors and the presence of Central Sensitization will be administrated to these subjects. The outcomes will be assessed at baseline and 5 follow-ups (after 3, 6, 12, 18 and 24 months, t1-t6).
Subjects will attend for their routine clinical appointment. The examiners will carry out the clinical consultation according to usual practice. Subjects who fulfill the selection criteria will be asked whether they wish to be considered for trial participation. Examiners will inform subjects who are interested in participation. Ineligible subjects and those who do not wish to participate in the trial will receive normal clinical care delivered by clinicians according to the best clinical practice.
Anonymized age, gender and visual analogue scale (VAS)- verbal numeric rating scale (VNRS) for pain will be collected for those subjects who decline to take part in the project, in order to assess the external validity of the recruited sample of subjects.
Eligible patients who are interested in the trial will be asked to provide written informed consent to participate. The examiners will allocate the participants in an unique study group. Participants will then complete several questionnaires at baseline, 3, 6, 12, 18 and 24 months after the beginning of the study. A blinded examiner will deliver these questionnaires. Subsequent sessions will occur at the follow-up visits. Participants will be asked about any problems they had had during the previous months before following-up. There will be brief discussion about whether participants have subjected for any treatment (physical, pharmacological, injection and/or no treatment).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Shoulder Pain | – | Other: Diagnosis/Prognosis1. Men / women aged between 18 and 70 years. 2. Patients suffering from shoulder pain, defined as pain presented or exacerbated by movements in the shoulder, pain intensity ≥ 2 measured by a numerical scale with values from 0 to 10, meaning 0= no pain and 10= the worst pain, will be included in this study, among all these following shoulder pain conditions: (i) Rotator Cuff tendinopathy; (ii) Adhesive Capsulitis; (iii) glenohumeral instability; (iv) SLAP lesion; (v) and/or acromioclavicular pathology. Subjects will not be required to undergo diagnostic imaging (i.e. Magnetic Resonance Imaging) to diagnosis the pathology because of the recruitment will be carried out by clinical findings. 3. Duration of symptoms: greater than 3 months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects between 18-70 years with chronic shoulder pain
Key inclusion criteria (3 listed)
- Men / women aged between 18 and 70 years.
- Patients suffering from shoulder pain, defined as pain presented or exacerbated by movements in the shoulder, pain intensity = 2 measured by a numerical scale with values from 0 to 10, meaning 0= no pain and 10= the worst pain, will be included in this study, among all these following shoulder pain conditions: (i) rotator cuff (RC) tendinopathy ; (ii) adhesive capsulitis (AC) ; (iii) glenohumeral instability ; (iv) SLAP lesion; (v) and/or acromioclavicular pathology. Subjects will not be required to undergo diagnostic imaging (i.e MRI) to diagnosis the pathology because of the recruitment will be carried out by clinical findings.
- Duration of symptoms: greater than 3 months.
Key exclusion criteria (3 listed)
- Recent shoulder dislocation (1 year prior) and/or systemic diseases such as rheumatoid arthritis, osteoarthritis, fibromyalgia and/or polymyalgia rheumatica.
- Shoulder pain considered to be originated in the cervical region and other traumas or if there is a neurological dysfunction (i.e multiple sclerosis), osteoporosis, hemophilia and / or cancer.
- Inability to provide informed consent and/or complete written questionnaires.
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 |
|---|---|---|
| Diagnosis/PrognosisThe present study will be a 24 months multi-center, triple-blind, prospective, cohort study which will be carried out between April 2016 and March 2018. Subjects diagnosed of rotator cuff (RC) tendinopathy, adhesive capsulitis (AC), glenohumeral instability, SLAP lesion, and/or acromioclavicular pathology and fulfill the inclusion criteria will be asked for participating in our study. Several questionnaires that will test the influence of different biopsychosocial factors and the presence of Central Sensitization will be administrated to these subjects. The outcomes will be assessed at baseline and 5 follow-ups (after 3, 6, 12, 18 and 24 months, t1-t6). | Other | Chronic Shoulder Pain |
Primary outcome
Change from baseline The brief pain inventory short form (BIP-SF) at 3,6,12,18 and 24 months
Time frame: Pain will be evaluated at baseline and 5 follow-ups (3,6,12,18 and 24 months).
Pain will be assessed with The brief pain inventory short form (BIP-SF). This will be used to assess how pain interferes with patient's functioning in addition to measuring the intensity and location of pain.
5 secondary outcomes
Change from baseline Pain catastrophizing at 3, 6, 12, 18 and 24 months assessed with The Pain Catastrophizing Scale (PSC)
Time frame: Pain catastrophizing will be evaluated at baseline and 5 follow-ups (3,6,12,18 and 24 months).
Change from baseline Kinesiophobia at 3,6,12,18 and 24 months assessed with Tampa Scale For Kinesiophobia (TSK)
Time frame: Kinesiophobia will be evaluated at baseline and 5 follow-ups (3,6,12,18 and 24 months).
Change from baseline Fear avoidance at 3,6,12,18 and 24 months assessed with Fear Avoidance Belief Questionnaire (FABQ)
Time frame: Fear avoidance will be measured at baseline at 5 follow-ups (3,6,12,18 and 24 months)
Change from baseline Self-efficacy at 3,6,12,18 and 24 months assessed with Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: Self-efficacy will be measured at baseline at 5 follo-ups (3,6,12,18 and 24 months)
Change from baseline Shoulder Function at 3,6,12,18 and 24 months assessed with Shoulder Pain and Disability Index (SPADI)
Time frame: Function will be measured at baseline and 5 follow-ups (3,6,12,18 and 24 months)
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 25 Mar 2020.
- Derived from this study: PubMed 28264825Martinez-Calderon J, Struyf F, Meeus M, Morales-Ascencio JM, Luque-Suarez A. Influence of psychological factors on the prognosis of chronic shoulder pain: protocol for a prospective cohort study. BMJ Open. 2017 Mar 6;7(3):e012822. doi: 10.1136/bmjopen-2016-012822.
- Individual participant dataSharing planned: No
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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.
Alejandro Luque Suarez, PhD principal investigator
University of Malaga
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Shoulder Pain, run by University of Malaga.
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 3 inclusion and 3 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 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from baseline The brief pain inventory short form (BIP-SF) at 3,6,12,18 and 24 months (time frame: Pain will be evaluated at baseline and 5 follow-ups (3,6,12,18 and 24 months).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02738372, which also lists 1 linked publication.
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 25 Mar 2020.