Chronic Shoulder Pain Clinical Trial
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
NCT number | NCT02738372 |
Other study ID # | UMalaga |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 2016 |
Est. completion date | March 2020 |
Verified date | October 2018 |
Source | University of Malaga |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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:
1. 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.
2. The presence of central sensitization will predict a poor outcome in patients with
chronic shoulder pain.
Status | Completed |
Enrollment | 90 |
Est. completion date | March 2020 |
Est. primary completion date | November 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 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 (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. 3. Duration of symptoms: greater than 3 months. Exclusion Criteria: 1. Recent shoulder dislocation (1 year prior) and/or systemic diseases such as rheumatoid arthritis, osteoarthritis, fibromyalgia and/or polymyalgia rheumatica. 2. 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. 3. Inability to provide informed consent and/or complete written questionnaires. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Malaga |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Pain will be evaluated at baseline and 5 follow-ups (3,6,12,18 and 24 months). | |
Secondary | 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). | Pain catastrophizing will be evaluated at baseline and 5 follow-ups (3,6,12,18 and 24 months). | |
Secondary | 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). | Kinesiophobia will be evaluated at baseline and 5 follow-ups (3,6,12,18 and 24 months). | |
Secondary | 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). | Fear avoidance will be measured at baseline at 5 follow-ups (3,6,12,18 and 24 months) | |
Secondary | 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) | Self-efficacy will be measured at baseline at 5 follo-ups (3,6,12,18 and 24 months) | |
Secondary | 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) | Function will be measured at baseline and 5 follow-ups (3,6,12,18 and 24 months) |
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