Influence of Biopsychosocial Factors and Central Sensitization in Predicting the Recovery of Chronic Shoulder Pain

NCT02738372 | Completed DMC

• 1 other identifier: UMalaga
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 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. 2.The presence of central sensitization will predict a poor outcome in patients with chronic shoulder pain.

Conditions

Chronic Shoulder Pain

Keywords

Chronic Pain; Biopsychosocial Factors; Shoulder pain; Prognosis; Central Nervous System Sensitization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change from baseline Pain catastrophizing at 3, 6, 12, 18 and 24 months 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).

• Change from baseline Kinesiophobia at 3,6,12,18 and 24 months assessed with Tampa Scale For Kinesiophobia (TSK)

  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 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 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 measured at baseline and 5 follow-ups (3,6,12,18 and 24 months)

Study Arms (1)

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.

Other: Diagnosis/Prognosis

Interventions

Diagnosis/Prognosis OTHER

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).

Chronic Shoulder Pain

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects between 18-70 years with chronic shoulder pain

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaga: lead

Related Publications (1)

• 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.

  PMID: 28264825 DERIVED

MeSH Terms

Conditions

Chronic Pain; Shoulder Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Alejandro Luque Suarez, PhD

  University of Malaga

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 5, 2016
• First Posted: April 14, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2019
• Study Completion: March 1, 2020
• Last Updated: March 25, 2020

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share