Back PainNCT02704845

Biopsychosocial Exploration of Pain Profiles in Inflammatory and Chronic Non-specific Axial Low Back Pain

An observational study of Back Pain and Spondylitis, Ankylosing, run by University of Dublin, Trinity College at 3 sites in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Back Pain, Spondylitis, Ankylosing, Low Back Pain
How many people: 58 participants
Where: 3 sitesIreland
Study dates: Sep 2015to Aug 2016
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: A convenience sample of adults with Ankylosing Spondylitis (AS) will be consecutively recruited from a pool of patients referred to AS clinic in the Rheumatology and Physiotherapy Departments of St. James's and Tallaght Hospitals in Dublin. Adults with chronic non-specifi low back pain (CNSLBP) (control group) will be consecutively recruited from a pool of patients referred to the Physiotherapy Department of St. James's and Tallaght Hospitals in Dublin. An invitation to participate in the study and an information leaflet will be extended to the patients who potentially meet the recruitment criteria.

Who may be able to join

Adult between 18 and 65 years of age
Low back pain >3 months
On stable medication
Ability to walk independently without an assistive device
Specific inclusion criteria for AS group: clinical diagnosis of ankylosing spondylitis by a rheumatologist
Specific inclusion for CNSLBP group: clinical diagnosis by a physician for CLBP

Who cannot join

Spinal surgery or compression fracture within the last 6 months
Cauda equine and conus medullaris syndromes
Severe musculoskeletal conditions affecting the upper and/or the lower limbs, such as severe inflammatory arthritis of the peripheral joints
Severe osteoporosis
Leg-length discrepancy
Cancer

Show all 13Show fewer

Morbid obesity, or pregnancy
Progressive neurological disease
Psychiatric disease and/or cognitive limitations that could affect the ability to complete the study questionnaires
Inability to read and/or understand the English language
Severe cardiac, respiratory or neurological diseases
Uncontrolled epilepsy
Specific exclusion criteria for CNSLBP group: Spondyloarthropathy, or any structural abnormalities in the lumbar spine that result in serious neurological dysfunction, such as stage III-IV lumbar disc herniation, and grade III-IV spondylolisthesis

Trial locations and contacts

3 sites in 1 country.

Ireland3 sites

Physiotherapy Department, Adelaide and Meath Incorporating the National Children's Hospital (Tallaght Hospital)
Dublin, D24
Ankylosing Spondylitis clinic, Rheumatology Department, St. James's Hospital
Dublin, D8
Physiotherapy Department, St. James's Hospital
Dublin, D8

Other trials in Ireland

About this study

Official title: Biopsychosocial Exploration of Pain Profiles in Inflammatory and Chronic Non-specific Axial Low Back Pain: An Exploration of Similarities and Differences

The biopsychosocial model is well established in chronic low back pain (CLBP) research. Nevertheless, researchers to date have overlooked the biopsychosocial aspects of Inflammatory Low Back pain (ILBP). Most health care providers are biologically oriented in their treatment of ILBP, neglecting its possible multidimensional nature. It is true that people with ILBP may present with more complex pain and physical limitations than those with chronic non-specific low back pain (CNSLBP), but it remains unexplored whether or not these limitations are affected by the same pain factors that affect CNSLBP patients. This study aims to explore and compare the biopsychosocial back pain profiles of adults with ILBP and CNSLBP.

Read the detailed description

This is a multicentre case-control study that will compare back pain in patients with ankylosing spondylitis and CNSLBP. A multidimensional pain assessment will be conducted for patients in both groups. Each patient will be assessed on one occasion by the same experienced physiotherapist.

Conditions: Back Pain, Spondylitis, Ankylosing, Low Back Pain
Keywords: Inflammatory back pain, Ankylosing spondylitis, Non-specific low back pain, Pain experience, Disability, Behavioural, Psychological, Biopsychosocial, Pain profiles
Medical subject headings: Back Pain, Spondylitis, Ankylosing, Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02704845
Study group	Role	What they receive
Ankylosing Spondylitis		Not described
Chronic non-specific low back pain		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Back pain intensity - total
The average total back pain intensity in the last week will be measured by the Numeric Rating Scale (NRS)
Measured: Day 1, no follow-up will be required.
Back pain-related functional disability
Oswestry Disability Index (ODI)
Measured: Day 1, no follow-up will be required.

Secondary outcomes (21)

Back pain beliefs
Back Beliefs Questionnaire (BBQ)
Measured: Day 1, no follow-up will be required.
Pain-related fear, fear of movement/(re)injury
Tampa Scale for Kinesiophobia (TSK)
Measured: Day 1, no follow-up will be required.
The fear-avoidance behaviours of physical activity
modified Fear Avoidance Behaviour Questionnaire (mFABQ)
Measured: Day 1, no follow-up will be required.
Pain catastrophizing behavior
Pain catastrophizing scale (PCS)
Measured: Day 1, no follow-up will be required.
Self-efficacy for AS patients
Ankylosing Spondylitis-specific Arthritis Self-Efficacy Scale (ASES-AS)
Measured: Day 1, no follow-up will be required.
Pain cognition and coping
Pain Coping Inventory (PCI)
Measured: Day 1, no follow-up will be required.
Psychological distress (depression & anxiety)
Hospital Anxiety and Depression Scale (HADS)
Measured: Day 1, no follow-up will be required.
The extent and location of pain
Pain drawings will be completed for NSCLBP patients on a digital tablet (iPad 2, Apple Computer, Cupertino, CA, USA) using a commercially available sketching software (SketchBook)
Measured: Day 1, no follow-up will be required.
Back pain intensity - nocturnal
The average nocturnal back pain intensity in the last week will be measured by the Numeric Rating Scale (NRS)
Measured: Day 1, no follow-up will be required.
Physical function for AS patients
Bath Ankylosing Spondylitis Functional Index (BASFI)
Measured: Day 1, no follow-up will be required.
Disease activity for AS patients
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Measured: Day 1, no follow-up will be required.
Disease activity for AS patients
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Measured: Day 1, no follow-up will be required.
Global well-being for AS patients
Bath Ankylosing Spondylitis Global score (BAS-G)
Measured: Day 1, no follow-up will be required.
Flexibility and spinal mobility for AS patients
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Measured: Day 1, no follow-up will be required.
Chest expansion
Chest expansion will be measured circumferentially using a tape measure
Measured: Day 1, no follow-up will be required.
Forward bending
Finger-to-Floor Distance in centimetres (cm) will be measured using a tape measure
Measured: Day 1, no follow-up will be required.
Isometric endurance of the trunk extensor muscles
Ito test
Measured: Day 1, no follow-up will be required.
Isometric endurance of the the trunk flexor muscles
Shirado test
Measured: Day 1, no follow-up will be required.
Grip strength
Hand grip dynamometer (Jamar Hydraulic Hand Dynamometer)
Measured: Day 1, no follow-up will be required.
Functional performance
50-foot walk test
Measured: Day 1, no follow-up will be required.
Functional performance and endurance
6-min walk distance (6MWD) test
Measured: Day 1, no follow-up will be required.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2015Aug 2016

First posted10 Mar 2016 (estimated)
Study startSep 2015
Primary completionAug 2016
Study completionAug 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Back 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: Case-control
Time perspective: Cross-sectional
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02704845
Sponsor's protocol ID: UDublinTC 12
Status last verified: Oct 2016
First submitted: 27 Feb 2016
Last updated: 21 Oct 2016
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain

All Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Biopsychosocial Exploration of Pain Profiles in Inflammatory and Chronic Non-specific Axial Low Back Pain: An Exploration of Similarities and Differences
ClinicalTrials.gov ID: NCT02704845
Acronym / sponsor ID: UDublinTC 12
Conditions: Back Pain, Spondylitis, Ankylosing, Low Back Pain
Keywords: Inflammatory back pain, Ankylosing spondylitis, Non-specific low back pain, Pain experience, Disability, Behavioural, Psychological, Biopsychosocial
Study type: Observational
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: University of Dublin, Trinity CollegeUniversity, hospital or other
Study start: Sep 2015
Primary completion: Aug 2016 (actual)
Study completion: Aug 2016 (actual)
First posted: 10 Mar 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.

Detailed description

Study design

Observational model: Case-control
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
Ankylosing Spondylitis	–	–
Chronic non-specific low back pain	–	–

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: A convenience sample of adults with Ankylosing Spondylitis (AS) will be consecutively recruited from a pool of patients referred to AS clinic in the Rheumatology and Physiotherapy Departments of St. James's and Tallaght Hospitals in Dublin. Adults with chronic non-specifi low back pain (CNSLBP) (control group) will be consecutively recruited from a pool of patients referred to the Physiotherapy Department of St. James's and Tallaght Hospitals in Dublin. An invitation to participate in the study and an information leaflet will be extended to the patients who potentially meet the recruitment criteria.

Key inclusion criteria (6 listed)

Adult between 18 and 65 years of age
Low back pain >3 months
On stable medication
Ability to walk independently without an assistive device
Specific inclusion criteria for AS group: clinical diagnosis of ankylosing spondylitis by a rheumatologist

Key exclusion criteria (13 listed)

Spinal surgery or compression fracture within the last 6 months
Cauda equine and conus medullaris syndromes
Severe musculoskeletal conditions affecting the upper and/or the lower limbs, such as severe inflammatory arthritis of the peripheral joints
Severe osteoporosis
Leg-length discrepancy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Back pain intensity - total
Time frame: Day 1, no follow-up will be required.
The average total back pain intensity in the last week will be measured by the Numeric Rating Scale (NRS)
Back pain-related functional disability
Time frame: Day 1, no follow-up will be required.
Oswestry Disability Index (ODI)

21 secondary outcomes

Back pain beliefs
Time frame: Day 1, no follow-up will be required.
Pain-related fear, fear of movement/(re)injury
Time frame: Day 1, no follow-up will be required.
The fear-avoidance behaviours of physical activity
Time frame: Day 1, no follow-up will be required.
Pain catastrophizing behavior
Time frame: Day 1, no follow-up will be required.
Self-efficacy for AS patients
Time frame: Day 1, no follow-up will be required.
Pain cognition and coping
Time frame: Day 1, no follow-up will be required.
Psychological distress (depression & anxiety)
Time frame: Day 1, no follow-up will be required.
The extent and location of pain
Time frame: Day 1, no follow-up will be required.
Back pain intensity - nocturnal
Time frame: Day 1, no follow-up will be required.
Physical function for AS patients
Time frame: Day 1, no follow-up will be required.
Disease activity for AS patients
Time frame: Day 1, no follow-up will be required.
Disease activity for AS patients
Time frame: Day 1, no follow-up will be required.
Global well-being for AS patients
Time frame: Day 1, no follow-up will be required.
Flexibility and spinal mobility for AS patients
Time frame: Day 1, no follow-up will be required.
Chest expansion
Time frame: Day 1, no follow-up will be required.
Forward bending
Time frame: Day 1, no follow-up will be required.
Isometric endurance of the trunk extensor muscles
Time frame: Day 1, no follow-up will be required.
Isometric endurance of the the trunk flexor muscles
Time frame: Day 1, no follow-up will be required.
Grip strength
Time frame: Day 1, no follow-up will be required.
Functional performance
Time frame: Day 1, no follow-up will be required.
Functional performance and endurance
Time frame: Day 1, no follow-up will be required.

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 21 Oct 2016.

Related trials for Back Pain

RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain

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.

Fiona Wilson principal investigator

Trinity College Dublin, Ireland

Lolwah A Al-Rashed principal investigator

Trinity College Dublin, Ireland

Finbar O'Shea principal investigator

St. James's Hospital, Dublin, Ireland

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Back Pain and Spondylitis, Ankylosing, run by University of Dublin, Trinity College at 3 sites in Ireland.

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 6 inclusion and 13 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 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Ireland. 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?

Back pain intensity - total (time frame: Day 1, no follow-up will be required.). 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?

On the ClinicalTrials.gov record for NCT02704845.

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 21 Oct 2016.