Pain Experience in Individuals With Chronic Low Back Pain

NCT03972332 | Completed

• 1 other identifier: 17112
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

Low back pain is a very common musculoskeletal condition that affects many people each year regardless of age, gender, and ethnicity. Most people get better however, some continue suffering from painful episodes despite treatment. Self-management strategies for the management of chronic low back pain are very important to patients as they help them develop skills to manage their pain more effectively. However, self-management strategies are not always effective as expected. It is possible that the brain has become very sensitive to signals coming from peripheral parts of the body (e.g. low back) affecting the ability of patients to self-manage their condition. The aim of this study is to establish whether central sensitisation (sensitivity of the brain to peripheral signals) predicts how effective self-management approaches will be. On three different occasions, scheduled sessions will include a clinical assessment session and completion of a questionnaire booklet. The clinical assessment will measure three features of central sensitisation: 1) sensitivity to blunt pressure on the forearm, 2) changes in pain, felt during repeated light pricking of the forearm skin, and 3) reduction in pain that accompanies inflation of a blood pressure cuff on the opposite arm. Participant involvement at each session is expected to last for 70 minutes. Individuals over 18, diagnosed with chronic low back pain and enlisted to follow a pain management program are eligible to participate. The clinical assessments, questionnaire completion and subsequent statistical analysis are expected to be completed within 18 months of study commencement. Based on our findings, future research may use similar clinical assessment to identify people who might be helped to self-manage by using treatment that reduces central sensitisation.

Conditions

Low Back Pain

Keywords

Low Back Pain; Central Sensitisation; Hyperalgesia; Hypersensitivity

Outcome Measures

Primary Outcomes (1)

• Self-management

  Self-management will be assessed with the Health Education Impact Questionnaire (heiQ) that measures the ability of a patient to self-manage their condition and features 40 questions that spread across 8 distinct domains (Health Directed Behavior: 4 items; Positive and Active Engagement in Life: 5 items; Self-Monitoring and Insight: 6 items; Constructive Attitudes and Approaches: 5 items; Skill and Technique Acquisition: 4 items; Social Integration and Support: 5 items Health Service Navigation: 5 items; and Emotional Wellbeing: 6 items). Each item is rated with a 4-level scale (Strongly agree to Strongly disagree) and a number (1-4) is allocated that leads to the calculation of a mean. No single value can be produced for heiQ. Rather, each domain must be used individually. The higher the value the best the self-management ability in all domains apart from Emotional Wellbeing where a high value represents a low self-management ability.

  3 months

Secondary Outcomes (14)

• Pain Severity: Numerical Rating Scale (NRS)

  3 months

• Levels of Disability

  3 months

• Patient Quality of Life: EQ-5D-5L questionnaire

  3 months

• Self-efficacy: Pain Self-efficacy Questionnaire (PSEQ)

  3 months

• Fatigue

  3 months

Other Outcomes (1)

• Course of low back pain: Keele Stratification and Screening Tool for Low Back Pain (STarT-Back)

  3 months

Study Arms (2)

Sensitised

Participants with sensitisation that significantly deviates from the normal mean as assessed by Quantitative Sensory Testing

Diagnostic Test: Quantitative Sensory Testing

Non-sensitised

All other participants with sensitisation that is not significantly deviating from the normal mean as assessed by Quantitative Sensory Testing

Diagnostic Test: Quantitative Sensory Testing

Interventions

Quantitative Sensory Testing DIAGNOSTIC_TEST

PPT: An electronic data collection unit will be used featuring an electronic algometer connected with a laptop where the amount of pressure will be displayed on the screen. When the pressure pain detection threshold is reached (the point where the pressure sensation starts to be experienced as pain), the individual will press a button at a handheld device, that will automatically store the pressure value in the system and serve as an indication, for the examiner, to stop the testing. TS: A pinprick stimulator (Weight: 256mNewton) will be used. The examiner will apply the pen that features a retractable blunt needle in a repetitive manner (once per second for ten seconds). The individual will be asked for the intensity of pain (NRS) at the first and at the last time and the given score will be noted. CPM: A manual blood pressure sphygmomanometer will be used in conjunction with the electronic algometer described above (PPT).

Also known as: Pain Pressure Detection Threshold (PPT), Temporal Summation (TS), Conditioned Pain Modulation (CPM)

Non-sensitised; Sensitised

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with a confirmed diagnosis of CLBP that have been assigned for participation to a self-management program at a clinical or community setting

You may qualify if:

• have the ability to give informed consent.
• be 18 years old or over
• be diagnosed with chronic LBP
• be enlisted for participation in a self-management program
• be able to speak and understand English as all questionnaires are validated in the English language.

You may not qualify if:

• Inability to give informed consent due to cognitive impairment or otherwise
• Inability to understand key aspects of the study due to cognitive impairment or otherwise
• Patients giving history of additional co-morbidities such as cancer, diabetic neuropathies, fractures or other conditions causing greater disability than their back pain.
• Pregnancy

Sponsors & Collaborators

• University of Nottingham: lead
• Versus Arthritis: collaborator
• Nottingham Biomedical Research Centre: collaborator
• Muculoskeletal Association of Chartered Physiotherapists: collaborator

Study Sites (1)

King's Mill Hospital

Sutton in Ashfield, Nittinghamshire, NG17 4JL, United Kingdom

Location

Related Publications (27)

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  BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Hyperalgesia; Hypersensitivity

Interventions

Postsynaptic Potential Summation

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Somatosensory Disorders; Sensation Disorders; Nervous System Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Synaptic Transmission; Signal Transduction; Biochemical Phenomena; Chemical Phenomena; Synaptic Potentials; Membrane Potentials; Cell Physiological Phenomena; Electrophysiological Phenomena; Physiological Phenomena; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• David A. Walsh

  The University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 3, 2019
• Study Start: July 27, 2018
• Primary Completion: March 20, 2020
• Study Completion: March 20, 2020
• Last Updated: March 25, 2020

Record last verified: 2020-03

Locations

GB (1)