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Trial record 45 of 3395 for:    Recruiting, Not yet recruiting, Available Studies | Pain

Pain Experience in Individuals With Chronic Low Back Pain

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ClinicalTrials.gov Identifier: NCT03972332
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : June 13, 2019
Sponsor:
Collaborators:
Versus Arthritis
Nottingham Biomedical Research Centre
Muculoskeletal Association of Chartered Physiotherapists
Information provided by (Responsible Party):
University of Nottingham

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.


Condition or disease Intervention/treatment
Low Back Pain Diagnostic Test: Quantitative Sensory Testing

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pain Experience in Individuals With Chronic Low Back Pain: a Cohort Study
Actual Study Start Date : July 27, 2018
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Group/Cohort Intervention/treatment
Sensitised
Participants with sensitisation that significantly deviates from the normal mean as assessed by Quantitative Sensory Testing
Diagnostic Test: Quantitative Sensory Testing

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).

Other Names:
  • Pain Pressure Detection Threshold (PPT)
  • Temporal Summation (TS)
  • Conditioned Pain Modulation (CPM)

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

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).

Other Names:
  • Pain Pressure Detection Threshold (PPT)
  • Temporal Summation (TS)
  • Conditioned Pain Modulation (CPM)




Primary Outcome Measures :
  1. Self-management [ Time Frame: 3 months ]
    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.


Secondary Outcome Measures :
  1. Pain Severity: Numerical Rating Scale (NRS) [ Time Frame: 3 months ]
    Pain will be assessed with the Numerical Rating Scale (NRS) where patients will be asked to rate their current pain on a scale from 0 to 10 with 0 indicating no pain and 10 the worst pain imaginable.

  2. Levels of Disability [ Time Frame: 3 months ]
    Disability will be assessed with the Roland-Morris Disability Questionnaire (RMDQ) where patients are asked to tick a box if they agree with 24 statements regarding their ability to perform certain activities (dressing, housework, walking). If the don't agree with the statement (able to perform thoe activities) they need to leave the tick-box blank or unchecked. Every agreement (tick) counts as a point and an absolute value is formed (min: 0, max: 24). The higher the value the higher the disability level.

  3. Patient Quality of Life: EQ-5D-5L questionnaire [ Time Frame: 3 months ]
    Quality of Life will be assessed with the EQ-5D-5L questionnaire. EQ-5D-5L has two components: health state description and evaluation. In the description part, health status is measured in terms of 5 dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondents self-rate their level of severity for each dimension using a five-level (5L) scale (no problem to extremely severe). Each dimension can be used for analysis as a categorical variable or combined with the others as a 5-digit value according to responses (example 11231). On a single dimension, a categorical value of 1 signifies no problem and a value of 5 extremely severe problem. Similarly, a combined value of 11111 shows excellent quality of life whereas a value of 55555 shows a severely affected quality of life.

  4. Self-efficacy: Pain Self-efficacy Questionnaire (PSEQ) [ Time Frame: 3 months ]
    Self-efficacy will be assessed with the Pain Self-efficacy Questionnaire (PSEQ) where patients are asked to indicate their levels of confidence with a 0-6 scale (0 indicates not at all confident and 6 extremely confident)on an array of 10 questions. A sum of all responses is calculated (60 being the maximum) for analysis. The higher the value the higher the levels of self-efficacy.

  5. Fatigue [ Time Frame: 3 months ]

    Fatigue will be assessed with the Fatigue Severity Scale (FSS) where patients are asked to indicate their levels of agreement with a 0-7 scale (0 indicates strong disagreement and 7 strong agreement) at 9 questions. A sum of all responses is calculated (63 being the maximum) for analysis. The higher the value the higher the level of fatigue.

    Also, patients are asked to rate their global fatigue on a 0-10 scale with 0 being worst and 10 being normal fatigue. This sub-scale will be used on its own for analysis.


  6. Anxiety [ Time Frame: 3 months ]
    Anxiety will be assessed with the Anxiety part of the Hospital Anxiety and Depression Scale (HADS) where patients are asked to indicate their levels of emotion frequency with a 4-level scale (0-3: 0 indicates never and 3 all the time) at 7 questions. A sum of all responses is calculated (21 being the maximum) for analysis. The higher the value the higher the levels of anxiety.

  7. Depression [ Time Frame: 3 months ]
    Depression will be assessed with the Depression part of the Hospital Anxiety and Depression Scale (HADS) where patients are asked to indicate their levels of emotion frequency with a 4-level scale (0-3: 0 indicates all the time and 3 never) at 7 questions. A sum of all responses is calculated (21 being the maximum) for analysis. The higher the value the higher the levels of depression.

  8. Catastrophization [ Time Frame: 3 months ]
    Catastrophization will be assessed with the Pain Catastrophizing Scale (PCS) where patients are asked to indicate their levels of belief frequency with a 5-level scale (0-4: 0 indicates not at all and 3 all the time) at 13 questions. A sum of all responses is calculated (52 being the maximum) for analysis. The higher the value the higher the levels of catastrophizing.

  9. Kinesiophobia [ Time Frame: 3 months ]
    Kinesiophobia will be assessed with the Tampa Scale for Kinesiophobia (TSK) where patients are asked to indicate their levels of agreement with a 4-level scale (1-4: 1 indicates not at all and 3 all the time) at 17 questions. A sum of all responses is calculated (68 being the maximum) for analysis. The higher the value the higher the levels of kinesiophobia.

  10. Neuropathic Pain: Pain-DETECT questionnaire (PD-Q) [ Time Frame: 3 months ]
    Neuropathic pain will be assessed with the Pain-DETECT questionnaire (PD-Q) where patients are firstly asked to describe the course of their pain by choosing one of 3 different pictures. A value has been allocated to each picture (-1, 0, +1 and +1). Secondly they are asked to indicate (yes or no) whether their pain radiates to a different part of their body. Yes is marked with +2 whereas No with 0. Thirdly, patients are asked to indicate their symptom intensity with a 6-level scale (0-5: 0 indicates never and 5 very strongly) at 7 questions. A sum of all responses is calculated and a final value is formed with the addition of the values from step one and two (38 being the maximum) for analysis. The higher the value the higher the levels of neuropathic pain.

  11. Widespread Pain [ Time Frame: 3 months ]
    Widespread pain will be assessed with the the use of a blank body manikin where patients are asked to draw the areas of pain on the manikin. Unbeknownst to patients, the manikin is divided into 46 body areas. A categorical variable is entered (1 for pain on the area, 0 for no pain) according to the pain distribution of the patients. No single value can be produced for analysis. Areas distant to the primary area of pain (Lower Back), like the chest or the forearm, will be used as independent variables in a multivariate regression model.

  12. Fibromyalgia Severity [ Time Frame: 3 months ]
    Fibromyalgia severity will be assessed with the Fibromyalgia Severity Scale (FMSS) where patients are firstly asked to tick a box on a body manikin if they feel pain on that area. Each tick is marked with 1 point. Then, patients are asked to indicate their symptom severity with a 4-level scale (0-3: 0 = no problem and 3 = severe) at 3 questions about tiredness, sleep and forgetfulness. A sum of all responses is calculated and is added to the total manikin value. Lastly, patients are asked to indicate whether they experienced headaches, depression and abdominal pain amongst 37 other symptoms. If they did, a point for each symptom is added on their overall mark (min: 0, max: 31). The higher the overall value the higher the severity of fibromyalgia.

  13. Health care utilisation [ Time Frame: 3 months ]
    Health care utilisation will be measured with the unvalidated Health Care Utilisation Questionnaire for Low Back Pain (HCUQ-LBP) where patients will be asked to indicate the type and amount of health care utilisation (visits to hospital, visits/calls to general practitioners (GPs) and practice nurses, use of social care, physiotherapists, chiropractors, psychologists, osteopaths and occupational therapists) in the last 3 months. Every health care use will be marked with a point and a total value will be produced for analysis (min: 0, max: any). The higher the value the higher the health care utilisation.

  14. Medication type utilisation [ Time Frame: 3 months ]
    Medication type utilisation will be determined when patients will be asked to record on a specially designed sheet the type of received medication in the last three months. Separate categories will be formed according to medication type (e.g. anti-inflammatory non-steroidal drugs, steroids, opioids, non-opioids) and a categorical variable will be stored (1 for yes, 0 for no) on these categories. No single value can be produced for analysis for this sub-questionnaire. Categories of medication types will be used as categorical independent variables in a multivariate regression model.


Other Outcome Measures:
  1. Course of low back pain: Keele Stratification and Screening Tool for Low Back Pain (STarT-Back) [ Time Frame: 3 months ]
    The prognosis of Low Back Pain will be determined with the Keele Stratification and Screening Tool for Low Back Pain (STarT-Back) where patients are asked to agree or disagree with 8 sentences (tick appropriately) and on a 9th question indicate how bothersome their back pain is on a 5-level scale (not at all to extremely). Every agreement is marked with 1 point as well as if patients rate their back pain as very much or extremely bothersome. A sum of all responses is calculated (9 being the maximum) for interpretation and analysis. The higher the value the higher the risk of unfavourable prognosis.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03972332


Contacts
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Contact: Vasileios Georgopoulos +44 (0)115 823 1759 vasileios.georgopoulos@nottingham.ac.uk
Contact: David A. Walsh +44 (0) 115 823 1751 david.walsh@nottingham.ac.uk

Locations
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United Kingdom
King's Mill Hospital Recruiting
Sutton In Ashfield, Nittinghamshire, United Kingdom, NG17 4JL
Contact: Vasileios Georgopoulos    +44(0)1623676015 ext 3912    vasileios.georgopoulos@nottingham.ac.uk   
Contact: David Walsh       david.walsh@nottingham.ac.uk   
Sponsors and Collaborators
University of Nottingham
Versus Arthritis
Nottingham Biomedical Research Centre
Muculoskeletal Association of Chartered Physiotherapists
Investigators
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Principal Investigator: David A. Walsh The University of Nottingham

Publications:
Bridges, S., Chronic Pain, in Health Survey for England 2011. 2012, Health and Social Care Information Centre: UK.
de Silva, D., Helping people help themselves: A review of the evidence considering whether it is worthwhile to support self-management. 2011: Health Foundation.
O'Sullivan, P., et al., Multidimesional approach for the targeted management of low back pain, in Grieve's Modern Musculoskeletal Physiotherapy: Vertebral Column and Peripheral Joints, G. Jull, et al., Editors. 2015, Elsevier Health Sciences: UK. p. 465-470.
Nijs, J., et al., The neurophysiology of pain and pain modulation: Modern pain neuroscience for musculoskeletal physiotherapists, in Grieve's Modern Musculoskeletal Physiotherapy: Vertebral Column and Peripheral Joints, G. Jull, et al., Editors. 2015, Elsevier Health Sciences: UK.
Knofczynski, G.T. and D. Mundfrom, Sample sizes when using multiple linear regression for prediction. Educational and Psychological Measurement, 2008. 68(3): p. 431-442.

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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT03972332     History of Changes
Other Study ID Numbers: 17112
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Nottingham:
Low Back Pain
Central Sensitisation
Hyperalgesia
Hypersensitivity

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms