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PROs in Chronic Low Back Pain Patients With Accompanying Lower Limb Pain (Neuropathic Component) Treated With Pregabalin (PRO)

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ClinicalTrials.gov Identifier: NCT02273908
Recruitment Status : Completed
First Posted : October 24, 2014
Results First Posted : January 6, 2017
Last Update Posted : January 6, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The purpose of this study is to evaluate the effect of pregabalin comparing with the conventional analgesic care in chronic low back pain patients with accompanying lower limb pain (neuropathic component) treated in primary care settings under routine clinical practice.

Condition or disease Intervention/treatment
Low-Back Pain Other: No intervention

Detailed Description:

Rational and background :

The care for low back pain associated with neuropathic pain is a problem often encountered in daily outpatient.

And the care effectiveness has been frequently evaluated by the patients directly, because the pain would be felt by patients themselves.

On the view of those, we decided to investigate the clinical treatment outcome of pregabalin or other analgesics medication for relief of pain and improvement of sleep interference and QOLs by Patient-reported outcomes.

Research question and objectives :

To evaluate the effect of pregabalin comparing with the conventional analgesic care in chronic low back pain patients with accompanying lower limb pain (neuropathic component) treated in primary care settings under routine clinical practice.

Study design:

This is an 8-week, multicenter prospective observational study. Subjects who have chronic low back pain patients with accompanying lower limb pain (with a neuropathic component) and meet all other entry criteria are enrolled at baseline in the duration of study. The analgesic treatment is determined by the clinical judgment of the physician in charge of patient management. This therapeutic choice is not related to the decision to take part in the study. All enrolled subjects will be received with analgesic treatment. The study requires 3 visits at least, baseline/enrollment visit, Week 4 visit and Week 8 visit (or discontinuation).

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Study Type : Observational
Actual Enrollment : 331 participants
Time Perspective: Prospective
Official Title: Patient-reported-outcomes(PROs) in Chronic Low Back Pain Patients With Accompanying Lower Limb Pain (Neuropathic Component) Treated With Pregabalin in Primary Care Settings
Study Start Date : July 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
Drug Information available for: Pregabalin

Group/Cohort Intervention/treatment
Pregabalin
Patients will be treated for 8 weeks with pregabalin in primary care: no intervention
Other: No intervention
The study is observational

Usual care
Patients will be treated for 8 weeks with other analgesics in usual care: no intervention
Other: No intervention
The study is observational




Primary Outcome Measures :
  1. Change From Baseline in Pain Related Sleep Interference Scale (PRSIS - Past Week Recall) [ Time Frame: Baseline, Final Visit (Week 8) ]
    The Pain Related Sleep Interference Scale (past week recall) consists of an 11-point rating scale ranging from 0 (pain did not interfere with sleep) to 10 (pain completely interfered with sleep). Change the rating scale from baseline to week 8 in each group. Subjects are to describe how their pain has interfered with their sleep during the past week by choosing the appropriate number between 0 and 10.


Secondary Outcome Measures :
  1. Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Total Score- [ Time Frame: Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation) ]
    The RMDQ is an index of how well patients with low back pain are able to function with regard to daily activities. The score for the index ranges from 0 to 24 with a lower score indicating better function.

  2. Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Japanese Standardized Score- [ Time Frame: Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation) ]
    The RMDQ is an index of how well patients with low back pain are able to function with regard to daily activities. The score for the index ranges from 0 to 24 with a lower score indicating better function.

  3. Change From Baseline in Pain Numeric Rating Scale (Pain NRS - Past Week Recall) [ Time Frame: Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation) ]
    The Pain NRS (past week recall) consists of an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain). Subjects are asked to describe their average pain during the past week by choosing the appropriate number between 0 and 10.

  4. Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-QOL-Score- [ Time Frame: Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation) ]
    The EQ-5D-5L is a copyrighted, subject-completed questionnaire designed to assess health-related quality of life in terms of a single index value or utility score. The Health State Profile is designed to record the subject's level of current health for five domains comprising a health profile: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Responses from the five domains are used to calculate a single utility index value.; 1 indicates better health state (no problems); 5 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile; from 11111 to 55555. Score is transformed and results in a total score range -0.025 to 1.000; higher score indicates a better health state.

  5. Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-Visual Analogue Scale - [ Time Frame: Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation) ]

    The EQ-5D-5L is a copyrighted, subject-completed questionnaire designed to assess health-related quality of life in terms of a single index value or utility score. There are two components to the EQ-5D-5L: A Health State Profile and a Visual Analogue Scale (VAS). Recent guidance suggests that the Health State Profile and VAS should be administered together.

    The Visual Analogue Scale (VAS) is designed to rate the subject's current health state on a scale from 0 to 100 where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.


  6. Clinical Global Impression of Change (CGIC) [ Time Frame: Final Visit (Week8 or discontinuation) ]
    The CGIC assessment includes one question (1-7 scale) inquiring about the subject's improvement considering their current disease state.; range from 1 (very much improved) to 7 (very much worse).

  7. Patient Global Improvement of Change (PGIC) [ Time Frame: Final Visit (Week8 or discontinuation) ]
    The PGIC is a subject-rated instrument that measures change in the subject's overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse).

  8. Work Productivity and Activity Impairment Scale (WPAI:LBP) [ Time Frame: Final Visit (Week8 or discontinuation) ]

    The WPAI: LBP is a self-administered questionnaire that measures the effect of general health and symptom severity on work productivity and regular activities. Subscale scores include Percent work time missed due to pain (PWP), Percent overall work impairment (PWI), Percent work productivity impairment due to pain (PWPI), Percent overall activity impairment (PAI). Each subscale score is expressed as an impairment percentage (0-100) where higher numbers indicate greater impairment and less productivity. Here, "n" signifies "Number of participants" for Baseline.

    In this study, the WPAI: LBP will measure the effect of the patient's Chronic Low Back Pain (CLBP) with accompanying lower limb pain (neuropathic component) on work productivity and regular activities.



Other Outcome Measures:
  1. Number of Patients With Adverse Events [ Time Frame: Visit2(week4),Final Visit(Week8 or discontinuation) ]


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:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chronic low-back pain patients with neuropathic component will be treated with pregabalin or other analgesics
Criteria

Inclusion Criteria:

  1. Subject who received the enough study information and signed informed consent form.
  2. Subject who had chronic low back pain accompanying with lower limb pain from the knee to the ankle.
  3. Subject is male or female patient ≥18 years old.
  4. Subject who has complained low back pain for 3 months or more before Visit 1.
  5. Subject who is refractory to prior analgesics for 3 months and more.
  6. Subject who is able and willing to complete all study related assessment and comply with the study schedule and clinical procedures at clinic.
  7. Subject whose pain Numeric Rating Scale(NRS) ≥ 5 at baseline (based on recall over the past week)

Exclusion Criteria:

  1. Subject who, in the opinion of the investigator, was not likely to complete the trial for whatever reason.
  2. Subject who has been already treated by pregabalin

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): NCT02273908


Locations
Show Show 33 study locations
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Koichi Fujii, MD Director of Pain/Neuroscience Medical Affairs,Pfizer Japan Inc.

Publications of Results:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02273908    
Other Study ID Numbers: A0081333
First Posted: October 24, 2014    Key Record Dates
Results First Posted: January 6, 2017
Last Update Posted: January 6, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Pfizer:
Low-Back Pain
Neuropathic Pain
Pregabalin
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs