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Pain Assessment and Quality of Life in Back Pain Patients: Role of Milnacipran

This study has been withdrawn prior to enrollment.
(Company decided to discontinue)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01221740
First Posted: October 15, 2010
Last Update Posted: January 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Robert N. Jamison, PhD, Brigham and Women's Hospital
  Purpose
  1. To show that patients with greater pain sensitivity will show greater improvement in their symptoms (self-reported pain intensity, mood, sleep, and quality of life) than those with lower pain sensitivity, based on QST, after taking milnacipran.
  2. To compare outcome differences (pain intensity, mood, activity interference, sleep, and side effects) with those patients who are either taking or not taking opioids for their pain 10 weeks after being prescribed milnacipran.
  3. To show that patients who are older, male, with more medical comorbidities, greater disability, and longer pain duration will report less improvement (pain, mood, sleep, health-related quality of life) and treatment satisfaction while taking milnacipran compared with others without such characteristics.

Condition Intervention Phase
Back Pain Drug: Savella Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pain Assessment and Quality of Life in Back Pain Patients: Role of Milnacipran

Resource links provided by NLM:


Further study details as provided by Robert N. Jamison, PhD, Brigham and Women's Hospital:

Primary Outcome Measures:
  • Decreased Back Pain [ Time Frame: Over the course of 10 weeks ]
    Decreased Back Pain on the Brief Pain Inventory Scale.


Enrollment: 0
Study Start Date: August 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Milnacipran

The patients will be titrated to the maintenance dose of 50 mg BID over a 7-day period.

12.5 mg QD on day 1 12.5 mg BID on days 2 and 3 25 mg BID on days 4, 5, 6, and 7 50 mg BID beginning day 8

Drug: Savella

The patients will be titrated to the maintenance dose of 50 mg BID over a 7-day period, and will be on the medication for 10 weeks.

12.5 mg QD on day 1 12.5 mg BID on days 2 and 3 25 mg BID on days 4, 5, 6, and 7 50 mg BID beginning day 8

Other Name: HCL (Savella), Milnacipran

Detailed Description:

Chronic pain is a costly syndrome that influences every aspect of a patient's life. Significant interference with sleep, employment, social functioning, and daily activities is common. Chronic pain patients frequently report depression, anxiety, irritability, sexual dysfunction, and decreased energy. Family roles are altered, and worries abound about financial limitations and future consequences of a restricted lifestyle. Epidemiological studies have independently documented that chronic pain is an immense international problem. Chronic pain symptoms afflict one third of the American population (more than 80 million people). Chronic pain accounts for 21% of emergency room visits and 25% of annual missed work days. When direct and indirect costs are considered, chronic pain imposes a greater economic burden than any other disease, with annual estimates up to $100 billion.

Patients will complete a number of questionnaires at baseline and undergo quantitative sensory testing (QST) as well as complete a handheld electronic diary PDA throughout the entire 10 weeks of the study. Patients will be evaluated by a physician and receive a complete history and physical. Radiological studies will be consulted to confirm diagnosis. All subjects who consent to participate in this study will be started on or converted to milnacipran if they are currently taking an SSRI, buproprion, or a TCA. This will be done over a 1 to 2 week period of gradually weaning the antidepressant and escalating milnacipran. All other adjuvant medication will remain constant through the course of the 10-week trial. Efforts will be made to recruit at least 40% of the patients (N= 24) who are not taking opioids for pain.

At the end of the study, all patients will repeat the baseline questionnaires listed above except the demographic questionnaire. They will also be asked to complete the Treatment Helpfulness Questionnaire. We will compare secondary outcome differences (treatment satisfaction and helpfulness) between patients either on or off of opioids.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • Primary diagnosis of spinal pain for at least 6 months' duration
  • Average pain intensity score of 4 or greater

Exclusion Criteria:

  • Current diagnosis of cancer or malignant disease
  • Acute bone disease
  • History of DSM-IV psychotic disorder
  • Pregnancy
  • Any illness judged by the PI to interfere with treatment
  • Any acute condition requiring surgery
  • Currently taking SNRI or MAOI
  Contacts and Locations
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): NCT01221740


Locations
United States, Massachusetts
Brigham and Women's Hospital Pain Trials Center
Chestnut Hill, Massachusetts, United States, 02467
Sponsors and Collaborators
Brigham and Women's Hospital
Forest Laboratories
  More Information

Responsible Party: Robert N. Jamison, PhD, Robert Jamison, PhD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01221740     History of Changes
Other Study ID Numbers: 2010-P-00977/1
First Submitted: October 14, 2010
First Posted: October 15, 2010
Last Update Posted: January 12, 2017
Last Verified: January 2017

Keywords provided by Robert N. Jamison, PhD, Brigham and Women's Hospital:
To show that patients with greater pain sensitivity
will show greater improvement in their symptoms
(self-reported pain intensity, mood, sleep, and
quality of life) than those with lower pain
sensitivity, based on QST, after taking milnacipran.
To compare outcome differences
(pain intensity, mood, activity interference,
sleep, and side effects) with those patients
who are either taking or not taking opioids for
their pain 10 weeks after being prescribed milnacipran.
To show that patients who are older, male,
with more medical comorbidities, greater disability,
and longer pain duration will report less improvement
(pain, mood, sleep, health-related quality of life)
and treatment satisfaction while taking milnacipran
compared with others without such characteristics.
identify patients back or neck pain
greater 6 months
QST
10 weeks
milnacipran
pain intensity
mood
activity
interference
sleep
side effects
age
gender
medical comorbidities

Additional relevant MeSH terms:
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Milnacipran
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents