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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Brigham and Women's Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01221740
First received: October 14, 2010
Last updated: January 18, 2011
Last verified: October 2010
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Brigham and Women's Hospital:

Primary Outcome Measures:
  • Decreased Back Pain [ Time Frame: Over the course of 10 weeks ] [ Designated as safety issue: No ]
    Decreased Back Pain on the Brief Pain Inventory Scale.


Estimated Enrollment: 66
Study Start Date: August 2010
Estimated Study Completion Date: August 2011
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221740

Locations
United States, Massachusetts
Brigham and Women's Hospital Pain Trials Center Recruiting
Chestnut Hill, Massachusetts, United States, 02467
Contact: Juliana L Serraillier, BS    617-732-9462    jserraillier@partners.org   
Contact: Kathy Howard, RN, BSN    6177329462    khoward4@partners.org   
Principal Investigator: Robert N Jamison, PhD         
Sponsors and Collaborators
Brigham and Women's Hospital
Forest Laboratories
  More Information

No publications provided

Responsible Party: Robert Jamison, PhD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01221740     History of Changes
Other Study ID Numbers: 2010-P-00977/1
Study First Received: October 14, 2010
Last Updated: January 18, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by 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
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Milnacipran
Adrenergic Agents
Adrenergic Uptake Inhibitors
Antidepressive Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014