Efficacy of Pregabalin in Patients With Radicular Pain

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00908375
• Collaborator: (none)
• Enrollment: 39
• Location: 1
• Arms: 2
• Duration (Months): 43
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate whether pregabalin is effective in reducing the pain in patients who present with radicular pain due to a herniated disc, spinal stenosis or failed back surgery syndrome.

Condition or Disease	Intervention/Treatment	Phase
Neuropathy; Radicular, Lumbar, Lumbosacral; Failed Back Surgery Syndrome; Spinal Stenosis; Herniated Disc	Drug: Pregabalin; Drug: Sugar Pill	Phase 4

Detailed Description

Although the efficacy of pregabalin has been demonstrated in several pain states and it is approved by the FDA for use in post herpetic neuralgia, diabetic neuropathy and fibromyalgia there are few studies of its efficacy in patients with radicular pain from herniated disc, spinal stenosis or failed back surgery syndrome. This study was conducted to evaluate the efficacy of pregabalin in these pain states.

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy of Pregabalin in Patients With Radicular Pain
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Pregabalin A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.	Drug: Pregabalin; One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.; Other Names: Lyrica®, Pfizer NY, NY 10017
Placebo Comparator: Surgar Pill One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.	Drug: Sugar Pill; One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks.; Other Names: Placebo

Outcome Measures

Primary Outcome Measures

1. Pain Scores (NRS) at 3-weeks [3 weeks]

   Standard numeric rating pain scale ranging from 0 (no pain) to 10 (worst pain imaginable) after 3 weeks of treatment. .

Secondary Outcome Measures

1. Patient's Global Impression of Change at 3 Weeks [3 weeks]

   Global impression of change in patient status reported at 3 weeks. The global impression of change consists of a Likert scale as below: Very Much Improved Much Improved Minimally Improved No Change Minimally Worse Much Worse Very Much Worse

2. Oswestry Disability Questionnaires [3 weeks]

   Oswestry disability index (ODI) is a tool to measure a subject's functional disability. The Oswestry disability index consists of 10 questions with a Likert 0-5 scale. Each individual score is converted into a percent which represents the "percent disability." There are five tiers, 0-20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled), 81%-100% (i.e. bed bound). We report the Oswestry disability scores at 3 weeks.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients with pain in dermatomal distribution, in either cervical or lumbar region.

2. History of pain for more than 3 months.

3. History of herniated disc, spinal stenosis or failed back surgery.

4. A series of epidural steroid injections within the past 6 months.

5. Presence of motor or sensory neurological signs (hypoesthesia, hyperesthesia, allodynia, dysesthesia) in the affected dermatomes.

6. Patients must be cognitively capable of completing the pain questionnaires.

Exclusion Criteria:

1. Patients below 18 or over 65 years of age.

2. Patients with mostly axial spinal pain.

3. Presence of significant motor deficits, and /or bowel and/or bladder dysfunction.

4. Workmen's compensation or disability issues.

5. Patients with chronic depression and on depression medications.

6. Addiction and/or substance abuse issues.

7. Patients using gabapentin or failure to respond to previous gabapentin use.

8. Patients with known peripheral neuropathy (e.g. DPN, PHN etc.).

9. Known hypersensitivity to pregabalin use (hives, blisters, rash, dypnea and wheezing).

10. History of angioedema with pregabalin use.

11. Patients with known renal insufficiency, diabetes, congestive heart failure, cardiac conduction abnormalities, and/or thrombocytopenia.

12. Patients using ACE-inhibitors and thiazolidinedione antidiabetic agents (Avandia®, Actos®).

13. Pregnant patients.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pain Medicine Center	Chicago	Illinois	United States	60610

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: Khalid M Malik, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: kahlid malik, Assistant Professor of Anesthesiology, Northwestern University
• ClinicalTrials.gov Identifier: NCT00908375
• Other Study ID Numbers: FRA7057
• First Posted: May 25, 2009
• Last Update Posted: Oct 13, 2014
• Last Verified: Sep 1, 2014

• Keywords provided by kahlid malik, Assistant Professor of Anesthesiology, Northwestern University: Pregabalin; Radicular pain; Failed back surgery; Of greater than 3 months duration
• Additional relevant MeSH terms: Spinal Stenosis; Intervertebral Disc Displacement; Radiculopathy; Failed Back Surgery Syndrome; Pregabalin

Study Results

Participant Flow

Arm/Group Title	Pregabalin	Sugar Pill
Arm/Group Description	A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks. Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.	One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks. Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks.
Period Title: Overall Study
STARTED	20	19
COMPLETED	10	9
NOT COMPLETED	10	10

Baseline Characteristics

Arm/Group Title	Pregabalin	Sugar Pill	Total
Arm/Group Description	A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks. Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.	One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks. Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks.	Total of all reporting groups
Overall Participants	20	19	39
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47 (10.17)	44 (13.38)	45 (11.78)
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	20 100%	19 100%	39 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	11 55%	8 42.1%	19 48.7%
Male	9 45%	11 57.9%	20 51.3%
Pain Score (Numeric Rating Scale , 0-10) (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	6.5	6	6

Outcome Measures

1. Primary Outcome

Title	Pain Scores (NRS) at 3-weeks
Description	Standard numeric rating pain scale ranging from 0 (no pain) to 10 (worst pain imaginable) after 3 weeks of treatment. .
Time Frame	3 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pregabalin	Sugar Pill
Arm/Group Description	A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks. Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.	One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks. Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks.
Measure Participants	10	9
Median (Full Range) [units on a scale]	6	3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Sugar Pill
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Sample size was determined based on the primary outcome variable, the VAS pain score at three weeks. Based on the results of the study of Siddall et al., group sample sizes of 19 and 19 achieve 82% power to detect a difference of 2.00 between the null hypothesis that both group means are 6.50 and the alternative hypothesis that the mean of pregabalin group is 4.50 with estimated group standard deviations of 2.10 and 2.10 and with a significance level of 0.05 using a two-sided two-sample t-test.
Statistical Test of Hypothesis	p-Value	0.279
	Comments	The criterion for rejection of the null hypothesis (P < 0.05) was adjusted for multiple application of the test to the same data set using the Bonferroni correction.
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-2
	Confidence Interval	(2-Sided) 99%; -6 to 3
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Patient's Global Impression of Change at 3 Weeks
Description	Global impression of change in patient status reported at 3 weeks. The global impression of change consists of a Likert scale as below: Very Much Improved Much Improved Minimally Improved No Change Minimally Worse Much Worse Very Much Worse
Time Frame	3 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pregabalin	Sugar Pill
Arm/Group Description	A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks. Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.	One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks. Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks.
Measure Participants	10	9
Median (Full Range) [units on a scale]	3.5	3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Sugar Pill
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.282
	Comments	The criterion for rejection of the null hypothesis (P < 0.05) was adjusted for multiple applications of the test to the same data using the Bonferroni correction.
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-1
	Confidence Interval	(2-Sided) 99%; -2.0 to 1.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Oswestry Disability Questionnaires
Description	Oswestry disability index (ODI) is a tool to measure a subject's functional disability. The Oswestry disability index consists of 10 questions with a Likert 0-5 scale. Each individual score is converted into a percent which represents the "percent disability." There are five tiers, 0-20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled), 81%-100% (i.e. bed bound). We report the Oswestry disability scores at 3 weeks.
Time Frame	3 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pregabalin	Sugar Pill
Arm/Group Description	A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks. Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.	One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks. Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks.
Measure Participants	10	9
Median (Full Range) [percent disability]	41	20

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Sugar Pill
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.139
	Comments	The criterion for rejection of the null hypothesis (P < 0.05) was adjusted for multiple applications of the test to the same data using the Bonferroni correction.
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-16
	Confidence Interval	(2-Sided) 99%; -42 to 16
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Subject reported difficulty in swallowing sensation 4 days following the start of the study. Symptoms resolved within 48 hrs following discontinuation of the study drug.
Arm/Group Title	Pregabalin		Sugar Pill
Arm/Group Description	A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks. Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.		One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks. Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks.
All Cause Mortality
	Pregabalin		Sugar Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Pregabalin		Sugar Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/20 (5%)		2/19 (10.5%)
Cardiac disorders
Palpitations	0/20 (0%)	0	1/19 (5.3%)	1
Nervous system disorders
Headache	1/20 (5%)	1	0/19 (0%)	0
Skin and subcutaneous tissue disorders
Rash	0/20 (0%)	0	1/19 (5.3%)	1
Other (Not Including Serious) Adverse Events
	Pregabalin		Sugar Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/19 (0%)

Limitations/Caveats

Early subject withdrawal and lost to follow-up leading to small numbers of subjects analyzed.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.