Effectiveness of Cervical Facet Joint Nerve Blocks

• Sponsor: Pain Management Center of Paducah (Other)
• Overall Status: Completed
• CT.gov ID: NCT00332722
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Duration (Months): 42
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

1. To demonstrate whether:

1. Facet joint nerve blocks have therapeutic value beyond the duration of local anesthetic effect.

1. Adjuvant medications (Sarapin and Depo-Medrol) provide additional relief of cervical facet joint pain when used with facet joint nerve blocks.

1. To demonstrate whether or not there are clinically significant improvements in function of patients who receive cervical facet joint nerve block with or without Sarapin and Depo-Medrol (Group II) compared to patients randomized to Group I who receive only local anesthetic blocks.

2. To determine the adverse event profile in both groups.

Condition or Disease	Intervention/Treatment	Phase
Neck Pain	Procedure: Cervical facet joint nerve blocks	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Effectiveness of Cervical Facet Joint Nerve Blocks: A Randomized, Prospective, Double-Blind Controlled Evaluation
• Study Start Date: Sep 1, 2003
• Actual Primary Completion Date: Jan 1, 2007
• Actual Study Completion Date: Mar 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1- without steroid Cervical Facet Joint Nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)	Procedure: Cervical facet joint nerve blocks
Active Comparator: Group 2 - with steroid Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)	Procedure: Cervical facet joint nerve blocks

Outcome Measures

Primary Outcome Measures

1. Numeric Rating Scale (NRS) [over 2 years]

   Numeric Rating Scale (range 0-10) is represented as 0 for no pain and 10 for worst pain imaginable.

Secondary Outcome Measures

1. Neck Disability Index (NDI) [2 years]

   Neck Disability Index (range 0-50) is represented as 0-4 no disability, 5-14 mild disability, 15 - 24 moderate disability, 25 - 34 severe disability and >34 (35-50) complete disability.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Positive for facet joint pain with comparative local anesthetic blocks

Candidates are over 18 years of age

Subjects with a history of chronic, function limiting neck pain of at least six months in duration Subjects who are able to give voluntary, written informed consent to participate in this investigation Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the center for all the required post-operative follow-ups The subject has not had recent surgical procedures within the last three months.

Exclusion Criteria:

Negative or false-positive response to controlled comparative local anesthetic blocks

Narcotic use of greater than Hydrocodone 100 mg/day, Methadone 80 mg or Morphine 100 mg, or dose equivalent

Uncontrolled major Depression or uncontrolled psychiatric disorders

Uncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, chronic liver dysfunction, progressive neurological deficit, urinary sphincter dysfunction, infection, increased intercranial pressure, pseudotumor cerebri, intercranial tumors, unstable angina, and severe chronic obstructive pulmonary disease.

Chronic severe conditions that could interfere with the interpretations of the outcome assessments for pain and bodily function

Women who are pregnant or lactating

Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment

Patients with multiple complaints involving concomitant hip osteoarthritis, will not be amenable to study due to the overlap of pain complaints.

Inability to achieve appropriate positioning and inability to understand informed consent and protocol History of adverse reaction to local anesthetic or anti-inflammatory drugs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ambulatory Surgery Center	Paducah	Kentucky	United States	42003

Sponsors and Collaborators

• Pain Management Center of Paducah

Investigators

• Principal Investigator: Laxmaiah Manchikanti, MD,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Laxmaiah Manchikanti, MD, C.E.O, Pain Management Center of Paducah
• ClinicalTrials.gov Identifier: NCT00332722
• Other Study ID Numbers: Protocol4
• First Posted: Jun 2, 2006
• Last Update Posted: Oct 1, 2013
• Last Verified: Sep 1, 2013

• Additional relevant MeSH terms: Neck Pain

Study Results

Participant Flow

Recruitment Details	Consecutive new patients presenting to interventional pain management practice with neck pain without suspected disc herniation or radiculitis.

Arm/Group Title	Group 1 Without Steroids	Group 2 With Steroids
Arm/Group Description	Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)	Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)
Period Title: Overall Study
STARTED	60	60
COMPLETED	60	60
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Group 1- Without Steroid	Group 2 - With Steroid	Total
Arm/Group Description	Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)	Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)	Total of all reporting groups
Overall Participants	60	60	120
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	60 100%	60 100%	120 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46 (13.2)	43 (14.1)	44 (13.7)
Sex: Female, Male (Count of Participants)
Female	41 68.3%	48 80%	89 74.2%
Male	19 31.7%	12 20%	31 25.8%
duration of pain (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	120 (122)	87 (104)	103 (174)

Outcome Measures

1. Primary Outcome

Title	Numeric Rating Scale (NRS)
Description	Numeric Rating Scale (range 0-10) is represented as 0 for no pain and 10 for worst pain imaginable.
Time Frame	over 2 years

Outcome Measure Data

Analysis Population Description

A sample size of 60 patients for each group was chosen.

Arm/Group Title	Group 1 - Without Steroids	Group 2 - With Steroids
Arm/Group Description	Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)	Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)
Measure Participants	60	60
Baseline	8.2 (0.8)	8.2 (1.1)
2 years	3.5 (1.1)	3.2 (1.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1 - Without Steroids, Group 2 - With Steroids
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Paired t test
	Comments

2. Secondary Outcome

Title	Neck Disability Index (NDI)
Description	Neck Disability Index (range 0-50) is represented as 0-4 no disability, 5-14 mild disability, 15 - 24 moderate disability, 25 - 34 severe disability and >34 (35-50) complete disability.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1 - Without Steroids	Group 2 - With Steroids
Arm/Group Description	Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)	Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)
Measure Participants	60	60
Baseline	25.4 (5.7)	25.1 (5.0)
24 months	11.6 (5.2)	11.0 (4.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1 - Without Steroids, Group 2 - With Steroids
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Paired t test
	Comments

Adverse Events

Time Frame	24 months
Adverse Event Reporting Description	Infection, Nerve root or Spinal cord trauma
Arm/Group Title	Group 1- Without Steroid		Group 2 - With Steroid
Arm/Group Description	Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)		Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)
All Cause Mortality
	Group 1- Without Steroid		Group 2 - With Steroid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Group 1- Without Steroid		Group 2 - With Steroid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/60 (0%)
Infections and infestations
Infection	0/60 (0%)	0	0/60 (0%)	0
Other (Not Including Serious) Adverse Events
	Group 1- Without Steroid		Group 2 - With Steroid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/60 (0%)

Limitations/Caveats

The study limitations include the lack of a placebo group.

More Information

Certain Agreements

Principal Investigators are NOT 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.