Cervical RadiculopathyNCT01144923
Conservative Therapy Versus Epidural Steroids for Cervical Radiculopathy
A study testing Gabapentin and/or Nortriptyline, Physical therapy, Epidural Steroid Injections (ESI) and Combination treatment in people with Cervical Radiculopathy, run by Johns Hopkins University at 2 sites in United States.
Trial summary
The main objective of this study is to determine whether interventional treatment (i.e. epidural steroids), conservative therapy, or the combination, is superior for cervical radiculopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- Gabapentin and/or Nortriptyline, Physical therapy, Epidural Steroid Injections (ESI) and Combination treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2010to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cervical radicular pain based on history and physical exam (e.g. pain radiating into one or both extremities, sensory loss, muscle weakness, Spurling's test etc.)
- NRS arm pain score > 3
- MRI evidence of disc pathology consistent with symptoms
Who cannot join
- Untreated coagulopathy
- Previous spine surgery
- No MRI study
- Arm pain > 4 years duration
- Epidural steroid injection within past 3 years
- Radiculopathy not resulting from disc pathology (e.g. foraminal stenosis or tumor)
Show all 12Show fewer
- Signs or symptoms or myelopathy or spinal cord compression
- Previous failed trials with gabapentin or pregabalin, and nortriptyline or amitriptyline
- Allergic reactions to gabapentin or nortriptyline
- Referrals from surgery for diagnostic injections for surgical evaluation
- Serious medical (e.g. congestive heart failure) or psychiatric (untreated depression) condition that might preclude optimal outcome
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Medical Institutions
Baltimore, Maryland, 21205
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
About this study
Official title: Randomized, Comparative-effectiveness Study Comparing Epidural Steroid Injections to Conservative Management With Medications and Physical Therapy in Patients With Cervical Radiculopathy
The main objective of this study is to determine whether interventional treatment (i.e. epidural steroids), conservative therapy, or the combination, is superior for cervical radiculopathy. One hundred and sixty eight patients with radicular neck pain will be randomized in a 1:1:1 ratio to receive either cervical epidural steroid injections (CESI), non-interventional management with physical therapy and medications, or a combination of the two. The first follow-up visit will be at 1-month. In patients who obtain some benefit but continue to report significant pain, either a 2nd CESI can be done, the patient's medications can be adjusted, or both in the combination group. Those patients who fail to obtain any benefit will exit the study to receive another treatment or alternative care. The second follow-up visit will be at 3-months. Similar to the 1-month follow-up, the doctor may elect to change nothing in patients who are satisfied, adjust medications, schedule the patient for another CESI, or do both in the combination group. Patients who fail to obtain any benefit can exit the study to receive alternative treatment. The final follow-up visit will be at 6 months.
- Conditions
- Cervical Radiculopathy
- Being tested
- Gabapentin and/or Nortriptyline, Physical therapy, Epidural Steroid Injections (ESI), Combination treatment
- Keywords
- epidural steroid injection, neck pain, pharmacotherapy, radiculopathy
- Medical subject headings
- Radiculopathy, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gabapentin and/or Nortriptyline, Physical therapyOther
Nortriptyline up to 125 mg po qhs, and / or Gabapentin up to 1200 mg po q8h, Physical therapy (e.g. range of motion, strengthening, therapeutic massage, TENS)
Epidural Steroid Injections (ESI)Procedure or surgery
Series of up to 3 cervical epidural steroid injections (ESI) with depo-methylprednisolone
Combination treatmentOther
Series of up to 3 cervical epidural steroid injections with depo- methylprednisolone plus Nortriptyline up to 125 mg po qhs and /or Gabapentin up to 1200 mg po q8h, and Physical therapy (e.g. TENS, exercise, range of motion)
| Study group | Role | What they receive |
|---|---|---|
| Conservative treatment | Active comparator | Pharmacotherapy with nortriptyline and/ or gabapentin, physical therapy (e.g. range of motion, therapeutic massage, strengthening exercises), and possibly others (e.g. acupuncture) Receives: Other: Gabapentin and/or Nortriptyline, Physical therapy |
| Epidural Steroids | Experimental | A series of up to 3 epidural steroid injections (ESI)with depo-methylprednisolone Receives: Procedure: Epidural Steroid Injections (ESI) |
| Combination Treatment | Experimental | These patients will receive both treatments. They can have up to 3 epidural steroid injections (ESI) with depo-methylprednisolone, and conservative treatment (i.e. pharmacotherapy with nortriptyline and/ or gabapentin, and physical therapy) Receives: Other: Combination treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
numerical rating scale (NRS) arm pain scores
arm pain on a 0-10 scale
Measured: 1 month after treatment
Secondary outcomes (7)
NRS Arm pain
0-10 scale
Measured: 3 months
NRS arm pain
0-10 scale
Measured: 6 months
NRS neck pain
0-10 scale
Measured: 1- month
NRS neck pain
0-10 scale
Measured: 3 months
NRS neck pain
0-10 scale
Measured: 6 months
medication reduction
Cessation of non-opioid analgesic and/ or > 20% decrease in opioid consumption
Measured: 1-6 months
Global perceived effect
categorical variable assessing "satisfaction" with treatment
Measured: 1-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Walter Reed Army Medical Center
- Responsible party
- Principal investigator, Steven P. Cohen, Johns Hopkins University
- Investigators
- Steven P Cohen, MD, Study director, Johns Hopkins UniversitySalim Hayek, MD, PhD, Principal investigator, Case WesternRick Fisher, MD, Principal investigator, Walter Reed National Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144923
- Sponsor's protocol ID
- NA_00036062
- Status last verified
- Apr 2014
- First submitted
- 14 Jun 2010
- Last updated
- 24 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hogg-Johnson S, van der Velde G, Carroll LJ, Holm LW, Cassidy JD, Guzman J, Cote P, Haldeman S, Ammendolia C, Carragee E, Hurwitz E, Nordin M, Peloso P; Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. The burden and determinants of neck pain in the general population: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine (Phila Pa 1976). 2008 Feb 15;33(4 Suppl):S39-51. doi: 10.1097/BRS.0b013e31816454c8.
PubMed 18204398Carragee EJ, Hurwitz EL, Cheng I, Carroll LJ, Nordin M, Guzman J, Peloso P, Holm LW, Cote P, Hogg-Johnson S, van der Velde G, Cassidy JD, Haldeman S; Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Treatment of neck pain: injections and surgical interventions: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine (Phila Pa 1976). 2008 Feb 15;33(4 Suppl):S153-69. doi: 10.1097/BRS.0b013e31816445ea.
PubMed 18204388Hurwitz EL, Carragee EJ, van der Velde G, Carroll LJ, Nordin M, Guzman J, Peloso PM, Holm LW, Cote P, Hogg-Johnson S, Cassidy JD, Haldeman S; Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Treatment of neck pain: noninvasive interventions: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine (Phila Pa 1976). 2008 Feb 15;33(4 Suppl):S123-52. doi: 10.1097/BRS.0b013e3181644b1d.
PubMed 18204386
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Comparative-effectiveness Study Comparing Epidural Steroid Injections to Conservative Management With Medications and Physical Therapy in Patients With Cervical Radiculopathy
- ClinicalTrials.gov ID
- NCT01144923
- Acronym / sponsor ID
- NA_00036062
- Conditions
- Cervical Radiculopathy
- Keywords
- epidural steroid injection, neck pain, pharmacotherapy, radiculopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Walter Reed Army Medical Center
- Study start
- Jun 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 16 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to determine whether interventional treatment (i.e. epidural steroids), conservative therapy, or the combination, is superior for cervical radiculopathy. One hundred and sixty eight patients with radicular neck pain will be randomized in a 1:1:1 ratio to receive either cervical epidural steroid injections (CESI), non-interventional management with physical therapy and medications, or a combination of the two. The first follow-up visit will be at 1-month. In patients who obtain some benefit but continue to report significant pain, either a 2nd CESI can be done, the patient's medications can be adjusted, or both in the combination group. Those patients who fail to obtain any benefit will exit the study to receive another treatment or alternative care. The second follow-up visit will be at 3-months. Similar to the 1-month follow-up, the doctor may elect to change nothing in patients who are satisfied, adjust medications, schedule the patient for another CESI, or do both in the combination group. Patients who fail to obtain any benefit can exit the study to receive alternative treatment. The final follow-up visit will be at 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conservative treatment | Active comparator | Other: Gabapentin and/or Nortriptyline, Physical therapyPharmacotherapy with nortriptyline and/ or gabapentin, physical therapy (e.g. range of motion, therapeutic massage, strengthening exercises), and possibly others (e.g. acupuncture) |
| Epidural Steroids | Experimental | Procedure: Epidural Steroid Injections (ESI)A series of up to 3 epidural steroid injections (ESI)with depo-methylprednisolone |
| Combination Treatment | Experimental | Other: Combination treatmentThese patients will receive both treatments. They can have up to 3 epidural steroid injections (ESI) with depo-methylprednisolone, and conservative treatment (i.e. pharmacotherapy with nortriptyline and/ or gabapentin, and physical therapy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cervical radicular pain based on history and physical exam (e.g. pain radiating into one or both extremities, sensory loss, muscle weakness, Spurling's test etc.)
- NRS arm pain score > 3
- MRI evidence of disc pathology consistent with symptoms
Key exclusion criteria (12 listed)
- Untreated coagulopathy
- Previous spine surgery
- No MRI study
- Arm pain > 4 years duration
- Epidural steroid injection within past 3 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gabapentin and/or Nortriptyline, Physical therapyNortriptyline up to 125 mg po qhs, and / or Gabapentin up to 1200 mg po q8h, Physical therapy (e.g. range of motion, strengthening, therapeutic massage, TENS) | Other | Conservative treatment |
| Epidural Steroid Injections (ESI)Series of up to 3 cervical epidural steroid injections (ESI) with depo-methylprednisolone | Procedure or surgery | Epidural Steroids |
| Combination treatmentSeries of up to 3 cervical epidural steroid injections with depo- methylprednisolone plus Nortriptyline up to 125 mg po qhs and /or Gabapentin up to 1200 mg po q8h, and Physical therapy (e.g. TENS, exercise, range of motion) | Other | Combination Treatment |
Primary outcome
numerical rating scale (NRS) arm pain scores
Time frame: 1 month after treatment
arm pain on a 0-10 scale
7 secondary outcomes
NRS Arm pain
Time frame: 3 months
NRS arm pain
Time frame: 6 months
NRS neck pain
Time frame: 1- month
NRS neck pain
Time frame: 3 months
NRS neck pain
Time frame: 6 months
medication reduction
Time frame: 1-6 months
Global perceived effect
Time frame: 1-6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2014.
- Background: PubMed 18204398Hogg-Johnson S, van der Velde G, Carroll LJ, Holm LW, Cassidy JD, Guzman J, Cote P, Haldeman S, Ammendolia C, Carragee E, Hurwitz E, Nordin M, Peloso P; Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. The burden and determinants of neck pain in the general population: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine (Phila Pa 1976). 2008 Feb 15;33(4 Suppl):S39-51. doi: 10.1097/BRS.0b013e31816454c8.
- Background: PubMed 18204388Carragee EJ, Hurwitz EL, Cheng I, Carroll LJ, Nordin M, Guzman J, Peloso P, Holm LW, Cote P, Hogg-Johnson S, van der Velde G, Cassidy JD, Haldeman S; Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Treatment of neck pain: injections and surgical interventions: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine (Phila Pa 1976). 2008 Feb 15;33(4 Suppl):S153-69. doi: 10.1097/BRS.0b013e31816445ea.
- Background: PubMed 18204386Hurwitz EL, Carragee EJ, van der Velde G, Carroll LJ, Nordin M, Guzman J, Peloso PM, Holm LW, Cote P, Hogg-Johnson S, Cassidy JD, Haldeman S; Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Treatment of neck pain: noninvasive interventions: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine (Phila Pa 1976). 2008 Feb 15;33(4 Suppl):S123-52. doi: 10.1097/BRS.0b013e3181644b1d.
Related trials for Cervical Radiculopathy
Recruiting
Ultrasound-Guided Electrical Dry Needling for Chronic Cervical Radiculopathy
Cervical Radiculopathy
Not yet recruitingObservational study
Correlation Between Forward Head Posture and Executive Functions in Cervical Radiculopathy
Cervical Radiculopathy, Forward Head Posture
Recruiting
Myo-Electrical and Nerve Root Function Response to Focused Extracorpeal Shock Wave in Cervical Radiculopathy
Cervical Radiculopathy
Not yet recruiting
Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
Cervical Disc Herniation, Cervical Foraminal Stenosis
RecruitingObservational study
Cervical Spinal Cord Signal Abnormalities in Patients With Cervical Radicular Pain
Cervical Radiculopathy, Cervical Myelomalacia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven P Cohen, MD study director
Johns Hopkins University
Salim Hayek, MD, PhD principal investigator
Case Western
Rick Fisher, MD principal investigator
Walter Reed National Military Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gabapentin and/or Nortriptyline, Physical therapy, Epidural Steroid Injections (ESI) and Combination treatment in people with Cervical Radiculopathy, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
numerical rating scale (NRS) arm pain scores (time frame: 1 month after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01144923, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2014.