AzTrials
AzTrials

Pain, ChronicPhase 4NCT03973177

Phenol Neurolysis of Genicular Nerves for Chronic Knee Pain

A Phase 4 study testing Phenol Injection and Methylprednisolone Injection in people with Pain, Chronic, run by Northwestern University.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

Chronic knee pain from osteoarthritis (OA) is commonly treated with total knee arthroplasty (TKA) when conservative therapies fail to provide pain relief. More than 600,000 TKAs are performed in the U.S. annually, a number that continues to increase. Read more about this study

Who is it for?
Ages 40 to 95 years
Conditions the study is for
Pain, Chronic
What is being tested?
Phenol Injection and Methylprednisolone Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
24 May 2019to Mar 2023
Phase
Phase 4
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 40 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ages 40-95 years
  • Patients with knee pain, on average > 4 (NRS) persisting more than 6 months after TKA
  • Willingness to undergo image guided diagnostic nerve block and the study intervention

Who cannot join

  • Pain score (NRS) < 4 at time of study enrollment
  • Conditions that preclude the diagnostic block or the study intervention (e.g., irreversible coagulopathy or bleeding disorder, allergic reaction/contraindication to local anesthetic, contrast dye, steroids, and/or phenol, pregnancy, severe or uncontrolled medical illness).
  • Evidence of indolent infection of the knee prosthesis (elevated C-reactive protein assessed when clinically indicated)
  • Inability to write, speak, or read in English
  • Pregnancy

About this study

Official title: Phenol Neurolysis of Genicular Nerves for Chronic Knee Pain Following Total Knee Arthroplasty: a Pilot Prospective, Randomized, Crossover Trial

Chronic knee pain from osteoarthritis (OA) is commonly treated with total knee arthroplasty (TKA) when conservative therapies fail to provide pain relief. More than 600,000 TKAs are performed in the U.S. annually, a number that continues to increase. A logistic-regression model suggests that the incidence rate of TKA will increase by 143% in the United States by 2050 compared to 2012. Although TKA is successful in reducing knee pain and joint stiffness in most cases, it can be associated with a 7-35% incidence of persistent refractory post-surgical knee pain.

Aim:

Read more

To determine whether chemical neurolysis of the genicular nerves with 6% aqueous phenol is non-inferior in reducing knee pain as compared to corticosteroid injection of the genicular nerves, in patients with refractory chronic knee pain for more than 6 months after total knee replacement.

Hypothesis:

Chemical neurolysis of genicular nerves with phenol will provide equal or superior pain relief than corticosteroid genicular nerve injections at 3 months, as measured by the Oxford Knee Score.

Conditions
Pain, Chronic
Being tested
Phenol Injection, Methylprednisolone Injection
Keywords
Total knee arthroplasty, Chronic Pain
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Phenol InjectionDrug

    Also called Phenol

    6% aqueous phenol 2.5 mL will be mixed with 0.5 mL iopamidol 300 and will be injected at each target site with live, pulsed fluoroscopy (5-8 seconds at each location) to observe the contrast dye-tagged phenol covering the lateral margin of the femur or tibia respectively on AP and lateral views. The needles will then be removed and band-aids placed.

  • Methylprednisolone InjectionDrug

    Also called Methylprednisolone acetate

    Methylprednisolone acetate 10 mg with 2 mL preservative saline and 0.5 mL iopamidol 300 will be injected at each of the 3 target sites with live, pulsed fluoroscopy (5-8 seconds at each location) to observe the contrast dye-tagged steroid mixture covering the lateral margin of the femur or tibia respectively on AP and lateral views; the needles will be removed and band-aids placed.

Study groups in NCT03973177
Study groupRoleWhat they receive
Treatment Group: Phenol injectionExperimental6% aqueous phenol 2.5 mL will be mixed with 0.5 mL iopamidol 300 and will be injected at each target sites
Receives: Drug: Phenol Injection
Control Group: Methylprednisolone injectionOtherMethylprednisolone acetate 10 mg with 2 mL preservative free saline and 0.5 mL iopamidol 300 will be injected at each of the target site
Receives: Drug: Methylprednisolone Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oxford Knee Score

    Oxford Knee Score is a tool which measures 6 post operative items (pain,flexion contracture, extension lag, total range of flexion, alignment of varus and valgus,stability (antero-posterior and mediolateral). The scoring is: below 60 is poor, scoring 60-69 fair, scoring 70-79 good, 80-100 excellent.

    Measured: 3 months

Secondary outcomes (22)

  1. Numeric Rating Scale Score

    The proportion of subjects who have > 50% reduction in pain based on the Numeric Rating Scale at 3 months. The NRS is a scale of 0 (no pain) to 10 (worst pain imaginable)

    Measured: 3months

  2. Numeric Rating Scale Score

    The proportion of subjects who have > 50% reduction in pain based on the Numeric Rating Scale at 6 months. The NRS is a scale of 0 (no pain) to 10 (worst pain imaginable)

    Measured: 6 months

  3. Patients Global Impression of Change

    Patients Global Impression of Change (GPIC) is a scale of 0 (much better) to 10 (much worse)

    Measured: 3 Months

  4. Patients Global Impression of Change

    Patients Global Impression of Change (GPIC) is a scale of 0 (much better) to 10 (much worse)

    Measured: 6 Months

  5. Opioid analgesic use at 3 months

    Opioid analgesic daily use by self reporting .

    Measured: 3 months

  6. Opioid analgesic use at 6 months

    Opioid analgesic daily use by self reporting.

    Measured: 6 months

  7. Non-opioid analgesic use at 3 months

    Non opioid analgesic daily use by self reporting.

    Measured: 3 Months

  8. Non-opioid analgesic use at 6 months

    Non opioid analgesic daily use by self reporting.

    Measured: 6 Months

  9. PROMIS Pain Intensity Short Form 3a

    3 question pain survey. 5 responses (had no pain),(mild), (moderate), (severe) and (very severe)

    Measured: Baseline

  10. PROMIS Pain Intensity Short Form 3a

    3 question pain survey. 5 responses (had no pain),(mild), (moderate), (severe) and (very severe)

    Measured: 3 Months

  11. PROMIS Pain Intensity Short Form 3a

    3 question pain survey. 5 responses (had no pain),(mild), (moderate), (severe) and (very severe)

    Measured: 6 Months

  12. PROMIS Sleep Disturbance Short Form 4a

    4 question sleep survey. First section is quality of sleep rated on a 5 response (very poor)- (very good) scale.Section rating quality of sleep based on 5 response choices (not at all) to (very much)

    Measured: Baseline

  13. PROMIS Sleep Disturbance Short Form 4a

    4 question sleep survey. First section is quality of sleep rated on a 5 response (very poor)- (very good) scale.Section rating quality of sleep based on 5 response choices (not at all) to (very much)

    Measured: 3 Months

  14. PROMIS Sleep Disturbance Short Form 4a

    4 question sleep survey. First section is quality of sleep rated on a 5 response (very poor)- (very good) scale.Section rating quality of sleep based on 5 response choices (not at all) to (very much)

    Measured: 6 Months

  15. PROMIS Pain Interference Short Form 6b

    6 question pain survey. First section is interference of pain rated on a 5 response (not at all)- (very much) scale. Section is one socialization question with 5 response choices (never)- (always)

    Measured: Baseline

  16. PROMIS Pain Interference Short Form 6b

    6 question pain survey. First section is interference of pain rated on a 5 response (not at all)- (very much) scale. Section is one socialization question with 5 response choices (never)- (always)

    Measured: 3 Months

  17. PROMIS Pain Interference Short Form 6b

    6 question pain survey. First section is interference of pain rated on a 5 response (not at all)- (very much) scale. Section is one socialization question with 5 response choices (never)- (always)

    Measured: 6 Months

  18. Oxford Knee Score

    12 question survey with 5 choice responses based on severity of pain while accomplishing activities of daily living.

    Measured: Baseline

  19. Oxford Knee Score

    12 question survey with 5 choice responses based on severity of pain while accomplishing activities of daily living.

    Measured: 6 Months

  20. Hospital Anxiety and Depression Scale

    Hospital Anxiety and Depression Scale (HADS) is a 14 question survey (7 anxiety and 7 depression) questions answered on a 0 (low) - 3 (high) scale.Total score of 0-7 is normal, 8-10 is baseline abnormal and a score between 11-21 is abnormal.

    Measured: Baseline

  21. Hospital Anxiety and Depression Scale

    Hospital Anxiety and Depression Scale (HADS) is a 14 question survey (7 anxiety and 7 depression) questions answered on a 0 (low) - 3 (high) scale.Total score of 0-7 is normal, 8-10 is baseline abnormal and a score between 11-21 is abnormal.

    Measured: 3 Month

  22. Hospital Anxiety and Depression Scale

    Hospital Anxiety and Depression Scale (HADS) is a 14 question survey (7 anxiety and 7 depression) questions answered on a 0 (low) - 3 (high) scale. Total score of 0-7 is normal, 8-10 is baseline abnormal and a score between 11-21 is abnormal.

    Measured: 6 Month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2019
  2. Study start24 May 2019
  3. Primary completionJul 2022 (estimated)
  4. Study completionMar 2023 (estimated)

Why it stopped: Covid restrictions on recruitment

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
A Pilot Prospective, Randomized, Crossover Trial. (Block randomization scheme with 2:1 allocation (phenol neurolysis : perineural steroid injection) The crossover will occur in subjects who received the steroid injection who did not achieve adequate pain relief at 3 months.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03973177
Sponsor's protocol ID
STU00209591
Status last verified
Apr 2022
First submitted
28 May 2019
Last updated
28 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nguyen US, Zhang Y, Zhu Y, Niu J, Zhang B, Felson DT. Increasing prevalence of knee pain and symptomatic knee osteoarthritis: survey and cohort data. Ann Intern Med. 2011 Dec 6;155(11):725-32. doi: 10.7326/0003-4819-155-11-201112060-00004.

    PubMed 22147711

  • Buvanendran A, Fiala J, Patel KA, Golden AD, Moric M, Kroin JS. The Incidence and Severity of Postoperative Pain following Inpatient Surgery. Pain Med. 2015 Dec;16(12):2277-83. doi: 10.1111/pme.12751. Epub 2015 Apr 27.

    PubMed 25917518

  • Lewis GN, Rice DA, McNair PJ, Kluger M. Predictors of persistent pain after total knee arthroplasty: a systematic review and meta-analysis. Br J Anaesth. 2015 Apr;114(4):551-61. doi: 10.1093/bja/aeu441. Epub 2014 Dec 26.

    PubMed 25542191

  • Drosos GI, Triantafilidou T, Ververidis A, Agelopoulou C, Vogiatzaki T, Kazakos K. Persistent post-surgical pain and neuropathic pain after total knee replacement. World J Orthop. 2015 Aug 18;6(7):528-36. doi: 10.5312/wjo.v6.i7.528. eCollection 2015 Aug 18.

    PubMed 26301182

  • Puolakka PA, Rorarius MG, Roviola M, Puolakka TJ, Nordhausen K, Lindgren L. Persistent pain following knee arthroplasty. Eur J Anaesthesiol. 2010 May;27(5):455-60. doi: 10.1097/EJA.0b013e328335b31c.

    PubMed 20299989

  • Fischer HB, Simanski CJ, Sharp C, Bonnet F, Camu F, Neugebauer EA, Rawal N, Joshi GP, Schug SA, Kehlet H; PROSPECT Working Group. A procedure-specific systematic review and consensus recommendations for postoperative analgesia following total knee arthroplasty. Anaesthesia. 2008 Oct;63(10):1105-23. doi: 10.1111/j.1365-2044.2008.05565.x. Epub 2008 Jul 10.

    PubMed 18627367

  • Inacio MCS, Paxton EW, Graves SE, Namba RS, Nemes S. Projected increase in total knee arthroplasty in the United States - an alternative projection model. Osteoarthritis Cartilage. 2017 Nov;25(11):1797-1803. doi: 10.1016/j.joca.2017.07.022. Epub 2017 Aug 8.

    PubMed 28801208

  • Sylvester LN, Goree JH. Genicular Radiofrequency Ablation for Treatment of Post Total Knee Arthroplasty Posterior Thigh Pain: A Case Report. A A Case Rep. 2017 Nov 15;9(10):292-293. doi: 10.1213/XAA.0000000000000596.

    PubMed 28697032

  • Qudsi-Sinclair S, Borras-Rubio E, Abellan-Guillen JF, Padilla Del Rey ML, Ruiz-Merino G. A Comparison of Genicular Nerve Treatment Using Either Radiofrequency or Analgesic Block with Corticosteroid for Pain after a Total Knee Arthroplasty: A Double-Blind, Randomized Clinical Study. Pain Pract. 2017 Jun;17(5):578-588. doi: 10.1111/papr.12481. Epub 2016 Sep 19.

    PubMed 27641918

  • Protzman NM, Gyi J, Malhotra AD, Kooch JE. Examining the feasibility of radiofrequency treatment for chronic knee pain after total knee arthroplasty. PM R. 2014 Apr;6(4):373-6. doi: 10.1016/j.pmrj.2013.10.003. Epub 2013 Dec 27.

    PubMed 24373908

  • Walega DR, McCormick ZL. Chemical Neurolysis of the Genicular Nerves for Chronic Knee Pain: Reviving an Old Dog and an Old Trick. Pain Med. 2018 Sep 1;19(9):1882-1884. doi: 10.1093/pm/pny023. No abstract available.

    PubMed 29514315

  • Koyyalagunta D, Engle MP, Yu J, Feng L, Novy DM. The Effectiveness of Alcohol Versus Phenol Based Splanchnic Nerve Neurolysis for the Treatment of Intra-Abdominal Cancer Pain. Pain Physician. 2016 May;19(4):281-92.

    PubMed 27228515

  • Wang PJ, Shang MY, Qian Z, Shao CW, Wang JH, Zhao XH. CT-guided percutaneous neurolytic celiac plexus block technique. Abdom Imaging. 2006 Nov-Dec;31(6):710-8. doi: 10.1007/s00261-006-9153-5.

    PubMed 17151902

  • Kirazli Y, On AY, Kismali B, Aksit R. Comparison of phenol block and botulinus toxin type A in the treatment of spastic foot after stroke: a randomized, double-blind trial. Am J Phys Med Rehabil. 1998 Nov-Dec;77(6):510-5. doi: 10.1097/00002060-199811000-00012.

    PubMed 9862538

  • Ahmed A, Arora D, Kochhar AK. Ultrasound-guided alcohol neurolysis of lateral femoral cutaneous nerve for intractable meralgia paresthetica: a case series. Br J Pain. 2016 Nov;10(4):232-237. doi: 10.1177/2049463716668811. Epub 2016 Sep 16.

    PubMed 27867513

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Phenol Injection and Methylprednisolone Injection in people with Pain, Chronic, run by Northwestern University.

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 5 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: withdrawn, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Oxford Knee Score (time frame: 3 months). 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 NCT03973177, which also lists 15 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 28 Apr 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in