A Phase 2/3 interventional study of Intraarticular platelet rich plasma cervical facet injection and Corticosteroid injection in Cervical Pain, sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-20.
Sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's · Phase 2/3, Interventional, and Treatment
Chronic neck pain, either after trauma (e.g. whiplash injury) or due to arthritis, is a significant issue for many Canadians. Steroid injections into the small joints of the neck can provide temporary pain relief, but patients require repeat injections every few months. The investigator will assess whether a different type of injection (platelet-rich plasma, PRP) can provide enhanced and longer-lasting pain relief compared to steroid. PRP is made from the patient's own blood but contains higher levels of components that promote healing. Patients with neck pain will receive either an injection of steroid or PRP into the small joints of the neck, but they won't know which one they are getting. After the injection they will be contacted to answer questions about their pain and function, up to 12 months after injection. The goal of this study is to determine if PRP is a viable alternative to current treatments to help reduce chronic neck pain and improve function after a whiplash injury. PRP may be a more permanent treatment for chronic neck pain which could reduce the need for repeated injections, thus reducing health care costs and wait times.
The project utilizes a randomized control trial design. Ethics approval was obtained from the Western Research Ethics Board. Participants with chronic neck pain will be recruited from the SJHC Pain Clinic.
Eligible candidates who consent to study participation will be block randomized using randomizer.org into two groups (A or B). All patients will be blinded both before and after injections as to which therapy they receive. Group A will receive an intra-articular (IA) injection of autologous PRP (0.5 mL per level) and Group B will receive IA injections of corticosteroid (1.5 mL per level).
PRP: PRP preparation will occur at St. Joseph's Hospital using a standard 2-step centrifugation method. The Co-Investigator will draw 5-10cc of venous blood under sterile conditions (all patients) and subsequently centrifuge these samples at 200g for 10 minutes at room temperature. The plasma will then be separated from the sedimented erythrocytes and centrifuged again at 400g for 10 min to remove additional platelet-poor plasma. Finally, 1-2cc of PRP will be prepared for intra-articular injection. To maintain blinding, those in Group B will also have blood collection done, although their samples will not be injected.
Corticosteroid: 0.5 cc saline and 0.5cc of 10 mg/mL dexamethasone per facet joint (up to 6 mL total volume for 4 facet injections) will be prepared by the Principal Investigator or Co-Investigator.
Depending on randomization, the appropriate syringe will be delivered to the SJHC Pain Clinci interventional suite immediately after preparation. All injections will be performed by the same physician under fluoroscopic guidance at the same level(s) as the prior successful medial branch blocks. A small amount of contrast will be injected to ensure IA placement. It is recognized that IA placement may not be possible in every situation. It will be noted by the physician whether the injection is felt to be peri- or intra-articular.
Follow-up: Primary and secondary outcomes will be collected via phone or in person, pre-injection, and at 1, 3, and 6 months post-injection. If there is ongoing benefit ≥2 points on the NRS at 6 months, additional follow-up of primary and secondary outcomes at 9 and 12 months will be done.
1,360 studies on the registry are indexed under Neck Pain; 299 are open to participants now.
This study's enrollment of 55 is close to the median of 50 across 1,116 interventional studies indexed under Neck Pain.
Browse Neck Pain studies →London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's is the lead sponsor of 351 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One time injection of 1.5-6cc of platelet rich plasma prepared from a blood sample into cervical facet joints. There is no trade/generic name
Drug: Intraarticular platelet rich plasma cervical facet injection
Corticosteroid: 0.5 cc saline and 0.5cc of 10 mg/mL dexamethasone per facet joint (up to 6 mL total volume for 4 facet injections)
Drug: Corticosteroid injection
Injection of PRP into the cervical facet joints.
Also known as: PRP injection
Injection of corticosteroid into the cervical facet joints.
Pain intensity
Numeric Rating Scale (NRS) rating from 0-10, 0 indicating no pain, and 10 indicating worst pain
Time frame: Baseline, 1, 3 and 6 months (+ 9 and 12 months) if at least an ongoing 2 point reduction at 6 months
Proportion attaining at least a 2 point reduction in pain on Numeric Rating Scale
Measured by Numeric Rating Scale questionnaire scores at Baseline, 1, 3 and 6 months (+ 9 and 12 months) if at least an ongoing 2 point reduction at 6 months. rating from 0-10, 0 indicating no pain, and 10 indicating worst pain
Time frame: 12 months
Proportion attaining 90% and 50% pain relief on Numeric Rating Scale
Measured by Numeric Rating Scale scores at Baseline, 1, 3 and 6 months (+ 9 and 12 months) if at least an ongoing 2 point reduction at 6 months. rating from 0-10, 0 indicating no pain, and 10 indicating worst pain
Time frame: 12 months
Time to return of at least 50% baseline pain on Numeric Rating Scale
Measured by Numeric Rating Scale questionnaire scores at baseline, 1, 3 and 6 months (+ 9 and 12 months) if at least an ongoing 2 point reduction at 6 months. rating from 0-10, 0 indicating no pain, and 10 indicating worst pain.
Time frame: 12 months
Adverse Events
Including : increased pain, bleeding, infection, allergy, neurologic deficit, new hyperglycemia. Adverse events will be recorded through case report forms and reported to the principal investigator. Side effects will be assessed using standardized case report forms at each visit. Participants are encouraged to contact the coordinator to report any concerns.
Time frame: 12 months
Patient reported function in the presence of neck pain
Measured by the Neck Disability Index questionnaire, which is not a scale.
Time frame: 12 months
Patient's subjective satisfaction with the procedure
Measured by Modified MacNab criteria questionnaire at baseline, 1, 3 and 6 months (+ 9 and 12 months) if at least an ongoing 2 point reduction at 6 months. The MacNab criteria answers range from 1-4, 1 being excellent and 4 being poor.
Time frame: 12 months
Work Productivity and Activity
Change from baseline to end of study in the Work Productivity and Activity Questionnaire: Specific Health Impairment Version 2 (not a scale)
Time frame: 12 months
Self efficacy
measured by self efficacy while performing daily activities in chronic WAD questionnaire.
Time frame: 12 weeks.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Platelet rich plasma
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