Chronic Low-back Pain Clinical Trial
— COPEOfficial title:
Cryoneurolysis Outcome on Pain Experience (COPE) in Patients With Low-back Pain - a Single-blinded Randomized Controlled Trial
Verified date | January 2022 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will provide information on the effectiveness of cryoneurolysis for patients with facet joint pain syndrome, and help to establish whether cryoneurolysis should be implemented in clinical practice for this patient population.
Status | Active, not recruiting |
Enrollment | 120 |
Est. completion date | October 1, 2022 |
Est. primary completion date | October 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Low-back pain from facet joint syndrom (facet joint pain) > 3 months' duration with or without neuropathic pain component. - Low-back pain on Numeric Rating Scale = 4 Exclusion Criteria: - Presence of nerve root or spinal canal compression; signs of inflammatory or erosive processes in the spine verified on magnetic resonance imaging (MRI). - Neurological deficits i.e. symptoms of nerve root compression; tingling, numbness, weakness/ paresis, and reflex loss in the lower extremities. - Major co-morbidity. - Anti-thrombotic or anti-platelet treatment which cannot be paused for a week. - Active malignancies. - Chronic inflammatory disease. - Known severe psychiatric disease. Patients with mild and well-treated depression and anxiety are not excluded. |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Neurosurgery, Aarhus University Hospital | Aarhus | Central Denmark |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Aarhus University Hospital |
Denmark,
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Birkenmaier C, Veihelmann A, Trouillier H, Hausdorf J, Devens C, Wegener B, Jansson V, von Schulze Pellengahr C. Percutaneous cryodenervation of lumbar facet joints: a prospective clinical trial. Int Orthop. 2007 Aug;31(4):525-30. Epub 2006 Aug 23. — View Citation
Birkenmaier C, Veihelmann A, Trouillier HH, Hausdorf J, von Schulze Pellengahr C. Medial branch blocks versus pericapsular blocks in selecting patients for percutaneous cryodenervation of lumbar facet joints. Reg Anesth Pain Med. 2007 Jan-Feb;32(1):27-33. — View Citation
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Leggett LE, Soril LJ, Lorenzetti DL, Noseworthy T, Steadman R, Tiwana S, Clement F. Radiofrequency ablation for chronic low back pain: a systematic review of randomized controlled trials. Pain Res Manag. 2014 Sep-Oct;19(5):e146-53. Epub 2014 Jul 28. Review. — View Citation
Maas ET, Ostelo RW, Niemisto L, Jousimaa J, Hurri H, Malmivaara A, van Tulder MW. Radiofrequency denervation for chronic low back pain. Cochrane Database Syst Rev. 2015 Oct 23;(10):CD008572. doi: 10.1002/14651858.CD008572.pub2. Review. — View Citation
Paulsen RT, Carreon L, Busch F, Isenberg-Jørgensen A. A pilot cohort study of lumbar facet joint denervation in patients with chronic low-back pain. Dan Med J. 2019 Mar;66(3). pii: A5533. — View Citation
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The effect of the intervention, assessed by Patient Global Impression of Change (PGIC) at 4 weeks follow-up | The Patient Global Impression of Change (PGIC) is a 7-point patient self-reporting scale of overall improvement after treatment ranging from 1) very much improved, 2) much improved, 3) minimally improved, 4) no change, 5) minimally worse, 6) much worse, or 7) very much worse | 4 weeks | |
Secondary | Change in Patient Global Impression of Change (PGIC) at day one, three, six and 12 months follow-up. | The Patient Global Impression of Change (PGIC) is a 7-point patient self-reporting scale of overall improvement after treatment ranging from 1) very much improved, 2) much improved, 3) minimally improved, 4) no change, 5) minimally worse, 6) much worse, or 7) very much worse. | 1-12 months | |
Secondary | Change in the Numeric Rating Scale (NRS-11) from baseline to day one, four weeks, three, six and 12 months follow-up | The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain from 0 no pain to 10 worst pain imaginable. | 1-12 months | |
Secondary | Change in the Pain Catastrophizing Scale (PCS) at baseline, four weeks, three, six and 12 months follow-up | The Pain Catastrophizing Scale (PCS) assesses the extent of catastrophic thinking due to low back pain according to 3 components: rumination, magnification, and helplessness.
It is a self-report measure, consisting of 13 items scored from 0 to 4, resulting in a total possible score of 52. The higher the score, the more catastrophizing thoughts are present. |
1-12 months | |
Secondary | Change from baseline to six and 12 months follow-up in the Oswestry Disability Index (ODI). | The Owestry Disability Index (ODI) comprises 10 sections with 5 questions in each to measure a patient's permanent functional disability. For each section the scores range of 0 to 5, resulting in a total possible score of 50. If all 10 sections are completed the score is calculated as follows: if 16 (total scored) out of 50 (total possible score) x 100 = 32%. The higher the calculated percentage, the more severe the disability is. | 1-12 months | |
Secondary | Change from baseline to six and 12 months follow-up in the European Quality of Life - 5 Dimensions (EQ5D) | The European Quality of Life - 5 Dimensions (EQ5D) comprises five questions on mobility, self care, pain, usual activities, and psychological status with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem. A summary index with a maximum score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state, in each dimension, where higher scores indicate more severe. In addition, there is a visual analogue scale (VAS) to indicate the general health status with 100 indicating the best health status. | 1-12 months | |
Secondary | Change from baseline to 12 months follow-up for change in Major Depression Inventory (MDI) and the Short Form (36) Health Survey (SF-36) | The Major Depression Inventory (MDI) is a self-reporting measure to assess the presence and severity of a depressive disorder. It consists of 10 questions with a total possible score of 50.
A score of under 20 indicates no depression and a score of more than 29 indicates severe depression. The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. it consists of 8 scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability while higher scores indicate the less disability .The maximum score of 100 indicates the best possible health state. |
1-12 months |
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