Neck Pain Clinical Trial
Official title:
Randomized Controlled Trial: Comparison of Radiological and Axial Pain Outcome Between C3-6 Open Door Laminoplasty and C3 Laminectomy With Cervical Laminoplasty
Verified date | January 2024 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Investigators performed a prospective randomized controlled trial for comparing postoperative clinical and radiological outcomes between C3 laminectomy with laminoplasty and C3-6 laminoplasty.
Status | Completed |
Enrollment | 126 |
Est. completion date | October 28, 2022 |
Est. primary completion date | October 28, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility | Inclusion Criteria: - Cervical stenosis patients with or without cervical myelopathy. Exclusion Criteria: - Metastatic cancer patients. - Any combined fracture. - Previous surgery to cervical spine. - inflammatory joint disease - psychiatric illness |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul | Korea |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
Chen C, Li J, Liao Z, Gao Y, Shao Z, Yang C. C3 laminectomy combined with modified unilateral laminoplasty and in situ reconstruction of the midline structures maintained cervical sagittal balance: a retrospective matched-pair case-control study. Spine J. 2020 Sep;20(9):1403-1412. doi: 10.1016/j.spinee.2020.04.023. Epub 2020 May 6. — View Citation
Kudo H, Takeuchi K, Wada K, Kumagai G, Tanaka S, Asari T, Araki R, Yokoyama T, Ishibashi Y. Ten-Year Long-term Results of Modified Cervical Double-door Laminoplasty With C3 Laminectomy Preserving the Semispinalis Cervicis Inserted Into the Axis Compared With Those of Conventional Cervical Laminoplasty. Clin Spine Surg. 2021 Apr 1;34(3):E147-E153. doi: 10.1097/BSD.0000000000001068. — View Citation
Lee GW, Cho CW, Shin JH, Ahn MW. Which Technique Is Better Option for C3 Segment in Multilevel Open-Door Laminoplasty of the Cervical Spine?: Laminectomy Versus Laminoplasty. Spine (Phila Pa 1976). 2017 Jul 15;42(14):E833-E840. doi: 10.1097/BRS.0000000000001974. — View Citation
Nakajima K, Nakamoto H, Kato S, Doi T, Matsubayashi Y, Taniguchi Y, Yoshida Y, Kawamura N, Nakarai H, Higashikawa A, Tozawa K, Takeshita Y, Fukushima M, Iizuka M, Ono T, Shirokoshi T, Azuma S, Tanaka S, Oshima Y. A Multicenter Observational Study on the Postoperative Outcomes of C3 Laminectomy in Cervical Double-door Laminoplasty. Clin Spine Surg. 2021 May 1;34(4):146-152. doi: 10.1097/BSD.0000000000001100. — View Citation
Takeuchi K, Yokoyama T, Aburakawa S, Saito A, Numasawa T, Iwasaki T, Itabashi T, Okada A, Ito J, Ueyama K, Toh S. Axial symptoms after cervical laminoplasty with C3 laminectomy compared with conventional C3-C7 laminoplasty: a modified laminoplasty preserving the semispinalis cervicis inserted into axis. Spine (Phila Pa 1976). 2005 Nov 15;30(22):2544-9. doi: 10.1097/01.brs.0000186332.66490.ba. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | C2-C7 Lordosis | Measuring C2-C7 lordosis angle by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked. | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) | |
Primary | the Neck Disability Index (NDI) | scores from 0 to 50 with 50 being the worst performance status related to neck pain. | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) | |
Secondary | C2-C3 Lordosis | Measuring C2-C3 lordosis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked. | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) | |
Secondary | C4-C7 Lordosis | Measuring C4-C7 lordosis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked. | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) | |
Secondary | Cervical Sagittal Vertical Axis (cSVA) | Measuring cervical sagittal vertical axis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked. | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) | |
Secondary | T1 Slope | Measuring T1 slope by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked. | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) | |
Secondary | T1 Slope Minus Cervical Lordosis | Measuring T1 slope minus cervical lordosis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked. | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) | |
Secondary | C2-C3 Interlaminar Spontaneous Fusion | Measuring the incidence of postoperative C2-C3 interlaminar spontaneous fusion by using standard lateral cervical x-ray series. | at 2 year | |
Secondary | EuroQol Five-dimensional Questionnaire (EQ-5D) Scores | Responses on a questionnaire with five dimensions, each comprised of five levels. Scores are revised into an index with a range from -0.59-1, with 1.00 indicating full health. The 243 possible health states on the EQ-5D are evaluated against a normal population using the time trade off method (TTO). | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) | |
Secondary | Posterior Neck With Numering Rating Scale (NRS-N) | Measuring pain intensity of the posterior neck with numeric rating scale (NRS), rated 1 to 10 with 10 being the most severe pain level. | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) | |
Secondary | Upper Limb Pain With Numering Rating Scale (NRS-L) | Measuring pain intensity of the upper limb with numeric rating scale (NRS), rated 1 to 10 with 10 being the most severe pain level. | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) | |
Secondary | Estimated Intraoperative Blood Loss | Measuring estimated intraoperative blood loss by using intraoperative records of anesthesiologists. | Intraoperative | |
Secondary | Operative Time | Measuring the time between start of the surgery (incision) and the finish of surgery (closure of the skin). | Intraoperative |
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