Clinical trial NCT03349580: Early Initiation of a Strength Training Based Rehabilitation After Lumbar Spine Fusion Improves Core Muscle Strength
Official title: Early Initiation of a Strength Training Based Rehabilitation After Lumbar Spine Fusion Improves Core Muscle Strength
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Spine Fusion
Keywords: rehabilitation
randomized controlled trial
strength training
early initiation
intra-abdominal pressure
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: University Medical Centre Ljubljana
name: University of Ljubljana
name: Slovenian Research Agency
First posted: 2017-11-21
Enrollment: 27
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: To analyze safety and the effects of early initiation of the rehabilitation. Including the objective measurement outcomes after lumbar spine fusion, based on the principles of strength training.

Detailed description: The 27 patients were recruited for the study, aged 45 to 70 years, who had undergone lumbar spine fusion. The patients were randomized in to two groups. The strength training group started rehabilitation 3 weeks after surgery. The patients exercised two times per week, over 9 weeks. The focus was on muscle activation of lumbopelvic muscles stabilization. The control group followed a standard postoperative protocol, where no exercises were performed at the rehabilitation stage. The functional outcomes and the plain radiographs were evaluated after 3 weeks and subsequently after 3 and 18 months after the surgery.

Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of degenerative, low-grade isthmic spondylolisthesis or degenerative disc disease with or without spinal stenosis.

Exclusion Criteria:

* Previous lumbar fusion surgery, degenerative or idiopathic scoliosis, inflammatory disease, and history of malignancy.

Primary outcomes:
measure: Change of isometric trunk muscle strength
timeFrame: Baseline, 9 weeks and 18 months.
measure: Change of low back pain disability as measured by the Oswestry Disability Index
timeFrame: Baseline, 9 weeks and 18 months.
Secondary outcomes:
measure: Change of walking distance as measured by the 6-min walking test
timeFrame: Baseline, 9 weeks and 18 months.
measure: Change the repetition of stand-ups during the Chair stand test.
timeFrame: Baseline, 9 weeks and 18 months.
measure: Change of height as measured by the Standing reach height test.
timeFrame: Baseline, 9 weeks and 18 months.
measure: Change of Intra-abdominal pressure pre-activation pattern.
timeFrame: Baseline, 9 weeks and 18 months.
measure: Change of pain disability as measured by the Visual Analogue Scale.
timeFrame: Baseline, 9 weeks and 18 months.
Other outcomes:
Locations:
Study officials:
affiliation: University Medical Centre Ljubljana
name: Rok Vengust, Phd
role: STUDY_CHAIR
References:
citation: Christensen FB, Laurberg I, Bunger CE. Importance of the back-cafe concept to rehabilitation after lumbar spinal fusion: a randomized clinical study with a 2-year follow-up. Spine (Phila Pa 1976). 2003 Dec 1;28(23):2561-9. doi: 10.1097/01.BRS.0000097890.96524.A1.
citation: Nielsen PR, Jorgensen LD, Dahl B, Pedersen T, Tonnesen H. Prehabilitation and early rehabilitation after spinal surgery: randomized clinical trial. Clin Rehabil. 2010 Feb;24(2):137-48. doi: 10.1177/0269215509347432.
citation: Greenwood J, McGregor A, Jones F, Mullane J, Hurley M. Rehabilitation Following Lumbar Fusion Surgery: A Systematic Review and Meta-Analysis. Spine (Phila Pa 1976). 2016 Jan;41(1):E28-36. doi: 10.1097/BRS.0000000000001132.
citation: Oestergaard LG, Nielsen CV, Bunger CE, Svidt K, Christensen FB. The effect of timing of rehabilitation on physical performance after lumbar spinal fusion: a randomized clinical study. Eur Spine J. 2013 Aug;22(8):1884-90. doi: 10.1007/s00586-013-2717-5. Epub 2013 Apr 6.
citation: Oestergaard LG, Christensen FB, Nielsen CV, Bunger CE, Fruensgaard S, Sogaard R. Early versus late initiation of rehabilitation after lumbar spinal fusion: economic evaluation alongside a randomized controlled trial. Spine (Phila Pa 1976). 2013 Nov 1;38(23):1979-85. doi: 10.1097/BRS.0b013e3182a7902c.
citation: Weinstein JN, Lurie JD, Tosteson TD, Hanscom B, Tosteson AN, Blood EA, Birkmeyer NJ, Hilibrand AS, Herkowitz H, Cammisa FP, Albert TJ, Emery SE, Lenke LG, Abdu WA, Longley M, Errico TJ, Hu SS. Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis. N Engl J Med. 2007 May 31;356(22):2257-70. doi: 10.1056/NEJMoa070302.
citation: Deyo RA, Gray DT, Kreuter W, Mirza S, Martin BI. United States trends in lumbar fusion surgery for degenerative conditions. Spine (Phila Pa 1976). 2005 Jun 15;30(12):1441-5; discussion 1446-7. doi: 10.1097/01.brs.0000166503.37969.8a.
citation: Cholewicki J, Juluru K, McGill SM. Intra-abdominal pressure mechanism for stabilizing the lumbar spine. J Biomech. 1999 Jan;32(1):13-7. doi: 10.1016/s0021-9290(98)00129-8.
citation: Hodges PW, Cresswell AG, Daggfeldt K, Thorstensson A. In vivo measurement of the effect of intra-abdominal pressure on the human spine. J Biomech. 2001 Mar;34(3):347-53. doi: 10.1016/s0021-9290(00)00206-2.
citation: Oestergaard LG, Nielsen CV, Bunger CE, Sogaard R, Fruensgaard S, Helmig P, Christensen FB. The effect of early initiation of rehabilitation after lumbar spinal fusion: a randomized clinical study. Spine (Phila Pa 1976). 2012 Oct 1;37(21):1803-9. doi: 10.1097/BRS.0b013e31825a17ab.
citation: Abbott AD, Tyni-Lenne R, Hedlund R. Early rehabilitation targeting cognition, behavior, and motor function after lumbar fusion: a randomized controlled trial. Spine (Phila Pa 1976). 2010 Apr 15;35(8):848-57. doi: 10.1097/BRS.0b013e3181d1049f.
citation: Kernc D, Strojnik V, Vengust R. Early initiation of a strength training based rehabilitation after lumbar spine fusion improves core muscle strength: a randomized controlled trial. J Orthop Surg Res. 2018 Jun 19;13(1):151. doi: 10.1186/s13018-018-0853-7.