Early Initiation of a Strength Training Based Rehabilitation After Lumbar Spine Fusion Improves Core Muscle Strength

Lumbar Spine Fusion Clinical Trial

Official title:

Early Initiation of a Strength Training Based Rehabilitation After Lumbar Spine Fusion Improves Core Muscle Strength

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03349580
• Other study ID #: EarlyRehab-LSF
• Status: Completed
• Phase: N/A
• First received: November 12, 2017
• Last updated: November 21, 2017
• Start date: April 4, 2014
• Est. completion date: September 15, 2017

Study information

• Verified date: November 2017
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: September 15, 2017
• Est. primary completion date: November 25, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lumbar Spine Fusion

Intervention

Behavioral:
• The training group
The training group performed rehabilitation program twice per week over 9 weeks. The group commenced rehabilitation 3 weeks after the surgery. During the phase one training (week 1 to week 5), the isometric exercises were preformed on the trunk extension, flexion and lateral flexion muscles. During the phase 2 (week 6 to week 9), the exercises were performed on the strength machines and duration of the exercises were maintained and prolonged to 30 seconds. The leg adduction and hip extension exercises were added. The patients were instructed to perform abdominal bracing (IAP) and maintain the neutral position of their lumbar spine before and during the exercises.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Dejan Kernc	Slovenian Research Agency, University Medical Centre Ljubljana, University of Ljubljana

References & Publications (11)

Abbott AD, Tyni-Lenné 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. — View Citation

Cholewicki J, Juluru K, McGill SM. Intra-abdominal pressure mechanism for stabilizing the lumbar spine. J Biomech. 1999 Jan;32(1):13-7. — View Citation

Christensen FB, Laurberg I, Bünger CE. Importance of the back-café 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. — View 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. — View 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. Review. — View 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. — View Citation

Nielsen PR, Jørgensen LD, Dahl B, Pedersen T, Tønnesen H. Prehabilitation and early rehabilitation after spinal surgery: randomized clinical trial. Clin Rehabil. 2010 Feb;24(2):137-48. doi: 10.1177/0269215509347432. — View Citation

Oestergaard LG, Christensen FB, Nielsen CV, Bünger 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. — View Citation

Oestergaard LG, Nielsen CV, Bünger 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. — View Citation

Oestergaard LG, Nielsen CV, Bünger 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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of isometric trunk muscle strength	The isometric trunk muscle extension, flexion and lateral flexion strength were measured using a strain-gauge dynamometer. Maximum torque was calculated from the force sensor data (Newton) and the lever as a distance between the middle line of the belt and the iliac crest level (meter). A higher values represent a better outcome. The scale range were 48 Nm -830 Nm for extension, 12 Nm - 1010 Nm for flexion, 35 Nm - 680 Nm for lateral flexion right and 16 Nm - 640 Nm for lateral flexion left.	Baseline, 9 weeks and 18 months.
Primary	Change of low back pain disability as measured by the Oswestry Disability Index	Self-reported levels of low back pain disability. The Oswestry Disability Index is presented as a score from 0 to 100 where lower scores represent lower levels of low back pain disability.	Baseline, 9 weeks and 18 months.
Secondary	Change of walking distance as measured by the 6-min walking test	The walked distance was measured. A higher values represent a better outcome. The scale range was from 40m to 800m.	Baseline, 9 weeks and 18 months.
Secondary	Change the repetition of stand-ups during the Chair stand test.	A number of stand-ups in 30 seconds. A higher values represent a better outcome. The scale range was from 1 to 29 repetitions.	Baseline, 9 weeks and 18 months.
Secondary	Change of height as measured by the Standing reach height test.	A height which someone can reach. A higher values represent a better outcome. The scale range was from 190cm to 236cm.	Baseline, 9 weeks and 18 months.
Secondary	Change of Intra-abdominal pressure pre-activation pattern.	A lateral abdominal force sensor was used to estimate the time delay between the start of the increase in intra-abdominal pressure and the start of the force rise from the force plate (action start). The initiation of intra-abdominal pressure before starting the action contributed to better performance and result. The scale range was from -0.7s to 0.7s.	Baseline, 9 weeks and 18 months.
Secondary	Change of pain disability as measured by the Visual Analogue Scale.	Self-reported levels of pain disability. The Visual Analogue Scale presents back pain intensity with scores from 0 to 10, where 0 = "no problems" and 10 = "maximum problems".	Baseline, 9 weeks and 18 months.