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

NCT03349580 | Completed DMC

• 1 other identifier: EarlyRehab-LSF
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lumbar Spine Fusion

Keywords

rehabilitation; randomized controlled trial; strength training; early initiation; intra-abdominal pressure

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (5)

• Change of walking distance as measured by the 6-min walking test

  Baseline, 9 weeks and 18 months.

• Change the repetition of stand-ups during the Chair stand test.

  Baseline, 9 weeks and 18 months.

• Change of height as measured by the Standing reach height test.

  Baseline, 9 weeks and 18 months.

• Change of Intra-abdominal pressure pre-activation pattern.

  Baseline, 9 weeks and 18 months.

• Change of pain disability as measured by the Visual Analogue Scale.

  Baseline, 9 weeks and 18 months.

Study Arms (2)

The training group

EXPERIMENTAL

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.

Behavioral: The training group

The control group

NO INTERVENTION

The control group followed the hospital's standard protocol. These do not include exercises or physiotherapy before 3 months after surgery.

Interventions

The training group BEHAVIORAL

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.

The training group

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dejan Kernc: lead
• University Medical Centre Ljubljana: collaborator
• University of Ljubljana: collaborator
• Slovenian Research Agency: collaborator

Related Publications (12)

• 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.

  PMID: 14652472 BACKGROUND

• 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.

  PMID: 20103575 BACKGROUND

• 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.

  PMID: 26555833 BACKGROUND

• 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.

  PMID: 23563500 BACKGROUND

• 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.

  PMID: 23928716 BACKGROUND

• 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.

  PMID: 17538085 BACKGROUND

• 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.

  PMID: 15959375 BACKGROUND

• 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.

  PMID: 10050947 BACKGROUND

• 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.

  PMID: 11182126 BACKGROUND

• 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.

  PMID: 22565381 BACKGROUND

• 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.

  PMID: 20354468 BACKGROUND

• 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.

  PMID: 29914580 DERIVED

Study Officials

• Rok Vengust, Phd

  University Medical Centre Ljubljana

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: November 12, 2017
• First Posted: November 21, 2017
• Study Start: April 4, 2014
• Primary Completion: November 25, 2016
• Study Completion: September 15, 2017
• Last Updated: November 24, 2017

Record last verified: 2017-11