Supervised Physical Therapy Versus Unsupervised Home Exercise After Surgery for Lumbar Disc Herniation

NCT03505918 | Completed DMC

• 1 other identifier: S-20150051
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled trial evaluation effect of postoperative rehabilitation after surgery for lumbar disc herniation. The primary aim of this study is to evaluate the effect of unsupervised home exercises compared to supervised physical rehabilitation. Secondary aims of this study are to determine if there is a difference in cost-effectiveness in patients undergoing supervised physical rehabilitation in patients after surgery for lumbar disc herniation compared to unsupervised home exercises.

Conditions

Disk Herniated Lumbar; Physiotherapy; Surgery

Outcome Measures

Primary Outcomes (1)

• Oswestry disability index

  Functional status questionaire

  6 month postoperative.

Secondary Outcomes (2)

• EuroQOL -5D

  12 month postoperative

• SF-6D

  12 month postoperative

Study Arms (2)

Standard municipal rehabilitation

NO INTERVENTION

Standard care with postoperative rehabilitation at the municipal facility.

No referral for rehabilitation

EXPERIMENTAL

No referral for supervised postoperative rehabilitation. Only standard information booklet and advice during hospitalization.

Other: No referral for rehabilitation

Interventions

No referral for rehabilitation OTHER

Intervention is that some patients will not be refered for postoperative physiotherapy.

No referral for rehabilitation

Eligibility Criteria

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

You may qualify if:

• Informed consent
• Clinical symptoms and concordant MRI findings of a lumbar disc herniation from L1 to S1 with indications for discectomy surgery, assessed by an experienced spinal surgeon
• Age 18-65 years

You may not qualify if:

• History of previous spine surgery or disease (eg. spinal fracture, scoliosis or stenosis)
• General contra-indication for spine surgery
• Diagnosis of psychiatric disorder
• Current malignant disease
• Hematologic disease
• Major surgical procedures within 12 months (eg. collum femoris fracture)
• Chronic, generalized connective tissue disorders or chronic, non-specific pain disorders (fibromyalgia, whiplash, etc.)

Sponsors & Collaborators

• Spine Centre of Southern Denmark: lead

Study Sites (1)

Spine Center of Southern Denmark

Middelfart, 5500, Denmark

Location

Related Publications (1)

• Paulsen RT, Sorensen J, Carreon LY, Andersen MO. Cost-effectiveness of postoperative rehabilitation after surgery for lumbar disc herniation: an analysis based on a randomized controlled trial. J Neurosurg Spine. 2020 Jan 17;32(5):733-740. doi: 10.3171/2019.11.SPINE191003. Print 2020 May 1.

  PMID: 31952034 DERIVED

MeSH Terms

Interventions

Rehabilitation

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Rune Paulsen, M.D

  Sygehus Lillebælt

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Randomised controlled trial with two parallel groups

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: April 23, 2018
• Study Start: October 1, 2015
• Primary Completion: February 1, 2019
• Study Completion: September 1, 2019
• Last Updated: September 24, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)