Exercise After Lumbar Disc Herniation Surgery

NCT ID: NCT06046781

Last Updated: 2023-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2023-09-07

Brief Summary

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Physical therapy and rehabilitation may improve low back pain and quality of life after lumbar disc herniation. But there is not any agreement of its optimal start time, and rehabilitative methods. This study evaluates the effects of early and late rehabilitation to the low back pain and quality of life following unilateral microdiscectomy.

Detailed Description

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Lumbar disc herniation (LDH) is a frequently encountered ailment in neurosurgery clinics and is prevalent among the general populace, with a reported incidence of about 2%. As it is primarily observed in the workforce, it adversely affects their quality of life. One common reason for referring a patient for surgery is radiculopathy and low back pain co-occurrence. LDH is typically observed in the adult population in active occupation. Most patients with LDH can be treated conservatively, but surgery may be necessary for around 13% of cases.

The decision to operate depends on the individual patient, but persistent radicular pain and neurological dysfunction unresponsive to conservative treatment are common indications. Minimally invasive surgical techniques are becoming more prevalent. Currently, microsurgery is the most common approach for lumbar disc herniation. In addition, endoscopic and minimally invasive surgeries have become more prevalent.

Lumbar microdiscectomy is a surgical procedure involving discectomy with paravertebral muscle dissection. Subsequently, patients may experience postoperative back pain, potentially impacting their quality of life. Physical rehabilitation is frequently suggested following surgery. Some studies have indicated that physical therapy and rehabilitation may not significantly improve low back pain and quality of life after lumbar disc herniation. There is yet to be an agreement on the effectiveness of physical therapy, its optimal start time, and rehabilitative methods.

This study evaluates the effects of early and late rehabilitation following unilateral microdiscectomy for lumbar disc herniation. It also examines the differences in low back pain and patients' quality of life due to exercise.

Conditions

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Disc Herniation Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A total of 204 patients who underwent surgery for lumbar disc herniation were included and subsequently randomized into five groups. One group served as the control and was advised not to participate in any postoperative exercise. The remaining groups were recommended different exercises, which began at various times after surgery.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

One group served as the control and was advised not to participate in any postoperative exercise.

Group Type OTHER

physical exercise

Intervention Type OTHER

The patients were randomized into 5 groups as control group, walking at 2 weeks, walking at 4 weeks, waist exercise at 2 weeks, waist exercise at 4 weeks.

Second week walking group

Postoperative walking initiated 2 weeks following surgery.

Group Type EXPERIMENTAL

physical exercise

Intervention Type OTHER

The patients were randomized into 5 groups as control group, walking at 2 weeks, walking at 4 weeks, waist exercise at 2 weeks, waist exercise at 4 weeks.

One month walking group

Postoperative walking initiated one month following surgery.

Group Type EXPERIMENTAL

physical exercise

Intervention Type OTHER

The patients were randomized into 5 groups as control group, walking at 2 weeks, walking at 4 weeks, waist exercise at 2 weeks, waist exercise at 4 weeks.

Second week waist exercise group

Postoperative waist exercise initiated 2 weeks following surgery.

Group Type EXPERIMENTAL

physical exercise

Intervention Type OTHER

The patients were randomized into 5 groups as control group, walking at 2 weeks, walking at 4 weeks, waist exercise at 2 weeks, waist exercise at 4 weeks.

One month waist exercise group

Postoperative waist exercise 1 month following surgery.

Group Type EXPERIMENTAL

physical exercise

Intervention Type OTHER

The patients were randomized into 5 groups as control group, walking at 2 weeks, walking at 4 weeks, waist exercise at 2 weeks, waist exercise at 4 weeks.

Interventions

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physical exercise

The patients were randomized into 5 groups as control group, walking at 2 weeks, walking at 4 weeks, waist exercise at 2 weeks, waist exercise at 4 weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* radicular pain that persisted despite 4-6 weeks of conservative treatment,
* detection of single-level disc herniation in MRI lumbar microsurgery.
* Individuals who underwent single-level unilateral lumbar microsurgery. Those with a surgical incision \<3 cm.

Exclusion Criteria

* Individuals with more than one level of muscle exposure at the time of surgery.
* those with a skin incision \>3 cm
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Medeniyet University

OTHER

Sponsor Role lead

Responsible Party

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Safak Cine

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istanbul Medeniyet University Medical Faculty Goztepe Suleyman Yalcin City Hospital

Istanbul, Kadıkoy, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Kim YK, Kang D, Lee I, Kim SY. Differences in the Incidence of Symptomatic Cervical and Lumbar Disc Herniation According to Age, Sex and National Health Insurance Eligibility: A Pilot Study on the Disease's Association with Work. Int J Environ Res Public Health. 2018 Sep 25;15(10):2094. doi: 10.3390/ijerph15102094.

Reference Type BACKGROUND
PMID: 30257414 (View on PubMed)

Hlubek RJ, Mundis GM Jr. Treatment for Recurrent Lumbar Disc Herniation. Curr Rev Musculoskelet Med. 2017 Dec;10(4):517-520. doi: 10.1007/s12178-017-9450-3.

Reference Type BACKGROUND
PMID: 29103156 (View on PubMed)

Huang W, Han Z, Liu J, Yu L, Yu X. Risk Factors for Recurrent Lumbar Disc Herniation: A Systematic Review and Meta-Analysis. Medicine (Baltimore). 2016 Jan;95(2):e2378. doi: 10.1097/MD.0000000000002378.

Reference Type BACKGROUND
PMID: 26765413 (View on PubMed)

Lewis RA, Williams NH, Sutton AJ, Burton K, Din NU, Matar HE, Hendry M, Phillips CJ, Nafees S, Fitzsimmons D, Rickard I, Wilkinson C. Comparative clinical effectiveness of management strategies for sciatica: systematic review and network meta-analyses. Spine J. 2015 Jun 1;15(6):1461-77. doi: 10.1016/j.spinee.2013.08.049. Epub 2013 Oct 4.

Reference Type BACKGROUND
PMID: 24412033 (View on PubMed)

Rasouli MR, Rahimi-Movaghar V, Shokraneh F, Moradi-Lakeh M, Chou R. Minimally invasive discectomy versus microdiscectomy/open discectomy for symptomatic lumbar disc herniation. Cochrane Database Syst Rev. 2014 Sep 4;2014(9):CD010328. doi: 10.1002/14651858.CD010328.pub2.

Reference Type BACKGROUND
PMID: 25184502 (View on PubMed)

Yoon SM, Ahn SS, Kim KH, Kim YD, Cho JH, Kim DH. Comparative Study of the Outcomes of Percutaneous Endoscopic Lumbar Discectomy and Microscopic Lumbar Discectomy Using the Tubular Retractor System Based on the VAS, ODI, and SF-36. Korean J Spine. 2012 Sep;9(3):215-22. doi: 10.14245/kjs.2012.9.3.215. Epub 2012 Sep 30.

Reference Type BACKGROUND
PMID: 25983818 (View on PubMed)

Parker SL, Mendenhall SK, Godil SS, Sivasubramanian P, Cahill K, Ziewacz J, McGirt MJ. Incidence of Low Back Pain After Lumbar Discectomy for Herniated Disc and Its Effect on Patient-reported Outcomes. Clin Orthop Relat Res. 2015 Jun;473(6):1988-99. doi: 10.1007/s11999-015-4193-1.

Reference Type BACKGROUND
PMID: 25694267 (View on PubMed)

Hebert JJ, Fritz JM, Thackeray A, Koppenhaver SL, Teyhen D. Early multimodal rehabilitation following lumbar disc surgery: a randomised clinical trial comparing the effects of two exercise programmes on clinical outcome and lumbar multifidus muscle function. Br J Sports Med. 2015 Jan;49(2):100-6. doi: 10.1136/bjsports-2013-092402. Epub 2013 Sep 12.

Reference Type BACKGROUND
PMID: 24029724 (View on PubMed)

Barbosa TP, Raposo AR, Cunha PD, Cruz Oliveira N, Lobarinhas A, Varanda P, Direito-Santos B. Rehabilitation after cervical and lumbar spine surgery. EFORT Open Rev. 2023 Aug 1;8(8):626-638. doi: 10.1530/EOR-23-0015.

Reference Type BACKGROUND
PMID: 37526242 (View on PubMed)

Vialle LR, Vialle EN, Suarez Henao JE, Giraldo G. LUMBAR DISC HERNIATION. Rev Bras Ortop. 2015 Nov 16;45(1):17-22. doi: 10.1016/S2255-4971(15)30211-1. eCollection 2010 Jan.

Reference Type RESULT
PMID: 27019834 (View on PubMed)

Other Identifiers

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SC/2023

Identifier Type: -

Identifier Source: org_study_id

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