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Exercise After Lumbar Disc Herniation Surgery

Primary Purpose

Disc Herniation, Surgery

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
physical exercise
Sponsored by
Istanbul Medeniyet University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disc Herniation focused on measuring Lumbar disc herniation, Lumbar microdiscectomy, physical exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul Medeniyet University Medical Faculty Goztepe Suleyman Yalcin City Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Other

Experimental

Experimental

Experimental

Experimental

Arm Label

Control group

Second week walking group

One month walking group

Second week waist exercise group

One month waist exercise group

Arm Description

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

Postoperative walking initiated 2 weeks following surgery.

Postoperative walking initiated one month following surgery.

Postoperative waist exercise initiated 2 weeks following surgery.

Postoperative waist exercise 1 month following surgery.

Outcomes

Primary Outcome Measures

Affect on back pain
Different effects of early and late rehabilitation to the low back pain following unilateral microdiscectomy. Pain status will be evaluated with the Visual Analogue Scale.

Secondary Outcome Measures

Full Information

First Posted
September 13, 2023
Last Updated
September 19, 2023
Sponsor
Istanbul Medeniyet University
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1. Study Identification

Unique Protocol Identification Number
NCT06046781
Brief Title
Exercise After Lumbar Disc Herniation Surgery
Official Title
The Necessity and Timing of Exercise After Lumbar Disc Herniation Surgery: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
September 1, 2023 (Actual)
Study Completion Date
September 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medeniyet University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disc Herniation, Surgery
Keywords
Lumbar disc herniation, Lumbar microdiscectomy, physical exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
204 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Other
Arm Description
One group served as the control and was advised not to participate in any postoperative exercise.
Arm Title
Second week walking group
Arm Type
Experimental
Arm Description
Postoperative walking initiated 2 weeks following surgery.
Arm Title
One month walking group
Arm Type
Experimental
Arm Description
Postoperative walking initiated one month following surgery.
Arm Title
Second week waist exercise group
Arm Type
Experimental
Arm Description
Postoperative waist exercise initiated 2 weeks following surgery.
Arm Title
One month waist exercise group
Arm Type
Experimental
Arm Description
Postoperative waist exercise 1 month following surgery.
Intervention Type
Other
Intervention Name(s)
physical exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Affect on back pain
Description
Different effects of early and late rehabilitation to the low back pain following unilateral microdiscectomy. Pain status will be evaluated with the Visual Analogue Scale.
Time Frame
0 - 1 Months in the post-operative period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Istanbul Medeniyet University Medical Faculty Goztepe Suleyman Yalcin City Hospital
City
Istanbul
State/Province
Kadıkoy
ZIP/Postal Code
34722
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The raw data could be shared for further experimental and statistics analysis purposes.
Citations:
PubMed Identifier
30257414
Citation
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.
Results Reference
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PubMed Identifier
29103156
Citation
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.
Results Reference
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PubMed Identifier
26765413
Citation
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.
Results Reference
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PubMed Identifier
24412033
Citation
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.
Results Reference
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PubMed Identifier
25184502
Citation
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;(9):CD010328. doi: 10.1002/14651858.CD010328.pub2.
Results Reference
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PubMed Identifier
25983818
Citation
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.
Results Reference
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PubMed Identifier
25694267
Citation
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.
Results Reference
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PubMed Identifier
24029724
Citation
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.
Results Reference
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PubMed Identifier
37526242
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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Exercise After Lumbar Disc Herniation Surgery

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