Exercise After Lumbar Disc Herniation Surgery

Surgery Clinical Trial

Official title:

The Necessity and Timing of Exercise After Lumbar Disc Herniation Surgery: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06046781
• Other study ID #: SC/2023
• Status: Completed
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: September 7, 2023

Study information

• Verified date: September 2023
• Source: Istanbul Medeniyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: September 7, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Disc Herniation
• Hernia
• Intervertebral Disc Displacement
• Surgery

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Istanbul Medeniyet University Medical Faculty Goztepe Suleyman Yalcin City Hospital	Istanbul	Kadikoy

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

References & Publications (10)

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

Barbosa TP, Raposo AR, Cunha PD, et al. Rehabilitation after cervical and lumbar spine surgery. EFORT Open Rev. 2023;8(8):626-638. Published 2023 Aug 1. doi:10.1530/EOR-23-0015

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;49(2):100-106. doi:10.1136/bjsports-2013-092402

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

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;95(2):e2378. doi:10.1097/MD.0000000000002378

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;15(10):2094. Published 2018 Sep 25. doi:10.3390/ijerph15102094

Lewis RA, Williams NH, Sutton AJ, et al. Comparative clinical effectiveness of management strategies for sciatica: systematic review and network meta-analyses. Spine J. 2015;15(6):1461-1477. doi:10.1016/j.spinee.2013.08.049

Parker SL, Mendenhall SK, Godil SS, et al. Incidence of Low Back Pain After Lumbar Discectomy for Herniated Disc and Its Effect on Patient-reported Outcomes. Clin Orthop Relat Res. 2015;473(6):1988-1999. doi:10.1007/s11999-015-4193-1

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;(9):CD010328. Published 2014 Sep 4. doi:10.1002/14651858.CD010328.pub2

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;9(3):215-222. doi:10.14245/kjs.2012.9.3.215

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0 - 1 Months in the post-operative period