- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06046781
Exercise After Lumbar Disc Herniation Surgery
The Necessity and Timing of Exercise After Lumbar Disc Herniation Surgery: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kadıkoy
-
Istanbul, Kadıkoy, Turkey, 34722
- Istanbul Medeniyet University Medical Faculty Goztepe Suleyman Yalcin City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Control group
One group served as the control and was advised not to participate in any postoperative 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.
|
|
Experimental: Second week walking group
Postoperative walking initiated 2 weeks following surgery.
|
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.
|
|
Experimental: One month walking group
Postoperative walking initiated one month following surgery.
|
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.
|
|
Experimental: Second week waist exercise group
Postoperative waist exercise initiated 2 weeks following surgery.
|
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.
|
|
Experimental: One month waist exercise group
Postoperative waist exercise 1 month following surgery.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Affect on back pain
Time Frame: 0 - 1 Months in the post-operative period
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SC/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.