Disc HerniationNCT06046781
Exercise After Lumbar Disc Herniation Surgery
A study testing physical exercise in people with Disc Herniation and Surgery, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Disc Herniation, Surgery
- What is being tested?
- physical exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 7 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Individuals with more than one level of muscle exposure at the time of surgery.
- those with a skin incision >3 cm
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medeniyet University Medical Faculty Goztepe Suleyman Yalcin City Hospital
Istanbul, Kadıkoy, 34722
About this study
Official title: The Necessity and Timing of Exercise After Lumbar Disc Herniation Surgery: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Disc Herniation, Surgery
- Being tested
- physical exercise
- Keywords
- Lumbar disc herniation, Lumbar microdiscectomy, physical exercise
- Medical subject headings
- Intervertebral Disc Displacement, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | One group served as the control and was advised not to participate in any postoperative exercise. Receives: Other: physical exercise |
| Second week walking group | Experimental | Postoperative walking initiated 2 weeks following surgery. Receives: Other: physical exercise |
| One month walking group | Experimental | Postoperative walking initiated one month following surgery. Receives: Other: physical exercise |
| Second week waist exercise group | Experimental | Postoperative waist exercise initiated 2 weeks following surgery. Receives: Other: physical exercise |
| One month waist exercise group | Experimental | Postoperative waist exercise 1 month following surgery. Receives: Other: physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 - 1 Months in the post-operative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Apr 2023
- Primary completion1 Sep 2023
- Study completion7 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safak Cine, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046781
- Sponsor's protocol ID
- SC/2023
- Status last verified
- Sep 2023
- First submitted
- 13 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The raw data could be shared for further experimental and statistics analysis purposes.
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 Sep 25;15(10):2094. doi: 10.3390/ijerph15102094.
PubMed 30257414Hlubek 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.
PubMed 29103156Huang 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.
PubMed 26765413Lewis 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.
PubMed 24412033Rasouli 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.
PubMed 25184502Yoon 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.
PubMed 25983818Parker 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.
PubMed 25694267Hebert 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.
PubMed 24029724Barbosa 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.
PubMed 37526242Vialle 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.
PubMed 27019834
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Necessity and Timing of Exercise After Lumbar Disc Herniation Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06046781
- Acronym / sponsor ID
- SC/2023
- Conditions
- Disc Herniation, Surgery
- Keywords
- Lumbar disc herniation, Lumbar microdiscectomy, physical exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 7 Sep 2023 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: physical exerciseOne group served as the control and was advised not to participate in any postoperative exercise. |
| Second week walking group | Experimental | Other: physical exercisePostoperative walking initiated 2 weeks following surgery. |
| One month walking group | Experimental | Other: physical exercisePostoperative walking initiated one month following surgery. |
| Second week waist exercise group | Experimental | Other: physical exercisePostoperative waist exercise initiated 2 weeks following surgery. |
| One month waist exercise group | Experimental | Other: physical exercisePostoperative waist exercise 1 month following surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Individuals with more than one level of muscle exposure at the time of surgery.
- those with a skin incision >3 cm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical exerciseThe 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. | Other | Control group, One month waist exercise group, One month walking group, Second week waist exercise group, Second week walking group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Background: PubMed 30257414Kim 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.
- Background: PubMed 29103156Hlubek 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.
- Background: PubMed 26765413Huang 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.
- Background: PubMed 24412033Lewis 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.
- Background: PubMed 25184502Rasouli 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.
- Background: PubMed 25983818Yoon 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.
- Background: PubMed 25694267Parker 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.
- Background: PubMed 24029724Hebert 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.
- Background: PubMed 37526242Barbosa 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 publication: PubMed 27019834Vialle 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.
- Individual participant dataSharing planned: Undecided. The raw data could be shared for further experimental and statistics analysis purposes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical exercise in people with Disc Herniation and Surgery, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Affect on back pain (time frame: 0 - 1 Months in the post-operative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06046781, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.