Exercise After Lumbar Disc Herniation Surgery

Sponsor

Istanbul Medeniyet University (Other)

Overall Status

Completed

CT.gov ID

NCT06046781

Collaborator

(none)

204

Enrollment

Location

Arms

5.2

Actual Duration (Months)

39.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Disc Herniation Surgery	Other: physical exercise	N/A

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

Study Type:

Interventional

Actual Enrollment :

204 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2023

Actual Primary Completion Date :

Sep 1, 2023

Actual Study Completion Date :

Sep 7, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Control group One group served as the control and was advised not to participate in any postoperative exercise.	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.
Experimental: Second week walking group Postoperative walking initiated 2 weeks following surgery.	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.
Experimental: One month walking group Postoperative walking initiated one month following surgery.	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.
Experimental: Second week waist exercise group Postoperative waist exercise initiated 2 weeks following surgery.	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.
Experimental: One month waist exercise group Postoperative waist exercise 1 month following surgery.	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.

Outcome Measures

Primary Outcome Measures

Affect on back pain [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul Medeniyet University Medical Faculty Goztepe Suleyman Yalcin City Hospital	Istanbul	Kadıkoy	Turkey	34722

Sponsors and Collaborators

Istanbul Medeniyet University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Safak Cine, MD, Istanbul Medeniyet University

ClinicalTrials.gov Identifier:

NCT06046781

Other Study ID Numbers:

SC/2023

First Posted:

Sep 21, 2023

Last Update Posted:

Sep 21, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Safak Cine, MD, Istanbul Medeniyet University

Lumbar disc herniation

Lumbar microdiscectomy

physical exercise

Additional relevant MeSH terms:

Intervertebral Disc Displacement

Hernia

Study Results

No Results Posted as of Sep 21, 2023