Rehabilitation in Lumbar Disc Herniation

Symptomatic Lumbar Disc Herniation Clinical Trial

Official title:

Comparison of Written and Video Home Exercise Program in the Patients With Chronic Symptomatic Lumbar Disc Herniation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05544331
• Other study ID #: 09.2021.351
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 10, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: September 2022
• Source: Marmara University
• Contact: Tugce Ozen, MSc
• Phone: +905052275829
• Email: tugceozen1709[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the effects of written and video based home exercise program in patients with symptomatic lumbar disc herniation on pain level, function and quality of life.

Description:

45 symptomatic lumbar disc herniation patients, who are in chronic period and aged between 18-65 years, will be included. The participants will be randomised into three groups. 15 patients will be included in the written home exercise group,15 patients will be in video based home exercise group and 15 patients in the control group. In the written exercise group and video based exercise group, exercise programs will be 8 weeks. In the control group, the exercise protocol will not be performed during 8 weeks. The outcomes will include the quality of life, pain level, functional capacity, kinesiophobia. In the exercise groups, the evaluations will be made in the first interview (before exercise program), at the end of 8 weeks of exercise (when the exercise program is completed) and in 12th weeks (4 weeks after the exercise program completion). Evaluations in the control group will be carried out at the first interview, at the 8th week, 12th weeks.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: June 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Aged between of 18-65 years
• Having been diagnosed with a lumbar disc herniation
• No need for surgery due to lumbar disc herniation
• Having pain in the lower back or leg for at least 12 weeks
• Not using corticosteroids
• To be oriented and cooperative
• To be volunteer to participate in the study

Exclusion Criteria:

• Having undergone lumbar spine surgery
• Having undergone lower extremity, upper extremity, spine surgery in the last 1 year
• Presence of lumbar stenosis
• Analgesic addiction, or any addiction
• Presence of tumor
• Presence of metastases
• Presence of rheumatological diseases
• The presence of scoliosis, congenital deformity
• Presence of leg length discrepancy
• Being pregnant
• To have uncontrolled hypertension
• To have exercise-dependent angina

Related Conditions & MeSH terms

• Hernia
• Intervertebral Disc Displacement
• Symptomatic Lumbar Disc Herniation

Intervention

Behavioral:
• Exercise group (written form)
The exercise program will be structUred with core stabilization exercises. Patients will be given the written form of exercises and will be applied as home exercises. Exercise progression will be provided by position changes.
• Exercise group (video based)
The exercise program will be structUred with core stabilization exercises. Patients will be given the exercise videos, which provide visual and auditory feedback, and will be applied as home exercises. Exercise progression will be provided by position changes.

Locations

Country	Name	City	State
Turkey	Marmara University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disability	Oswestry Disability Index (ODI) will be used to evaluate patients perceptions of low back related disability. ODI consists of 10 questions, scored between 0 and 5.	Change from baseline at week 8, and 12.week.
Primary	Pain perception	Numeric Rated Scale (NRS) will be used to evaluate pain perception. Patients will be asked rated their pain between 0 and 10.	Change from baseline at week 8, and12.week.
Primary	Kinesiophobia	Tampa Kinesiophobia Scale will be used. It consists of 17 questions about fear of movement and reinjury. Each question scored between 1 and 4.	Change from baseline at week 8, and12.week.
Primary	Emotional status	Hospital Anxiety and Depression Scale (HADS) will be used for evaluate the patients' anxiety and depression status. HADS consists of 14 questions, which scored between 1 and 3.	Change from baseline at week 8, and12.week.
Primary	Health related quality of life	SF-36 Health Related Quality of Life (SF-36) questionnaire will be used. SF-36 consists of 36 questions and evaluate different aspects of quality of life.	Change from baseline at week 8, and12.week.
Primary	Range of motion of lumbar spine	The range of lumbar flexion and extension will be measured by the inclinometer. While the person is standing on both feet, first the inclinometer will be placed on the reference points on the spine. For lumbar flexion value The person will be asked to bend forward as much as he can without bending his legs. For extension value, the person will be asked to bend backwards as much as possible without bending his legs, and at the last point, the inclinometer will be read and the value will be recorded.; Lumbar lordosis will be measured by the inclinometer. While the patients stands with his feet shoulder-width apart and knees straight, the measurement will be taken by the inclinometer placed on the reference points.	Change from baseline at week 8, and12.week.
Primary	Flexibility	Fingertip-to-Floor Test will be applied. The person will be asked to lean forward without bending their knees while standing on a high platform, and the distance between the fingertip and the platform will be measured. Values will be recorded as centimeter.; Side bending test will be used to measure the flexibility of spine in right and left lateral flexion. The patient will be asked to bend his back to the right and left sides, without separating his back from the wall. The results will be recorded as centimeter.	Change from baseline at week 8, and12.week.
Primary	Static endurance	Lateral Bridge Test will be used to evaluate the static endurance of the lateral core muscles. The subjects will be asked to turn on their right side, raise their body on their forearms and toes and keep them in this position, and the time until the position deteriorates will be recorded as second.; Sorensen Test will be used to evaluate the static endurance of trunk extensors. The subjects were positioned in the prone position, with the pelvis, hips and knees on the bed. The subjects will be asked to extend their upper body straight forward from the edge of the table and the time until the deterioration of the straight position is recorded.; Trunk Flexors Endurance Test will be used to evaluate static endurance of the trunk flexors. The subjects were positioned with the trunk in 60 degree flexion, knees and hips in 90 degree flexion position.When the 60 degree trunk flexion is impaired, the test will be terminated and the time will be recorded.	Change from baseline at week 8, and12.week.
Primary	Dynamic endurance	Sit-ups' Test will be used to evaluate the endurance of the abdominal muscles. The patients will be asked to flex the trunk while the knees are in the flexed position and the feet are stabilized. Each test of the patients is 30 seconds. The number of times they can do it will be recorded.; Modified 'Push-ups' Test will be used to evaluate the upper body strength endurance. Subjects will be asked to lift the head, shoulders and trunk from the ground in the prone position with the arms and elbows flexed and the elbows fully extended. During the test, the knees will be positioned in flexion (25). Each test of the patients is 30 seconds. The number of times they can do it will be recorded.	Change from baseline at week 8, and12.week.
Primary	Exercise adherence	The patients will be asked to note the number of the days they exercise in each week.	Change from baseline at week 8, and12.week.