Rehabilitation in Lumbar Disc Herniation

NCT05544331 | Unknown

• 1 other identifier: 09.2021.351
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Symptomatic Lumbar Disc Herniation

Outcome Measures

Primary Outcomes (10)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (3)

Written exercise group

EXPERIMENTAL

The exercise program will consist of core stabilization exercises, which target various trunk muscles to optimize segmental control, spinal stability, spinal stiffness, orientation and the interoperability of these features. The exercise program will be in writing form, which is a common home exercise program type.

Behavioral: Exercise group (written form)

Video based exercise group

EXPERIMENTAL

The exercise program will consist of core stabilization exercises, which provide segmental control optimization, spinal stabilization, spinal stiffness, orientation and the interoperability of these features. The exercise program will be given patients as video records, which provide visual and auditory feedbacks.

Behavioral: Exercise group (video based)

Control group

NO INTERVENTION

The patients, who are referred and will wait for the exercise program in their routine daily life. Measurements will be performed at the same time frame in experimental group. After the 12 weeks of follow up period, they will join the exercise program.

Interventions

Exercise group (written form) BEHAVIORAL

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.

Written exercise group

Exercise group (video based) BEHAVIORAL

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.

Video based exercise group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, 34000, Turkey (Türkiye)

Location

Study Officials

• Tugce Ozen, MSc

  Marmara University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tugce Ozen, MSc

CONTACT

+905052275829; tugceozen1709@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 16, 2022
• Study Start: October 10, 2022
• Primary Completion: March 30, 2023
• Study Completion: June 30, 2023
• Last Updated: September 16, 2022

Record last verified: 2022-09

Locations

TU (1)