Rehabilitation in Lumbar Disc Herniation

Back to results

Primary Purpose

Status

Not yet recruiting

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Exercise group (written form)

Exercise group (video based)

About this trial

This is an interventional treatment trial for Symptomatic Lumbar Disc Herniation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Marmara University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Written exercise group

Video based exercise group

Control group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Pain perception

Numeric Rated Scale (NRS) will be used to evaluate pain perception. Patients will be asked rated their pain between 0 and 10.

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.

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.

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.

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.

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.

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.

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.

Exercise adherence

The patients will be asked to note the number of the days they exercise in each week.

Secondary Outcome Measures

Full Information

NCT ID

NCT05544331

First Posted

September 14, 2022

Last Updated

September 14, 2022

Sponsor

Marmara University

1. Study Identification

Unique Protocol Identification Number

NCT05544331

Brief Title

Rehabilitation in Lumbar Disc Herniation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 10, 2022 (Anticipated)

Primary Completion Date

March 30, 2023 (Anticipated)

Study Completion Date

June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Symptomatic Lumbar Disc Herniation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Written exercise group

Arm Type

Experimental

Arm Description

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.

Arm Title

Video based exercise group

Arm Type

Experimental

Arm Description

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.

Arm Title

Control group

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Exercise group (written form)

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Exercise group (video based)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Disability

Description

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.

Time Frame

Change from baseline at week 8, and 12.week.

Title

Pain perception

Description

Numeric Rated Scale (NRS) will be used to evaluate pain perception. Patients will be asked rated their pain between 0 and 10.

Time Frame