Rehabilitation in Lumbar Disc Herniation

NCT ID: NCT05544331

Last Updated: 2022-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-10

Study Completion Date

2023-06-30

Brief Summary

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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

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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.

Conditions

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Symptomatic Lumbar Disc Herniation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Written exercise group

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.

Group Type EXPERIMENTAL

Exercise group (written form)

Intervention Type 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.

Video based exercise group

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.

Group Type EXPERIMENTAL

Exercise group (video based)

Intervention Type 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.

Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Tugce Ozen

research assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tugce Ozen, MSc

Role: PRINCIPAL_INVESTIGATOR

Marmara University

Locations

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Marmara University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Tugce Ozen, MSc

Role: CONTACT

+905052275829

Facility Contacts

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Tugce Ozen, MSc

Role: primary

5052275829

Other Identifiers

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09.2021.351

Identifier Type: -

Identifier Source: org_study_id

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