Clinical trial NCT05544331: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Symptomatic Lumbar Disc Herniation
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disability
timeFrame: Change from baseline at week 8, and 12.week.
measure: Pain perception
timeFrame: Change from baseline at week 8, and12.week.
measure: Kinesiophobia
timeFrame: Change from baseline at week 8, and12.week.
measure: Emotional status
timeFrame: Change from baseline at week 8, and12.week.
measure: Health related quality of life
timeFrame: Change from baseline at week 8, and12.week.
measure: Range of motion of lumbar spine
timeFrame: Change from baseline at week 8, and12.week.
measure: Flexibility
timeFrame: Change from baseline at week 8, and12.week.
measure: Static endurance
timeFrame: Change from baseline at week 8, and12.week.
measure: Dynamic endurance
timeFrame: Change from baseline at week 8, and12.week.
measure: Exercise adherence
timeFrame: Change from baseline at week 8, and12.week.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
affiliation: Marmara University
name: Tugce Ozen, MSc
role: PRINCIPAL_INVESTIGATOR
References: