- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06158685
The Effect of Hyperextension Exercises In Lumbal Disc Hernia
The Effect of Hyperextension Exercises on Pain, Disability, Flexibility and Performance Level in Patients With Lumbar Disc Herniation
The aim of this study was to examine the short-term effect on pain severity, disability level, flexibility and performance level of McKenzie hyperextension exercises applied in addition to conventional physiotherapy approaches in patients diagnosed with LDH.
A total of 48 consecutive female patients diagnosed with LDH at L4-S1 were randomly separated into 2 groups of 24 as the study group and control group. The control group subjects were applied with 15 sessions of conventional physiotherapy consisting of hotpack, ultrasound, and TENS. The study group subjects received 15 sessions of McKenzie hyperextension exercises in addition to the conventional physiotherapy program.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Aim: The aim of this study was to examine the short-term effect on pain severity, disability level, flexibility and performance level of McKenzie hyperextension exercises applied in addition to conventional physiotherapy approaches in patients diagnosed with LDH.
Method: A total of 48 consecutive female patients diagnosed with LDH at L4-S1 were randomly separated into 2 groups of 24 as the study group and control group. The control group subjects were applied with 15 sessions of conventional physiotherapy consisting of hotpack, ultrasound, and TENS. The study group subjects received 15 sessions of McKenzie hyperextension exercises in addition to the conventional physiotherapy program. Before treatment, immediately after treatment, and at 3 months after the end of treatment, the two groups were compared in respect of pain severity (Visual Analog Scale- VAS), performance level (Half-Squat Test and The 5 Times Sit-Stand Test), flexibility level (Modified Sit And Reach Test), and disability level (Oswestry Disability Index - ODI).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Kahramanmaraş, Turkey, 46100
- KahramanmarasISU
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The patients included were diagnosed on MRI with L4-S1 LDH (bulging level),
- were taking no drugs other than simple painkillers,
- had LDH symptoms ongoing for at least 3 months.
Exclusion Criteria:
- Patients were excluded from the study if they had a history of lumbar spinal surgery,
- had any disease involving the lumbar spine other than LDH (piriformis syndrome, infection, spondylosis, spondylolysis, spondylolisthesis, ankylosing spondylitis, spinal stenosis, facet syndrome, spinal malignancy, osteoporosis),
- severe neurological loss,
- diabetes mellitus, or were pregnant.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: control group
The control group subjects were applied with 15 sessions of conventional physiotherapy consisting of hotpack, ultrasound, and TENS.
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Treatment: Conventional physiotherapy program
|
Experimental: study group
The study group subjects received 15 sessions of McKenzie hyperextension exercises in addition to the conventional physiotherapy program.
|
Treatment: Hyperextension exercises as described by McKenzie (in addition to the conventional physiotherapy program) McKenzie Hyperextension Exercises:
Frequency: 5 days a week Duration: 3 consecutive weeks |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale (VAS)
Time Frame: Baseline and week 8
|
This is a simple, reliable and valid scale, used as the most apropriate tool to define the severity and intensity of pain.
The VAS is a 10 cm horizontal scale marked from 0-10, where 0= no pain and 10= the most intolerable pain.
Subjects are instructed to mark the point on the scale representing the severity of the pain they feel.
The marked points were measured and recorded.
|
Baseline and week 8
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Flexibility Evaluation
Time Frame: Baseline and week 8
|
To evaluate lumbar region flexibility, The Modified Sit And Reach Test (Back-saver Sit-and-Reach Test - BSRT) was used.
This test is applied on a test table 60 cm long, 45cm wide, and 32 cm high, with the subject seated with the legs extended in front.
The sole of the foot on the side to be tested rests against the test board with the knee in full extension and the contralateral leg is positioned with the knee in 45-90° flexion and the hip joint in 45° flexion.
The subject is then instructed to reach over the test board while in this position.
Two plastic measures marked in 1 mm gradations are attached to the board, taking the point where it rests against the foot as zero and extending back by 20 cm and forward by 40 cm.
Scores of the reach of the subject were recorded as negative (-) if before the zero point and as positive (+) if after.
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Baseline and week 8
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Performance Evaluation
Time Frame: Baseline and week 8
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The first test applied to determine the performance level of the subjects was the Half-Squat Test (HST). Throughout 1 minute, the subject is instructed to stand up straight then with the knees in 20° flexion to squat and then return to the upright position. A chronometer was started on the "start" command and at the end of 1 min, the score was recorded of the number of squats performed. The second performance test was the 5 x Sit To Stand Test (5x SST). On the "start" command, the subject sits and stands from a chair 5 times. The time was recorded on a chronometer. |
Baseline and week 8
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Disability Level Evaluation
Time Frame: Baseline and week 8
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The ODI was used to determine the level of disability.
The ODI is a scale used to determine the degree of functional incapacity in daily living activities caused by lower back pain.
The total score ranges from 0 to 50, with higher points showinga higher level of disability.
The points are evaluated as 0-10 points: low level disability, 11-30 points: moderate level disability, 31-50: severe level disability.17
Validity and reliability studies of the Turkish version of the scale were made by Yakut et al.
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Baseline and week 8
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Ejder Berk, Kahmanamaras Sutcü İmam University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- fztmehmetgogremis123
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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