Female Patients Diagnosed With LDH at L4-S1NCT06158685
The Effect of Hyperextension Exercises In Lumbal Disc Hernia
A study testing Study Group in people with Female Patients Diagnosed With LDH at L4-S1, run by Mehmet GÖĞREMİŞ at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Female Patients Diagnosed With LDH at L4-S1
- What is being tested?
- Study Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2017to 1 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Being tested
- Study Group, Control Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study GroupOther
Treatment: Hyperextension exercises as described by McKenzie (in addition to the conventional physiotherapy program)
McKenzie Hyperextension Exercises:
- Exercises:
- Prone position, arms by the side, deep breath, relax back muscles, holding for 2-3 minutes.
- Prone position, raise trunk by raising head above forearms, elbows at shoulder level, maintaining for 2-3 minutes (10 repetitions).
- Prone position, hands at elbow level, straighten elbows, raise the upper body from the floor and backwards as far as pain permits, holding for 2-3 seconds (10 repetitions).
- Standing with feet shoulder-width apart, hands on waist, leaning backwards as far as possible from the lumbar region without bending knees, holding for 2-3 seconds (10 repetitions). Additional Information:
- Researcher Consistency: All treatments and evaluations were performed by the same researcher.
Frequency: 5 days a week Duration: 3 consecutive weeks
Control GroupOther
Treatment: Conventional physiotherapy program
- Components:
- Hot pack was applied to the lumbar region for 20 minutes
- Ultrasound (ITO device) at 1 MHz and 1.5 W/cm2 for 5 minutes
- Transcutaneous Electrical Nerve Stimulation (TENS) at 50-100 Hz for 20 minutes
- Researcher Consistency: All treatments and evaluations for both groups were performed by the same researcher.
- Session Duration: An average of 45 minutes per session
- Frequency: 5 days a week
- Duration: 3 consecutive weeks
- Total Sessions: 15
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | The control group subjects were applied with 15 sessions of conventional physiotherapy consisting of hotpack, ultrasound, and TENS. Receives: Other: Control Group |
| study group | Experimental | The study group subjects received 15 sessions of McKenzie hyperextension exercises in addition to the conventional physiotherapy program. Receives: Other: Study Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
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.
Measured: Baseline and week 8
Flexibility Evaluation
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.
Measured: Baseline and week 8
Performance Evaluation
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.
Measured: Baseline and week 8
Disability Level Evaluation
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.
Measured: Baseline and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start1 Feb 2017
- Primary completion1 Jul 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Patients Diagnosed With LDH at L4-S1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mehmet GÖĞREMİŞ
- Sponsor type
- University, hospital or other
- Collaborators
- Kahramanmaras Sutcu Imam University
- Responsible party
- Sponsor-investigator, Mehmet GÖĞREMİŞ, Kahramanmaras Sutcu Imam University
- Investigators
- Ejder Berk, Study chair, Kahmanamaras Sutcü İmam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158685
- Sponsor's protocol ID
- fztmehmetgogremis123
- Status last verified
- Nov 2023
- First submitted
- 3 Aug 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hyperextension Exercises on Pain, Disability, Flexibility and Performance Level in Patients With Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT06158685
- Acronym / sponsor ID
- fztmehmetgogremis123
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Mehmet GÖĞREMİŞUniversity, hospital or other
- Collaborators
- Kahramanmaras Sutcu Imam University
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: Control GroupThe control group subjects were applied with 15 sessions of conventional physiotherapy consisting of hotpack, ultrasound, and TENS. |
| study group | Experimental | Other: Study GroupThe study group subjects received 15 sessions of McKenzie hyperextension exercises in addition to the conventional physiotherapy program. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study GroupTreatment: Hyperextension exercises as described by McKenzie (in addition to the conventional physiotherapy program) McKenzie Hyperextension Exercises: * Exercises: 1. Prone position, arms by the side, deep breath, relax back muscles, holding for 2-3 minutes. 2. Prone position, raise trunk by raising head above forearms, elbows at shoulder level, maintaining for 2-3 minutes (10 repetitions). 3. Prone position, hands at elbow level, straighten elbows, raise the upper body from the floor and backwards as far as pain permits, holding for 2-3 seconds (10 repetitions). 4. Standing with feet shoulder-width apart, hands on waist, leaning backwards as far as possible from the lumbar region without bending knees, holding for 2-3 seconds (10 repetitions). Additional Information: * Researcher Consistency: All treatments and evaluations were performed by the same researcher. Frequency: 5 days a week Duration: 3 consecutive weeks | Other | study group |
| Control GroupTreatment: Conventional physiotherapy program * Components: * Hot pack was applied to the lumbar region for 20 minutes * Ultrasound (ITO device) at 1 MHz and 1.5 W/cm2 for 5 minutes * Transcutaneous Electrical Nerve Stimulation (TENS) at 50-100 Hz for 20 minutes * Researcher Consistency: All treatments and evaluations for both groups were performed by the same researcher. * Session Duration: An average of 45 minutes per session * Frequency: 5 days a week * Duration: 3 consecutive weeks * Total Sessions: 15 | Other | control group |
Primary outcome
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.
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.
Performance Evaluation
Time frame: Baseline and week 8
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.
Disability Level Evaluation
Time frame: Baseline and week 8
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ejder Berk study chair
Kahmanamaras Sutcü İmam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study Group in people with Female Patients Diagnosed With LDH at L4-S1, run by Mehmet GÖĞREMİŞ at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: Baseline and week 8). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.