Lumbar Disc DiseaseNCT04061759

Physiotherapy in Lumbar Disc Pathologies

A study testing Effectiveness of four physical therapy approaches (soft tissue manual therapy, Kinesio® Taping techniques, stabilization exercises and reflex therapy) for treating lumbar disc pathologies. in people with Lumbar Disc Disease and Lumbar Disc Herniation, run by Guven Health Group at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 25 to 55 years
Conditions the study is for: Lumbar Disc Disease, Lumbar Disc Herniation, Low Back Pain, Mechanical
What is being tested?: Effectiveness of four physical therapy approaches (soft tissue manual therapy, Kinesio® Taping techniques, stabilization exercises and reflex therapy) for treating lumbar disc pathologies.
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 2 Sep 2020to 2 Feb 2021
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 25 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

The participants between the ages of 25 and 55 years,
Having a minimum pain level (at activity) of 3 out of 10 on visual analog scale
Having low back pain for at least 3 months with lumbar disc pathology (bulging or protrusion) diagnosed by clinical tests and magnetic resonance imaging.

Who cannot join

sacroiliac and lumbar degenerative pathologies,
another pathology related to neurological deficits,
physiotherapy previously received for at least 12 months,
any surgery affecting the lumbar region.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Anima Rapha Center
Ankara, 06770

Other trials in Turkey (Türkiye)

About this study

Official title: A Randomized Controlled Clinical Trial

The aim of this study is to compare the effectiveness of four physical therapy treatment approaches for lumbar region pathologies. Eighty volunteers who have back pain will be included in the study. Subjects will be randomly divided into four groups; Group 1: Soft tissue mobilisation techniques and stabilization exercises (n=20), Group 2: Kinesiotape and stabilization exercise (n=20), Group 3: Stabilization exercises (n=20), Group 4: Reflexology and stabilization exercises (n=20).

Read the detailed description

All patients will be measured with visual analog scale for pain level, goniometric measurement for range of motion, hamstring tension and sit and reach for flexibility, isokinetic evaluation for strength in 60degree/ sec, Side plank position test for trunk stabilization.

Function will be measured with Oswestry Disability Index. Manual muscle testing for flexion, extension, lateral flexion of back, flexion, extension, abduction of hip, flexion, extension of knee and inversion, eversion of ankle will be assessed. Group 1, 2 and 4 will be started to treatment twice a week for 4 weeks after first evaluation. Group 3 will be had home exercise programme after first evaluation.

Groups will be assessed again at 4th and 8th weeks after treatment. Multiway variant analysis will bee done within each group before the treatment and at follow-up. When differences observed, Tukey test will be used to find out the group that caused the differences.

Conditions: Lumbar Disc Disease, Lumbar Disc Herniation, Low Back Pain, Mechanical, Low Back Strain
Being tested: Effectiveness of four physical therapy approaches (soft tissue manual therapy, Kinesio® Taping techniques, stabilization exercises and reflex therapy) for treating lumbar disc pathologies.
Medical subject headings: Intervertebral disc disease, Intervertebral Disc Displacement, Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Effectiveness of four physical therapy approaches (soft tissue manual therapy, Kinesio® Taping techniques, stabilization exercises and reflex therapy) for treating lumbar disc pathologies.Other
Visual analog scale (VAS) scores for pain intensity, goniometric measurements for the range of motion and hamstring flexibility, the sit and reach test for flexibility, an isokinetic evaluation for strength at 60°/sec, and a side-plank position test for trunk stabilization were measured. The functional status was evaluated with the Oswestry Disability Index. All groups were assessed at the beginning, after a four-week treatment and four weeks of follow-up.

Study groups in NCT04061759
Study group	Role	What they receive
Soft tissue mobilization&stabilization exercises	Active comparator	The following manual therapy techniques will be applied: 1. Soft Tissue Mobilization; 2. Pretzel Maneuvers; 3. Pelvis Backward-Distraction; 4. Trunk Rotation; 5. Multifidus Mobilization; and 6. Piriformis Transverse Friction Massage Receives: Other: Effectiveness of four physical therapy approaches (soft tissue manual therapy, Kinesio® Taping techniques, stabilization exercises and reflex therapy) for treating lumbar disc pathologies.
Kinesiotape&stabilization exercises	Active comparator	The Kinesio® Taping muscle technique, with 10-25% of the stretch of the tape, will be applied to the sacrospinalis, quadratus lumborum, gluteus medius/maximus and piriformis muscles, based on the the weakness that patient's muscles had. Factors interfering with tape adhesion, such as sweat or hair, will be removed before the application. The tape can stay in place for 3-5 days due to its water resistant and breathable properties Receives: Other: Effectiveness of four physical therapy approaches (soft tissue manual therapy, Kinesio® Taping techniques, stabilization exercises and reflex therapy) for treating lumbar disc pathologies.
Stabilization exercises	Active comparator	The core stabilization exercise treatment program consisted of the following exercises: a posterior pelvic tilt exercise, lower abdominal muscle isometric strengthening, hip adductor muscle isometric strengthening, lumbar stabilization exercises with a Swiss ball, upper and lower abdominal muscle strengthening exercises with a Swiss ball, oblique abdominal muscle strengthening exercises with a Swiss ball, quadratus lumborum muscle stretching with a Swiss ball, back extensor muscle strengthening exercises with a Swiss ball, a slump exercise (sciatic nerve stretching), lumbar lordosis exercises with a Swiss ball, bridge exercises with a Swiss ball, single leg bridge exercises on a Swiss ball, posture exercises, push-up exercises with a Swiss ball, and squat exercises with a Swiss ball Receives: Other: Effectiveness of four physical therapy approaches (soft tissue manual therapy, Kinesio® Taping techniques, stabilization exercises and reflex therapy) for treating lumbar disc pathologies.
Reflex therapy&Stabilization exercises	Active comparator	Mobilization of each vertebra and pulls were applied from the medial side of the toe to the medial malleolus and to the heel by hand or with the help of an apparatus, including the cervical, thoracic and lumbar spine reflex zones. Finally, the procedure was finished by making a V-shaped maneuver with a thumb in the direction of spinal nerve exits. Receives: Other: Effectiveness of four physical therapy approaches (soft tissue manual therapy, Kinesio® Taping techniques, stabilization exercises and reflex therapy) for treating lumbar disc pathologies.

What is being measured

The primary outcome is the main question the study is designed to answer.

pain intensity
All patients will be assessed with the visual analog scale (VAS) for pain intensity at rest, at night and during activity. VAS is a 100-mm line with no marks along it, anchored with the words "no pain" on one side and "the most severe pain" on the other. The subjects were simply instructed to place a mark along the line at a level representing the intensity of their pain.
Measured: 8weeks
range of motion
Trunk and hip range of motion measurements were taken with a universal goniometer. Active trunk flexion and extension, lateral flexion, and hip flexion and extension will recorded. Hamstring flexibility will be also measured with universal goniometry using the passive 90/90 test. For this test, the patients will be positioned supine, lying on the back, with the knee and hip stabilized at 90° of flexion. The goniometer will be pivoted at the lateral condyle of the femur, and knee extension will be measured in order to determine the loss of the range of motion due to hamstring tightness.
Measured: 8weeks
muscular strength
All patients were assessed with isokinetic testing for strength at 60°/sec. Isokinetic testing is commonly used for testing and training of patients in clinics. It calculates the muscle power at the full range of motion, providing the opportunity to act at the angular velocity. An IsoMed 2000 (D\&R GmbH, Germany) will be used bilaterally for isokinetic evaluation of hip flexion and abduction at 60°/sec. After proper positioning, the patient will be asked to push the force arm of the system as strongly as possible at this angular velocity in the flexion and abduction directions. The peak torque and total work values will be recorded.
Measured: 8weeks
Trunk stabilization test
A side-plank position test was used for evaluation of trunk stabilization. The test is one of the most functional stabilization tests and examines trunk strength, endurance and stabilization during synchronized extremity movements. Basically, the lateral core muscles are assessed but oblique abdominal muscles and hip flexors are also examined. Patients are positioned in side lying, with 90° elbow flexion, 60° shoulder abduction, legs extended and whole body aligned. After trial repetition, patients are asked to raise their pelvis off the ground and stay in that position as long as possible without disrupting the smoothness of the motion. The test is finished when the position is disrupted or the patient falls.
Measured: 8weeks
Functional performance
The functional status will be evaluated with the Oswestry Disability Index. Knowing the symptoms and disabilities of low back pain patients gives us valuable information for planning the treatment process. The Oswestry Disability Index has 10 main topics, namely, pain intensity, self-care, lifting, walking, sitting, standing, sleep quality, sexual function, social life, and traveling. Each section is scored from 0 to 5 points. The degree of disability increases as the score increases.
Measured: 1hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Sep 20202 Feb 2021

First posted20 Aug 2019
Study start2 Sep 2020
Primary completion2 Feb 2021
Study completion2 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Lumbar Disc DiseaseStudies 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: Factorial
Masking: Single blind
Who is masked: Investigator
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04061759
Sponsor's protocol ID: 515
Status last verified: Feb 2021
First submitted: 17 Aug 2019
Last updated: 4 Feb 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Standaert CJ, Weinstein SM, Rumpeltes J. Evidence-informed management of chronic low back pain with lumbar stabilization exercises. Spine J. 2008 Jan-Feb;8(1):114-20. doi: 10.1016/j.spinee.2007.10.015.
PubMed 18164459
Burns SA, Cleland JA, Rivett DA, Snodgrass SJ. Effectiveness of physical therapy interventions for low back pain targeting the low back only or low back plus hips: a randomized controlled trial protocol. Braz J Phys Ther. 2018 Sep-Oct;22(5):424-430. doi: 10.1016/j.bjpt.2018.08.014. Epub 2018 Sep 7.
PubMed 30217693
Burns SA, Cleland JA, Cook CE, Bade M, Rivett DA, Snodgrass S. Variables Describing Individuals With Improved Pain and Function With a Primary Complaint of Low Back Pain: A Secondary Analysis. J Manipulative Physiol Ther. 2018 Jul-Aug;41(6):467-474. doi: 10.1016/j.jmpt.2017.11.006. Epub 2018 Aug 9.
PubMed 30100096

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lumbar Disc Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Clinical Trial
ClinicalTrials.gov ID: NCT04061759
Acronym / sponsor ID: 515
Conditions: Lumbar Disc Disease, Lumbar Disc Herniation, Low Back Pain, Mechanical, Low Back Strain
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Guven Health GroupUniversity, hospital or other
Study start: 2 Sep 2020 (actual)
Primary completion: 2 Feb 2021 (actual)
Study completion: 2 Feb 2021 (actual)
First posted: 20 Aug 2019 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (investigator)
Number of arms: 4

Arm	Type	Receives
Soft tissue mobilization&stabilization exercises	Active comparator	Other: Effectiveness of four physical therapy approaches (soft tissue manual therapy, Kinesio® Taping techniques, stabilization exercises and reflex therapy) for treating lumbar disc pathologies.The following manual therapy techniques will be applied: 1. Soft Tissue Mobilization; 2. Pretzel Maneuvers; 3. Pelvis Backward-Distraction; 4. Trunk Rotation; 5. Multifidus Mobilization; and 6. Piriformis Transverse Friction Massage
Kinesiotape&stabilization exercises	Active comparator	Other: Effectiveness of four physical therapy approaches (soft tissue manual therapy, Kinesio® Taping techniques, stabilization exercises and reflex therapy) for treating lumbar disc pathologies.The Kinesio® Taping muscle technique, with 10-25% of the stretch of the tape, will be applied to the sacrospinalis, quadratus lumborum, gluteus medius/maximus and piriformis muscles, based on the the weakness that patient's muscles had. Factors interfering with tape adhesion, such as sweat or hair, will be removed before the application. The tape can stay in place for 3-5 days due to its water resistant and breathable properties
Stabilization exercises	Active comparator	Other: Effectiveness of four physical therapy approaches (soft tissue manual therapy, Kinesio® Taping techniques, stabilization exercises and reflex therapy) for treating lumbar disc pathologies.The core stabilization exercise treatment program consisted of the following exercises: a posterior pelvic tilt exercise, lower abdominal muscle isometric strengthening, hip adductor muscle isometric strengthening, lumbar stabilization exercises with a Swiss ball, upper and lower abdominal muscle strengthening exercises with a Swiss ball, oblique abdominal muscle strengthening exercises with a Swiss ball, quadratus lumborum muscle stretching with a Swiss ball, back extensor muscle strengthening exercises with a Swiss ball, a slump exercise (sciatic nerve stretching), lumbar lordosis exercises with a Swiss ball, bridge exercises with a Swiss ball, single leg bridge exercises on a Swiss ball, posture exercises, push-up exercises with a Swiss ball, and squat exercises with a Swiss ball
Reflex therapy&Stabilization exercises	Active comparator	Other: Effectiveness of four physical therapy approaches (soft tissue manual therapy, Kinesio® Taping techniques, stabilization exercises and reflex therapy) for treating lumbar disc pathologies.Mobilization of each vertebra and pulls were applied from the medial side of the toe to the medial malleolus and to the heel by hand or with the help of an apparatus, including the cervical, thoracic and lumbar spine reflex zones. Finally, the procedure was finished by making a V-shaped maneuver with a thumb in the direction of spinal nerve exits.

Who may qualify

Ages: 25 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

The participants between the ages of 25 and 55 years,
Having a minimum pain level (at activity) of 3 out of 10 on visual analog scale
Having low back pain for at least 3 months with lumbar disc pathology (bulging or protrusion) diagnosed by clinical tests and magnetic resonance imaging.

Key exclusion criteria (4 listed)

sacroiliac and lumbar degenerative pathologies,
another pathology related to neurological deficits,
physiotherapy previously received for at least 12 months,
any surgery affecting the lumbar region.

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
Effectiveness of four physical therapy approaches (soft tissue manual therapy, Kinesio® Taping techniques, stabilization exercises and reflex therapy) for treating lumbar disc pathologies.Visual analog scale (VAS) scores for pain intensity, goniometric measurements for the range of motion and hamstring flexibility, the sit and reach test for flexibility, an isokinetic evaluation for strength at 60°/sec, and a side-plank position test for trunk stabilization were measured. The functional status was evaluated with the Oswestry Disability Index. All groups were assessed at the beginning, after a four-week treatment and four weeks of follow-up.	Other	Kinesiotape&stabilization exercises, Reflex therapy&Stabilization exercises, Soft tissue mobilization&stabilization exercises, Stabilization exercises

Primary outcome

pain intensity
Time frame: 8weeks
All patients will be assessed with the visual analog scale (VAS) for pain intensity at rest, at night and during activity. VAS is a 100-mm line with no marks along it, anchored with the words "no pain" on one side and "the most severe pain" on the other. The subjects were simply instructed to place a mark along the line at a level representing the intensity of their pain.
range of motion
Time frame: 8weeks
Trunk and hip range of motion measurements were taken with a universal goniometer. Active trunk flexion and extension, lateral flexion, and hip flexion and extension will recorded. Hamstring flexibility will be also measured with universal goniometry using the passive 90/90 test. For this test, the patients will be positioned supine, lying on the back, with the knee and hip stabilized at 90° of flexion. The goniometer will be pivoted at the lateral condyle of the femur, and knee extension will be measured in order to determine the loss of the range of motion due to hamstring tightness.
muscular strength
Time frame: 8weeks
All patients were assessed with isokinetic testing for strength at 60°/sec. Isokinetic testing is commonly used for testing and training of patients in clinics. It calculates the muscle power at the full range of motion, providing the opportunity to act at the angular velocity. An IsoMed 2000 (D\&R GmbH, Germany) will be used bilaterally for isokinetic evaluation of hip flexion and abduction at 60°/sec. After proper positioning, the patient will be asked to push the force arm of the system as strongly as possible at this angular velocity in the flexion and abduction directions. The peak torque and total work values will be recorded.
Trunk stabilization test
Time frame: 8weeks
A side-plank position test was used for evaluation of trunk stabilization. The test is one of the most functional stabilization tests and examines trunk strength, endurance and stabilization during synchronized extremity movements. Basically, the lateral core muscles are assessed but oblique abdominal muscles and hip flexors are also examined. Patients are positioned in side lying, with 90° elbow flexion, 60° shoulder abduction, legs extended and whole body aligned. After trial repetition, patients are asked to raise their pelvis off the ground and stay in that position as long as possible without disrupting the smoothness of the motion. The test is finished when the position is disrupted or the patient falls.
Functional performance
Time frame: 1hour
The functional status will be evaluated with the Oswestry Disability Index. Knowing the symptoms and disabilities of low back pain patients gives us valuable information for planning the treatment process. The Oswestry Disability Index has 10 main topics, namely, pain intensity, self-care, lifting, walking, sitting, standing, sleep quality, sexual function, social life, and traveling. Each section is scored from 0 to 5 points. The degree of disability increases as the score increases.

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 4 Feb 2021.
Results publication: PubMed 18164459Standaert CJ, Weinstein SM, Rumpeltes J. Evidence-informed management of chronic low back pain with lumbar stabilization exercises. Spine J. 2008 Jan-Feb;8(1):114-20. doi: 10.1016/j.spinee.2007.10.015.
Results publication: PubMed 30217693Burns SA, Cleland JA, Rivett DA, Snodgrass SJ. Effectiveness of physical therapy interventions for low back pain targeting the low back only or low back plus hips: a randomized controlled trial protocol. Braz J Phys Ther. 2018 Sep-Oct;22(5):424-430. doi: 10.1016/j.bjpt.2018.08.014. Epub 2018 Sep 7.
Results publication: PubMed 30100096Burns SA, Cleland JA, Cook CE, Bade M, Rivett DA, Snodgrass S. Variables Describing Individuals With Improved Pain and Function With a Primary Complaint of Low Back Pain: A Secondary Analysis. J Manipulative Physiol Ther. 2018 Jul-Aug;41(6):467-474. doi: 10.1016/j.jmpt.2017.11.006. Epub 2018 Aug 9.
related physiotherapy techniques for lumbar spine pathologyLink provided by the sponsor.
Individual participant dataSharing planned: No

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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.

Yesim Sardan Cetinkaya, MD study director

Guven Health Group

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 Feb 2021. 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?

pain intensity (time frame: 8weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04061759, which also lists 3 linked publications.

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 4 Feb 2021.