Lumbar Disc HerniationNCT03198273
The Efficacy of Clinical Pilates Exercises on Individuals With Lumbar Disc Herniation
A study testing Clinical pilates exercises and physiotherapy program in people with Lumbar Disc Herniation, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
The aim of the study is to determine the effects of clinical Pilates Exercises on the level of pain, functional status, flexibility, static and dynamic endurance of the truncus muscles and quality of life in patients with lumbar disc herniation. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- Clinical pilates exercises and physiotherapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteCyprus
- Study dates
- 1 May 2017to 31 Dec 2017
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals, between the ages of 30-60,
- Have been diagnosed according to Magnetic Resonance Imaging results, in one or several of the levels of L3-L4 / L4-L5 / L5-S1 in the case of Bulging and Protuberance lumbar disc hernia,
- At least 6 weeks with back and leg pain,
- Those who will be able to participate in the exercise program regularly,
- Those who are not included in the physiotherapy program in the last 6 months,,
- With mental, auditory and visual problems that will prevent communication will be included in the study.
Who cannot join
- Individuals, with spinal stenosis,
- Having previously described lumbar spine surgery,
- Having severe neurological deficits,
- Having primary or metastatic spinal malignancy,
- Having vascular problem at a later stage in the lower extremity,
- Diagnosed with osteoporosis,
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- Those who are pregnant,
- Having uncontrolled hypertension,
- With anger-dependent anguish will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Cyprus1 site, 1 recruiting
- Recruiting
Kyrenia 7/24 Orthopedics and Traumatology Clinic
Kyrenia, Karakum, 43/1
Gulsan Taspınar, pt, 05338525221, gulsan_taspinar@hotmail.com
About this study
The aim of the study is to determine the effects of clinical Pilates Exercises on the level of pain, functional status, flexibility, static and dynamic endurance of the truncus muscles and quality of life in patients with lumbar disc herniation.
- Conditions
- Lumbar Disc Herniation
- Being tested
- Clinical pilates exercises, physiotherapy program
- Keywords
- clinical pilates, exercise, lumbar disc herniation, chronic low back pain
- Medical subject headings
- Intervertebral Disc Displacement, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical pilates exercisesOther
Also called exercise program
servical, lumbal, pelvic muscles
physiotherapy programOther
Also called standart physiotherapy program
hot-pack will apply for 20 minutes. Convansionel TENS will apply on the lumbar regions of the cases of the control group paravertebrally with
| Study group | Role | What they receive |
|---|---|---|
| Clinical pilates exercises | Experimental | Participants will exercise 3 times a week for 6 weeks (18 sessions in total, 45-60 minutes each session) in accompany with a physiotherapist. Since the chosen model for exercise training is clinical pilates exercises, separate patient training will be needed. First 3 weeks planned as Warming Phase, Exercise Phase (first 3 weeks), Cooling Phase; and Second 3 weeks planned as Warming Phase, Exercise Phase (first 3 weeks), Cooling Phase. Receives: Other: Clinical pilates exercises |
| Physiotherapy Program | Experimental | Standard physiotherapy program consisting of conservative treatment is applied to both groups. The conservative treatment schedule to be applied to planned as 10 sessions, 3 times a week. Receives: Other: physiotherapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Severity
Visual Analogue Scale (VAS) is a pain intensity measurement scale with validity and reliability. The patient will be told that they can evaluate their pain from 0 to 10 on a 10 cm horizontal line. It will be explained that if there is no pain, 0 (the leftmost point), the most severe pain will be 10 (the rightmost point). According to these explanations, patients will be asked to mark their pain intensity on a 10 cm chart. On the 10 cm chart, the distance between the point marked by the patient and the leftmost 0 will be measured by the ruler and the value will be recorded.
Measured: nine weeks
Secondary outcomes (2)
Functional Level Status
The Oswestry Lumbar Scale (ODI) was developed by Fairbank to assess functional impairment. There are 10 questions evaluating various daily activities of this scale and 6 options for each question between 0-5. In this scale, the degree of clinical pain severity, personal care, lifting, walking, sitting, standing, sleeping, social life, travel and change degree of the pain are questioned. The minimum score taken from the scale is 0, the maximum score is 50. 0-4 points mean there is no disability, 5-14 points are mild, 15-24 points are moderate, 25-30 points are severe and 35-50 points are considered to be complete functional disability.
Measured: nine weeks
Quality of Life Level
Short Form-36 (SF-36) will assess the health-related quality of life of individuals. The form consists of a total of 36 articles which can be filed by the patient. The scale consists of 8 subscales related to health. Physical function (10 articles), social function (2 articles), role limitations due to physical problems (3 articles), role limitations due to emotional problems (3 articles), mental health (5 articles), fitness (4 articles), pain (2 articles), general health [general overview point (5 articles) and health change (1 article)]. The scores from each subscale range from 0-100. 0 indicates the worst condition and 100 the best health condition. The SF-36 is suitable for personal evaluation, and can be applied to people over 14 years of age or face to face computerized or trained personnel.
Measured: nine weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start1 May 2017
- Primary completion30 Sep 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc HerniationStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülşan Taşpınar, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198273
- Sponsor's protocol ID
- EasternMediterranianUniversity
- Status last verified
- Jun 2017
- First submitted
- 2 Jun 2017
- Last updated
- 26 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Taspinar G, Angin E, Oksuz S. The effects of Pilates on pain, functionality, quality of life, flexibility and endurance in lumbar disc herniation. J Comp Eff Res. 2023 Jan;12(1):e220144. doi: 10.2217/cer-2022-0144. Epub 2022 Dec 1.
PubMed 36453667
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Clinical Pilates Exercises on Individuals With Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT03198273
- Acronym / sponsor ID
- EasternMediterranianUniversity
- Conditions
- Lumbar Disc Herniation
- Keywords
- clinical pilates, exercise, lumbar disc herniation, chronic low back pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Sep 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 26 Jun 2017 (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 the study is to determine the effects of clinical Pilates Exercises on the level of pain, functional status, flexibility, static and dynamic endurance of the truncus muscles and quality of life in patients with lumbar disc herniation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical pilates exercises | Experimental | Other: Clinical pilates exercisesParticipants will exercise 3 times a week for 6 weeks (18 sessions in total, 45-60 minutes each session) in accompany with a physiotherapist. Since the chosen model for exercise training is clinical pilates exercises, separate patient training will be needed. First 3 weeks planned as Warming Phase, Exercise Phase (first 3 weeks), Cooling Phase; and Second 3 weeks planned as Warming Phase, Exercise Phase (first 3 weeks), Cooling Phase. |
| Physiotherapy Program | Experimental | Other: physiotherapy programStandard physiotherapy program consisting of conservative treatment is applied to both groups. The conservative treatment schedule to be applied to planned as 10 sessions, 3 times a week. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Individuals, between the ages of 30-60,
- Have been diagnosed according to Magnetic Resonance Imaging results, in one or several of the levels of L3-L4 / L4-L5 / L5-S1 in the case of Bulging and Protuberance lumbar disc hernia,
- At least 6 weeks with back and leg pain,
- Those who will be able to participate in the exercise program regularly,
- Those who are not included in the physiotherapy program in the last 6 months,,
Key exclusion criteria (9 listed)
- Individuals, with spinal stenosis,
- Having previously described lumbar spine surgery,
- Having severe neurological deficits,
- Having primary or metastatic spinal malignancy,
- Having vascular problem at a later stage in the lower extremity,
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 |
|---|---|---|
| Clinical pilates exercisesAlso: exercise programservical, lumbal, pelvic muscles | Other | Clinical pilates exercises |
| physiotherapy programAlso: standart physiotherapy programhot-pack will apply for 20 minutes. Convansionel TENS will apply on the lumbar regions of the cases of the control group paravertebrally with | Other | Physiotherapy Program |
Primary outcome
Pain Severity
Time frame: nine weeks
Visual Analogue Scale (VAS) is a pain intensity measurement scale with validity and reliability. The patient will be told that they can evaluate their pain from 0 to 10 on a 10 cm horizontal line. It will be explained that if there is no pain, 0 (the leftmost point), the most severe pain will be 10 (the rightmost point). According to these explanations, patients will be asked to mark their pain intensity on a 10 cm chart. On the 10 cm chart, the distance between the point marked by the patient and the leftmost 0 will be measured by the ruler and the value will be recorded.
2 secondary outcomes
Functional Level Status
Time frame: nine weeks
Quality of Life Level
Time frame: nine weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
- Derived from this study: PubMed 36453667Taspinar G, Angin E, Oksuz S. The effects of Pilates on pain, functionality, quality of life, flexibility and endurance in lumbar disc herniation. J Comp Eff Res. 2023 Jan;12(1):e220144. doi: 10.2217/cer-2022-0144. Epub 2022 Dec 1.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical pilates exercises and physiotherapy program in people with Lumbar Disc Herniation, run by Eastern Mediterranean University at 1 site in Cyprus.
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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 26 Jun 2017. 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 Cyprus. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GULSAN TASPINAR (05338525221, gulsan_taspinar@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Severity (time frame: nine weeks). 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 NCT03198273, which also lists 1 linked publication.
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 26 Jun 2017.