Back to resultsThe Efficacy of Clinical Pilates Exercises on Individuals With Lumbar Disc Herniation
Primary Purpose
Lumbar Disc Herniation
Status
Unknown status
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Clinical pilates exercises
physiotherapy program
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Disc Herniation focused on measuring clinical pilates, exercise, lumbar disc herniation, chronic low back pain
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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,
- Those who are pregnant,
- Having uncontrolled hypertension,
- With anger-dependent anguish will not be included in the study.
Sites / Locations
- Kyrenia 7/24 Orthopedics and Traumatology ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Clinical pilates exercises
Physiotherapy Program
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03198273
First Posted
June 2, 2017
Last Updated
June 22, 2017
Sponsor
Eastern Mediterranean University
1. Study Identification
Unique Protocol Identification Number
NCT03198273
Brief Title
The Efficacy of Clinical Pilates Exercises on Individuals With Lumbar Disc Herniation
Official Title
The Efficacy of Clinical Pilates Exercises on Individuals With Lumbar Disc Herniation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
September 30, 2017 (Anticipated)
Study Completion Date
December 31, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Mediterranean University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation
Keywords
clinical pilates, exercise, lumbar disc herniation, chronic low back pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Clinical pilates exercises
Arm Type
Experimental
Arm Description
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.
Arm Title
Physiotherapy Program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Clinical pilates exercises
Other Intervention Name(s)
exercise program
Intervention Description
servical, lumbal, pelvic muscles
Intervention Type
Other
Intervention Name(s)
physiotherapy program
Other Intervention Name(s)
standart physiotherapy program
Intervention Description
hot-pack will apply for 20 minutes. Convansionel TENS will apply on the lumbar regions of the cases of the control group paravertebrally with
Primary Outcome Measure Information:
Title
Pain Severity
Description
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.
Time Frame
nine weeks
Secondary Outcome Measure Information:
Title
Functional Level Status
Description
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.
Time Frame
nine weeks
Title
Quality of Life Level
Description
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.
Time Frame
nine weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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,
Those who are pregnant,
Having uncontrolled hypertension,
With anger-dependent anguish will not be included in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
GULSAN TASPINAR
Phone
05338525221
Email
gulsan_taspinar@hotmail.com
Facility Information:
Facility Name
Kyrenia 7/24 Orthopedics and Traumatology Clinic
City
Kyrenia
State/Province
Karakum
ZIP/Postal Code
43/1
Country
Cyprus
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gulsan Taspınar, pt
Phone
05338525221
Email
gulsan_taspinar@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Efficacy of Clinical Pilates Exercises on Individuals With Lumbar Disc Herniation
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