The Efficacy of Clinical Pilates Exercises on Individuals With Lumbar Disc Herniation

Lumbar Disc Herniation Clinical Trial

Official title:

The Efficacy of Clinical Pilates Exercises on Individuals With Lumbar Disc Herniation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03198273
• Other study ID #: EasternMediterranianUniversity
• Status: Recruiting
• Phase: N/A
• First received: June 2, 2017
• Last updated: June 22, 2017
• Start date: May 1, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: June 2017
• Source: Eastern Mediterranean University
• Contact: GULSAN TASPINAR
• Phone: 05338525221
• Email: gulsan_taspinar[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: December 31, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Intervertebral Disc Displacement
• Lumbar Disc Herniation

Intervention

Other:
• Clinical pilates exercises
servical, lumbal, pelvic muscles
• 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

Locations

Country	Name	City	State
Cyprus	Kyrenia 7/24 Orthopedics and Traumatology Clinic	Kyrenia	Karakum

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Mediterranean University

Country where clinical trial is conducted

Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	nine weeks
Secondary	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.	nine weeks
Secondary	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.	nine weeks