Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03198273
Recruitment Status : Unknown
Verified June 2017 by Gülşan Taşpınar, Eastern Mediterranean University.
Recruitment status was:  Recruiting
First Posted : June 26, 2017
Last Update Posted : June 26, 2017
Sponsor:
Information provided by (Responsible Party):
Gülşan Taşpınar, Eastern Mediterranean University

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.

Condition or disease Intervention/treatment Phase
Lumbar Disc Herniation Other: Clinical pilates exercises Other: physiotherapy program Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy of Clinical Pilates Exercises on Individuals With Lumbar Disc Herniation
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : September 30, 2017
Estimated Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Clinical pilates exercises
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.
Other: Clinical pilates exercises
servical, lumbal, pelvic muscles
Other Name: exercise program

Experimental: Physiotherapy Program
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.
Other: 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
Other Name: standart physiotherapy program




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Functional Level Status [ Time Frame: nine weeks ]
    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.

  2. Quality of Life Level [ Time Frame: nine weeks ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198273


Contacts
Layout table for location contacts
Contact: GULSAN TASPINAR 05338525221 gulsan_taspinar@hotmail.com

Locations
Layout table for location information
Cyprus
Kyrenia 7/24 Orthopedics and Traumatology Clinic Recruiting
Kyrenia, Karakum, Cyprus, 43/1
Contact: Gulsan Taspınar, pt    05338525221    gulsan_taspinar@hotmail.com   
Sponsors and Collaborators
Eastern Mediterranean University

Layout table for additonal information
Responsible Party: Gülşan Taşpınar, physiotherapist, Eastern Mediterranean University
ClinicalTrials.gov Identifier: NCT03198273     History of Changes
Other Study ID Numbers: EasternMediterranianUniversity
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: June 26, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gülşan Taşpınar, Eastern Mediterranean University:
clinical pilates
exercise
lumbar disc herniation
chronic low back pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Hernia
Pathological Conditions, Anatomical