The Efficacy of Clinical Pilates Exercises on Individuals With Lumbar Disc Herniation
1 other identifier
interventional
88
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2017
CompletedFirst Submitted
Initial submission to the registry
June 2, 2017
CompletedFirst Posted
Study publicly available on registry
June 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2017
CompletedJune 26, 2017
June 1, 2017
5 months
June 2, 2017
June 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Functional Level Status
nine weeks
Quality of Life Level
nine weeks
Study Arms (2)
Clinical pilates exercises
EXPERIMENTALParticipants 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
EXPERIMENTALStandard 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.
Interventions
servical, lumbal, pelvic muscles
hot-pack will apply for 20 minutes. Convansionel TENS will apply on the lumbar regions of the cases of the control group paravertebrally with
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kyrenia 7/24 Orthopedics and Traumatology Clinic
Kyrenia, Karakum, 43/1, Cyprus
Related Publications (1)
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.
PMID: 36453667DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- physiotherapist
Study Record Dates
First Submitted
June 2, 2017
First Posted
June 26, 2017
Study Start
May 1, 2017
Primary Completion
September 30, 2017
Study Completion
December 31, 2017
Last Updated
June 26, 2017
Record last verified: 2017-06