NCT03198273

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 2, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 26, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

June 26, 2017

Status Verified

June 1, 2017

Enrollment Period

5 months

First QC Date

June 2, 2017

Last Update Submit

June 22, 2017

Conditions

Keywords

clinical pilatesexerciselumbar disc herniationchronic low back pain

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

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.

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.

Other: physiotherapy program

Interventions

servical, lumbal, pelvic muscles

Also known as: exercise program
Clinical pilates exercises

hot-pack will apply for 20 minutes. Convansionel TENS will apply on the lumbar regions of the cases of the control group paravertebrally with

Also known as: standart physiotherapy program
Physiotherapy Program

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

RECRUITING

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.

MeSH Terms

Conditions

Intervertebral Disc DisplacementMotor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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

Locations