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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06461494
Other study ID # REC/RCR & AHS/23/ 0195 Ghazala
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date August 30, 2024

Study information

Verified date June 2024
Source Riphah International University
Contact Samrood Akram, MPhil
Phone 923324806143
Email samrood.akram@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Mechanical low back pain arises intrinsically from the spine, intervertebral disc,or surrounding soft tissues.It is causes by muscular spasm, and other soft tissue injuries. The aim of the study will be to compare the effect of Egoscue versus Pilates exercises on pain, range of motion and muscle endurance in patient with mechanical low back pain.


Description:

A Randomized Clinical Trial will be conducted at Riphah Clinic Lahore through consecutive sampling technique on 30 patients which will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will be treated with Pilates exercises at frequency 2 sets 5 repetitions 5 days a week and Group B will be treated with Egoscue exercises at the frequency of 2 sets with 5 repetitions 5 days a week. Outcome measures will be conducted through pain, disability,lumber range of motion, Muscle flexibility, Extensor muscle endurance, Lateral muscle endurance, Flexors muscle endurance questionnaires after 4 weeks. Data will be analyzed during SPSS software version 21. After assessing normality of data by ANOVA test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 34
Est. completion date August 30, 2024
Est. primary completion date August 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Age 18 to 40 years - Both gender - Patient with non-radiating pain - Pain NPRS <7 - Positive McGill Extensor Endurance Test ( <101 seconds) - Positive McGill lateral flexor endurance test (<54 sec Right side, <55sec left side) - Positive McGill flexor endurance test < 120 seconds - Positive Finger to Floor Test : > 48cm in males, >50cm for females - Patient with Oswestry disability index (ODI) < 40 ODI score - Decrease lumbar ROM; Lateral flexion, Extension, Flexion Exclusion Criteria: - Sacroiliac Joint Dysfunction (SIJD) - Coccydynia - Lumber disc pathology - Malignancy - Recent fractures

Study Design


Related Conditions & MeSH terms


Intervention

Other:
baseline treatment
hot pack will be applied for 10 minutes

Locations

Country Name City State
Pakistan Med care hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (8)

Altinbilek T, Murat S. A comparison of application frequency of physical therapy modalities in patients with chronic mechanical low back pain. Turk J Phys Med Rehabil. 2020 May 18;66(2):201-209. doi: 10.5606/tftrd.2020.4192. eCollection 2020 Jun. — View Citation

Baillie L, Bacon CJ, Hewitt CM, Moran RW. Predictors of functional improvement in people with chronic low back pain following a graded Pilates-based exercise programme. J Bodyw Mov Ther. 2019 Jan;23(1):211-218. doi: 10.1016/j.jbmt.2018.06.007. Epub 2018 Jun 30. — View Citation

Caglayan M, Tacar O, Demirant A, Oktayoglu P, Karakoc M, Cetin A, et al. Effects of lumbosacral angles on development of low back pain. 2014;22(3):251-5.

Jerome EJIJoP. Effects of core stabilization program and conventional exercises in the management of patients with chronic mechanical low back pain. 2015:441-7.

Kudchadkar GS, Gurudut P, Welling AJIJoPT, Research. Comparative effect of mat pilates and egoscue exercises in asymptomatic individuals with lumbar hyperlordosis: A randomized controlled trial. 2019;1(2):79-88.

Kumar SP. Efficacy of segmental stabilization exercise for lumbar segmental instability in patients with mechanical low back pain: A randomized placebo controlled crossover study. N Am J Med Sci. 2011 Oct;3(10):456-61. doi: 10.4297/najms.2011.3456. — View Citation

Russo M, Deckers K, Eldabe S, Kiesel K, Gilligan C, Vieceli J, Crosby P. Muscle Control and Non-specific Chronic Low Back Pain. Neuromodulation. 2018 Jan;21(1):1-9. doi: 10.1111/ner.12738. Epub 2017 Dec 12. — View Citation

Vining R, Potocki E, Seidman M, Morgenthal AP. An evidence-based diagnostic classification system for low back pain. J Can Chiropr Assoc. 2013 Sep;57(3):189-204. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Numeric pain rating scale (NPRS) Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain.The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). upto 4 weeks
Primary Muscle flexibility (Finger to floor test) The patient is asked to bend forward and attempt to reach for the floor with their fingertips.
The physical therapist then measures the distance between the patient's right long finger and the floor using a standard measuring tape
Ask the client whether pain, stiffness or both limit the movement(Fingertips to floor (FTF) test).
If the FTF test is limited by pain, the location and pain score out of 10 should be documented.
If the FTF test is 0cm or the patient is able to place their palms to the floor with no pain, a different outcome measure should be considered.
upto 4 weeks
Primary Trunk Flexor Endurance Test The flexor endurance test is the first in the battery of three tests that assesses muscular endurance of the deep core muscles (i.e., transverse abdominis, quadratus lumborum, and erector spinae). It is a timed test involving a static, isometric contraction of the anterior muscles, stabilizing the spine until the individual exhibits fatigue and can no longer hold the assumed position. upto 4 weeks
Primary Trunk Lateral Endurance Test The trunk lateral endurance test, also called the side-bridge test, assesses muscular endurance of the lateral core muscles (i.e., transverse abdominis, obliques, quadratus lumborum, and erector spinae). Similar to the trunk flexor endurance test, this timed test involves static, isometric contractions of the lateral muscles on each side of the trunk that stabilize the spine. upto 4 weeks
Primary Trunk Extensor Endurance Test The trunk extensor endurance test is generally used to assess muscular endurance of the torso extensor muscles (i.e., erector spinae, longissimus, iliocostalis, and multifidi). This is a timed test involving a static, isometric contraction of the trunk extensor muscles that stabilize the spine. upto 4 weeks
Primary universal goniometer The purpose of goniometry is to measure the joint angle or range of motion. It is assumed that the angle created by aligning the arms of a universal goniometer with bony landmarks truly represents the angle created by the proximal and distal bones composing the joint. upt0 4 weeks
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