NCT06461494

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 11, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 17, 2024

Completed
13 days until next milestone

Study Start

First participant enrolled

June 30, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

June 11, 2024

Last Update Submit

October 10, 2024

Conditions

Keywords

muscle endurancepainrange of motionmuscle flexibility

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Group A: Pilates exercise

ACTIVE COMPARATOR

Group A received the pilates exercise. It doesn't require any special equipment and can be done in any training center. Week 1: Leg slides, hip release, knee to chest, spinal rotation, single knee extension, cat stretch, neutral to imprint Week 2: Imprint table top position, ab prep, Imprint table top toe touching floor, imprint table top knee extensions, spine twist, Ab prep in table top position, bridging Week 3: Half roll back, pull up; pull up with leg extension, swimming exercise, single leg extension, leg circles, and single leg stretch Week 4: Bridging on the ball, spine stretch forward, single leg lift, double knee lifts, upward dog, and shell stretch Each exercise was performed for 5 times

Other: baseline treatment

Group B: Egoscue exercise

EXPERIMENTAL

Static back and static back with breathing, abdominal contraction while in the static back position, abductor press, overhead extension, elbow curls on wall, static wall, upper spinal twist, pelvic tilts, supine groin progressive, and air bench Week 1: 3 times with 30 s hold time Week 2: 5 times with 30 s hold time Week 3: 15 times with 30 s hold time Week 4: 20 times with 30 s hold time

Other: baseline treatment

Interventions

hot pack will be applied for 10 minutes

Group A: Pilates exerciseGroup B: Egoscue exercise

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Sacroiliac Joint Dysfunction (SIJD)
  • Coccydynia
  • Lumber disc pathology
  • Malignancy
  • Recent fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Med care hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (8)

  • 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.

    BACKGROUND
  • 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.

    PMID: 30691755BACKGROUND
  • 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.

    PMID: 32760898BACKGROUND
  • Jerome EJIJoP. Effects of core stabilization program and conventional exercises in the management of patients with chronic mechanical low back pain. 2015:441-7.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 22363083BACKGROUND
  • 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.

    PMID: 29230905BACKGROUND
  • 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.

    PMID: 23997245BACKGROUND

MeSH Terms

Conditions

Low Back PainPain

Condition Hierarchy (Ancestors)

Back PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ghazala Arshad, MSPT*

    Riphah International University,Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2024

First Posted

June 17, 2024

Study Start

June 30, 2024

Primary Completion

August 30, 2024

Study Completion

October 10, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations