NCT05877469

Brief Summary

This study will be a randomized clinical trial. Total 44 Subjects with mechanical low back pain will be assigned randomly by using non probability convenient random sampling in to two groups with 22 subjects in each group. Subjects in one group will be treated with mat Pilates training and the other group with the functional training. NPRS, Inclinometer and urdu version of Modified Oswestry Disablility questionair would be used to measure the outcome of pain, Range of Motion and Disability respectively. After data collection from defined study setting, data will be entered and analyzed at Riphah International University lahore.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

February 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 26, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

September 25, 2023

Status Verified

September 1, 2023

Enrollment Period

6 months

First QC Date

May 18, 2023

Last Update Submit

September 22, 2023

Conditions

Mechanical Low Back Pain

Keywords

Disabilitypilates TrainingRange of motionPain

Outcome Measures

Primary Outcomes (3)

  • Modified Oswestry LBP disability index

    MODI consists of 10 items questioning daily life activities. These are; pain severity, personal care, lifting, walking, sitting, standing, sleeping, social life, travel and pain. There are 6 options between 0-5 points for each item. Zero indicates mild case, 5 indicates worst case, 0-14 weak, 15-29 moderate, 30 above the functional limit

    3 weeks

  • Numeric Pain Rating Scale

    NPRS consists of a scale with 0-10 readings. The zero denotes no pain while 1, 2, 3 denotes to mild pain, 4, 5, 6 denotes to moderate pain while 7-10 denotes to severe pain.

    3 weeks

  • Inclinometer

    Inclinometer is used to measure range of motion of lumber flexion, extension and left/Right side bending

    3 weeks

Study Arms (2)

mat pilates training group

ACTIVE COMPARATOR

Mat pilates training involve leg lifts, toe taps, Single leg stretch, one leg circle, side bend preparation, side kicks, side leg lifts, swan dive, hovers, roll down, crisscross and planks. Treatments will be provided in 30 mins, three sessions per week for 8 consecutive weeks.

Other: Mat pilates Training

Functional training group

EXPERIMENTAL

Functional training involve glute bridge, squats, pushups, lateral lunge, step up to shoulder press, goblet squats and woodchop. Treatments will be provided in 30 mins, three sessions per week for 8 consecutive weeks.

Other: Functional Training

Interventions

Mat pilates TrainingOTHER

In this group 22 patients will perform mat pilates training. Patients will be asked to stay comfortable while performing mat pilates exercies that involve different types of movements of whole body like leg lifts, toe taps, Single leg stretch, one leg circle, side bend preparation, side kicks, side leg lifts, roll down and crisscross to improve the core strength. Treatments will be provided in 30 mins, three sessions per week for 8 consecutive weeks.

mat pilates training group
Functional TrainingOTHER

In this group 22 patients will perform functional training. Patients will be instructed to perform their daily living movements like squatting, reaching, or even carrying a heavy object. These exercises typically use the whole body and emphasize core strength and stability. Functional training typically uses weight-bearing activities that work the core muscles in the torso. the functional movements include involve glute bridge, squats, pushups, lateral lunge, step up to shoulder press, goblet and squats. Treatments will be provided in 30 mins, three sessions per week for 8 consecutive weeks.

Functional training group

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both male and female
  • Age group 25-40
  • Patient having mechanical low back pain for more than 12 weeks

You may not qualify if:

  • Pregnancy
  • Previous spinal surgery
  • Orthopedic and neurological diseases
  • Patients with serious spinal pathologies( tumor, fracture and autoimmune conditions)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

District Headquarter Hospital Sahiwal

Sahiwal, Punjab Province, 57000, Pakistan

Location

Related Publications (15)

  • Will JS, Bury DC, Miller JA. Mechanical Low Back Pain. Am Fam Physician. 2018 Oct 1;98(7):421-428.

    PMID: 30252425BACKGROUND

  • Stevans JM, Delitto A, Khoja SS, Patterson CG, Smith CN, Schneider MJ, Freburger JK, Greco CM, Freel JA, Sowa GA, Wasan AD, Brennan GP, Hunter SJ, Minick KI, Wegener ST, Ephraim PL, Friedman M, Beneciuk JM, George SZ, Saper RB. Risk Factors Associated With Transition From Acute to Chronic Low Back Pain in US Patients Seeking Primary Care. JAMA Netw Open. 2021 Feb 1;4(2):e2037371. doi: 10.1001/jamanetworkopen.2020.37371.

    PMID: 33591367BACKGROUND

  • Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21.

    PMID: 29573870BACKGROUND

  • Urits I, Burshtein A, Sharma M, Testa L, Gold PA, Orhurhu V, Viswanath O, Jones MR, Sidransky MA, Spektor B, Kaye AD. Low Back Pain, a Comprehensive Review: Pathophysiology, Diagnosis, and Treatment. Curr Pain Headache Rep. 2019 Mar 11;23(3):23. doi: 10.1007/s11916-019-0757-1.

    PMID: 30854609BACKGROUND

  • Yalfani A, Raeisi Z, Koumasian Z. Effects of eight-week water versus mat pilates on female patients with chronic nonspecific low back pain: Double-blind randomized clinical trial. J Bodyw Mov Ther. 2020 Oct;24(4):70-75. doi: 10.1016/j.jbmt.2020.06.002. Epub 2020 Jun 27.

    PMID: 33218568BACKGROUND

  • Paolucci T, Attanasi C, Cecchini W, Marazzi A, Capobianco SV, Santilli V. Chronic low back pain and postural rehabilitation exercise: a literature review. J Pain Res. 2018 Dec 20;12:95-107. doi: 10.2147/JPR.S171729. eCollection 2019.

    PMID: 30588084BACKGROUND

  • Cortell-Tormo JM, Sanchez PT, Chulvi-Medrano I, Tortosa-Martinez J, Manchado-Lopez C, Llana-Belloch S, Perez-Soriano P. Effects of functional resistance training on fitness and quality of life in females with chronic nonspecific low-back pain. J Back Musculoskelet Rehabil. 2018 Feb 6;31(1):95-105. doi: 10.3233/BMR-169684.

    PMID: 28826168BACKGROUND

  • Batibay S, Kulcu DG, Kaleoglu O, Mesci N. Effect of Pilates mat exercise and home exercise programs on pain, functional level, and core muscle thickness in women with chronic low back pain. J Orthop Sci. 2021 Nov;26(6):979-985. doi: 10.1016/j.jos.2020.10.026. Epub 2020 Dec 29.

    PMID: 33386201BACKGROUND

  • O'Keeffe M, O'Sullivan P, Purtill H, Bargary N, O'Sullivan K. Cognitive functional therapy compared with a group-based exercise and education intervention for chronic low back pain: a multicentre randomised controlled trial (RCT). Br J Sports Med. 2020 Jul;54(13):782-789. doi: 10.1136/bjsports-2019-100780. Epub 2019 Oct 19.

    PMID: 31630089BACKGROUND

  • Eliks M, Zgorzalewicz-Stachowiak M, Zenczak-Praga K. Application of Pilates-based exercises in the treatment of chronic non-specific low back pain: state of the art. Postgrad Med J. 2019 Jan;95(1119):41-45. doi: 10.1136/postgradmedj-2018-135920. Epub 2019 Jan 12.

    PMID: 30636192BACKGROUND

  • Tsauo JY, Chen WH, Liang HW, Jang Y. The effectiveness of a functional training programme for patients with chronic low back pain--a pilot study. Disabil Rehabil. 2009;31(13):1100-6. doi: 10.1080/09638280802511047.

    PMID: 19802926BACKGROUND

  • Amaral DDV, Miyamoto GC, Franco KFM, Dos Santos Franco YR, Bastos De Oliveira NT, Hancock MJ, Van Tulder MW, Nunes Cabral CM. Examination of a Subgroup of Patients With Chronic Low Back Pain Likely to Benefit More From Pilates-Based Exercises Compared to an Educational Booklet. J Orthop Sports Phys Ther. 2020 Apr;50(4):189-197. doi: 10.2519/jospt.2019.8839. Epub 2019 Aug 23.

    PMID: 31443627BACKGROUND

  • Amjad F, Mohseni-Bandpei MA, Gilani SA, Ahmad A, Waqas M, Hanif A. Urdu version of Oswestry disability index; a reliability and validity study. BMC Musculoskelet Disord. 2021 Mar 29;22(1):311. doi: 10.1186/s12891-021-04173-0.

    PMID: 33781267BACKGROUND

  • Neeley DK, George SZ, Minick K, Snow G, Brennan G. Four Variables Were Sufficient for Low Back Pain: Determining Which Patient-Reported Tools Pain and Disability Improvements. J Orthop Sports Phys Ther. 2022 Oct;52(10):685-693. doi: 10.2519/jospt.2022.11018. Epub 2022 Aug 12.

    PMID: 35960508BACKGROUND

  • Sedrez JA, Furlanetto TS, Gelain GM, Candotti CT. Validity and Reliability of Smartphones in Assessing Spinal Kinematics: A Systematic Review and Meta-analysis. J Manipulative Physiol Ther. 2020 Jul-Aug;43(6):635-645. doi: 10.1016/j.jmpt.2019.10.012. Epub 2020 Sep 6.

    PMID: 32900546BACKGROUND

MeSH Terms

Conditions

Low Back PainPain

Condition Hierarchy (Ancestors)

Back PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Muhammad sanaullah, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 18, 2023

First Posted

May 26, 2023

Study Start

February 1, 2023

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

September 25, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)