NCT06110026

Brief Summary

The aim of this study is to compare the effects of brunkow exercise program and lumbar stabilization exercises on pain, range of motion and disability in patients with chronic non- specific low back pain

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
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

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 8, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2023

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2024

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

8 months

First QC Date

October 25, 2023

Last Update Submit

October 25, 2023

Conditions

Keywords

Brunkow exerciseDisabilitynon-specific low back painpainrange of motion

Outcome Measures

Primary Outcomes (3)

  • Numeric rating scale (NRS-11)

    It is is an eleven-point scale in which the end points are the extremes of no pain at all (score of 0) and the worst pain the patient has ever experienced (score of 10). NRS-11 pain severity score of "4" is frequently given special significance in this regard, suggesting it as a potential threshold value for pain severity in clinical practice. (28). This scale has high reliability (0.95-0.96) and validity (0.86-0.96).

    4 weeks

  • Modified oswestry disability index

    The ODI is a disease-specific disability measure is used to establish a level of disability, stage a patient's acuity status and monitor change over time. The ODI is made up of 10 questions. Each question is scored from 0-5 (minimum to maximum). This tool is considered as a gold standard for back pain functional. Test-retest reliability has been shown to be high. Values range from r= 0.83 to 0.99 and vary according to the time interval between measurements. ODI = (Sum of items scored/Sum of sections answered) X 100

    4 weeks

  • Inclinometer

    Inclinometers are portable, lightweight, and inexpensive pieces of equipment that are used to measure range of motion, like goniometry.1 Inclinometers are typically found in clinics and are used as a part of a physical examination. An intraclass correlation coefficient (ICC) was found to be between 0.87- 0.95. Range of motion is the measurement of movement around a specific joint or body part.

    4 weeks

Study Arms (2)

Brunkow exercise program

EXPERIMENTAL

Brunkow program includes Push up and stabilization against the wrists and heels,brunkow- from plank to a standing position ,plank from lying on the stomach to a sitting in a tilted position, Turning from the back to the position on all four

Other: Brunkow Exercise Program

Lumbar stabilization exercises

EXPERIMENTAL

lumbar stabilization exercises protocol includes Diaphragmatic breathing and abdominal bracing, bridging, side plank on knees, bird dog

Other: Lumbar Stabilization Exercises

Interventions

The brunkow exercise program will be comprised of four exercise programs. Each exercise will be performed with two sets of 15 reps, 10 sec per rep 40 min per day, thrice per week for a total of four weeks.

Brunkow exercise program

The lumbar stabilization exercises will be comprised of four exercise programs. Each exercise will be performed with two sets of 15 reps, 10 sec per rep 40 min per day, thrice per week for a total of four weeks.

Lumbar stabilization exercises

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 20 to 45 years
  • Both male and female
  • Low back pain \> 6 months
  • NPRS\>3
  • The symptoms of pain are lessened or disappeared after bed rest, while pain symptoms are aggravated after bending over, sitting for a long time, or standing for a long time.

You may not qualify if:

  • Pelvic bone fracture
  • Pregnancy
  • Pelvic implants
  • Lumbosacral disc herniation
  • Sacroiliac joint inflammation
  • Lumbar spine fracture
  • Inflammatory bowel disease
  • Malignancy
  • Ankylosing spondylitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lahore Teaching Hospital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (30)

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    PMID: 23570655BACKGROUND
  • Savigny P, Watson P, Underwood M; Guideline Development Group. Early management of persistent non-specific low back pain: summary of NICE guidance. BMJ. 2009 Jun 4;338:b1805. doi: 10.1136/bmj.b1805. No abstract available.

    PMID: 19502217BACKGROUND
  • Garcia JB, Hernandez-Castro JJ, Nunez RG, Pazos MA, Aguirre JO, Jreige A, Delgado W, Serpentegui M, Berenguel M, Cantemir C. Prevalence of low back pain in Latin America: a systematic literature review. Pain Physician. 2014 Sep-Oct;17(5):379-91.

    PMID: 25247896BACKGROUND
  • Nijs J, Apeldoorn A, Hallegraeff H, Clark J, Smeets R, Malfliet A, Girbes EL, De Kooning M, Ickmans K. Low back pain: guidelines for the clinical classification of predominant neuropathic, nociceptive, or central sensitization pain. Pain Physician. 2015 May-Jun;18(3):E333-46.

    PMID: 26000680BACKGROUND
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    PMID: 23844179BACKGROUND
  • Violante FS, Mattioli S, Bonfiglioli R. Low-back pain. Handb Clin Neurol. 2015;131:397-410. doi: 10.1016/B978-0-444-62627-1.00020-2.

    PMID: 26563799BACKGROUND
  • Waseem M, Karimi H, Gilani SA, Hassan D. Treatment of disability associated with chronic non-specific low back pain using core stabilization exercises in Pakistani population. J Back Musculoskelet Rehabil. 2019;32(1):149-154. doi: 10.3233/BMR-171114.

    PMID: 30248035BACKGROUND
  • Faas A. Exercises: which ones are worth trying, for which patients, and when? Spine (Phila Pa 1976). 1996 Dec 15;21(24):2874-8; discussion 2878-9. doi: 10.1097/00007632-199612150-00016.

    PMID: 9112711BACKGROUND
  • Mujic Skikic E, Trebinjac S, Sakota S, Avdic D. The effects of McKenzie and Brunkow exercise program on spinal mobility comparative study. Bosn J Basic Med Sci. 2004 Feb;4(1):62-8. doi: 10.17305/bjbms.2004.3466.

    PMID: 15628984BACKGROUND
  • Yeom S, Jeong H, Lee H, Jeon K. Effects of Lumbar Stabilization Exercises on Isokinetic Strength and Muscle Tension in Sedentary Men. Bioengineering (Basel). 2023 Mar 8;10(3):342. doi: 10.3390/bioengineering10030342.

    PMID: 36978733BACKGROUND
  • Skikic EM, Trebinjac S, Sakota S, Avdic D, Delic A. Brunkow exercises and low back pain. Bosn J Basic Med Sci. 2004 Oct;4(4):37-41. doi: 10.17305/bjbms.2004.3359.

    PMID: 15628994BACKGROUND
  • Lee HS, Kim DJ, Oh Y, Min K, Ryu JS. The effect of individualized gradable stabilization exercises in patients with chronic low back pain: Case-control study. J Back Musculoskelet Rehabil. 2016 Jun 17;29(3):603-10. doi: 10.3233/BMR-160724.

    PMID: 27341643BACKGROUND
  • Kim CR, Park DK, Lee ST, Ryu JS. Electromyographic Changes in Trunk Muscles During Graded Lumbar Stabilization Exercises. PM R. 2016 Oct;8(10):979-989. doi: 10.1016/j.pmrj.2016.05.017. Epub 2016 Jun 16.

    PMID: 27317910BACKGROUND
  • Lee K. Motion Analysis of Core Stabilization Exercise in Women: Kinematics and Electromyographic Analysis. Sports (Basel). 2023 Mar 10;11(3):66. doi: 10.3390/sports11030066.

    PMID: 36976952BACKGROUND
  • Kim KS, An J, Kim JO, Lee MY, Lee BH. Effects of Pain Neuroscience Education Combined with Lumbar Stabilization Exercise on Strength and Pain in Patients with Chronic Low Back Pain: Randomized Controlled Trial. J Pers Med. 2022 Feb 17;12(2):303. doi: 10.3390/jpm12020303.

    PMID: 35207790BACKGROUND
  • Gianola S, Bargeri S, Del Castillo G, Corbetta D, Turolla A, Andreano A, Moja L, Castellini G. Effectiveness of treatments for acute and subacute mechanical non-specific low back pain: a systematic review with network meta-analysis. Br J Sports Med. 2022 Jan;56(1):41-50. doi: 10.1136/bjsports-2020-103596. Epub 2021 Apr 13.

    PMID: 33849907BACKGROUND
  • Akodu AK, Nwanne CA, Fapojuwo OA. Efficacy of neck stabilization and Pilates exercises on pain, sleep disturbance and kinesiophobia in patients with non-specific chronic neck pain: A randomized controlled trial. J Bodyw Mov Ther. 2021 Apr;26:411-419. doi: 10.1016/j.jbmt.2020.09.008. Epub 2020 Oct 3.

    PMID: 33992276BACKGROUND
  • Alhakami AM, Davis S, Qasheesh M, Shaphe A, Chahal A. Effects of McKenzie and stabilization exercises in reducing pain intensity and functional disability in individuals with nonspecific chronic low back pain: a systematic review. J Phys Ther Sci. 2019 Jul;31(7):590-597. doi: 10.1589/jpts.31.590. Epub 2019 Jul 9.

    PMID: 31417227BACKGROUND
  • 20. Pysna J, Pysny L, Petru D, Cihlar D, editors. PHYSIOTHERAPEUTICAL METHODS IN THE PREVENTION OF FUNCTIONAL DISORDERS OF THE MUSCULOSKELETAL SYSTEM-A NEW TREND IN TEACHING REMEDIAL PHYSICAL EDUCATION TO UNIVERSITY STUDENTS. ICERI2019 Proceedings; 2019: IATED.

    BACKGROUND
  • Gomes-Neto M, Lopes JM, Conceicao CS, Araujo A, Brasileiro A, Sousa C, Carvalho VO, Arcanjo FL. Stabilization exercise compared to general exercises or manual therapy for the management of low back pain: A systematic review and meta-analysis. Phys Ther Sport. 2017 Jan;23:136-142. doi: 10.1016/j.ptsp.2016.08.004. Epub 2016 Aug 18.

    PMID: 27707631BACKGROUND
  • Bhadauria EA, Gurudut P. Comparative effectiveness of lumbar stabilization, dynamic strengthening, and Pilates on chronic low back pain: randomized clinical trial. J Exerc Rehabil. 2017 Aug 29;13(4):477-485. doi: 10.12965/jer.1734972.486. eCollection 2017 Aug.

    PMID: 29114516BACKGROUND
  • 23. Nasreen A, Majeed Z, Awan MAH, Maqbool S, Asghar HMU, Tahir H, et al. Comparison Of The Effectiveness Of Back School Exercises And Mckenzie Exercises In The Treatment Of Chronic Low Back Pain; A Randomized Controlled Trial" RCT: Back School Exercises and Mckenzie Exercises in The Treatment of Chronic Low Back Pain. Pakistan BioMedical Journal. 2022:112-6.

    BACKGROUND
  • Chiarotto A, Koes BW. Nonspecific Low Back Pain. N Engl J Med. 2022 May 5;386(18):1732-1740. doi: 10.1056/NEJMcp2032396. No abstract available.

    PMID: 35507483BACKGROUND
  • Zhou X, Yang J, Ma QY, Guo Y, He KJ, Shen LB, Fan Q, Philip CKC, Keng TB, Celia TIC, Bauer BA, Chen JX. The effectiveness of Tuina in managing chronic non-specific low back pain: A protocol of a multicenter international randomized controlled trial. Medicine (Baltimore). 2022 Feb 18;101(7):e28883. doi: 10.1097/MD.0000000000028883.

    PMID: 35363203BACKGROUND
  • Ahmed UA, Maharaj SS, Van Oosterwijck J. Effects of dynamic stabilization exercises and muscle energy technique on selected biopsychosocial outcomes for patients with chronic non-specific low back pain: a double-blind randomized controlled trial. Scand J Pain. 2021 Feb 24;21(3):495-511. doi: 10.1515/sjpain-2020-0133. Print 2021 Jul 27.

    PMID: 33641272BACKGROUND
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    BACKGROUND
  • Al-Hadidi F, Bsisu I, AlRyalat SA, Al-Zu'bi B, Bsisu R, Hamdan M, Kanaan T, Yasin M, Samarah O. Association between mobile phone use and neck pain in university students: A cross-sectional study using numeric rating scale for evaluation of neck pain. PLoS One. 2019 May 20;14(5):e0217231. doi: 10.1371/journal.pone.0217231. eCollection 2019.

    PMID: 31107910BACKGROUND
  • 29. Waqar S, Khalid M, Khalid N. EFFECTIVENESS OF ELONGATION LONGITUDINAUX AVEC DECOAPTION OSTEOARTICULAIRE IN CORRECTING FORWARD HEAD POSTURE: soi: 21-2017/re-trjvol06iss01p284. The Rehabilitation Journal. 2022;6(01):284-9.

    BACKGROUND
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    PMID: 19646379BACKGROUND
  • Kolber MJ, Pizzini M, Robinson A, Yanez D, Hanney WJ. The reliability and concurrent validity of measurements used to quantify lumbar spine mobility: an analysis of an iphone(R) application and gravity based inclinometry. Int J Sports Phys Ther. 2013 Apr;8(2):129-37.

    PMID: 23593551BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Humera Mubashar, MSPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

October 25, 2023

First Posted

October 31, 2023

Study Start

May 8, 2023

Primary Completion

December 23, 2023

Study Completion

January 8, 2024

Last Updated

October 31, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations