Clinical trial NCT05832918: Effects of Core Stability Exercises and Cognitive Tasks on Chronic Non-specific Back Pain
Official title: Effects of Core Stability Exercises and Cognitive Tasks Compared to General Exercises and Cognitive Tasks on Chronic Non-specific Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Non-specific Low Back Pain
Keywords: Low back pain
Disability
Postural control
Core Stability Exercise
cognitive task
Lead sponsor: Iran University of Medical Sciences
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized control trial study aims to compare the effect of core stability exercises and cognitive tasks with general exercises and cognitive tasks on pain, disability, and postural control strategies of chronic non-specific low back pain patients. The main questions are:

1. Are core stability exercises and cognitive tasks more effective than general exercises and cognitive tasks in reducing the pain of chronic non-specific low back pain patients?
2. Are core stability exercises and cognitive tasks more effective than general exercises and cognitive tasks in reducing the disability of chronic non-specific low back pain patients?
3. Are core stability exercises and cognitive tasks more effective than general exercises and cognitive tasks in improving postural stability parameters of chronic non-specific low back pain patients?
4. Are core stability exercises and cognitive tasks more effective than general exercises and cognitive tasks in improving stabilogram diffusion analysis parameters of chronic non-specific low back pain patients? This study is designed to apply two exercise protocols on two groups of 17 people with non-specific back pain. Group A will receive core stability exercises along with cognitive tasks, and group B will receive general exercises along with cognitive tasks.

Detailed description: Patients will be aged between 18-50 years. All patients meeting the inclusion criteria will receive 16 training sessions (thrice a week). The primary outcome measure will be pain and disability. Secondary outcome measures will be postural control strategies (including postural control stability and stabilogram diffusion analysis), quality of life, fear of movement, and fear-avoidance beliefs that will be assessed before and after training sessions and at 3-month follow-up; only primary outcomes will be evaluated in each group.

Eligibility criteria: Inclusion Criteria:

* Orthopedist-confirmed diagnosis of chronic nonspecific low back pain that has lasted at least three months since its onset.
* Pain score of 3 or more on a visual analog scale.
* Pain during quiet standing.
* Cognitive level above 24 based on mini-mental state examination (MMSE).

Exclusion Criteria:

* Radicular pain and any neurological signs.
* Uncorrected vision impairment.
* Hearing problems.
* Vestibular dysfunctions.
* Cognitive deficit.
* Previous spinal surgery.
* Severe deformity or injury to the lower extremities.

Primary outcomes:
measure: Oswestry Disability Index
timeFrame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ", "change from baseline at three months "
Secondary outcomes:
measure: Center of pressure (COP) sway range for anteroposterior (AP range)
timeFrame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
measure: COP sway range for mediolateral (MA range)
timeFrame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
measure: COP sway velocity
timeFrame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
measure: Sway area
timeFrame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
measure: Short-term diffusion coefficient of stabilogram diffusion plot
timeFrame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
measure: Long-term diffusion coefficient of stabilogram diffusion plot
timeFrame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
measure: Critical point coordinates.
timeFrame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
measure: 12-item short form health survey
timeFrame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
measure: Tampa scale for kinesiophobia
timeFrame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
measure: Fear-avoidance beliefs questionnaire
timeFrame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
measure: Visual analog scale
timeFrame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ", "change from baseline at three months "
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Iran University of Medical Sciences
state: Iran (the Islamic Republic Of)
Study officials:
affiliation: Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences
name: Zeinab Raoufi, PhD student
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences
name: Reza Salehi, PhD
role: STUDY_DIRECTOR
References:
citation: Frizziero A, Pellizzon G, Vittadini F, Bigliardi D, Costantino C. Efficacy of Core Stability in Non-Specific Chronic Low Back Pain. J Funct Morphol Kinesiol. 2021 Apr 22;6(2):37. doi: 10.3390/jfmk6020037.
citation: Agnus Tom A, Rajkumar E, John R, Joshua George A. Determinants of quality of life in individuals with chronic low back pain: a systematic review. Health Psychol Behav Med. 2022 Jan 5;10(1):124-144. doi: 10.1080/21642850.2021.2022487. eCollection 2022.
citation: van Tulder M, Becker A, Bekkering T, Breen A, del Real MT, Hutchinson A, Koes B, Laerum E, Malmivaara A; COST B13 Working Group on Guidelines for the Management of Acute Low Back Pain in Primary Care. Chapter 3. European guidelines for the management of acute nonspecific low back pain in primary care. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S169-91. doi: 10.1007/s00586-006-1071-2. No abstract available.
citation: Lamoth CJ, Stins JF, Pont M, Kerckhoff F, Beek PJ. Effects of attention on the control of locomotion in individuals with chronic low back pain. J Neuroeng Rehabil. 2008 Apr 25;5:13. doi: 10.1186/1743-0003-5-13.
citation: Kanekar N, Aruin AS. Aging and balance control in response to external perturbations: role of anticipatory and compensatory postural mechanisms. Age (Dordr). 2014 Jun;36(3):9621. doi: 10.1007/s11357-014-9621-8. Epub 2014 Feb 16.
citation: Hodges PW, Richardson CA. Inefficient muscular stabilization of the lumbar spine associated with low back pain. A motor control evaluation of transversus abdominis. Spine (Phila Pa 1976). 1996 Nov 15;21(22):2640-50. doi: 10.1097/00007632-199611150-00014.
citation: Bussey MD, Aldabe D, Shemmell J, Jowett T. Anticipatory postural control differs between low back pain and pelvic girdle pain patients in the absence of visual feedback. Hum Mov Sci. 2020 Feb;69:102529. doi: 10.1016/j.humov.2019.102529. Epub 2019 Nov 11.
citation: Hodges PW. Changes in motor planning of feedforward postural responses of the trunk muscles in low back pain. Exp Brain Res. 2001 Nov;141(2):261-6. doi: 10.1007/s002210100873.
citation: Mitchell SL, Collins JJ, De Luca CJ, Burrows A, Lipsitz LA. Open-loop and closed-loop postural control mechanisms in Parkinson's disease: increased mediolateral activity during quiet standing. Neurosci Lett. 1995 Sep 8;197(2):133-6. doi: 10.1016/0304-3940(95)11924-l.
citation: Collins JJ, De Luca CJ. Open-loop and closed-loop control of posture: a random-walk analysis of center-of-pressure trajectories. Exp Brain Res. 1993;95(2):308-18. doi: 10.1007/BF00229788.
citation: Collins JJ, De Luca CJ, Burrows A, Lipsitz LA. Age-related changes in open-loop and closed-loop postural control mechanisms. Exp Brain Res. 1995;104(3):480-92. doi: 10.1007/BF00231982.
citation: Wong JJ, Cote P, Sutton DA, Randhawa K, Yu H, Varatharajan S, Goldgrub R, Nordin M, Gross DP, Shearer HM, Carroll LJ, Stern PJ, Ameis A, Southerst D, Mior S, Stupar M, Varatharajan T, Taylor-Vaisey A. Clinical practice guidelines for the noninvasive management of low back pain: A systematic review by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration. Eur J Pain. 2017 Feb;21(2):201-216. doi: 10.1002/ejp.931. Epub 2016 Oct 6.
citation: Owen PJ, Miller CT, Mundell NL, Verswijveren SJJM, Tagliaferri SD, Brisby H, Bowe SJ, Belavy DL. Which specific modes of exercise training are most effective for treating low back pain? Network meta-analysis. Br J Sports Med. 2020 Nov;54(21):1279-1287. doi: 10.1136/bjsports-2019-100886. Epub 2019 Oct 30.
citation: Koumantakis GA, Watson PJ, Oldham JA. Trunk muscle stabilization training plus general exercise versus general exercise only: randomized controlled trial of patients with recurrent low back pain. Phys Ther. 2005 Mar;85(3):209-25.
citation: Hlaing SS, Puntumetakul R, Khine EE, Boucaut R. Effects of core stabilization exercise and strengthening exercise on proprioception, balance, muscle thickness and pain related outcomes in patients with subacute nonspecific low back pain: a randomized controlled trial. BMC Musculoskelet Disord. 2021 Nov 30;22(1):998. doi: 10.1186/s12891-021-04858-6.
citation: Coulombe BJ, Games KE, Neil ER, Eberman LE. Core Stability Exercise Versus General Exercise for Chronic Low Back Pain. J Athl Train. 2017 Jan;52(1):71-72. doi: 10.4085/1062-6050-51.11.16. Epub 2016 Nov 16.
citation: Saragiotto BT, Maher CG, Yamato TP, Costa LOP, Costa LCM, Ostelo RWJG, Macedo LG. Motor Control Exercise for Nonspecific Low Back Pain: A Cochrane Review. Spine (Phila Pa 1976). 2016 Aug 15;41(16):1284-1295. doi: 10.1097/BRS.0000000000001645.
citation: Ganesh GS, Kaur P, Meena S. Systematic reviews evaluating the effectiveness of motor control exercises in patients with non-specific low back pain do not consider its principles - A review. J Bodyw Mov Ther. 2021 Apr;26:374-393. doi: 10.1016/j.jbmt.2020.08.010. Epub 2020 Sep 6.
citation: Remy F, Wenderoth N, Lipkens K, Swinnen SP. Dual-task interference during initial learning of a new motor task results from competition for the same brain areas. Neuropsychologia. 2010 Jul;48(9):2517-27. doi: 10.1016/j.neuropsychologia.2010.04.026. Epub 2010 Apr 29.
citation: Burcal CJ, Needle AR, Custer L, Rosen AB. The Effects of Cognitive Loading on Motor Behavior in Injured Individuals: A Systematic Review. Sports Med. 2019 Aug;49(8):1233-1253. doi: 10.1007/s40279-019-01116-7.
citation: Hemmati L, Piroozi S, Rojhani-Shirazi Z. Effect of dual tasking on anticipatory and compensatory postural adjustments in response to external perturbations in individuals with nonspecific chronic low back pain: Electromyographic analysis. J Back Musculoskelet Rehabil. 2018;31(3):489-497. doi: 10.3233/BMR-170992.
citation: Wang XQ, Zheng JJ, Yu ZW, Bi X, Lou SJ, Liu J, Cai B, Hua YH, Wu M, Wei ML, Shen HM, Chen Y, Pan YJ, Xu GH, Chen PJ. A meta-analysis of core stability exercise versus general exercise for chronic low back pain. PLoS One. 2012;7(12):e52082. doi: 10.1371/journal.pone.0052082. Epub 2012 Dec 17.
citation: Woollacott M, Shumway-Cook A. Attention and the control of posture and gait: a review of an emerging area of research. Gait Posture. 2002 Aug;16(1):1-14. doi: 10.1016/s0966-6362(01)00156-4.
citation: Sherafat S, Salavati M, Takamjani IE, Akhbari B, Rad SM, Mazaheri M, Negahben H, Lali P. Effect of dual-tasking on dynamic postural control in individuals with and without nonspecific low back pain. J Manipulative Physiol Ther. 2014 Mar-Apr;37(3):170-9. doi: 10.1016/j.jmpt.2014.02.003. Epub 2014 Mar 15.
citation: Akhtar MW, Karimi H, Gilani SA. Effectiveness of core stabilization exercises and routine exercise therapy in management of pain in chronic non-specific low back pain: A randomized controlled clinical trial. Pak J Med Sci. 2017 Jul-Aug;33(4):1002-1006. doi: 10.12669/pjms.334.12664.
citation: Shamsi MB, Rezaei M, Zamanlou M, Sadeghi M, Pourahmadi MR. Does core stability exercise improve lumbopelvic stability (through endurance tests) more than general exercise in chronic low back pain? A quasi-randomized controlled trial. Physiother Theory Pract. 2016;32(3):171-8. doi: 10.3109/09593985.2015.1117550. Epub 2016 Feb 11.
citation: Ghorbanpour A, Azghani MR, Taghipour M, Salahzadeh Z, Ghaderi F, Oskouei AE. Effects of McGill stabilization exercises and conventional physiotherapy on pain, functional disability and active back range of motion in patients with chronic non-specific low back pain. J Phys Ther Sci. 2018 Apr;30(4):481-485. doi: 10.1589/jpts.30.481. Epub 2018 Apr 13.
citation: Collins JJ, De Luca CJ. The effects of visual input on open-loop and closed-loop postural control mechanisms. Exp Brain Res. 1995;103(1):151-63. doi: 10.1007/BF00241972.
citation: Cano-de-la-Cuerda R, Molero-Sanchez A, Carratala-Tejada M, Alguacil-Diego IM, Molina-Rueda F, Miangolarra-Page JC, Torricelli D. Theories and control models and motor learning: clinical applications in neuro-rehabilitation. Neurologia. 2015 Jan-Feb;30(1):32-41. doi: 10.1016/j.nrl.2011.12.010. Epub 2012 Feb 18. English, Spanish.
citation: Shamsi MB, Sarrafzadeh J, Jamshidi A. Comparing core stability and traditional trunk exercise on chronic low back pain patients using three functional lumbopelvic stability tests. Physiother Theory Pract. 2015 Feb;31(2):89-98. doi: 10.3109/09593985.2014.959144. Epub 2014 Oct 15.
citation: Mousavi SJ, Parnianpour M, Mehdian H, Montazeri A, Mobini B. The Oswestry Disability Index, the Roland-Morris Disability Questionnaire, and the Quebec Back Pain Disability Scale: translation and validation studies of the Iranian versions. Spine (Phila Pa 1976). 2006 Jun 15;31(14):E454-9. doi: 10.1097/01.brs.0000222141.61424.f7.
citation: Rostami M, Noorian N, Mansournia MA, Sharafi E, Babaki AE, Kordi R. Validation of the Persian version of the fear avoidance belief questionnaire in patients with low back pain. J Back Musculoskelet Rehabil. 2014;27(2):213-21. doi: 10.3233/BMR-130439.
citation: Vlaeyen JWS, Seelen HAM, Peters M, de Jong P, Aretz E, Beisiegel E, Weber WEJ. Fear of movement/(re)injury and muscular reactivity in chronic low back pain patients: an experimental investigation. Pain. 1999 Sep;82(3):297-304. doi: 10.1016/S0304-3959(99)00054-8.
citation: Abedi M, Manshadi FD, Khalkhali M, Mousavi SJ, Baghban AA, Montazeri A, Parnianpour M. Translation and validation of the Persian version of the STarT Back Screening Tool in patients with nonspecific low back pain. Man Ther. 2015 Dec;20(6):850-4. doi: 10.1016/j.math.2015.04.006. Epub 2015 Apr 15.