Effects of Core Stability Exercises and Cognitive Tasks on Chronic Non-specific Back Pain

Chronic Non-specific Low Back Pain Clinical Trial

Official title:

Effects of Core Stability Exercises and Cognitive Tasks Compared to General Exercises and Cognitive Tasks on Chronic Non-specific Back Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05832918
• Other study ID #: IUMS
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2023
• Est. completion date: March 15, 2024

Study information

• Verified date: May 2023
• Source: Iran University of Medical Sciences
• Contact: Zeinab Raoufi
• Phone: 00982122222059
• Email: zraoofi93[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: March 15, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Non-specific Low Back Pain
• Low Back Pain

Intervention

Other:
• exercise therapy
Exercise therapy is one of the rehabilitation methods that is defined as a regimen or plan of physical activities designed and prescribed to facilitate the patient's recovery from diseases and any conditions which disturb their movement and activity of daily life or maintain a state of well-being through neuro re-education, gait training, and therapeutic exercises.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Iran University of Medical Sciences	Tehran	Iran (the Islamic Republic Of)

Sponsors (1)

Lead Sponsor	Collaborator
Iran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (34)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog scale	Questionnaire evaluating pain intensity. Total score range from 0-10 (higher scores mean more pain)	"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ", "change from baseline at three months "
Primary	Oswestry Disability Index	Questionnaire evaluating the level of disability. Total score range from 0-100 (higher scores mean more disability)	"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ", "change from baseline at three months "
Secondary	Center of pressure (COP) sway range for anteroposterior (AP range)	AP range is one kind of COP displacement evaluation method characterized as traditional linear measures for evaluating postural control stability.	"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Secondary	COP sway range for mediolateral (MA range)	MA range is one kind of COP displacement evaluation method characterized as traditional linear measures for evaluating postural control stability.	"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Secondary	COP sway velocity	COP sway velocity is one kind of COP displacement evaluation method characterized as traditional linear measures for evaluating postural control stability.	"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Secondary	Sway area	Sway area is one kind of COP displacement evaluation method characterized as traditional linear measures for evaluating postural control stability.	"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Secondary	Short-term diffusion coefficient of stabilogram diffusion plot	The short-term diffusion coefficient is the slope of the open-loop part of the stabilogram diffusion plot, indicating stochastic activity in open loop control phase in a quiet standing position.	"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Secondary	Long-term diffusion coefficient of stabilogram diffusion plot	The long-term diffusion coefficient is the slope of the close loop part of the stabilogram diffusion plot, indicating stochastic activity in the immediate loop control phase in the quiet standing position.	"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Secondary	Critical point coordinates.	Critical point coordinates are the estimated values of the time intervals and mean square displacements defining the stabilogram-diffusion critical points (the point that open-loop control changed to close loop control)	"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Secondary	12-item short form health survey	Questionnaire evaluating the quality of life. Total score range from 0-100 (higher scores mean better quality of life)	"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Secondary	Tampa scale for kinesiophobia	Questionnaire evaluating the kinesiophobia because of feeling re-injury. Total score range from 17-68 (higher scores mean more kinesiophobia)	"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Secondary	Fear-avoidance beliefs questionnaire	Questionnaire evaluating fear of pain and consequent avoidance of physical activity because of their fear. Total score range from 0-66 (higher scores mean more fear of pain)	"Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "

External Links

•   A meta-analysis of core stability exercise versus general exercise for chronic low back pain
•   Age-related changes in open-loop and closed-loop postural control mechanisms
•   Aging and balance control in response to external perturbations: role of anticipatory and compensatory postural mechanisms
•   Anticipatory postural control differs between low back pain and pelvic girdle pain patients in the absence of visual feedback
•   Attention and the control of posture and gait: a review of an emerging area of research
•   Changes in motor planning of feedforward postural responses of the trunk muscles in low back pain
•   Chapter 3. European guidelines for the management of acute nonspecific low back pain in primary care
•   Clinical practice guidelines for the noninvasive management of low back pain: A systematic review by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration
•   Compensatory but not anticipatory adjustments are altered in older adults during lateral postural perturbations
•   Core Stability Exercise Versus General Exercise for Chronic Low Back Pain
•   Determinants of quality of life in individuals with chronic low back pain: a systematic review
•   Dual-task interference during initial learning of a new motor task results from competition for the same brain areas
•   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
•   Effect of dual-tasking on dynamic postural control in individuals with and without nonspecific low back pain
•   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
•   Effects of attention on the control of locomotion in individuals with chronic low back pain
•   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
•   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
•   Efficacy of Core Stability in Non-Specific Chronic Low Back Pain
•   Fear of movement/(re)injury and muscular reactivity in chronic low back pain patients: an experimental investigation
•   Inefficient muscular stabilization of the lumbar spine associated with low back pain. A motor control evaluation of transversus abdominis
•   Motor Control Exercise for Nonspecific Low Back Pain: A Cochrane Review
•   Open-loop and closed-loop control of posture: a random-walk analysis of center-of-pressure trajectories
•   Open-loop and closed-loop postural control mechanisms in Parkinson's disease: increased mediolateral activity during quiet standing
•   Systematic reviews evaluating the effectiveness of motor control exercises in patients with non-specific low back pain do not consider its principles - A review
•   The Effects of Cognitive Loading on Motor Behavior in Injured Individuals: A Systematic Review
•   The effects of visual input on open-loop and closed-loop postural control mechanisms
•   The Oswestry Disability Index, the Roland-Morris Disability Questionnaire, and the Quebec Back Pain Disability Scale: translation and validation studies of the Iranian versions
•   Theories and control models and motor learning: clinical applications in neuro-rehabilitation
•   Translation and validation of the Persian version of the STarT Back Screening Tool in patients with nonspecific low back pain
•   Trunk muscle stabilization training plus general exercise versus general exercise only: randomized controlled trial of patients with recurrent low back pain
•   Validation of the Persian version of the fear avoidance belief questionnaire in patients with low back pain
•   Which specific modes of exercise training are most effective for treating low back pain? Network meta-analysis