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Chronic Non-specific Low Back PainNCT05832918

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

A study testing exercise therapy in people with Chronic Non-specific Low Back Pain, run by Iran University of Medical Sciences at 1 site in Iran.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Chronic Non-specific Low Back Pain
What is being tested?
exercise therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteIran
Study dates
2 May 2023to 15 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Iran1 site, 1 recruiting
  • Iran University of Medical Sciences

    Tehran, Iran (the Islamic Republic Of), 1449614535

    Reza Salehi, Associate Professor, 0098212222059, Salehi.re@iums.ac.ir

    Zeinab Raoufi, PhD candidate, 0098212222059, zraoofi93@gmail.com

    Recruiting

Other trials in Iran

About this study

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

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.
Read the 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.

Being tested
exercise therapy
Keywords
Low back pain, Disability, Postural control, Core Stability Exercise, cognitive task
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • exercise therapyOther

    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.

Study groups in NCT05832918
Study groupRoleWhat they receive
core stability exercises with cognitive tasks groupExperimentalThis research will use core stability exercises to strengthen local muscles (transversus abdominis and multifidus) based on the training program provided by Shamsi et al., which is modified from the exercise program of Koumantakis et al.. Participants will be treated for six weeks, three sessions a week, and 16 sessions. We will also combine stabilization exercises with cognitive tasks.
Receives: Other: exercise therapy
general exercises with cognitive tasks groupActive comparatorThis research will use general exercises to strengthen global muscles (abdominal flexor muscles and back extensor muscles) based on the training program provided by Shamsi et al.(110), which is modified by Koumantakis et al.. Participants will be treated for six weeks, three sessions a week, and 16 sessions. We will also combine general exercises with cognitive tasks.
Receives: Other: exercise therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oswestry Disability Index

    Questionnaire evaluating the level of disability. Total score range from 0-100 (higher scores mean more disability)

    Measured: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ", "change from baseline at three months "

Secondary outcomes (11)
  1. 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.

    Measured: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "

  2. 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.

    Measured: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "

  3. COP sway velocity

    COP sway velocity is one kind of COP displacement evaluation method characterized as traditional linear measures for evaluating postural control stability.

    Measured: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "

  4. Sway area

    Sway area is one kind of COP displacement evaluation method characterized as traditional linear measures for evaluating postural control stability.

    Measured: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "

  5. 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.

    Measured: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "

  6. 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.

    Measured: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "

  7. 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)

    Measured: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "

  8. 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)

    Measured: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "

  9. Tampa scale for kinesiophobia

    Questionnaire evaluating the kinesiophobia because of feeling re-injury. Total score range from 17-68 (higher scores mean more kinesiophobia)

    Measured: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "

  10. 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)

    Measured: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "

  11. Visual analog scale

    Questionnaire evaluating pain intensity. Total score range from 0-10 (higher scores mean more pain)

    Measured: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ", "change from baseline at three months "

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2023
  2. Study start2 May 2023
  3. Primary completion30 Nov 2025 (estimated)
  4. Study completion15 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05832918
Sponsor's protocol ID
IUMS
Status last verified
May 2025
First submitted
31 Mar 2023
Last updated
7 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33922389
  • 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.

    PubMed 35003902
  • 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.

    PubMed 16550447
  • 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.

    PubMed 18439264
  • 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.

    PubMed 24532389
  • 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.

    PubMed 8961451
  • 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.

    PubMed 31726292
  • 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.

    PubMed 11713638
  • 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.

    PubMed 8552278
  • 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.

    PubMed 8224055
  • 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.

    PubMed 7589299
  • 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.

    PubMed 27712027
  • 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.

    PubMed 31666220
  • 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.

    PubMed 15733046
  • 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.

    PubMed 34847915

Questions about this trial

What is this clinical trial studying?

A study testing exercise therapy in people with Chronic Non-specific Low Back Pain, run by Iran University of Medical Sciences at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zeinab Raoufi (00982122222059, zraoofi93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oswestry Disability Index (time frame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ", "change from baseline at three months "). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05832918, which also lists 35 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.

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