An interventional study of exercise therapy in Chronic Non-specific Low Back Pain, sponsored by Iran University of Medical Sciences. Recruiting at 1 site in Iran. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-05-07.
Sponsored by Iran University of Medical Sciences · Not applicable, Interventional, and Treatment
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:
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.
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's planned enrollment of 48 is below the median of 60 across 2,364 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →Iran University of Medical Sciences is the lead sponsor of 25 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This 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.
Other: exercise therapy
This 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.
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.
Oswestry Disability Index
Questionnaire evaluating the level of disability. Total score range from 0-100 (higher scores mean more disability)
Time frame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ", "change from baseline at three months "
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.
Time frame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
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.
Time frame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
COP sway velocity
COP sway velocity is one kind of COP displacement evaluation method characterized as traditional linear measures for evaluating postural control stability.
Time frame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Sway area
Sway area is one kind of COP displacement evaluation method characterized as traditional linear measures for evaluating postural control stability.
Time frame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
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.
Time frame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
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.
Time frame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
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)
Time frame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
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)
Time frame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Tampa scale for kinesiophobia
Questionnaire evaluating the kinesiophobia because of feeling re-injury. Total score range from 17-68 (higher scores mean more kinesiophobia)
Time frame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
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)
Time frame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "
Visual analog scale
Questionnaire evaluating pain intensity. Total score range from 0-10 (higher scores mean more pain)
Time frame: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ", "change from baseline at three months "
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started May 2023 (actual). Primary completion is estimated for Nov 2025, 30 months after the start.
Of 1,231 non-industry interventional studies with no phase under Low Back Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 30 months is above that.
Counting every sponsor, half of 1,286 studies reached it within 11 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
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Iran University of Medical Sciences