- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07726797
Pelvic Control Training Using Pressure Biofeedback Versus Core Stability Training in Non-Specific Low Back Pain (NLBP)
Effect of Pelvic Control Training Using Pressure Biofeedback Versus Core Stability Training on Pain, Range of Motion, Muscle Strength, and Functional Disability in Patients With Non-Specific Low Back Pain
Studieoversigt
Status
Detaljeret beskrivelse
A randomized controlled trial compared core stabilization exercises with routine exercise therapy in patients with chronic nonspecific low back pain. Participants were randomly allocated into two groups, with both groups receiving conventional hot pack therapy three times per week for four weeks. Pain and functional disability were assessed using the Visual Analogue Scale (VAS) and Oswestry Disability Index (ODI). Both interventions significantly improved outcomes; however, core stabilization exercises produced greater reductions in pain and disability than routine exercise therapy.
Another randomized controlled trial investigated the effects of core stability training (CST) alone versus combined core and pelvic floor muscle (PFM) training in sedentary women with low back pain. Participants were allocated into a control group, a CST group, and a combined training group, with supervised sessions conducted three times weekly for four weeks. Although both exercise interventions significantly improved trunk muscle endurance and reduced pain, CST alone demonstrated greater improvements in lumbar function than the combined intervention.
A randomized controlled trial compared traditional lumbar dynamic strength training with stabilization exercises using pressure biofeedback in patients with chronic low back pain. Outcomes included pain intensity, disability, lumbar mobility, transversus abdominis strength, quality of life, and fear-avoidance beliefs. Both interventions significantly improved all measured outcomes, with no statistically significant differences between groups, indicating comparable effectiveness.
A comparative study evaluated Maitland mobilization and core stability exercises in adults with chronic nonspecific low back pain. Pain and disability were measured using the VAS and ODI before and after treatment. Both interventions significantly reduced pain and improved functional disability, with no clear superiority of either treatment approach.
A randomized study compared pelvic floor muscle training (PFMT) with conventional physiotherapy treatment. Participants received routine physiotherapy alone, PFMT, or PFMT combined with transversus abdominis co-activation. Functional disability and pain were assessed using the ODI and Numeric Pain Rating Scale (NPRS). PFMT, particularly when combined with transversus abdominis activation, resulted in greater improvements in pain and disability, supporting its role as an adjunct to conservative management.
Another study evaluated the effectiveness of a core stability training program in women with chronic nonspecific low back pain. Participants who completed the structured exercise program demonstrated significant reductions in pain intensity and improvements in functional performance compared with the control group, supporting the therapeutic benefits of core stabilization exercises.
A randomized trial compared stabilization exercises alone with stabilization exercises combined with pelvic floor muscle training and physical therapy in women with nonspecific low back pain. The combined intervention produced greater improvements in pain, functional ability, and static and dynamic trunk muscle endurance than stabilization exercises alone.
A clinical study examined the effects of performing proprioceptive neuromuscular facilitation (PNF) lower extremity patterns with and without a pressure biofeedback unit (PBU) in individuals with chronic low back pain. The use of the PBU significantly increased abdominal muscle activation and reduced lumbopelvic rotation, indicating enhanced lumbopelvic stability and motor control during exercise.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Imran Amjad, PhD
- Telefonnummer: 03324390125
- E-mail: imran.amjad@riphah.edu.pk
Studiesteder
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Punjab Province
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Lahore, Punjab Province, Pakistan, 60000
- Rekruttering
- Nishter Hospital Multan, CMH Multan
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Kontakt:
- Annum Manzoor, MS-OMPT
- Telefonnummer: 03324880984
- E-mail: drannummanzoor20@gmail.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Children aged 18-30 years.
- The body mass index within the typical range of 18.5 to 24.9 kg/m².
- No history of musculoskeletal, neurological, or vestibular disorders.
- Physically active individuals not engaged in regular core or balance training programs in the last 3 months.
- Willing to provide informed consent and comply with the study protocol.
Exclusion Criteria:
- History of lower extremity, spinal, or pelvic injuries in the past 6 months.
- Current pain, dizziness, or balance impairments.
- Known postural deformities (e.g., scoliosis, hyper lordosis).
- Neurological, cardiovascular, or systemic conditions affecting balance or motor performance.
- Pregnancy or recent childbirth (<6 months)
- Participation in any other interventional study during the study period.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Pelvic Control Training intervention with a Pressure Biofeedback Unit (PBU)
Participants in the PBU-guided pelvic floor muscle training group completed a 6-week program, performed 3-5 sessions per week, with each session lasting 25 minutes.
During Week 1, participants were trained in isolated pelvic floor muscle contractions in a crook-lying position using a Pressure Biofeedback Unit (PBU) set at 40 mmHg.
They performed 8-12 repetitions with 5-10-second holds and 5-10-second rest periods for 1-2 sets.
In Week 2, the program progressed to 2-3 sets, with emphasis on correct muscle activation and minimizing compensatory activity using visual feedback from the PBU.
Week 3 focused on improving endurance and maintaining lumbopelvic stability during sustained contractions.
In Week 4, functional tasks such as reaching, supine leg slides, and supported bridging were introduced.
Week 5 incorporated advanced exercises, including marching and bridging with continued biofeedback, while promoting pelvic control in supported sitting.
During Week 6, participants practiced pe
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Participants in the core stability exercise group completed a 6-week program performed 3-5 sessions per week, with each session lasting 25 minutes.
The program progressed from core activation exercises (abdominal drawing-in, pelvic tilts, heel slides, and supine marching) to low- and moderate-load stabilization exercises, including dead bugs, glute bridges, bird-dogs, and modified side planks.
Exercise intensity and complexity were gradually increased by adding full planks, unstable limb movements, and functional reaching tasks.
Throughout the intervention, emphasis was placed on maintaining a neutral spine, controlled breathing, postural stability, and proper neuromuscular control while avoiding compensatory movements.
Andre navne:
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Aktiv komparator: Core stability training
Participants in the core stability exercise group completed a 6-week program consisting of 3-5 sessions per week, with each session lasting 25 minutes.
Training progressed from core muscle activation exercises (abdominal drawing-in, pelvic tilts, heel slides, and supine marching) to low- and moderate-load stabilization exercises, including dead bugs, glute bridges, bird-dogs, and modified side planks.
Exercise intensity and complexity were gradually increased by adding full planks, unstable limb movements, and functional reaching tasks.
Throughout the program, emphasis was placed on maintaining a neutral spine, proper breathing, neuromuscular control, postural stability, and avoiding compensatory movements.
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Participants in the core stability exercise group completed a 6-week program consisting of 3-5 sessions per week, with each session lasting 25 minutes.
Training progressed from core muscle activation exercises (abdominal drawing-in, pelvic tilts, heel slides, and supine marching) to low- and moderate-load stabilization exercises, including dead bugs, glute bridges, bird-dogs, and modified side planks.
Exercise intensity and complexity were gradually increased by adding full planks, unstable limb movements, and functional reaching tasks.
Throughout the program, emphasis was placed on maintaining a neutral spine, proper breathing, neuromuscular control, postural stability, and avoiding compensatory movements.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Oswestry Disability Index (ODI)
Tidsramme: 6 weeks
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The ODI is comprised of ten categories, each of which evaluates a distinct element of daily functioning.
These sections include the following: the level of pain, personal care, lifting, walking, sitting, standing, sleeping, social life, sexual function, and traveling.
Every sentence has a score between 0 and 5, where 0 denotes the least amount of handicap and 5 the greatest score.
The index, which varies from 0 to 100, is calculated by adding the scores for each question that has been answered, then multiplying the amount by two.
A higher score denotes a higher degree of low back pain-related disability
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6 weeks
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Numeric Pain Rating Scale (NPRS)
Tidsramme: 6 weeks
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The 11-point Numeric Rating Scale (NRS) goes from 0 to 10, with 10 denoting "the highest level of pain imaginable" and 0 denoting "no pain".
It is a simple indicator of pain intensity since patients choose the number that most accurately represents their level of pain.
Both the NRS and other well-validated pain measuring scales have shown strong correlation, validity, and sensitivity to treatments that are known to improve pain.
The test-retest reliability for patients has been fairly high, with values of 0.96 and 0.95, respectively.
The NRS and the Visual Analog Scale (VAS) demonstrated a high construct validity relationship in individuals with chronic pain syndromes (correlations varied from 0.86 to 0.95)
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6 weeks
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Bubble Inclinometer
Tidsramme: 6 weeks
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The bubble inclinometer has high reliability for measuring lumbar range of motion in healthy individuals and patients with LBP.
They can be used for evaluating lumbar range of motion in healthy individuals and patients suffering from lumbar back pain, as well as for monitoring therapeutic interventions.
For healthy persons, the bubble inclinometer reliably measures the range of motion both within and between days (ICC˃0.75).
Regarding the ICC measure, they deemed it high if it was between 0.80 and 1.00, average if it was between 0.60-0.79,
and low if it was ≥0.59.
Bubble inclinometer has a high degree of reliability when it comes to monitoring all of the aforementioned ranges of motion in the within-day test on patients.
Regarding the Between Days Test, while the measurement reliability for side flexions, back extensions, and forward bends was excellent when standing, cut off value for lumbar flexion is less than 40 degrees, while for lumbar extension, it is less than 20 degrees.
T
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6 weeks
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Pressure Biofeedback Unit (PBU)
Tidsramme: 6 weeks
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The Pressure Biofeedback Unit (PBU) is a clinical instrument that assesses and trains the lumbopelvic stability through the changes in the pressure of an inflated cushion that is placed beneath the lumbar spine or Abdomen.
It entails the employment of a pressure gauge that gets attached to a pressure cell so that the slightest movement in the pelvic or spinal region can be sensed during the period that particular muscles are being used in a synergistic exercise.
One of the numerous functions of the PBU in the field of physical therapy and rehabilitation is the assessment of the capacity of the patient to maintain his spine in a neutral position when his deep abdominal muscles, i.e., multifidus and transversus abdominis, are contracted.
When training, the unit is inflated to a basal pressure, which is usually 40 mmHg when the unit is below the lumbar spine.
Subsequently, the patient performs the exercises (leg sliding, bridging and belly hollowing) against the desired range of pressure
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6 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Annum Manzoor, MS OMPT, Gulab Devi Teaching institute
Publikationer og nyttige links
Generelle publikationer
- 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.
- Abdel-Aziem AA, Abdelraouf OR, El-Basatiny HMY, Draz AH. The Effects of Stabilization Exercises Combined With Pelvic Floor Exercise in Women With Nonspecific Low Back Pain: A Randomized Clinical Study. J Chiropr Med. 2021 Dec;20(4):229-238. doi: 10.1016/j.jcm.2021.12.008. Epub 2022 Apr 6.
- Alarab A, Salhab I, Darawy D, Aker M, Naji R, Hroub N. Maitland Mobilization versus Core Stability Exercises in Management Chronic Nonspecific LBP. Biomedical and Pharmacology Journal. 2024;17:1115-24.
- Ozturk U, Corekci AA, Alaca N, Subasi F. Comparison of Pressure Feedback Biofeedback Training with Conventional Lumbar Dynamic Strength Exercises for Chronic Low Back Pain: A Prospective Randomized Trial. Altern Ther Health Med. 2024 Dec;30(12):6-12.
- Si X, Zhang L, Li F, Liang H. The effectiveness of pelvic floor muscle training on lumbar function and muscle performance in sedentary women with lower back pain: a randomized controlled trial. BMC Womens Health. 2025 Mar 19;25(1):125. doi: 10.1186/s12905-025-03644-z.
- Ko MJ, Koo MS, Jung EJ, Jeong WJ, Oh JS. Effect of Pelvic Floor Muscle Training Using Pressure Biofeedback on Pelvic Floor Muscle Contraction and Trunk Muscle Activity in Sitting in Healthy Women. Healthcare (Basel). 2022 Mar 18;10(3):570. doi: 10.3390/healthcare10030570.
- Karang N. Effectiveness of Pressure Biofeedback in Core Stabilization for Low Back Pain: A Literature Review. Majalah Ilmiah Fisioterapi Indonesia. 2025;13:552-6.
- Lee K. Effects of Core Stability Training on Deep Stabilizing Muscle Function and Neuromuscular Control. Medicina (Kaunas). 2025 Feb 20;61(3):364. doi: 10.3390/medicina61030364.
- Fernandes ACN, Jorge CH, Weatherall M, Ribeiro IV, Wallace SA, Hay-Smith EJC. Pelvic floor muscle training with feedback or biofeedback for urinary incontinence in women. Cochrane Database Syst Rev. 2025 Mar 11;3(3):CD009252. doi: 10.1002/14651858.CD009252.pub2.
- Zhang C, Qin L, Yin F, Chen Q, Zhang S. Global, regional, and national burden and trends of Low back pain in middle-aged adults: analysis of GBD 1990-2021 with projections to 2050. BMC Musculoskelet Disord. 2024 Nov 7;25(1):886. doi: 10.1186/s12891-024-08002-y.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- REC/RCR & AHS/25/043
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