Pelvic Control Training Using Pressure Biofeedback Versus Core Stability Training in Non-Specific Low Back Pain

NCT07726797 | Recruiting DMC

• 1 other identifier: REC/RCR & AHS/25/043
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the effects of pelvic control training using pressure biofeedback with core stability training on pain, range of motion, muscle strength, and functional disability in patients with non specific low back pain

Conditions

Non Specific Low Back Pain; Core Stability; Core Stabilization Exercise

Keywords

range of motion; disability; strength

Outcome Measures

Primary Outcomes (4)

• Oswestry Disability Index (ODI)

  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

  6 weeks

• Numeric Pain Rating Scale (NPRS)

  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)

  6 weeks

• Bubble Inclinometer

  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

  6 weeks

• Pressure Biofeedback Unit (PBU)

  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

  6 weeks

Study Arms (2)

Pelvic Control Training intervention with a Pressure Biofeedback Unit (PBU)

EXPERIMENTAL

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

Other: Pelvic Control Training intervention with a Pressure Biofeedback Unit (PBU)

Core stability training

ACTIVE COMPARATOR

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.

Other: Core stability training

Interventions

Pelvic Control Training intervention with a Pressure Biofeedback Unit (PBU) OTHER

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.

Also known as: PCT, PBU

Pelvic Control Training intervention with a Pressure Biofeedback Unit (PBU)

Core stability training OTHER

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.

Also known as: CST

Core stability training

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Nishter Hospital Multan, CMH Multan

Lahore, Punjab Province, 60000, Pakistan

RECRUITING

Related Publications (10)

• 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.

  PMID: 35496721 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 39565706 BACKGROUND

• 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.

  PMID: 40108595 BACKGROUND

• 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.

  PMID: 29067082 BACKGROUND

• 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.

  PMID: 35327048 BACKGROUND

• Karang N. Effectiveness of Pressure Biofeedback in Core Stabilization for Low Back Pain: A Literature Review. Majalah Ilmiah Fisioterapi Indonesia. 2025;13:552-6.

  BACKGROUND

• 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.

  PMID: 40142175 BACKGROUND

• 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.

  PMID: 40066950 BACKGROUND

• 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.

  PMID: 39511565 BACKGROUND

Study Officials

• Annum Manzoor, MS OMPT

  Gulab Devi Teaching Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, PhD

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor will be an experienced musculoskeletal physiotherapist and will be familiar with the outcome tools used. Blinding will help prevent bias in the outcome assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Clinical Trial

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: July 16, 2026
• Primary Completion (Estimated): August 25, 2026
• Study Completion (Estimated): September 16, 2026
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)