Effects of Motor Control Exercises With and Without Pressure Biofeedback in Recurrent Low Back Pain (MCE)

NCT07892079 | Not Yet Recruiting DMC

• 1 other identifier: RE-167-2026
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the effects of Motor Control Exercises (MCE) with and without Pressure Biofeedback-Guided Training in patients with recurrent low back pain. It will evaluate the effectiveness of both interventions in reducing pain, improving Transversus abdominis (TrA) muscle activation, and decreasing disability. The study will determine whether adding pressure biofeedback to motor control exercises provides better clinical outcomes than motor control exercises alone.

Conditions

Low Back Pain

Keywords

Motor control exercise; Revised Oswestry Disability Index.; Pressure biofeedback; Transversus Abdominis; Recurrent Low Back Pain

Outcome Measures

Primary Outcomes (4)

• Numeric Pain Rating Scale

  11-point numeric with 0 representing No pain, 1-3 representing Mild Pain (nagging, annoying, interfering little with ADLs), 4-6 representing Moderate Pains (interferes significantly with ADLs), 7-10 representing Sever Pain

  Baseline, 3 weeks and after 6 weeks post treatment

• REVISED OSWESTERY DISABILITY QUESTIONNAIRE (RODQ)

  The Revised Oswestry Disability Questionnaire (RODQ) is a valid and reliable 10-item questionnaire. Each item is scored 0-5, with total disability expressed as a percentage: 0-20% (minimal), 21-40% (moderate), 41-60% (severe), 61-80% (crippled/severe functional limitation), and 81-100% (very severe disability). Higher scores indicate greater disability.

  Baseline, 3 weeks and after 6 weeks post treatment

• REHABILITATIVE ULTRASOUND IMAGING (RUSI)

  Rehabilitative Ultrasound Imaging (RUSI) is a non-invasive, reliable technique used to assess deep trunk muscle morphology, thickness, and activation. Transversus Abdominis (TrA) activation will be evaluated by measuring muscle thickness at rest and during contraction. Changes in muscle thickness will serve as an indirect indicator of muscle activation and lumbopelvic stability.

  Baseline, 3 weeks and after 6 weeks post treatment

• PRESSURE BIOFEEDBACK

  The Pressure Biofeedback Unit (PBU) is a non-invasive device consisting of an inflatable pressure cell and gauge that provides visual feedback to improve lumbopelvic control during motor control exercises. It helps enhance abdominal muscle recruitment, reduce lumbopelvic instability, and improve movement control in patients with chronic low back pain.

  Baseline, 3 weeks and after 6 weeks post treatment

Study Arms (2)

Motor Control Training with Pressure Bio-feedback

EXPERIMENTAL

Other: Motor Control Exercise with Pressure Biofeedback-Guided Training

Motor Control Training

ACTIVE COMPARATOR

Other: Motor Control Exercise

Interventions

Motor Control Exercise with Pressure Biofeedback-Guided Training OTHER

Participants will receive 45-minute sessions comprising a 5-minute warm-up, 35-minute Motor Control Exercises (MCE), and 5-minute cool-down, guided by Pressure Biofeedback (PBU). Weeks 1-2: ADIM, diaphragmatic breathing, multifidus activation, and heel slides (2-3 sets × 10 repetitions). Weeks 3-4: Straight leg raises, double-leg lowering, bridging, and quadruped arm/leg extensions (3 sets × 8-10 repetitions). Weeks 5-6: Standing ADIM, partial squats, planks, and sit-to-stand exercises (3 sets × 10 repetitions; planks 20-45 seconds).

Motor Control Training with Pressure Bio-feedback

Motor Control Exercise OTHER

Participants will receive the same 45-minute Motor Control Exercise (MCE) program as in experimental group, including warm-up, phased exercises (Weeks 1-6), and cool-down, with identical sets, repetitions, hold times, rest intervals, and progression criteria, but without Pressure Biofeedback (PBU). Standardized verbal instructions and tactile cues (TrA palpation) will guide muscle activation. The same physiotherapist will supervise both groups, with exercise completion and adverse events recorded in session logs.

Motor Control Training

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Recurrent LBP patients aged ≥ 18 to 45 years old. Both genders. Mild to moderate back pain with NPRS pain score value of between 3-6. At least 2 episodes of pain in the past 12 months, each episode lasting for 24 hours. No radiating pain below the gluteal fold. Patient able to perform ADIM.

You may not qualify if:

• Specific LBP attributable to identifiable pathology: fracture, malignancy, infection, inflammatory arthropathy Active lumbar radiculopathy with neurological deficit (sensory loss, motor weakness, or reflex changes in the lower limbs). Any referred pain below gluteal fold or neurological involvement in lower limbs is not included. Pathological conditions or diagnosed with disk herniation, spinal stenosis, spondylolisthesis, and spondylitis and other medical illnesses such as tumor, kidney disease, and visceral disease that can be related with low back pain excluded in this study. Participants who had undergone surgery for LBP in past 12 months. Pregnancy. Current participation in other physiotherapy or rehabilitation program

Sponsors & Collaborators

• University of Management and Technology Lahore: lead

Study Sites (1)

University of Management & Technology

Lahore, Punjab Province, 54000, Pakistan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study aims to compare the effects of Motor Control Exercises (MCE) with and without Pressure Biofeedback-Guided Training in patients with recurrent low back pain. It will evaluate the effectiveness of both interventions in reducing pain, improving transversus abdominis muscle activation, and decreasing functional disability. Muscle activation will be assessed using real-time ultrasound imaging, while disability will be measured using the Revised Oswestry Disability Index. The study will determine whether adding pressure biofeedback to motor control exercises provides better clinical outcomes than motor control exercises alone.

Study Record Dates

• First Submitted: October 17, 2026
• First Posted: October 23, 2026
• Study Start: October 20, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months after the publication of the manuscript.
• Access Criteria: The data can be requested from the corresponding author

Locations

PA (1)