NCT07738965

Brief Summary

Chronic Non-Specific Low Back Pain means pain in the lower back that lasts for more than 3 months and does not have a serious cause like a fracture, infection, or nerve damage. It is very common and affects many people at some point in their lives. This type of back pain usually happens because the muscles that support your spine become weak or do not work properly. It can also be linked to poor posture, sitting too long, lack of exercise, stress, or anxiety. Over time, this can lead to stiffness, reduced movement, and difficulty doing daily activities. Treatment mainly focuses on exercise and staying active. Simple physiotherapy treatments like stretching, strengthening, and heat therapy can help reduce pain, but they may not fully improve the deeper muscles that support your back. Two helpful exercise approaches are: Mind-Body Pilates: This involves slow, controlled movements with proper breathing. It helps improve posture, strengthen core muscles, and reduce stress. Pressure Biofeedback Training: This uses a small device to help you learn how to correctly activate deep abdominal muscles that support your spine. Both methods can reduce pain and improve movement. Pilates focuses on whole-body control and relaxation, while biofeedback training focuses more on activating specific muscles. In simple terms, regular exercise, good posture, and learning how to properly use your core muscles are key to managing long-term back pain and improving your quality of life.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Jul 2026Nov 2026

Study Start

First participant enrolled

July 1, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 31, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

July 9, 2026

Last Update Submit

July 27, 2026

Conditions

Keywords

Mind-Body Pilatespressure biofeedbackchronic Non specific low back pain

Outcome Measures

Primary Outcomes (1)

  • Numeric Pain Rating Scale

    Pain intensity will be measured using the Numeric Pain Rating Scale (NPRS). score range from 0 to 10, High score indicating greater pain

    week 6

Secondary Outcomes (1)

  • Pressure Biofeedback Unit

    week 6

Other Outcomes (1)

  • 36-item Short Form Health Survey (SF-36)

    week 6

Study Arms (2)

Mind-Body Pilates

EXPERIMENTAL

Participants in this group will receive a structured Mind-Body Pilates exercise program focusing on core stability, postural control, breathing, and functional movement. The program will be supervised by a physiotherapist and performed over a specified duration

Behavioral: Mind-Body Pilates

Pressure Biofeed Back

ACTIVE COMPARATOR

Participants in this group will receive core stabilization exercises using pressure biofeedback to facilitate activation of deep trunk muscles. The intervention will be supervised by a physiotherapist and performed over a specified duration.

Behavioral: Pressure Biofeedback

Interventions

A structured Mind-Body Pilates exercise program focusing on core stability, postural alignment, breathing control, and functional movement patterns. The program includes mat-based exercises targeting deep trunk muscles (transversus abdominis, multifidus) with emphasis on controlled movements and neuromuscular coordination. Sessions will be supervised by a physiotherapist, conducted 3 times per week for 6 weeks, with each session lasting approximately 45-60 minutes

Mind-Body Pilates

A core stabilization exercise program using a pressure biofeedback unit to facilitate activation and control of deep abdominal muscles, particularly the transversus abdominis. Exercises will be performed in progressive positions (supine, sitting, standing) with visual feedback to ensure correct muscle activation. Sessions will be supervised by a physiotherapist, conducted 3 times per week for 6 weeks, with each session lasting approximately 30-45 minutes

Pressure Biofeed Back

Eligibility Criteria

Age40 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 40-55 years.
  • Diagnosed with chronic non-specific low back pain (pain lasting ≥12 weeks).
  • Numeric Rating Scale (NRS) pain score ≥3.
  • Able to understand study procedures and provide written informed consent.
  • Able to participate in the exercise program and attend treatment sessions.

You may not qualify if:

  • History of lumbar spine surgery within the past 12 months.
  • Serious spinal pathology (fracture, tumor, infection, inflammatory disease).
  • Neurological deficits or radiculopathy requiring surgical management.
  • Pregnancy.
  • Participation in a structured Pilates or core stabilization program within the previous 6 months.
  • Any medical condition that prevents safe participation in exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Rehabilitation Sciences

Lahore, Punjab Province, Pakistan

Location

Related Publications (4)

  • Xu C, Fu Z, Wang X. Effect of Transversus abdominis muscle training on pressure-pain threshold in patients with chronic low Back pain. BMC Sports Sci Med Rehabil. 2021 Apr 1;13(1):35. doi: 10.1186/s13102-021-00262-8.

    PMID: 33794983BACKGROUND
  • Khan M, et al. Inter-rater reliability of the Pressure Biofeedback Unit among clinicians measuring TrA activation. J Clin Physiother Res. 2022.

    BACKGROUND
  • Gilliam JR, George SZ, Norman KS, Hendren S, Sahu PK, Silfies SP. Mind-Body Exercise Performed by Physical Therapists for Reducing Pain and Disability in Low Back Pain: A Systematic Review With Meta-analysis. Arch Phys Med Rehabil. 2023 May;104(5):776-789. doi: 10.1016/j.apmr.2022.10.004. Epub 2022 Dec 17.

    PMID: 36535419BACKGROUND
  • Amjad F, Mohseni-Bandpei MA, Gilani SA, Ahmad A, Waqas M, Hanif A. Urdu version of Oswestry disability index; a reliability and validity study. BMC Musculoskelet Disord. 2021 Mar 29;22(1):311. doi: 10.1186/s12891-021-04173-0.

    PMID: 33781267BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Prof. Dr. Shoaib Waqas

    drshoaibwaqas@gmail.com

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Muzamil Arif, Masters of Physical Therapy

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor will be blinded to group allocation. Participants and treating physiotherapists will not be blinded due to the nature of the interventions. All outcome measures will be recorded by an independent assessor who is not involved in treatment allocation or intervention delivery.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Mind-Body Pilates is a gentle exercise program designed to help reduce back pain and improve strength, posture, and movement. It focuses on slow, controlled movements combined with proper breathing and body awareness. In this program, patients perform specific exercises that target the deep muscles of the abdomen and back, which support the spine. These muscles are important for keeping the lower back stable and preventing pain from coming back. Each session usually includes: Breathing exercises to relax the body and improve control Core strengthening exercises to support the spine Stretching and flexibility exercises to reduce stiffness Posture training to improve body alignment Controlled movements to improve balance and coordination The exercises are done on a mat and are adjusted according to the patient's ability and comfort level. Movements are slow and precise, helping patients focus on how their body moves. Mind-Body Pilates not only improves physical strength but also hel
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2026

First Posted

July 31, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

July 31, 2026

Record last verified: 2026-07

Locations