NCT07026097

Brief Summary

The study will be Randomized Controlled Trial and will be conducted in Riphah Rehabilitation Research Center. The study duration will be 9 months. Non- probability convenient sampling technique will be used to collect the data. Patients with chronic non-specific low back pain will be included in this study after meeting the inclusion criteria. The sample size of this study is 40 participants 20 in each group. Both groups will be an experimental group and will receive Pilates exercise protocol and common standard physical therapy treatment, 02 times a week for 04 weeks. Group A will receive supervised online Pilates exercise plan with common standard physical therapy and Group B will receive clinical supervised Pilates with common standard physical therapy treatment. The common standard physical therapy plan will be a hot pack for lumbar region for 10 mins, hamstring stretch, participants should maintain this stretch for 30 secs with 10 repetitions and strengthening of abdominal muscles in crook lying position with 10 repetitions with hold of 30 sec. The Pilates exercise protocol will include rollup, one leg circle exercise, crook leg lying, prone single leg kick, side-lying clamshell, supine stretch exercise, bug roll, prone attitude rotation, side kick and saw exercise. The Pilates protocol will be of 30 mins with 06-10 repetitions for each exercise withhold time for 30 sec. The outcome measure will be Numeric Pain Rating Scale (NPRS) for pain, Oswestry Low Back Disability Questionnaire (ODI) for disability and inclinometer for range of motion.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
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 Start

First participant enrolled

May 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 11, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 18, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2025

Completed
Last Updated

June 18, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

June 11, 2025

Last Update Submit

June 11, 2025

Conditions

Keywords

Low Back PainPilates TrainingPilates Based ExercisesRange of MotionDisability

Outcome Measures

Primary Outcomes (3)

  • Numeric Pain Rating Scale

    Baseline, 4th week

  • Oswetry Disability Index

    Baseline, 4th week

  • Lumbar Range of Motion

    Baseline, 4th week

Study Arms (2)

Group A

EXPERIMENTAL
Other: Pilates Exercise - Online

Group B

ACTIVE COMPARATOR
Other: Pilates Exercise - Supervised

Interventions

Will receive Pilates exercise protocol online under supervision as patient will instructed to join online meeting and do their exercise 02 times a week along with standard physical therapy protocol for 4 weeks. The Pilates exercise protocol will be of 30 minutes. Repetitions: Exercises started with 6 to 10 reps. and hold time for 30 sec for each exercise. Rest period of 2 mins will be given

Group A

Will receive Pilates exercise protocol clinically supervised as patient will instructed to do their exercise 0 times a week along with standard physical therapy protocol for 4 weeks. The Pilates and common standard physical therapy protocol will be the same which is mention in detail in group A description

Group B

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with LBP
  • Minimum chronicity of LBP 03
  • Both Gender
  • Age ranges from 18-40
  • Numeric pain rating scale (NPRS) score 3 to 8 for pain intensity
  • Patient who can maintain their standing posture independently for ≥30 minutes, have enough physical autonomy to participate in the physical activities required by the study
  • Oswestry Disability Index score 20-34

You may not qualify if:

  • History of trauma or fracture of the supine
  • Chronic systemic soft tissue or bony disease
  • Post Operative
  • Pregnancy
  • Diagnosis of osteoarthritis and herniated disc
  • Any medical red flags
  • Neurological and visual impairments
  • Presence of root symptoms (e-g sciatica and cauda equina syndrome)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah Rehabilitation Clinic

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (2)

  • Siddiqui AS, Javed S, Abbasi S, Baig T, Afshan G. Association Between Low Back Pain and Body Mass Index in Pakistani Population: Analysis of the Software Bank Data. Cureus. 2022 Mar 30;14(3):e23645. doi: 10.7759/cureus.23645. eCollection 2022 Mar.

    PMID: 35510015BACKGROUND
  • Nieminen LK, Pyysalo LM, Kankaanpaa MJ. Prognostic factors for pain chronicity in low back pain: a systematic review. Pain Rep. 2021 Apr 1;6(1):e919. doi: 10.1097/PR9.0000000000000919. eCollection 2021.

    PMID: 33981936BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Syed Shakil ur Rehman, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Syed Shakil ur Rehman, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2025

First Posted

June 18, 2025

Study Start

May 1, 2025

Primary Completion

August 30, 2025

Study Completion

September 28, 2025

Last Updated

June 18, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations