NCT06762951

Brief Summary

This study sought to determine the effect of Pilates exercises versus segmental control exercises on spinopelvic angles, pain intensity, and functional disability in patients with chronic non-specific low back pain.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

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

First Submitted

Initial submission to the registry

January 2, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 8, 2025

Completed
24 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

January 8, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

January 2, 2025

Last Update Submit

January 2, 2025

Conditions

Chronic Non-Specific Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Spinopelvic angels

    Spinopelvic angles consists of (Sacral slope, lumber lordosis, pelvic incidence, and pelvic tilt) from the X-ray picture of the lateral view of the lumbosacral region by using CorelDraw graphic suits X7 software program. (Bhosale et al.2020)

    6 weeks

Secondary Outcomes (2)

  • Pain intensity

    6 weeks

  • Functional disability

    6 weeks

Study Arms (3)

Group (A)

EXPERIMENTAL

Group (A): Twenty patients will receive Pilates mat exercise which consists of (single leg stretch + Pelvic press + Swimming + Opposite arm and leg reach + Side to side), 3 sets of 10 repetitions. And conventional physiotherapy treatment which consists of traditional physical therapy eg. (Back, hamstring, calf and hip flexors stretches, Abdominal curl-up exercise in supine, Back extensors exercise in prone, and Hip extensors exercises in prone along with ultrasound and Transcutaneous electrical nerve stimulation (TENS), two sessions per week for six weeks.

Other: Pilates mat exercicesOther: Traditional physical therapy

Group (B)

EXPERIMENTAL

Group B: Twenty patients will receive Segmental control exercise which consists of (Segmental control over primary stabilizers, Exercises in closed chain, and Exercises in open chain) and conventional physiotherapy treatment which consists of traditional physical therapy eg. (Back, hamstring, calf and hip flexors stretches, Abdominal curl-up exercise in supine, Back extensors exercise in prone, and Hip extensors exercises in prone along with ultrasound and Transcutaneous electrical nerve stimulation (TENS), two sessions per week for six weeks

Other: Segmental control exercisesOther: Traditional physical therapy

Group (C)

ACTIVE COMPARATOR

Group C: Twenty patients will receive conventional physiotherapy treatment only which consists of traditional physical therapy eg. (Back, hamstring, calf and hip flexors stretches, Abdominal curl-up exercise in supine, Back extensors exercise in prone, and Hip extensors exercises in prone along with ultrasound and Transcutaneous electrical nerve stimulation (TENS), two sessions per week for six weeks.

Other: Traditional physical therapy

Interventions

Pilates mat exercicesOTHER

Pilates mat exercise which consists of (single leg stretch + Pelvic press + Swimming + Opposite arm and leg reach + Side to side), 3 sets of 10 repetitions.

Group (A)
Segmental control exercisesOTHER

Segmental control exercise which consists of (Segmental control over primary stabilizers, Exercises in closed chain, and Exercises in open chain)

Group (B)
Traditional physical therapyOTHER

Traditional physical therapy eg. (Back, hamstring, calf and hip flexors stretches, Abdominal curl-up exercise in supine, Back extensors exercise in prone, and Hip extensors exercises in prone along with ultrasound and Transcutaneous electrical nerve stimulation (TENS)

Group (A)Group (B)Group (C)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age group: 18 to 65 years. (Yentür et al., 2021)
  • Both male and female gender will be included in the study. (Akhtar et al., 2017)
  • Nonspecific, non-radicular (axial) chronic LBP diagnosis with hyperlordosis (LBP for at least three months). (Kızıltaş et al., 2022)
  • Visual Analog Scale (VAS) score of 3 or higher. (Mannion et al., 2009)

You may not qualify if:

  • Patients with acute attacks of LBP. (Caglayan et al.,2014)
  • Pain referred from the lumbar to the lower extremities.
  • Serious spinal disorder including malignancy, osteoporosis, ankylosing spondylitis, cauda equina compression, and infection.
  • Fracture of vertebrae, and administered epidural injection. (Sarker et al., 2020)
  • Pregnancy and feeding
  • Structural abnormalities in the lumbar region
  • Surgical history in the lumbar spine area
  • Heart disease. (Kızıltaş et al., 2022)
  • History of Vestibular dysfunction
  • Regular Pilates/any other specific exercise program in the last 3 months. (Mehta et al.,2022)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo Univercity

Egypt, Egypt

Location

Related Publications (5)

  • Dimitrijevic V, Scepanovic T, Milankov V, Milankov M, Drid P. Effects of Corrective Exercises on Lumbar Lordotic Angle Correction: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2022 Apr 18;19(8):4906. doi: 10.3390/ijerph19084906.

    PMID: 35457772BACKGROUND

  • Tamartash H, Bahrpeyma F. Evaluation of Lumbar Myofascial Release Effects on Lumbar Flexion Angle and Pelvic Inclination Angle in Patients with Non-Specific Low Back Pain. Int J Ther Massage Bodywork. 2022 Mar 2;15(1):15-22. doi: 10.3822/ijtmb.v15i1.709. eCollection 2022 Mar.

    PMID: 35280247BACKGROUND

  • Koivunen K, Widbom-Kolhanen S, Pernaa K, Arokoski J, Saltychev M. Reliability and validity of Oswestry Disability Index among patients undergoing lumbar spinal surgery. BMC Surg. 2024 Jan 3;24(1):13. doi: 10.1186/s12893-023-02307-w.

    PMID: 38172794BACKGROUND

  • Bhosale S, Pinto D, Srivastava S, Purohit S, Gautham S, Marathe N. Measurement of spinopelvic parameters in healthy adults of Indian origin - A cross sectional study. J Clin Orthop Trauma. 2020 Sep-Oct;11(5):883-888. doi: 10.1016/j.jcot.2019.07.013. Epub 2019 Jul 23.

    PMID: 32879575BACKGROUND

  • Huang C, Hsieh YL, Chou LW, Wang JL, Chien A. Effects of pilates exercises on radiographic lumbo-pelvic alignment and range of motion in non-specific low back pain patients. J Bodyw Mov Ther. 2024 Apr;38:339-345. doi: 10.1016/j.jbmt.2023.10.004. Epub 2024 Feb 5.

    PMID: 38763578BACKGROUND

Central Study Contacts

Alyaa MAM Elgendy, Master

CONTACT

+201111447459dr.alyaaelgendy55@gmail.com

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
Doctor

Study Record Dates

First Submitted

January 2, 2025

First Posted

January 8, 2025

Study Start

February 1, 2025

Primary Completion

February 1, 2026

Study Completion

March 1, 2026

Last Updated

January 8, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

Locations

EG(1)