NCT06524089

Brief Summary

This study aims to determine whether Pilates-based stability or eccentric training is more effective for patients with multiple sclerosis(MS) with chronic non-specific low back pain(NSLBP).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

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

July 22, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 29, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

July 30, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2025

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

7 months

First QC Date

July 22, 2024

Last Update Submit

March 4, 2025

Conditions

Keywords

Pilateseccentricmultiple sclerosislow back pain

Outcome Measures

Primary Outcomes (2)

  • pain intensity

    VAS for measuring pain severity

    At baseline and after 6 week

  • Function

    The Trunk impairment scale (TIS) The static subscale investigates: (1) the ability of the subject to maintain a sitting position with feet supported; (2) the ability to maintain a sitting position while the legs are passively crossed, and (3) the ability to maintain a sitting position when the subject crosses the legs actively. The dynamic subscale contains items on lateral flexion of the trunk and unilateral lifting of the hip. To assess the coordination of the trunk, the subject is asked to rotate the upper or lower part of his or her trunk 6 times, initiating the movements either from the shoulder girdle or from the pelvic girdle, respectively. For each item, a 2-, 3- or 4- point ordinal scale is used. On the static and dynamic sitting balance and coordination subscales the maximal scores that can be attained are 7, 10 and 6 points. Therefore, TIS ranges between 0 for a minimal performance to 23 for a perfect performance.

    At baseline and after 6 week

Secondary Outcomes (1)

  • back muscle strength

    At baseline and after 6 week

Study Arms (2)

Pilates

EXPERIMENTAL

Fifteen patients will receive Pilates exercises

Other: Pilate training

eccentric

EXPERIMENTAL

Fifteen patients will receives eccentric training

Other: eccentric training

Interventions

Pilates based training exercises group will perform Pilates divided into two levels (beginner and intermediate). Each level will last for six sessions.

Pilates

eccentric trunk training exercises group:The course of the intervention period is 12 sessions total, exercises performed for two to three sets with 10 to 15 repetitions each set and 2 min rest between each set

eccentric

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age range 18 to 40 years.
  • Relapsing-remitting free for at least 90 days before testing.

You may not qualify if:

  • Having a neurologic disease other than MS.
  • A relapse within 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university hospital

Giza, 12625, Egypt

Location

Related Publications (2)

  • Duff WRD, Andrushko JW, Renshaw DW, Chilibeck PD, Farthing JP, Danielson J, Evans CD. Impact of Pilates Exercise in Multiple Sclerosis: A Randomized Controlled Trial. Int J MS Care. 2018 Mar-Apr;20(2):92-100. doi: 10.7224/1537-2073.2017-066.

    PMID: 29670495BACKGROUND
  • Demaneuf T, Aitken Z, Karahalios A, Leong TI, De Livera AM, Jelinek GA, Weiland TJ, Marck CH. Effectiveness of Exercise Interventions for Pain Reduction in People With Multiple Sclerosis: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Arch Phys Med Rehabil. 2019 Jan;100(1):128-139. doi: 10.1016/j.apmr.2018.08.178. Epub 2018 Sep 19.

    PMID: 30240593BACKGROUND

MeSH Terms

Conditions

Multiple SclerosisLow Back Pain

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Karima A Hassan

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel group prospective randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

July 22, 2024

First Posted

July 29, 2024

Study Start

July 30, 2024

Primary Completion

March 2, 2025

Study Completion

March 2, 2025

Last Updated

March 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations