NCT06946966

Brief Summary

Non-specific low back pain (NSLBP) is a common musculoskeletal condition that affects a significant portion of the population and often leads to limitations in daily activities, reduced quality of life, and increased levels of kinesiophobi

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable low-back-pain

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

Study Start

First participant enrolled

April 17, 2025

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 27, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2025

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2025

Completed
Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

April 21, 2025

Last Update Submit

August 11, 2025

Conditions

Keywords

pain

Outcome Measures

Primary Outcomes (5)

  • visual pain scal

    A 10-cm line where participants mark their pain intensity, ranging from 'no pain' to 'worst pain'.

    12 weeks

  • Quebec Back Pain Disability Scale (QBPDS)

    Assesses functional disability related to back pain through 20 daily activity items. Higher scores indicate greater limitation in performing physical tasks.

    12 weeks

  • Pressure Algometer

    Measures the minimum pressure that causes pain in a specific muscle or soft tissue, helping to quantify pain sensitivity objectively.

    12 weeks

  • Y-Balance Test (YBT)

    Evaluates balance by measuring reach distance in three directions while standing on one leg. It reflects dynamic stability, core control, and lower limb function.

    12 weeks

  • Tampa Scale of Kinesiophobia (TSK)

    Assesses fear of movement and re-injury through a 17-item questionnaire. Higher scores indicate increased avoidance behavior and movement-related fear.The final score can be a minimum of 17 points and a maximum of 68 points.

    12 weeks

Study Arms (3)

Reformer Pilates

EXPERIMENTAL

Reformer Pilates

Other: Reformer Pilates

Pilates control

ACTIVE COMPARATOR

Pilates control

Other: Pilates control

pilates online pilates

ACTIVE COMPARATOR

online pilates

Other: pilates online pilates

Interventions

Reformer Pilates

Reformer Pilates

Pilates control

Pilates control

pilates online pilates

pilates online pilates

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 18 and 60 years
  • Non-specific low back pain for more than 12 weeks
  • No clear pathological diagnosis
  • Physically and cognitively capable of performing the exercises
  • Pain level between 3 and 7 on the Visual Analog Scale (VAS)

You may not qualify if:

  • Pregnancy
  • Spinal surgery in the last 6 months
  • Neurological or chronic systemic diseases
  • Movement restriction due to severe pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahceşehir University Health Center

Istanbul, 34070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back PainPain

Condition Hierarchy (Ancestors)

Back PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 21, 2025

First Posted

April 27, 2025

Study Start

April 17, 2025

Primary Completion

July 17, 2025

Study Completion

August 11, 2025

Last Updated

August 12, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations