NCT06099470

Brief Summary

The goal of this study is to investigate the efficacy of different internet based delivery methods for patients with chronic non-specific low back pain. The parameters we want to study is pain, disability, fear of movement, and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

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

June 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
Last Updated

October 25, 2023

Status Verified

September 1, 2023

Enrollment Period

3 months

First QC Date

September 19, 2023

Last Update Submit

October 24, 2023

Conditions

Chronic Non-specific Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale

    is a visual scale with various types to measure the intensity of the pain where 0 is considered no pain and 10 is unbearable pain. VAS can be just a 100mm horizontal line where patients can put a mark anywhere on the line, or graphics indicating the severity of pain. Also, it can be numerical line from 0 to 10 which we intend to use in this thesis.

    12 weeks

Secondary Outcomes (4)

  • Roland Morris Disability Questionnaire

    12 weeks

  • Oswestry Disability Index

    12 weeks

  • Tampa Scale for Kinesiophobia

    12 weeks

  • SF-12 Health Questionnaire

    12 weeks

Study Arms (3)

Real-time synchronized telerehabilitation program (STP).

EXPERIMENTAL

Subjects in this group will have face to face real-time video tele-habilitation sessions twice a week using Zoom

Other: Real-time synchronized telerehabilitation program (STP).

Pre-recording non-synchronized telerehabilitation program (NSTP)

EXPERIMENTAL

Subjects in this group will receive their therapeutic exercises through instructional videos sent via Email or WhatsAPP.

Other: Pre-recording non-synchronized telerehabilitation program (NSTP)

Home non-supervised control group (HCG)

OTHER

Minimum intervention which is a PDF file containing the same exercises with no follow ups.

Other: Home non-supervised control group (HCG)

Interventions

Real-time synchronized telerehabilitation program (STP).OTHER

patient education, core stabilization exercises, strengthening exercises, stretching exercises

Real-time synchronized telerehabilitation program (STP).
Pre-recording non-synchronized telerehabilitation program (NSTP)OTHER

Pre-recording non-synchronized telerehabilitation program (NSTP)

Pre-recording non-synchronized telerehabilitation program (NSTP)
Home non-supervised control group (HCG)OTHER

Home non-supervised control group (HCG)

Home non-supervised control group (HCG)

Eligibility Criteria

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

You may qualify if:

  • Persisting low back pain for the past 3 months.
  • VAS score of at least 4.
  • Age between 18 and 65.
  • Ability to perform exercises.
  • Internet access.

You may not qualify if:

  • Pregnancy.
  • History of spinal surgery.
  • History of spinal injury.
  • Misalignment or specific condition in the lumbar region.
  • Inflammatory joint diseases.
  • Any neurological symptoms.
  • Diagnosed osteoporosis.
  • Spondylosis.
  • Radiculopathy in the lumbar region.
  • Having a current inflammation in the trunk, lumbar or pelvic region.
  • Receiving physical therapy or other conventional therapy for LBP in the past 6 months.
  • Regular practice for Pilates or other specific exercise programs in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeditepe University

Istanbul, Ataşehir, Turkey (Türkiye)

Location

Related Publications (10)

  • Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.

    PMID: 21982256BACKGROUND

  • Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11.

    PMID: 27745712BACKGROUND

  • Sipaviciene S, Kliziene I. Effect of different exercise programs on non-specific chronic low back pain and disability in people who perform sedentary work. Clin Biomech (Bristol). 2020 Mar;73:17-27. doi: 10.1016/j.clinbiomech.2019.12.028. Epub 2020 Jan 3.

    PMID: 31923778BACKGROUND

  • In TS, Jung JH, Jung KS, Cho HY. Effects of the Multidimensional Treatment on Pain, Disability, and Sitting Posture in Patients with Low Back Pain: A Randomized Controlled Trial. Pain Res Manag. 2021 Jun 30;2021:5581491. doi: 10.1155/2021/5581491. eCollection 2021.

    PMID: 34306274BACKGROUND

  • Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21.

    PMID: 29573870BACKGROUND

  • Narouei S, Barati AH, Akuzawa H, Talebian S, Ghiasi F, Akbari A, Alizadeh MH. Effects of core stabilization exercises on thickness and activity of trunk and hip muscles in subjects with nonspecific chronic low back pain. J Bodyw Mov Ther. 2020 Oct;24(4):138-146. doi: 10.1016/j.jbmt.2020.06.026. Epub 2020 Jul 30.

    PMID: 33218502BACKGROUND

  • Zhang Y, Tang S, Chen G, Liu Y. Chinese massage combined with core stability exercises for nonspecific low back pain: a randomized controlled trial. Complement Ther Med. 2015 Feb;23(1):1-6. doi: 10.1016/j.ctim.2014.12.005. Epub 2015 Jan 3.

    PMID: 25637146BACKGROUND

  • Macedo LG, Maher CG, Latimer J, McAuley JH. Motor control exercise for persistent, nonspecific low back pain: a systematic review. Phys Ther. 2009 Jan;89(1):9-25. doi: 10.2522/ptj.20080103. Epub 2008 Dec 4.

    PMID: 19056854BACKGROUND

  • Saragiotto BT, Maher CG, Yamato TP, Costa LO, Menezes Costa LC, Ostelo RW, Macedo LG. Motor control exercise for chronic non-specific low-back pain. Cochrane Database Syst Rev. 2016 Jan 8;2016(1):CD012004. doi: 10.1002/14651858.CD012004.

    PMID: 26742533BACKGROUND

  • Paatelma M, Kilpikoski S, Simonen R, Heinonen A, Alen M, Videman T. Orthopaedic manual therapy, McKenzie method or advice only for low back pain in working adults: a randomized controlled trial with one year follow-up. J Rehabil Med. 2008 Nov;40(10):858-63. doi: 10.2340/16501977-0262.

    PMID: 19242624BACKGROUND

Study Officials

  • Elif Tuğçe ÇİL, Dr

    Yeditepe University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2023

First Posted

October 25, 2023

Study Start

June 1, 2023

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

October 25, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)