NCT03984903

Brief Summary

This study evaluates the effects of self-learning exercise from multimedia content on pain and disability in patients with low back pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

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

First Submitted

Initial submission to the registry

May 30, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 13, 2019

Completed
17 days until next milestone

Study Start

First participant enrolled

June 30, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

May 30, 2019

Last Update Submit

February 27, 2023

Conditions

Keywords

Back Pain without RadiationLow Back Pain, Mechanical

Outcome Measures

Primary Outcomes (3)

  • Change from Baseline Pain Level at Eight Week and Third Month

    Full Scale Name: Visual Analog Scale Pain change will be measured throughout Study and Follow-up with Visual Analog Scale. This scale is a 100 millimeter line drawn horizontally on an A4 sheet of paper. The left end of the line shows "no pain at all", the right end shows "my pain is as bad as it could be", while the remaining part shows the intermediate values. So minimum score was 0, and maximum score was 100. The patient is asked to mark the severity of the pain on the chart. Validity and reliability were made. The minimal clinical significance difference in chronic low back pain was 20 millimeters.

    At baseline, eighth week and third month

  • Change from Baseline Disability Score Level at Eight Week and Third Month

    Full Scale Name: Turkish version of the Oswestry Disability Index (ODI) (2.0) The last reliable and validate Turkish Version of Oswestry Disability Index will be used. This version contains 10 multiple-choice questions that question how low back pain affects a person in his or her daily life. Each question has 6 options. As the disability increases, the score of each problem increases. In the worst case you can get 50 points. The last point is the patient's score 100.

    At baseline, eighth week and third month

  • Change in Exercise Adherence Level between Eight Week and Third Month

    The Exercise Adherence Rating Scale (EARS), which evaluates exercise compliance, will be administered 2 times to determine change at eight weeks and third month. This scale consists of 3 parts: A, B, C. Section A, consists of 6 items not included in the scale scoring. Section B consists 6 items, and every item have five point likert scale and describes how to do the recommended home exercise. Minimum point for this section 0, and maximum point is 24. The higher score shown exercise adherece is high. Section C is the section that evaluates the reason for the absence of compliance with the recommended home exercise and contains 10 items, every item have five point likert scale. Sections are calculated to result in a possible score between 0 and 40. The higher score shown exercise adherece is high.

    At eighth week and third month

Secondary Outcomes (1)

  • Change from Baseline Walking Parameters at Eight Week and Third Month

    At baseline, eighth week and third month

Study Arms (2)

Face-to-face Learning Group

ACTIVE COMPARATOR
Other: Face-to-face Learning of ExercisesOther: Manual TherapyOther: Home Exercise Program

Multimedia Learning Group

EXPERIMENTAL
Other: Multimedia Learning of ExercisesOther: Manual TherapyOther: Home Exercise Program

Interventions

Patients learn exercise from multimedia content.

Multimedia Learning Group

Physiotherapist teach exercises to patients

Face-to-face Learning Group

Myofascial Release Techniques and Joint Mobilizations to the Lumbal Area

Face-to-face Learning GroupMultimedia Learning Group

Patients do at least 20 minutes motor control exercise in a day at home.

Face-to-face Learning GroupMultimedia Learning Group

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Chronic (\>3 month), non-specific low back pain
  • years old
  • Have a capacity can understand exercise instructions (Montreal Cognitive Assessment \> 21)
  • Being a computer literate

You may not qualify if:

  • Root nerve signs
  • Cauda equina syndrome
  • Fracture in the vertebra
  • Tumour
  • Have a neurologic disease
  • History of spine surgery
  • Knowing motor control exercises
  • Visual impairment
  • Hearing loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Samanpazari, 06100, Turkey (Türkiye)

Location

Related Publications (3)

  • 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
  • Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G; COST B13 Working Group on Guidelines for Chronic Low Back Pain. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S192-300. doi: 10.1007/s00586-006-1072-1. No abstract available.

    PMID: 16550448BACKGROUND
  • 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

MeSH Terms

Conditions

Back PainLow Back Pain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

May 30, 2019

First Posted

June 13, 2019

Study Start

June 30, 2019

Primary Completion

September 30, 2019

Study Completion

October 30, 2019

Last Updated

February 28, 2023

Record last verified: 2023-02

Locations