NCT04270422

Brief Summary

This study compares the effect of multidimensional physiotherapy to usual evidence-based physiotherapy in the treatment of chronic nonspecific low back pain in adults. Half of the participants will receive multidimensional physiotherapy based on biopsychosocial approach while the other half will receive usual evidence based physiotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

February 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

1.9 years

First QC Date

February 10, 2020

Last Update Submit

September 11, 2023

Conditions

Low Back Pain, Mechanical

Keywords

PainDisabilityPain catastrophisingQuality of lifeFear of movementChronic non specific low back pain

Outcome Measures

Primary Outcomes (4)

  • Pain intensity(questionnaire): Numeric Rating Scale

    Self reported pain intensity based on Numeric Rating Scale,that is composed of 0 (no pain at all) to 10 (worst imaginable pain).

    At baseline

  • Change of Pain intensity (questionnaire): Numeric Rating Scale

    Self reported pain intensity based on Numeric Rating Scale,that is composed of 0 (no pain at all) to 10 (worst imaginable pain).

    At 6 weeks, after 12 treatment sessions in 38 days

  • Change of Pain intensity (questionnaire): Numeric Rating Scale

    Self reported pain intensity based on Numeric Rating Scale,that is composed of 0 (no pain at all) to 10 (worst imaginable pain).

    At 1 month

  • Change of Pain intensity(questionnaire): Numeric Rating Scale

    Self reported pain intensity based on Numeric Rating Scale,that is composed of 0 (no pain at all) to 10 (worst imaginable pain).

    At 4 months

Secondary Outcomes (28)

  • Quality of Life assessment

    At baseline

  • Fear Avoidance Believes

    At baseline

  • Kinesiophobia

    At baseline

  • Pain Catastrophizing

    At baseline

  • Disability

    At baseline

  • +23 more secondary outcomes

Study Arms (2)

Multidimensional physiotherapy

EXPERIMENTAL

Multidimensional physiotherapy based on biopsychosocial, twice a week, 12 sessions

Other: Multidimensional physiotherapy

Usual physiotherapy

ACTIVE COMPARATOR

Usual evidence based physiotherapy, twice a week, 12 sessions

Other: Usual physiotherapy

Interventions

Multidimensional physiotherapyOTHER

Multidimensional physiotherapy based on biopsychosocial approach

Multidimensional physiotherapy
Usual physiotherapyOTHER

Usual evidence based physiotherapy

Usual physiotherapy

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18-50
  • Low back pain for 3 months or more
  • Disability based on Oswestry Disability Index (ODI) between 20-60
  • Fear of movement based on Tampa scale of kinesiophobia \>37
  • Minimum level of education
  • Native Persian speaking

You may not qualify if:

  • Any evidence of e specific medical diagnosis
  • Rheumatoid disease,fibromyalgia, neuropathy, progressive neurological disease
  • History of headache, dizziness, nausea, epilepsy, migraines and mental disorder
  • Beck's Anxiety Inventory\> 26
  • Beck's Depression Inventory II\> 29
  • Pregnancy
  • Having other therapies during the present research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Iran University of Medical Sciences

Tehran, 1545913487, Iran

Location

School of Rehabilitation Sciences, Iran University of Medical Sciences

Tehran, Iran

Location

Related Publications (2)

  • Bemani S, Sarrafzadeh J, Dehkordi SN, Talebian S, Salehi R, Zarei J. Effect of multidimensional physiotherapy on non-specific chronic low back pain: a randomized controlled trial. Adv Rheumatol. 2023 Dec 4;63(1):57. doi: 10.1186/s42358-023-00329-9.

    PMID: 38049905DERIVED

  • Bemani S, Dehkordi SN, Sarrafzadeh J, Talebian S, Salehi R, Zarei J. Efficacy of a multidimensional versus usual care physiotherapy on pain and electroencephalography (EEG) spectrum in chronic nonspecific low back pain: study protocol for a randomized controlled trial. Trials. 2021 Oct 7;22(1):679. doi: 10.1186/s13063-021-05580-3.

    PMID: 34620205DERIVED

MeSH Terms

Conditions

Low Back PainPainKinesiophobia

Condition Hierarchy (Ancestors)

Back PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPhobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Javad Sarrafzadeh

    IIran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2020

First Posted

February 17, 2020

Study Start

December 1, 2020

Primary Completion

November 1, 2022

Study Completion

January 22, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

All data or results of the present study will present in an article that will be published after completing the study.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
8 months after completing the study
Access Criteria
Data access requests will be reviewed by the Corresponding Author will be required to sign a Data Access Agreement.

Locations

IR(2)