Effect of Multidimensional Physiotherapy in Chronic Nonspecific Low Back Pain

NCT ID: NCT04270422

Last Updated: 2023-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2023-01-22

Brief Summary

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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.

Detailed Description

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multidimensional physiotherapy treatment include: psychoeducation based on cognitive behavioral therapy (CBT), education, graded exposure, postural correction exercise, lifestyle change, and electrotherapy.

usual evidence-based physiotherapy include: electrotherapy, education, and trunk general exercises.

Conditions

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Low Back Pain, Mechanical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Multidimensional physiotherapy

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

Group Type EXPERIMENTAL

Multidimensional physiotherapy

Intervention Type OTHER

Multidimensional physiotherapy based on biopsychosocial approach

Usual physiotherapy

Usual evidence based physiotherapy, twice a week, 12 sessions

Group Type ACTIVE_COMPARATOR

Usual physiotherapy

Intervention Type OTHER

Usual evidence based physiotherapy

Interventions

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Multidimensional physiotherapy

Multidimensional physiotherapy based on biopsychosocial approach

Intervention Type OTHER

Usual physiotherapy

Usual evidence based physiotherapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Iran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Javad Sarrafzadeh

Role: PRINCIPAL_INVESTIGATOR

IIran University of Medical Sciences

Locations

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Iran University of Medical Sciences

Tehran, , Iran

Site Status

School of Rehabilitation Sciences, Iran University of Medical Sciences

Tehran, , Iran

Site Status

Countries

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Iran

References

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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.

Reference Type DERIVED
PMID: 38049905 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34620205 (View on PubMed)

Other Identifiers

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IranUMS

Identifier Type: -

Identifier Source: org_study_id

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