Low Back Pain, MechanicalNCT04270422
Effect of Multidimensional Physiotherapy in Chronic Nonspecific Low Back Pain
A study testing Multidimensional physiotherapy and Usual physiotherapy in people with Low Back Pain, Mechanical, run by Iran University of Medical Sciences at 2 sites in Iran.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Mechanical
- What is being tested?
- Multidimensional physiotherapy and Usual physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesIran
- Study dates
- 1 Dec 2020to 22 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Iran2 sites
Iran University of Medical Sciences
Tehran, 1545913487
School of Rehabilitation Sciences, Iran University of Medical Sciences
Tehran
About this study
Official title: Effect of Multidimensional Physiotherapy Based on Biopsychosocial Approach on Clinical Findings and Electroencephalography (EEG) Spectrum in Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial
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.
Read the detailed description
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
- Low Back Pain, Mechanical
- Being tested
- Multidimensional physiotherapy, Usual physiotherapy
- Keywords
- Pain, Disability, Pain catastrophising, Quality of life, Fear of movement, Chronic non specific low back pain
- Medical subject headings
- Low Back Pain, Pain, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidimensional physiotherapyOther
Multidimensional physiotherapy based on biopsychosocial approach
Usual physiotherapyOther
Usual evidence based physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Multidimensional physiotherapy | Experimental | Multidimensional physiotherapy based on biopsychosocial, twice a week, 12 sessions Receives: Other: Multidimensional physiotherapy |
| Usual physiotherapy | Active comparator | Usual evidence based physiotherapy, twice a week, 12 sessions Receives: Other: Usual physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: At 4 months
Secondary outcomes (28)
Quality of Life assessment
Self-reported quality of life based on health service (SF-36) questionnaire, the lower score the more disability and the higher score means the less disability.
Measured: At baseline
Fear Avoidance Believes
Self reported Fear Avoidance Believes based on Fear Avoidance Believes questionnaire. A higher score indicates more strongly held fear avoidance beliefs.
Measured: At baseline
Kinesiophobia
Self reported kinesiophobia based on Tampa scale of kinesiophobia. A higher score means more fear of movement.
Measured: At baseline
Pain Catastrophizing
Self reported pain Catastrophizing based on Pain Catastrophizing Scale.The scale is a 13 item scale, with each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time).
Measured: At baseline
Disability
Self reported disability based on Oswestry disability scale Questionnaire. A higher number indicates a greater disability.
Measured: At baseline
Forward flexion range of motion (ROM)
Forward flexion ROM measure by meter
Measured: At baseline
Brain function
Relative power and absolute power of the frequency spectrum of EEG
Measured: At baseline
Change in Quality of Life
Self-reported quality of life based on health service (SF-36) questionnaire, the lower score the more disability and the higher score means the less disability.
Measured: At 6 weeks, after 12 treatment sessions in 38 days
Change of Fear Avoidance Believes
Self reported Fear Avoidance Believes based on Fear Avoidance Believes questionnaire. A higher score indicates more strongly held fear avoidance beliefs.
Measured: At 6 weeks, after 12 treatment sessions in 38 days
Kinesiophobia
Change of Self reported kinesiophobia based on Tampa scale of kinesiophobiaA higher score means more fear of movement.
Measured: At 6 weeks, after 12 treatment sessions in 38 days
Change of Pain Catastrophizing
Self reported pain Catastrophizing based on Pain Catastrophizing Scale
Measured: At 6 weeks, after 12 treatment sessions in 38 days
Change of Disability
Self reported disability based on Oswestry disability scale Questionnaire. A higher number indicates a greater disability.
Measured: At 6 weeks, after 12 treatment sessions in 38 days
Change of Forward flexion range of motion (ROM)
Forward flexion ROM measure by meter
Measured: At 6 weeks, after 12 treatment sessions in 38 days
Change of Brain function
Relative power and absolute power of the frequency spectrum of EEG
Measured: At 6 weeks, after 12 treatment sessions in 38 days
Change of Quality of Life
Self-reported quality of life based on health service (SF-36) questionnaire, the lower score the more disability and the higher score means the less disability.
Measured: At 1 months
Change of Fear Avoidance Believes
Self reported Fear Avoidance Believes based on Fear Avoidance Believes questionnaire. A higher score indicates more strongly held fear avoidance beliefs.
Measured: At 1 months
Change of Kinesiophobia
Self reported kinesiophobia based on Tampa scale of kinesiophobiaA higher score means more fear of movement.
Measured: At 1 months
Change of Pain Catastrophizing
Self reported pain Catastrophizing based on Pain Catastrophizing Scale.The scale is a 13 item scale, with each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time).
Measured: At 1 months
Change of Disability
Self reported disability based on Oswestry disability scale Questionnaire. A higher number indicates a greater disability.
Measured: At 1 months
Change of Forward flexion range of motion (ROM)
Forward flexion ROM measure by meter
Measured: At 1 months
Change of Brain function
Relative power and absolute power of the frequency spectrum of EEG
Measured: At 1 months
Change of Quality of Life
Self-reported quality of life based on health service (SF-36) questionnaire, the lower score the more disability and the higher score means the less disability.
Measured: At 4 months
Change of Fear Avoidance Believes
Self reported Fear Avoidance Believes based on Fear Avoidance Believes questionnaire.A higher score indicates more strongly held fear avoidance beliefs.
Measured: At 4 months
Change of Kinesiophobia
Self reported kinesiophobia based on Tampa scale of kinesiophobiaA higher score means more fear of movement.
Measured: At 4 months
Change of Pain Catastrophizing
Self reported pain Catastrophizing based on Pain Catastrophizing Scale.The scale is a 13 item scale, with each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time).
Measured: At 4 months
Change of Disability
Self reported disability based on Oswestry disability scale Questionnaire. A higher number indicates a greater disability.
Measured: At 4 months
Change of Forward flexion range of motion (ROM)
Forward flexion ROM measure by meter
Measured: At 4 months
Change of Brain function
Relative power and absolute power of the frequency spectrum of EEG
Measured: At 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 Dec 2020
- Primary completion1 Nov 2022
- Study completion22 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Back Pain, MechanicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javad Sarrafzadeh, Principal investigator, IIran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270422
- Sponsor's protocol ID
- IranUMS
- Status last verified
- Sep 2023
- First submitted
- 10 Feb 2020
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data or results of the present study will present in an article that will be published after completing the study.
Publications
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.
PubMed 38049905Bemani 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.
PubMed 34620205
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Multidimensional Physiotherapy Based on Biopsychosocial Approach on Clinical Findings and Electroencephalography (EEG) Spectrum in Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04270422
- Acronym / sponsor ID
- IranUMS
- Conditions
- Low Back Pain, Mechanical
- Keywords
- Pain, Disability, Pain catastrophising, Quality of life, Fear of movement, Chronic non specific low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Iran University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 22 Jan 2023 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multidimensional physiotherapy | Experimental | Other: Multidimensional physiotherapyMultidimensional physiotherapy based on biopsychosocial, twice a week, 12 sessions |
| Usual physiotherapy | Active comparator | Other: Usual physiotherapyUsual evidence based physiotherapy, twice a week, 12 sessions |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidimensional physiotherapyMultidimensional physiotherapy based on biopsychosocial approach | Other | Multidimensional physiotherapy |
| Usual physiotherapyUsual evidence based physiotherapy | Other | Usual physiotherapy |
Primary outcome
Pain intensity(questionnaire): Numeric Rating Scale
Time frame: At baseline
Self reported pain intensity based on Numeric Rating Scale,that is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Change of Pain intensity (questionnaire): Numeric Rating Scale
Time frame: At 6 weeks, after 12 treatment sessions in 38 days
Self reported pain intensity based on Numeric Rating Scale,that is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Change of Pain intensity (questionnaire): Numeric Rating Scale
Time frame: At 1 month
Self reported pain intensity based on Numeric Rating Scale,that is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Change of Pain intensity(questionnaire): Numeric Rating Scale
Time frame: At 4 months
Self reported pain intensity based on Numeric Rating Scale,that is composed of 0 (no pain at all) to 10 (worst imaginable pain).
28 secondary outcomes
Quality of Life assessment
Time frame: At baseline
Fear Avoidance Believes
Time frame: At baseline
Kinesiophobia
Time frame: At baseline
Pain Catastrophizing
Time frame: At baseline
Disability
Time frame: At baseline
Forward flexion range of motion (ROM)
Time frame: At baseline
Brain function
Time frame: At baseline
Change in Quality of Life
Time frame: At 6 weeks, after 12 treatment sessions in 38 days
Change of Fear Avoidance Believes
Time frame: At 6 weeks, after 12 treatment sessions in 38 days
Kinesiophobia
Time frame: At 6 weeks, after 12 treatment sessions in 38 days
Change of Pain Catastrophizing
Time frame: At 6 weeks, after 12 treatment sessions in 38 days
Change of Disability
Time frame: At 6 weeks, after 12 treatment sessions in 38 days
Change of Forward flexion range of motion (ROM)
Time frame: At 6 weeks, after 12 treatment sessions in 38 days
Change of Brain function
Time frame: At 6 weeks, after 12 treatment sessions in 38 days
Change of Quality of Life
Time frame: At 1 months
Change of Fear Avoidance Believes
Time frame: At 1 months
Change of Kinesiophobia
Time frame: At 1 months
Change of Pain Catastrophizing
Time frame: At 1 months
Change of Disability
Time frame: At 1 months
Change of Forward flexion range of motion (ROM)
Time frame: At 1 months
Change of Brain function
Time frame: At 1 months
Change of Quality of Life
Time frame: At 4 months
Change of Fear Avoidance Believes
Time frame: At 4 months
Change of Kinesiophobia
Time frame: At 4 months
Change of Pain Catastrophizing
Time frame: At 4 months
Change of Disability
Time frame: At 4 months
Change of Forward flexion range of motion (ROM)
Time frame: At 4 months
Change of Brain function
Time frame: At 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Derived from this study: PubMed 38049905Bemani 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.
- Derived from this study: PubMed 34620205Bemani 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.
- Individual participant dataSharing planned: Yes. All data or results of the present study will present in an article that will be published after completing the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javad Sarrafzadeh principal investigator
IIran University of Medical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidimensional physiotherapy and Usual physiotherapy in people with Low Back Pain, Mechanical, run by Iran University of Medical Sciences at 2 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity(questionnaire): Numeric Rating Scale (time frame: At baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04270422, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.