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The effect of lumbar manipulation on neurometabolites of the thalamus in non-specific chronic low back pain patients

Protocol summary

Study aim
Investigating the effect of lumbar manipulation on neurometabolites of the thalamus in non-specific chronic low back pain patients
Design
In this clinical trial study, 16 patients with non-specific chronic back pain will be subjected to manipulation treatment without randomization, and will be compared with control group( 16 healthy people).
Settings and conduct
Patients with back pain referred to clinics affiliated and not affiliated with Behbahan University of Medical Sciences and referred by a specialist doctor were examined and participated in the study if they were eligible. After registering the metabolic map of the thalamus, the patients enter the treatment stage. In this stage of treatment, patients receive only 3 treatment sessions of lumbar and pelvic spine manipulation in one day. 5 weeks after manipulation treatment, information related to pain , functional ability and brain metabolic map will be collected again.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 16 patients with non-specific chronic back pain for more than three months in the age range of 20 to 50 years and 16 healthy people without any pain in the age range of 20 to 50 years. Exclusion criteria: patients with chronic back pain of specific origin, as well as patients with non-specific chronic back pain who were treated in the last three months.
Intervention groups
Patients were treated with lumbar and pelvic manipulation, and healthy people did not receive any intervention.
Main outcome variables
The level of neurometabolites of the thalamus, the level of pain intensity and functional disability

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230103057029N1
Registration date: 2023-01-30, 1401/11/10
Registration timing: registered_while_recruiting

Last update: 2023-01-30, 1401/11/10
Update count: 0
Registration date
2023-01-30, 1401/11/10
Registrant information
Name
Daryoush Didehdar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 917 148 7091
Email address
dary1358@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-03-18, 1401/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lumbar manipulation on neurometabolites of the thalamus in non-specific chronic low back pain patients
Public title
The effect of lumbar manipulation on neurometabolites of the thalamus in non-specific chronic low back pain patients
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
16 patients with non-specific chronic back pain for more than three months, in the age range of 20 to 50 years 16 healthy people without any pain in the age range of 20 to 50 years.
Exclusion criteria:
Patients with chronic back pain with specific neurological origin and specific pathology (tumor, etc.), patients with neurological and rheumatoid disorders, diabetes, patients with broken ribs, vertebrae, and pelvis, tailbone syndrome, abdominal aortic aneurysm, neoplasm , neuropathy and radiculopathy, osteoporosis, fibromyalgia, pain in other areas of the body, injury and use of drug during the study. People who used antidepressants and anxiety medications Patients with non-specific chronic back pain who were treated for the last three months.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 32
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Behbahan Faculty of Medical Sciences
Street address
Behbahan Faculty of Medical Sciences ,Shahid Zibayeenejad Ave, Behbahan.
City
Behbahan
Province
Khouzestan
Postal code
7576198664
Approval date
2022-12-20, 1401/09/29
Ethics committee reference number
IR.BHN.REC.1401.058

Health conditions studied

1

Description of health condition studied
Unspecific Chronic Low Back Pain
ICD-10 code
M54.9
ICD-10 code description
Dorsalgia, unspecified

Primary outcomes

1

Description
Thalamus Neurometabolits
Timepoint
Before and 5 weeks after the intervention
Method of measurement
Recording the neurometabolic map of the thalamus by magnetic resonance spectroscopy(MRS)

Secondary outcomes

1

Description
Pain Intencity
Timepoint
Before and 5 weeks after the intervention
Method of measurement
Numerical Rating Scale

Intervention groups

1

Description
Intervention group: spinal manipulation of lumbar and pelvic.Patients will receive 3 sessions of manipulation therapy (every other day) of the lumbar spine and pelvis
Category
Treatment - Other

2

Description
Control group: Healthy people Whiteout intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Behbahan Faculty of Medical Sciences
Full name of responsible person
Daryoush Didehdar
Street address
Shahidzadeh hospital, Shahid Zibayeenejad Avenue, Behbahan Faculty of Medical Sciences
City
Behbahan
Province
Khouzestan
Postal code
6361796819
Phone
+98 61 5283 5094
Email
Dary1358@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Behbahan University of Medical Sciences
Full name of responsible person
Dr Sabaghan
Street address
ُShahidzadeh hospital, Shahid Zibayeenejad Avenue, Behbahan Faculty of Medical Sciences
City
behbahan
Province
Khouzestan
Postal code
6361796819
Phone
+98 61 5283 5094
Email
Dary1358@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Behbahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Behbahan University of Medical Sciences
Full name of responsible person
Daryoush Didehdar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
ُShahidzadeh hospital, Shahid Zibayeenejad Avenue, Behbahan Faculty of Medical Sciences
City
Behbahan
Province
Khouzestan
Postal code
7576198664
Phone
+98 917 148 7091
Email
dary1358@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Behbahan University of Medical Sciences
Full name of responsible person
Daryoush Didehdar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
ُShahidzadeh hospital, Shahid Zibayeenejad Avenue, Behbahan Faculty of Medical Sciences
City
Behbahan
Province
Khouzestan
Postal code
7576198664
Phone
+98 931 936 0791
Email
dary1358@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Behbahan University of Medical Sciences
Full name of responsible person
Daryoush Didehdar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
ُShahidzadeh hospital, Shahid Zibayeenejad Avenue, Behbahan Faculty of Medical Sciences
City
Behbahan
Province
Khouzestan
Postal code
7576198664
Phone
+98 936 931 0791
Email
dary1358@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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