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The effect of pain neuroscience education with and without conventional physical therapy on psychosocial factors, function and pain in people with chronic neck pain - a clinical trial

Protocol summary

Study aim
The effect of pain neuroscience education on psychosocial factors, function and pain in people with chronic neck pain
Design
A clinical trial with a control group, with parallel groups, three-way blind, randomized, on 50 patients, Random Allocation computer software (version 1. 1 of Isfahan University of Medical Sciences, Iran) used for randomization.
Settings and conduct
The available population includes people with neck pain based on the diagnosis of specialists who will refer to physiotherapy clinics in Ahvaz, will be selected from the available population by simple non-probability sampling method and then randomly divided into two groups. And after obtaining informed consent, people enter the study. This is a three-way blind clinical trial in which patients are evaluated by another physiotherapist who is unaware of the group assignment, and patients and data analysts are unaware of the group assignment
Participants/Inclusion and exclusion criteria
Participants must be literate, have a central sensitization score above 40, a visual scale score above 30, with out cancer, fractures, metabolic diseases, rheumatism, cardiovascular disease, neurological and osteoporotic disorders, or psychiatric disorders.
Intervention groups
In this study, people will be received 12 sessions of treatment (4 weeks of treatment with frequency 3 times a week), in the first 4 sessions of treatment, group 2 (conventional physiotherapy treatment with pain neuroscience education) in addition to conventional physiotherapy treatment, will be received pain neuroscience education.
Main outcome variables
Primary outcome measures including pain, central sensitivity, function, concept of biological mechanism of pain, catastrophic pain, fear of movement, pain awareness and vigilance, and secondary outcome measures including, perception of pain, quality of life and general changes in this case study Was investigated.

General information

Reason for update
Acronym
PNE
IRCT registration information
IRCT registration number: IRCT20210607051508N1
Registration date: 2021-06-21, 1400/03/31
Registration timing: registered_while_recruiting

Last update: 2021-06-21, 1400/03/31
Update count: 0
Registration date
2021-06-21, 1400/03/31
Registrant information
Name
Farzaneh Soleimani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3441 2754
Email address
soleimani.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-19, 1400/03/29
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pain neuroscience education with and without conventional physical therapy on psychosocial factors, function and pain in people with chronic neck pain - a clinical trial
Public title
The effect of pain neuroscience education on the treatment of chronic neck pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-65 years Nonspecific neck pain with a history of at least 12 weeks (chronic) Ability to understanding, speaking and writing in Persian Has not used any other treatment 6 weeks before participating in this project and during it. (To get steady state) Minimum visual analog scale (VAS) 30 of100 mm Confirmation of central sensitization in people with CSI questionnaire (score above 40 CSI questionnaire is the reason for central sensitization)
Exclusion criteria:
Cancer, fracture, metabolic diseases, rheumatism, cardiovascular, neurological disorders and osteoporosis Neck radiculopathy, myelopathy and dizziness People with widespread pain disorders such as fibromyalgia syndrome or chronic fatigue syndrome Psychiatric disorders
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is performed by Random Allocation computer software (version 1.1 of Isfahan University of Medical Sciences, Iran) by a statistician Which has no role in the study in such a way that a random order of two letters A (intervention) and B (control) in blocks will be made with random numbers 4 and 6 (For example ABBA and ABABA). A research assistant then puts them in sealed envelopes. Before starting the intervention, one of the researchers opens one of the envelopes and thus the person will be placed in one of the two intervention groups (conventional physiotherapy with pain neuroscience education) or control (conventional physiotherapy).
Blinding (investigator's opinion)
Double blinded
Blinding description
A physiotherapist who has no information about patients' allocation and treatment will perform the assessments. The participants will receive information about their treatment program, but they will not be informed if they are in intervention or control group, and for this purpose we will make arrangements so that patients do not see each other. Patients in the intervention group receive treatment on even days and the control group receives treatment on odd days. A statistician who has no information about patients' allocation will perform the statistical analysis.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
No.5, Yas Ave., Shahrak Aghajari Area., Ahvaz City
City
َAhvaz
Province
Khouzestan
Postal code
6166754871
Approval date
2021-05-16, 1400/02/26
Ethics committee reference number
IR.AJUMS.REC.1400.098

Health conditions studied

1

Description of health condition studied
Neck pain
ICD-10 code
M50.9
ICD-10 code description
Cervical disc disorder, unspecified

Primary outcomes

1

Description
Score of 100 mm visual analog scale to assess pain intensity
Timepoint
Pre intervention, Post intervention, one month and 3 months after baseline
Method of measurement
Visual Analogue Scale

2

Description
Central Sensitization Inventory questionnaire to assess central sensitivity
Timepoint
Pre intervention, Post intervention, one month and 3 months after baseline
Method of measurement
Central Sensitization Inventory questionnaire score

3

Description
Lutron Model 5020 Digital Tensile and pressure Algometer for Measuring Pressure Pain Threshold (PPT)
Timepoint
Pre intervention, Post intervention, one month and 3 months after baseline
Method of measurement
Digital Tensile and pressure Algometer

4

Description
Score of Neurophysiology of Pain Questionnaire to evaluate the concept of biological mechanism of pain
Timepoint
Pre intervention, Post intervention, one month and 3 months after baseline
Method of measurement
Neurophysiology of Pain Questionnaire

5

Description
Neck Disability Index questionnaire for disability evaluation
Timepoint
Pre intervention, Post intervention, one month and 3 months after baseline
Method of measurement
Neck Disability Index questionnaire score

6

Description
Pain Catastrophizing Scale to assess pain catastrophizing
Timepoint
Pre intervention, Post intervention, one month and 3 months after baseline
Method of measurement
Pain Catastrophizing Scale score

7

Description
Tampa Scale for Kinesiophobia Questionnaire to assess fear of movement
Timepoint
Pre intervention, Post intervention, one month and 3 months after baseline
Method of measurement
Tampa Scale for Kinesiophobia Questionnaire score

8

Description
Pain Awareness and Vigilance questionnaire to assess pain awareness and alertness
Timepoint
Pre intervention, Post intervention, one month and 3 months after baseline
Method of measurement
Pain Awareness and Vigilance questionnaire score

Secondary outcomes

1

Description
Quality of life score
Timepoint
Pre Intervention, Post Intervention, one month and three months after baseline
Method of measurement
Score of SF3 6 questionnaires to assess the quality of life

2

Description
Score of a person's perception of their illness
Timepoint
Pre Intervention, Post Intervention, one month and three months after baseline
Method of measurement
Score of Brief illness perception questionnaire to assess a person's perception of their illness

3

Description
General measurement of the rate of change
Timepoint
Pre Intervention, Post Intervention, one month and three months after baseline
Method of measurement
General review of the amount of changes with the general form of the amount of changes

Intervention groups

1

Description
Control group: conventional physiotherapy treatment, Individuals 12 sessions of therapy (4 weeks of frequency therapy 3 times a week) including 1-20 minutes of TENS and hot packs 2- Exercises to improve mobility (stretching exercises) 3- Exercises that aim to use deep muscles 4- Endurance exercises (Endurance) 5- They will receive strengthening exercises.
Category
Treatment - Other

2

Description
Intervention group: conventional physiotherapy treatment with pain neuroscience education. In this study, people will be received 12 sessions of treatment (4 weeks of treatment with frequency 3 times a week), in the first 4 sessions of treatment, conventional physiotherapy treatment with pain neuroscience education in addition to conventional physiotherapy treatment, will be received pain neuroscience education.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Musculoskeletal Rehabilitation Research Center of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hossein kouhzad Mohammadi
Street address
No. 5, Yas Ave., Shahrak Aghajari, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6166754871
Phone
+98 61 3441 2754
Email
soleimani_pt.1391@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Ahmadimoghaddam
Street address
Ground floor, Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Science,Ahvaz,Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135733133
Phone
+98 61 3374 3101
Email
kouhzad@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Hosein Kouhzad Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Physical therapy Department, Rehabilitation School, opposite the MRI Building, Jundishapour University of Medical Sciences, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733133
Phone
+98 61 3374 3101
Email
kouhzad@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hosein Kouhzad Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Khozestan
City
Ahvaz
Province
Khouzestan
Postal code
6135733133
Phone
+98 61 3374 3101
Email
kouhzad@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Farzaneh Soleimani
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Physical therapy Department, Rehabilitation School, opposite the MRI Building, Jundishapour University of Medical Sciences, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733133
Phone
+98 61 3374 3101
Email
soleimani.f@ajums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
This clinical trial will be an research article and its protocol, results report and statistical analysis will be published to be used by therapists.
When the data will become available and for how long
If the journal has requested access to the data at any time, the data will be provided.
To whom data/document is available
Journal editors and Reviewers
Under which criteria data/document could be used
Sometimes for re-analysis or for use in meta-analysis studies
From where data/document is obtainable
Project manager
What processes are involved for a request to access data/document
It should be send email to project manager and after reviewing the reason for requesting the data, they will be send
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