IRCT | Effect of proprioceptive neuromuscular facilitation training on physical and psycho-social characteristics of military personnel with sedentary lifestyle with chronic non-specific low back pain; Clinical Trial.

Protocol summary

Study aim: The effect of proprioceptive neuromuscular facilitation exercises on the physical and psychosocial characteristics of military personnel with a sedentary lifestyle suffering from non-specific chronic back pain; Clinical trial.
Design: Clinical trial, with control group, parallel group, single-blinded, randomized, on 38 chronic low back pain patients, random numbers from the website www.calculatorsoup.com were used for randomization.
Settings and conduct: Baqiyatallah Hospital, Tehran, Iran. First, about 15 minutes of common motor control exercises will be given to both groups, after the motor control exercises, only group A will be given PNF exercise instructions. Each exercise consists of a starting position and an ending position, which will be done as a back and forth movement and lasts about 15 to 20 minutes. In general, each session will be about 45 minutes, total sessions will include 16 sessions. Assessor will be blinded.
Participants/Inclusion and exclusion criteria: Inclusion criteria: Non-specific chronic back pain; Maximum pain intensity 30 to 60 in the last 24 hours based on the numerical pain scoring scale; Age between 18 and 50 years; Participant's ability to learn and perform exercises; Reading and writing literacy to complete the questionnaires; Sensory and motor health of upper and lower limbs. Exclusion criteria: Prohibition of performing therapeutic exercises for the patient (such as advanced heart and respiratory diseases); The existence of clear deformity in the spine, pelvis and lower limbs; existence of autoimmune diseases.
Intervention groups: The control group includes common motor control exercises that are used for low back pain patients. In addition to performing motor control exercises, the intervention group will also perform diagonal PNF exercises.
Main outcome variables: Pain; disability; pain catastrophizing; stress; anxiety; depression

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20200418047120N2

Registration date: 2023-09-07, 1402/06/16

Registration timing: prospective

Last update: 2023-09-07, 1402/06/16

Update count: 0
Registration date: 2023-09-07, 1402/06/16

Registrant information: Name

Hamid Zamani

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 21 8755 4408

Email address

zamani.pt@gmail.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2023-09-22, 1402/06/31
Expected recruitment end date: 2024-01-19, 1402/10/29
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Effect of proprioceptive neuromuscular facilitation training on physical and psycho-social characteristics of military personnel with sedentary lifestyle with chronic non-specific low back pain; Clinical Trial.

Public title: Effect of proprioceptive neuromuscular facilitation training on chronic non-specific low back pain.
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Non-specific chronic low back pain. Maximum pain intensity between 30 to 60 in last 24 hours according to Numerical Pain Rating Scale. Participants ability to learning and doing the exercises. Reading and writing literacy to complete the questionnaires. Sensory and motor health of upper and lower limbs.

Exclusion criteria:

prohibition of performing therapeutic exercises for the patient (such as advanced heart and respiratory diseases); existence of clear deformity in the spine, pelvis and lower limbs; existence of autoimmune diseases (such as rheumatic diseases).
Age: From 18 years old to 50 years old
Gender: Both

Phase

N/A

Groups that have been masked

Outcome assessor

Sample size

Target sample size: 38

Randomization (investigator's opinion)

Randomized

Randomization description

The randomization of the samples will be done using the variable block method. In this way, the letter A was determined for the intervention group (including motor control exercises + PNF diagonal exercises) and the letter B was determined for the control group (including motor control exercises). Then 4 non-repeating sequences of letters A and B were determined as follows: 1. AABB 2. BBAA 3. ABAB 4. BABA 5. ABBA 6. BAAB After determining the variable 4-letter blocks, considering that 38 people will be needed, 10 random numbers were extracted from the website (https://www.calculatorsoup.com/) (1 5 6 3 2 3 6 4 2 3). In this way, the placement of the participants in the desired groups was determined.

Blinding (investigator's opinion)

Single blinded

Blinding description

In this study, the evaluation including scoring and data extraction of the questionnaires will be done by someone other than the main researcher of the study who will provide the interventions to the patients.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Research Ethics Committees of Baqiyatallah Hospital

Street address

Sports Physiology Research Institute, Baqiyatullah University of Medical Sciences, South Sheikh Bahai St., Molla Sadra St.,

City

Tehran

Province

Tehran

Postal code

1435916471
Approval date: 2023-08-13, 1402/05/22
Ethics committee reference number: IR.BMSU.BAQ.REC.1402.055

Health conditions studied

1

Description of health condition studied: Non-specific chronic low back pain
ICD-10 code: M54.5
ICD-10 code description: Low back pain

Primary outcomes

1

Description: Pain intensity
Timepoint: At the baseline and after the end of the interventions
Method of measurement: Numerical Pain Rating Scale

Secondary outcomes

1

Description: Disability
Timepoint: At the baseline and after the last intervention session
Method of measurement: Roland-Morris Disability Questionnaire

2

Description: Pain Catastrophizing
Timepoint: At the baseline and after the last intervention session
Method of measurement: Pain Catastrophizing Scale

3

Description: Depression
Timepoint: At the baseline and after the last intervention session
Method of measurement: Depression-Anxiety and Stress Scale

4

Description: Anxiety
Timepoint: At the baseline and after the last intervention session
Method of measurement: Depression-Anxiety and Stress Scale

5

Description: Stress
Timepoint: At the baseline and after the last intervention session
Method of measurement: Depression-Anxiety and Stress Scale

Intervention groups

1

Description: Intervention group: 16 sessions of Diagonal exercises of proprioceptive neuromuscular facilitation training (PNF) for trunk, 3 weekly sessions, each session 15 to 20 minutes.
Category: Rehabilitation

2

Description: Control group: 16 sessions of common motor control exercises of low back pain, 3 weekly sessions, each session 15 to 20 minutes.
Category: Rehabilitation

Recruitment centers

1

Recruitment center: Name of recruitment center

Baqiyatullah University of Medical Sciences

Full name of responsible person

Alireza Shamsoddini

Street address

Baqiyatullah University of Medical Sciences, South Sheikh Bahai St., Molla Sadra St., Vanek Square, Tehran

City

Tehran

Province

Tehran

Postal code

1435916471

Phone

+98 21 8755 4408

Email

eprc.webinar@gmail.com

Web page address

https://research.bmsu.ac.ir/portal/home/?239518/%D9%85%D8%B1%DA%A9%D8%B2-%D8%AA%D8%AD%D9%82%DB%8C%D9%82%D8%A7%D8%AA-%D9%81%DB%8C%D8%B2%DB%8C%D9%88%D9%84%D9%88%DA%98%DB%8C-%D9%88%D8%B1%D8%B2%D8%B4

1

Sponsor: Name of organization / entity

Bagheiat-allah University of Medical Sciences

Full name of responsible person

Alireza Shamsoddini

Street address

Baqiyatullah University of Medical Sciences, South Sheikh Bahai St., Molla Sadra St., Vanak Square, Tehran

City

Tehran

Province

Tehran

Postal code

1435916471

Phone

+98 21 8804 0060

Email

eprc.webinar@gmail.com

Web page address

https://www.bmsu.ac.ir/portal/home/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Bagheiat-allah 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

Bagheiat-allah University of Medical Sciences

Full name of responsible person

Alireza Shamsoddini

Position

Assistant professor

Latest degree

Ph.D.

Other areas of specialty/work

Physiology

Street address

Baqiyatullah University of Medical Sciences, South Sheikh Bahai St., Molla Sadra St., Vanak Square, Tehran

City

Tehran

Province

Tehran

Postal code

1435916471

Phone

+98 21 8755 4408

Email

shamseddin23@gmail.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Bagheiat-allah University of Medical Sciences

Full name of responsible person

Alireza Shamsoddini

Position

Assistant professor

Latest degree

Ph.D.

Other areas of specialty/work

Physiology

Street address

Baqiyatullah University of Medical Sciences, South Sheikh Bahai St., Molla Sadra St., Vanak Square, Tehran

City

Tehran

Province

Tehran

Postal code

1435916471

Phone

+98 21 8755 4408

Email

shamseddin23@gmail.com

Person responsible for updating data

Contact: Name of organization / entity

Bagheiat-allah University of Medical Sciences

Full name of responsible person

Alireza Shamsoddini

Position

Assistant professor

Latest degree

Ph.D.

Other areas of specialty/work

Physiology

Street address

Baqiyatullah University of Medical Sciences, South Sheikh Bahai St., Molla Sadra St., Vanak Square, Tehran

City

Tehran

Province

Tehran

Postal code

1435916471

Phone

+98 21 8755 4408

Email

shamseddin23@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: 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: Results from the analysis of participant data, both primary and secondary outcomes, will be published.
When the data will become available and for how long: Access to the data will be possible after the publication of the article.
To whom data/document is available: Researchers of academic and scientific centers could access the data.
Under which criteria data/document could be used: Analyzes that do not overlap with the objectives of the present study will be allowed.
From where data/document is obtainable: Dr. Alireza Shamsoddini Email: shamseddin23@gmail.com
What processes are involved for a request to access data/document: The requester could access the data by providing the research area as well as the purpose of accessing the data.
Comments

Effect of proprioceptive neuromuscular facilitation training on physical and psycho-social characteristics of military personnel with sedentary lifestyle with chronic non-specific low back pain; Clinical Trial.