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The effects of dynamic neuromuscular stability (DNS) and low-level laser therapy on the muscle function and pain in People with low back pain from muscle weakness

Protocol summary

Study aim
Determining the effects of dynamic neuromuscular stability (DNS) and low-level laser therapy on the muscle function and pain in People with low back pain from muscle weakness
Design
Clinical trial with intervention and control groups, 40 female randomly assigned to 4 groups
Settings and conduct
Forty women with chronic non-specific low back pain were selected from 100 people and then randomly paired with a pre-test pain intensity score of 3 to 6 on the visual analogue scale and divided into four groups: combination of exercise and low-level laser, exercise, low-level laser and control
Participants/Inclusion and exclusion criteria
Inclusion criteria: Female; Non-Specific low back pain from muscle weakness; Duration of low back pain more than three months; Pain intensity between 3 and 6 on the visual pain scale Exclusion criteria Exclusion criteria: Use of anti-inflammatory and analgesic medications
Intervention groups
Intervention group 1: Exercise, Subject will perform exercises for 8 weeks, 3 sessions per week, each session lasting 90 minutes. Initially, they will perform myofascial release exercises for 25 minutes, stretching exercises for 15 minutes, then DNS exercises for 40 minutes along with breathing exercises, and finally cool down exercises for 10 minutes.exercises.Intervention group 2: low-level laser therapy, Subjects undergo low-level laser treatment on specific days and for a specific number of sessions Intervention group 3: Exercise with low-level laser therapy, Subject undergoes low-level laser and Exercise. Intervention group 4: Subjects will be controlled without exercise and without low-level laser
Main outcome variables
Chronic non-Specific Low Back Pain, movement function, quality of life, functional disability, lumbar spine range of motion, depression Inventory

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250508065647N1
Registration date: 2025-06-22, 1404/04/01
Registration timing: registered_while_recruiting

Last update: 2025-06-22, 1404/04/01
Update count: 0
Registration date
2025-06-22, 1404/04/01
Registrant information
Name
Atefeh Rafieeamjad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3267 1146
Email address
atefe.rafieeamjad@iau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-06-08, 1404/03/18
Expected recruitment end date
2025-06-23, 1404/04/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of dynamic neuromuscular stability (DNS) and low-level laser therapy on the muscle function and pain in People with low back pain from muscle weakness
Public title
The effect of exercise and laser therapy on the muscle function and pain in People with low back pain from muscle weakness
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Female gender Non-Specific low back pain from muscle weakness Confirmation of the type of low back pain with clinical examination and paraclinical evidence Duration of low back pain more than three months Age range 40 to 50 years Pain intensity between 3 and 6 on the visual pain scale
Exclusion criteria:
Aggravation of pain and disability with exercise Trauma or surgery during exercise Participation in regular weekly exercise activity Medical prohibition against participation in exercise activity Use of anti-inflammatory and analgesic medications
Age
From 40 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Pairing of participants: First, a VAS pre-test will be administered to all(with chronic non-specific low back pain, without discopathy) and based on the participants' pre-test scores, they will be divided into pairs with similar pain intensity scores between 3 and 6 on the visual analogue scale. Random assignment: Each pair will be randomly assigned to one of 4 groups: exercise and low-level laser, exercise group, laser group, and control group(10 people in each group. The intervention (exercise and low-level laser) will not be applied to the control group. Finally, a post-test will be administered and the data will be analyzed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee on Research Islamic Azad University - Marvdasht Branch
Street address
Marvdasht: Three kilometers of Persepolis Boulevard. Islamic Azad University of Marvdasht
City
Marvdasht
Province
Fars
Postal code
73711-13119
Approval date
2025-01-15, 1403/10/26
Ethics committee reference number
IR.IAU.M.REC.1403.560

Health conditions studied

1

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

Primary outcomes

1

Description
low back pain
Timepoint
At the beginning and end of 8 weeks of study
Method of measurement
Measuring muscle pain intensity using a visual analog scale

2

Description
Endurance of trunk flexor muscles
Timepoint
At the beginning and end of 8 weeks of study
Method of measurement
Measuring trunk flexor muscle endurance with modified sit-up tes

3

Description
Endurance of trunk extensor muscles
Timepoint
At the beginning and end of 8 weeks of study
Method of measurement
Measuring the endurance of the trunk extensor muscles using the trunk lift test (extensor endurance)

4

Description
Strength of trunk flexor muscles
Timepoint
At the beginning and end of 8 weeks of study
Method of measurement
Measuring the strength of trunk flexor muscles with a dynamometer

5

Description
Strength of trunk extensor muscles
Timepoint
At the beginning and end of 8 weeks of study
Method of measurement
Measuring the strength of trunk extensor muscles with a dynamometer

6

Description
Flexibility
Timepoint
At the beginning and end of 8 weeks of study
Method of measurement
Measuring the flexibility of the back and hamstring muscles with the Sit and Reach test

Secondary outcomes

1

Description
Quality of life
Timepoint
At the beginning and end of 8 weeks of study
Method of measurement
Measuring quality of life with the SF36 quality of life questionnaire

2

Description
Depression Inventory
Timepoint
At the beginning and end of 8 weeks of study
Method of measurement
Measuring depression Inventory using the modified version of the Beck Depression Inventory

3

Description
Functional disability
Timepoint
At the beginning and end of 8 weeks of study
Method of measurement
Measuring functional disability with Oswestry Disability Index

4

Description
Range of motion of the lumbar spine
Timepoint
At the beginning and end of 8 weeks of study
Method of measurement
Measuring the range of motion of the lumbar spine with the modified-modified schober test

Intervention groups

1

Description
Intervention group 1: Exercise; Ten female subjects will perform dynamic neuromuscular stability (DNS) exercises with myofascial release for 8 weeks, 3 sessions per week, each session lasting 90 minutes, as follows: First, 25 minutes of myofascial release exercises and 15 minutes of stretching exercises, then 40 minutes of DNS exercises with breathing exercises, and finally 10 minutes of cool-down exercises.
Category
N/A

2

Description
Intervention group 2: Low-level laser; Ten female subjects will undergo low-level laser on specific days and for a specific number of sessions. Also, the following model power meter will be used to measure the optical power of the device every two weeks (by a researcher who is not involved) and the type of laser device PHOTONCARE model Moonlight and Starlight (2020) made in Germany
Category
N/A

3

Description
Intervention group 3: Exercise and low-level laser; Ten female subjects will perform dynamic neuromuscular stability (DNS) exercises with myofascial release for 8 weeks, 3 sessions per week, each session lasting 90 minutes, as follows: First, 25 minutes of myofascial release exercises and 15 minutes of stretching exercises, then 40 minutes of DNS exercises with breathing exercises, and finally 10 minutes of cool-down exercises and also subjects will undergo low-level laser on specific days and for a specific number of sessions. Also, the following model power meter will be used to measure the optical power of the device every two weeks (by a researcher who is not involved) and the type of laser device PHOTONCARE model Moonlight and Starlight (2020) made in Germany
Category
N/A

4

Description
Control group 4: No intervention; Ten female subjects will be given control without Exercise and without low-level laser
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Health Land Institute
Full name of responsible person
Parvin Salsali
Street address
U 1, No. 42, Shahid Mehdi Salimian Aly, Bahar Azadi Ave, Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8173967793
Phone
+98 31 3620 5506
Email
psalsali5812@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ms. Salehi
Street address
Jahan Rd, Kish International Branch, Islamic Azad University
City
Kish
Province
Hormozgan
Postal code
7941775883
Phone
+98 76 9109 9071
Fax
+98 76 9109 9071
Email
atefe.rafieeamjad@iau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Atefeh Rafieeamjad
Position
Teacher
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
U 2,  No. 8, Aseman De, Roshan Aly, Moshtagh Aval Ave, Bozorgmehr Sq, Isfahan, 8153687813
City
Isfahan
Province
Isfehan
Postal code
8153687813
Phone
+98 31 3267 1146
Fax
Email
atefe.rafieeamjad@iau.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Atefeh Rafieeamjad
Position
Teacher
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
U 2,  No. 8, Aseman De, Roshan Aly, Moshtagh Aval Ave, Bozorgmehr Sq, Isfahan, 8153687813
City
Isfahan
Province
Isfehan
Postal code
8153687813
Phone
+98 31 3267 1146
Fax
Email
atefe.rafieeamjad@iau.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Atefeh Rafieeamjad
Position
Teacher
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
U 2,  No. 8, Aseman De, Roshan Aly, Moshtagh Aval Ave, Bozorgmehr Sq, Isfahan, 8153687813
City
Isfahan
Province
Isfehan
Postal code
8153687813
Phone
+98 31 3267 1146
Fax
Email
atefe.rafieeamjad@iau.ac.ir

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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