Protocol summary

Study aim
Comparison of pain and disability and quality of life in patients with disc herniation in patients with chronic low back pain before, 4 weeks and 3 months after starting treatment in three groups under laser treatment, acupuncture and medication (control)
Design
The study is a randomized clinical trial with the aim of comparing the therapeutic effects of acupuncture and high power laser in the treatment of patients with disc herniation in patients with chronic low back pain and by simple random allocation method were randomly divided into three groups A, B and C . The sample for each group is 30 people, a total of 90 samples have been calculated for all groups.
Settings and conduct
Patients with disc herniation with chronic low back pain are included in the study. Diagnosis will be made using a combination of clinical musculoskeletal and neurological examinations of the lower back and lower limbs. There is no prohibition for the patient to receive the studied interventions.
Participants/Inclusion and exclusion criteria
Patients aged 18 to 60 years volunteered to participate in the experiments. They have had back pain for more than 3 months and have local sensitivity in the back, buttocks and legs and shooting pain; Straight Leg Rising (SLR) test or Slump test was positive in lumbar disc herniation MRI and have the mental ability to answer questionnaire questions.
Intervention groups
Patients are divided into three groups, including the high-power laser treatment group, the acupuncture treatment group, and the control group treated with medication and exercise.
Main outcome variables
Reducing the severity of pain and reducing the degree of disability and improving the quality of life in patients with disc herniation and chronic low back pain in the group receiving high-power laser treatment is more than acupuncture.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220506054756N1
Registration date: 2022-06-17, 1401/03/27
Registration timing: prospective

Last update: 2022-06-17, 1401/03/27
Update count: 0
Registration date
2022-06-17, 1401/03/27
Registrant information
Name
Mahin Safari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 6552
Email address
mahinsafarikakroodi1368 @yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2022-11-21, 1401/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Acupuncture and High Intensity Laser Therapy on Pain, Quality of Life and Disability of Patients with Disc Herniation in Patients with Chronic Low Back Pain, a Randomized Control Study
Public title
The Effectiveness of Acupuncture and Laser in Low Back Pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18 to 60 years They signed informed consent forms and volunteered to participate in the experiments They have had back pain for more than 3 months On examination they have local sensitivity in the back, buttocks and legs, and shooting pain, and they have a Straight Leg Rising (SLR) test or a Slump test MRI of the lumbar disc herniation was seen Have the mental ability to answer questionnaire questions
Exclusion criteria:
Acute trauma or fracture of the lumbar spine or dysplasia of the spinal structure (spondylolysis) Congenital anomaly, abdominal aneurysm 3. Lumbar spine surgery Uncontrolled or severe metabolic disorders or cardiovascular, hepatic and renal disorders Lumbar spine surgery Uncontrolled or severe metabolic disorders or cardiovascular, hepatic and renal disorders Inflammatory pain Severe or progressive neurological disorders or lumbar instability Physiotherapy treatments on the back in the last 3 months History of lumbar injection in the last 4 weeks Severe osteopenia Systemic rheumatic disease (rheumatoid arthritis and fibromyalgia) Spinal cancers and patients with spinal tuberculosis Danger symptoms include nocturnal pain, recent involuntary weight loss, and symptoms of Cauda equina syndrome Spondylolisthesis Hypersensitivity to piroxicam and methocarbamol Patients who have undergone lumbar spine fusion or have indication for surgery Pregnant patients Patients who have had a tattoo or melanocytic moles in or near the treatment areas Patients with lupus or any other autoimmune disease, thrombophlebitis or anemia, and skin allergies Not participating in treatment sessions for more than 2 sessions Dissatisfaction with participating in the study at any stage of the study No referral for follow-up 4 weeks later and no phone response 3 months after starting treatment Emergence of severe medical diseases during the study that affect the individual's referral and follow-up
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients after selecting and obtaining informed consent to participate in the study after explaining the steps of the study, by simple random allocation using a table of random numbers by computer and online) using the site (www.random.org/ integres as Randomly divided into three groups A, B and C. Patients were divided into three groups, each with its own code, which were written on the sheets in which the patient group was identified. The codes placed patients in one of three groups by selecting each envelope.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, beginning of Vali Asr Highway, Joybar Three Ways,Imam Square, Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Approval date
2022-06-01, 1401/03/11
Ethics committee reference number
IR.MAZUMS.REC.1401.065

Health conditions studied

1

Description of health condition studied
Lumbar disc herniation, chronic low back pain, sciatica
ICD-10 code
M54.40
ICD-10 code description
Lumbago with sciatica, unspecified side

Primary outcomes

1

Description
Pain intensity, quality of life, degree of disability in patients with chronic low back pain
Timepoint
Initially studied, 4 weeks and three months after starting treatment
Method of measurement
McGill Pain Questionnaire ,Oswestry Low Back Pain Disability Questionnaire, WHO Quality of Life, Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the high-power laser intervention group, high-power laser treatment patients will receive high-power laser from the device manufactured by Novin Company. The device provides the following options: high-power laser with pulse emission (808 nm), very high peak power (1500 mW), frequency 100 Hz, energy density 1200 mJ / cm2 energy density), pulse duration 8:30 minutes, Work cycle about 0.1%, probe diameter 0.5 cm and spot size 0.2 cm2. While the patient is lying down, the handpiece will be treated in contact and perpendicular to the area. The laser will be applied transversely and longitudinally to the back of the waist in the paraspinal region, lower back, quadriceps and buttocks. Also includes hotspots and trigger points. This procedure is repeated three times a week (10 sessions in total)
Category
Rehabilitation

2

Description
Intervention group: Proximal and distal lumbar points are selected in the acupuncture treatment group. After disinfecting the skin with alcohol, the needle with a length of 25 and a diameter of 0.30 mm will be placed in the points ST36 GB30, GB34, BL25, BL23. In addition to the acupuncture mentioned, acupuncture is performed on the trigger points of the waist in each session. All needles are manipulated at 45 degrees clockwise and counterclockwise and held for 15 minutes. This procedure is repeated three times a week (10 sessions in total).
Category
Rehabilitation

3

Description
Control group: Control group: The group was treated with medication and exercise. The method of exercising was designed to be easily done at home. The exercises will be performed with the aim of increasing flexibility, endurance, strength, stability and painless mobility, as well as controlling the posture of the lumbar spine. General exercises and central stabilization are performed on the muscles responsible for central stabilization, and according to the patient's tolerance, gentle stretching of the lumbar, hip and thigh muscles is performed in the same way for all patients. All treatment groups will be given the same instructions to exercise three times a day for 4 weeks. Medication also includes 2 capsules of piroxicam once a day (a total of 20 mg and methocarbamol 500 mg tablets three times a day for 2 weeks. During this time, follow-up exercise and medication will be done by phone). became.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Sari
Full name of responsible person
Mahin Safari
Street address
Sports Medicine Department, Mostafavian Clinic, Razi St., Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 6552
Fax
+98 11 3336 3754
Email
Mahinsafarikakroodi1368@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Younes Panahi
Street address
Sports Medicine Department, Mostafavian Clinic, Razi St., Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3336 6552
Email
Mahinsafarikakroodi1368@yahoo.com
Web page address
http://www.mazums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Mahin Safari
Position
Sports medicine resident
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
Sports Medicine Department, Mostafavian Clinic, Razi St., Sari
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3336 6552
Fax
Email
Mahinsafarikakroodi1368 @yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mahin Safari
Position
Sports medicine resident
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
Sports Medicine Department, Mostafavian Clinic, Razi St., Sari
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3336 6552
Fax
Email
Mahinsafarikakroodi1368 @yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mahin Safari
Position
Sports medicine resident
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
Sports Medicine Department, Mostafavian Clinic, Razi St., Sari
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3336 6552
Fax
Email
Mahinsafarikakroodi1368 @yahoo.com

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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All potential personal data is shared after individuals are not identified.
When the data will become available and for how long
Access starts 6 months after the results are published
To whom data/document is available
For researchers working in academic and scientific institutions
Under which criteria data/document could be used
For researchers working in academic and scientific institutes, in order to conduct further studies in the future, the study method and study statistical data are available.
From where data/document is obtainable
Mahin Jafari Kakroodi 1368@yahoo.com; Dr. Mahin Safari 00981133366552
What processes are involved for a request to access data/document
After receiving the documentation request email, the data file will be sent.
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