Protocol summary
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Study aim
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Investigate the effect of dry needling on the trigger points of the iliopsoas muscle in patients with non-specific chronic back pain.
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Design
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Clinical trial with control group, with parallel groups, Tow-blinded, randomized, without phase on 40 patients, randomization allocation software was used for randomization
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Settings and conduct
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Patients will be divided into two groups by the table of numbers. The first group will receive dry needling of the iliopsoas muscle during 6 sessions. At the same time, they will also benefit from conventional physiotherapy treatment, but the control group will only use conventional physiotherapy treatment. The location of the project will be at the Physiotherapy clinic of Asadabadi Hospital.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
1) People between 30 and 65 years old
2) Chronic back pain that lasts 3 months or more
3) People with a disability score of >40 in the QBPDS questionnaire)
4) Not receiving any other physiotherapy treatment while participating in the study.
5) The presence of a trigger point in the iliopsoas muscle
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Intervention groups
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The intervention group includes patients with non-specific chronic back pain, whose conventional physical therapy includes continuous ultrasound treatment with a frequency of 1 MHz and intensity of 1.5 for 6 minutes, TENS burst electric current with a frequency of 2 Hz and diversion of 100 µs for 20 minutes, and the use of hot packs at the same time. Apply with current. Exercises are taught in the clinic under the supervision of a physiotherapist. 6 sessions of dry needling treatment are also done for them. The control group includes patients with non-specific chronic back pain who only receive conventional physiotherapy.
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Main outcome variables
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Pain; intensity in trigger points of Iliopsoas muscles; Intensity of back pain; Pressure threshold of trigger point pain; Functional disability
General information
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Reason for update
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I want to change the expected start date of the patient intake to 2024-10-22 due to the university's inability to solve the problems encountered in order to prepare the tools needed to measure this plan, and subsequently change the expected end date of the patient intake to 2025-03-05.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200215046499N4
Registration date:
2023-09-24, 1402/07/02
Registration timing:
prospective
Last update:
2024-09-07, 1403/06/17
Update count:
1
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Registration date
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2023-09-24, 1402/07/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-10-22, 1403/08/01
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Expected recruitment end date
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2025-03-05, 1403/12/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of iliopsoas muscle dry needling technique on the clinical symptoms of subject with non-specific low back Pain
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Public title
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Effect of dry needling technique of iliopsoas muscle
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
People between 30 and 65 years old
Chronic back pain that lasts for 3 months or more
People with a disability score of >40 in the QBPDS Questionnaire)
Not receiving any other physiotherapy treatment while participating in the study
The presence of a trigger point in the muscle Iliposoas
Exclusion criteria:
Patients with sensory and/or coagulation disorders
History of spine surgery
Heart complications
Simultaneous severe disease of the central or peripheral nervous system, Epilepsy
Needle phobia
Serious pathologies
Specific back pain (for example, the presence of spinal canal stenosis, spondylolisthesis, tumors, etc.)
People who have contraindications for transcutaneous electrical stimulation (TENS) and (US) will be excluded
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Age
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From 30 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization is done by someone outside the research team with a 1:1 parallel allocation method, which uses a computer randomization program to assign participants to groups, using blocks of four and six. Then he uses opaque sealed envelopes and hides the allocation of groups with the method pre-labeled with the letters A and B.) They will be placed in two control and intervention groups.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Double-blind, participants: In the control group, patients are told that routine physical therapy is the only treatment.
Outcome assessor: The person who assesses the patients does not know whether they belong to the control or intervention group
Data analyst: The person who evaluates the data of the two groups does not know whether they belong to the contr
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-09-04, 1402/06/13
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Ethics committee reference number
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IR.TBZMED.REC.1402.424
Health conditions studied
1
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Description of health condition studied
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Non-specific low back Pain
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ICD-10 code
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M54.5
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ICD-10 code description
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low back pain
Primary outcomes
1
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Description
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Pain intensity of trigger points
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Timepoint
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Before and after intervention
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Method of measurement
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Algometer
Secondary outcomes
1
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Description
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Pain intensity of back
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Timepoint
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Before and after intervention
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Method of measurement
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Numeric pain rating scale (NPRS)
2
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Description
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Intensity of depression and anxiety
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Timepoint
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Before and after intervention
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Method of measurement
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Hospital Anxiety and Depression Scale( HADS)
3
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Description
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Intensity of functional disability
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Timepoint
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Before and after intervention
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Method of measurement
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Quebec back pain disability scale(QBPDS)
4
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Description
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Pain pressure threshold of trigger points
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Timepoint
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Before and after intervention
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Method of measurement
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Algometer
Intervention groups
1
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Description
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Intervention group: In addition to receiving dry needling during 6 sessions (with a sterile dong bang needle with a size of 30*50 mm), they are included in the conventional physiotherapy treatment provided by the physiotherapist. People in the intervention group of the conventional treatment (as a modality It is possible to use continuous ultrasound with a frequency of 1 MHz and an intensity of 1.5 for 6 minutes (same side of the waist), using a burst TENS electric current with a frequency of 2 Hz and a diversion of 100 µs for 20 minutes, and using a hot pack simultaneously with the current. Also, sports exercises designed in the clinic are taught to the person under the supervision of a physiotherapist
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Category
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Rehabilitation
2
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Description
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Control group: People in the control group received conventional treatment (as a modality, continuous ultrasound with a frequency of 1 MHz and intensity of 1.5 for 6 minutes (same side of the back), use of TENS burst electric current with a frequency of 2 Hz and diversion of 100 µs for 20 minutes and using The hot pack is applied simultaneously with the current (76).Also, the person is taught the designed sports exercises in the clinic under the supervision of the physiotherapist.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Tabriz university of medical sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available