The effect of dry needling on pain intensity, pressure pain threshold, remote muscle performance and disability in subjects with fibromyalgia and chronic nonspecific low back pain
The purpose of this study is to investigate the effect of dry needling on pain intensity, pressure pain threshold, remote muscle performance and disability in subjects with fibromyalgia and chronic nonspecific low back pain
Design
A randomized (using block randomization method), single-blinded, clinical trial with two parallel group designs and a sample size of 30 patients
Settings and conduct
The study is performed in the rehabilitation faculty of Iran University of Medical Sciences. Then eligible participants sign an informed consent form and are randomly assigned to two groups of dry needling and control by Block balanced randomization technique. Treatment and assessment are done by separate persons and the assessor and analyzer of data will be kept blind
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Fibromyalgia diagnosed
The pain should be between the edge of the 12th rib and the lower gluteal fold
Patients have trigger points in the multifidus, quadratus lumborum and gluteus medius muscles
Exclusion criteria:
Spinal and pelvic pathologies such as fracture
Dry needling treatment in the last 6 months.
Intervention groups
Experiment group: Pharmacological treatment and dry needling
Control group: Pharmacological treatment
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191208045652N7
Registration date:2023-03-11, 1401/12/20
Registration timing:registered_while_recruiting
Last update:2023-03-11, 1401/12/20
Update count:0
Registration date
2023-03-11, 1401/12/20
Registrant information
Name
marzieh Yassin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8052
Email address
m.yassin.pt@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-20, 1401/10/30
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of dry needling on pain intensity, pressure pain threshold, remote muscle performance and disability in subjects with fibromyalgia and chronic nonspecific low back pain
Public title
The effect of dry needling in subjects with fibromyalgia with low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People aged 18 to 65
Fibromyalgia diagnosed by a rheumatologist
The pain should be between the edge of the 12th rib and the lower gluteal fold
The duration of pain is more than three months
The minimum Visual analogue scale at the time of visit should be 3 out of 10
Patients have trigger points in the multifidus, quadratus lumborum and gluteus medius muscles
Have a minimum Oswestry Disability Index score of 20 out of 100
The participants should be able to understand and read Persian language in order to fill the questionnaire
Exclusion criteria:
Spinal and pelvic pathologies such as fracture, infection and tumor
Presence of systemic infection
Coagulation and bleeding disorders
Presence of lymphedema or removal of lymph nodes
pregnancy
The presence of a pacemaker
Severe respiratory and cardiovascular disorders
epilepsy
History of trauma to the lumbopelvic region
History of surgery in the lumbopelvic region
Lumbar radiculopathy
Dry needling treatment in the last 6 months
Cognitive impairment
Needle phobia
Uncontrolled diabetes
Systemic joint disease such as rheumatoid arthritis
Symptoms of radiculopathy and pressure on the nerve root
Cauda equina syndrome
Spondyloarthropathies
Metal pins or prosthetic joints
Inability to communicate with the patient
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation is done by block method, blocks of 4 letters consisting of letters A and B are randomly selected. Blocks are created by Random Number Generator and their sequence is specified. The letter A represents the intervention group and the letter B represents the control group. A random sequence of random blocks is then generated. Referral buying companies are placed in one of two intervention or control groups with the help of this random sequence. The person who generates the randomization sequence will not participate in any other phase of the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the method of blinding the examiner will be used. The examiner of the results of the study, who is a physiotherapist with a history of examination, is not aware of the allocation of groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran university of medical sciences
Street address
Iran university of medical sciences, next to Milad tower, Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2022-10-24, 1401/08/02
Ethics committee reference number
IR.IUMS.REC.1401.610
Health conditions studied
1
Description of health condition studied
Fibromyalgia
ICD-10 code
M79.7
ICD-10 code description
Fibromyalgia
2
Description of health condition studied
Chronic Nonspecific Low Back Pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Pain
Timepoint
The first session before treatment, the fourth session before the start of the treatment, the sixth session before the start of the treatment, one month after the last treatment session, three months after the last treatment session
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Muscle performance
Timepoint
The first session before treatment, the sixth session before the start of the treatment, one month after the last treatment session
Method of measurement
dynamometer and Isometric test of neck flexor muscles
2
Description
Pressure pain threshold
Timepoint
The first session before treatment, the sixth session before the start of the treatment, one month after the last treatment session
Method of measurement
Algometer
3
Description
Functional disability
Timepoint
The first session before treatment, the sixth session before the start of the treatment, one month after the last treatment session
Method of measurement
Oswestry disability index
4
Description
Central sensitization
Timepoint
The first session before treatment, the sixth session before the start of the treatment, one month after the last treatment session
Method of measurement
fibromyalgia 2011 questionnaire, Algometer
Intervention groups
1
Description
Intervention group: Performing dry needling technique for lumbar multifidus, quadratus lumborum and gluteus medius. In order to apply dry needling to the lumbar multifidus muscle, the patient is placed in the prone position. The muscle is palpated flat next to the vertebral spines (about one centimeter outside the spines). This area is considered as a safe area for dry needling the multifidus muscle when the needle is applied in this area and inward and downward towards the lamina of the vertebra. Based on the size of the patient, a 40 or 50 mm needle is used. To apply dry needling to the quadratus lumborum muscle, the patient lies on the side of the non-involved side. Lumbar spine, twelfth rib and iliac crest are identified. The needle is applied from the outer side of the transverse process of the lumbar vertebrae directly down, and in order to avoid the risk of damage to the kidney, we will not go higher than the level of the transverse appendage of the second lumbar vertebra. Generally, a needle with a length of 50 to 60 mm is suitable. Also, in order to apply dry needling to the gluteus medius muscle, the patient lies in the prone position and the muscle is needled with a flat touch along the iliac crest. The tissue is pressed to reduce the distance between the skin and the desired muscle. The size of the needle varies based on the amount of fat tissue present. In fact, in the middle third of the distance between the upper anterior articular spine and the upper posterior articular spine is the needle application area. The examiner first washes his hands with soap and after drying them uses sterile latex gloves. According to the recommendation of the National Acupuncture Foundation, before applying the needles, the surface of the patient's skin will be disinfected with 70% isopropyl alcohol. The needles used are sterile and disposable and their size is selected according to the size of the patient, the target muscle and the desired penetration depth. The needles are TONY brand made in China. The dry needling technique is performed by a physiotherapist who has an official dry needling certificate from the Iranian Physiotherapy Association. The dry needling method in this study will be based on the method provided by César Fernández-de-las-Peñas Jan Dommerholt. The needles are applied in order to obtain a local contraction response and this process continues until no more local contraction occurs. Finally, the needles are removed from the tissue and the position is cleaned again with cotton soaked in alcohol
Category
Rehabilitation
2
Description
Control group: Patients in both groups will receive Pharmacotherapy under the supervision of a rheumatologist, and people in the experimental group will also receive dry needling intervention. For ethical considerations, after completing the plan and measuring the results, the patients in the control group will also receive dry needling
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy clinic of Rehabilitation Faculty of Iran University of Medical Sciences
Full name of responsible person
Marzieh Yassin
Street address
Faculty of Rehabilitation; Iran University of Medical Sciences; Madadkaran street, Shahid Shahnazari street, Madar square, Mirdamad boulevard
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 7124
Email
m.yassin.pt@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Hossein Keivani
Street address
Iran University of Medical Sciences, Milad tower, Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
Keyvanlab@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?