View older revisions Content changed at 2024-03-25, 1403/01/06

Protocol summary

Study aim
The effect of dry needling on pain and central sensitization (including the Central Sensitization Inventory, electroencephalography, conditional pain modulation, salivary cortisol concentration, and psychosocial variables (7-item general anxiety disorder scale, pain catastrophizing scale, and SF-36 questionnaire) in women with chronic pelvic pain.
Design
Single-blind randomized, parallel-group controlled clinical trial, on 36 patients. Randomization will be performed using a computerized Internet-based central randomization service (www.sealedenvelope.com). Assignments and allocation concealment will be sealed in sequentially numbered opaque envelopes by a person who had no direct role in the study.
Settings and conduct
Women will be recruited based on the definition of CPP and recognition by an expert in female pelvic floor physicians. All assessments and interventions will conduct in the Research Center of the Faculty of Rehabilitation Sciences of Shiraz University of Medical Sciences.
Participants/Inclusion and exclusion criteria
1. Non-pregnant women in an age range of 20-50 years who are not menopausal, and feel recurrent or constant pain in the pelvis, perineum, anterior abdominal wall below the umbilicus, or in the lower back, pelvic pain unrelated to menstruation, intercourse, or pregnancy lasting for at least 6months. 2. Presence of tenderness/pain when touched in at least one pelvic floor muscle including the levator ani , obturator internus, piriformis, rectus abdominis and external obliqus muscles, and gluteal muscles 3. Score 40-59 in CSI questionnaire (moderate to severe central sensitization level)
Intervention groups
dry needling group (DNG), placebo needling group (PNG), control group (CG)
Main outcome variables
-short-form McGill pain questionnaire -Central Sensitization Inventory -electroencephalography -conditional pain modulation -salivary cortisol concentration

General information

Reason for update
Adding secondary variables to the summary and adding abbreviations to the text and minor changes to the intervention (placebo method)
Acronym
IRCT registration information
IRCT registration number: IRCT20211114053057N1
Registration date: 2021-12-03, 1400/09/12
Registration timing: prospective

Last update: 2024-03-25, 1403/01/06
Update count: 1
Registration date
2021-12-03, 1400/09/12
Registrant information
Name
Najmeh Sedighimehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 1551
Email address
najmehsedighimehr@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-06, 1400/09/15
Expected recruitment end date
2022-08-22, 1401/05/31
Actual recruitment start date
2021-12-22, 1400/10/01
Actual recruitment end date
2023-01-20, 1401/10/30
Trial completion date
2023-01-20, 1401/10/30
Scientific title
The effect of dry needling on pain and central sensitization in women with chronic pelvic pain: a randomized parallel-group controlled clinical trial
Public title
The effect of dry needling on pain and central sensitization in women with chronic pelvic pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1.non-pregnant women in an age range of 20e50 years who are not menopausal, and feel recurrent or constant pain in the pelvis, perineum, anterior abdominal wall below the umbilicus, or in the lower back, pelvic pain unrelated to menstruation, intercourse, or pregnancy lasting for at least 6months. 2. Presence of tenderness / pain when touched by a physician at visit 1 and physiotherapist at visit 2 in at least one pelvic floor muscle including the levator ani ( pubococcygeus, iliococcygeus and coccygeus), obturator internus, piriformis, rectus abdominis and external obliqus muscles, and gluteal muscles including gluteus maximus, medius, and minimus . Muscles will be evaluated bilaterally. The presence of MTrP will be confirmed according to Travel and Simons diagnostic criteria, which are as follows: palpation of a taut band; , identification of an exquisitely tender nodule (MTrP) in the taut band; and reproduction of the patient's symptomatic pain with sustained pressure. tenderness/ pain assessments at visits 1 and 2 do not have to be the same in severity or location for the participant to be eligible. 3. Score 40-59 in CSI questionnaire (moderate to severe central sensitization level)
Exclusion criteria:
1. Active pelvic inflammatory disease, cancer, chronic pain in other areas (knee, neck, back, temporomandibular joint, and fibromyalgia syndrome), specific low back pain (proven low back pain due to disc herniation, stenosis, and spondylolisthesis), non-specific low back pain in last three months leading to treatment intervention and rest (145). 2. Taking physical therapy interventions in the last three months for pelvic pain (94, 95). 3. Contraindications and precautions related to dry needling: -Absolute contraindications:1. In a patient with needle phobia.2. Patient unwilling – fear, patient belief.3. Unable to give consent – communication, cognitive, age-related factors.4. Medical emergency or acute medical condition.5. Over an area or limb with lymphedema as this may increase the risk of infection/cellulitis and the difficulty of fighting the infection if one should occur .6. Inappropriate for any other reason.- Relative contraindications: 1. Abnormal bleeding tendency (e.g. hemophilia, blood thinning medication, etc.).2. Compromised immune system (1. Disease-related immunocompromised patients(e.g. blood-borne diseases, cancer, HIV, hepatitis, endocarditis, incompetent heart valve or valve replacements, etc.).2. Immunocompromised patients from immunosuppression therapy (e.g. drug cancer therapy).3. Acute immune disorders (e.g. acute states of rheumatoid arthritis, current infection – local or systemic, etc.).4. Debilitated patients and those with chronic illness, among others.). 3. Diabetes. 4. Patients with epilepsy, or Psychological status. Contraindications and precautions related to CPM and ice bath: Peripheral vascular defects or injuries - Cold sensitivity (vasospasm, cryoglobulinemia, cold urticaria) - Heart disease - Hypertension - Sensory defects - Emotional and psychological characteristics (147). Contraindications and precautions related to EEG recording: Diagnosed psychiatric disorders including dissociative disorder, obsessive-compulsive disorder, personality disorder, schizophrenia, and bipolar disorder - history of drug and alcohol dependence or substance abuse disorders - history of seizures - head trauma with loss of consciousness (64).
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 36
Actual sample size reached: 35
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be divided into 3 groups of dry needling, placebo, and untreated control group with block randomization method using a randomization software.
Blinding (investigator's opinion)
Single blinded
Blinding description
The assessor will be blind to group assignments.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Shiraz School of Rehabilitation Sciences
Street address
Shiraz School of Rehabilitation Sciences, Abiverdi 1 Ave., Chamran Blvd.
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Approval date
2021-11-03, 1400/08/12
Ethics committee reference number
IR.SUMS.REHAB.REC.1400.035

Health conditions studied

1

Description of health condition studied
chronic pelvic pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain intensity
Timepoint
At baseline (before the intervention), after the end of the intervention and 3 months after the intervention
Method of measurement
short form of McGill Pain Questionnaire (SF-MPQ)

2

Description
Central Sensitization
Timepoint
At baseline (before the intervention), after the end of the intervention and 3 months after the intervention
Method of measurement
Central Sensitization Inventory (CSI)

3

Description
Functional changes in the brain as an indicator of central sensitization
Timepoint
At baseline (before the intervention), after the end of the intervention and 3 months after the intervention
Method of measurement
Electroencephalography (EEG) (recording power of frequency bands of Delta (1.0-4.0 Hz), Theta (4.0-8.0 Hz), Alpha (8.0-12.0 Hz) and Beta (12.0-25.0 Hz))

4

Description
Changes in endogenous central pain inhibitory system as an indicator of central sensitization
Timepoint
At baseline (before the intervention), after the end of the intervention and 3 months after the intervention
Method of measurement
Conditioned pain modulation

5

Description
Changes in Hypothalamic-pituitary-adrenal (HPA) Axis as an indicator of central sensitization
Timepoint
At baseline (before the intervention), after the end of the intervention and 3 months after the intervention
Method of measurement
Measurement of salivary cortisol concentration

Secondary outcomes

1

Description
Health related Quality of Life
Timepoint
At baseline (before the intervention), after the end of the intervention and 3 months after the intervention
Method of measurement
Short Form Health Survey (SF-36)

2

Description
Pain Catastrophizing
Timepoint
At baseline (before the intervention), after the end of the intervention and 3 months after the intervention
Method of measurement
Pain Catastrophizing Scale(PCS)

3

Description
Anxiety level
Timepoint
At baseline (before the intervention), after the end of the intervention and 3 months after the intervention
Method of measurement
7-items General Anxiety Disorder scale (GAD-7)

Intervention groups

1

Description
Intervention group: Dry needling group (DNG): Females in DNG will receive 5 sessions of DN with an interval of at least 48 and at most 72 hours. The DN sessions will be scheduled immediately 1 day after baseline assessment (days 7-11 of the menstrual cycle). DN will be performed according to the second edition of Dommerholt (2018) [48], into active and latent MTrPs of the mentioned muscles. Females will receive DN using disposable stainless 0.25mm×50 mm needles (Bang Dong brand (Korean). Considering that frequent and severe manipulation of the needle may cause excessive damage and increase inflammatory pain in skeletal muscle fibers [51], the "static needling" method will be used in such a way that when the needle penetrates the skin and enters the muscle, the needle will be left in the muscle for seconds without manipulation [52]. Each needle will be kept in the muscle for up to 2 minutes according to Bradly’s category of patients to either strong, average, or weak responders to acupuncture [53]. After removing the needle, the tissue is compressed using a cotton swab for 10-5 seconds, or 30-60 seconds if bleeding is present [48]. Muscles that receive dry needles include the rectus abdominis, internal and external oblique muscles, gluteus maximus, medius, and minimus muscles, the obturator intrnus muscle, the piriformis muscle, the pubococcygeus, the iliococcygeus, and the coccygeus.
Category
Treatment - Other

2

Description
Intervention group: Placebo needling group (PNG): Females assigned to the PNG will receive a placebo needle procedure, the same as the DNG but using a non-penetrating method. The physiotherapist will perform the same procedure as with a real needle in the DNG to blind the patients. The needle guide will be only put over the skin, creating a mechanical stimulus on the tissue without making a hole. Patients experience a pressure sensation very similar to a real needle [54]. In PNG, each needle will be kept over the skin for 30 seconds.
Category
Placebo

3

Description
Control group (CG) (No- treatment) Women assigned to the CG received no needle intervention.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
gynecology clinics of hospitals affiliated to the shiraz university of medical sciences
Full name of responsible person
Dr. Mehrzad Lotfi
Street address
Headquarters of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
riasat@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mehrzad Lotfi
Street address
Headquarters of Shiraz University of Medical Sciences, Zand Street, Shiraz
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
riasat@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Najmeh Sedighimehr
Position
PhD candidate
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Shiraz Rehabilitation Sciences, Abiverdi 1 Ave., Chamran Blvd., Shiraz
City
Shiraz
Province
Fars
Postal code
33669-71947
Phone
+98 71 3627 1551
Email
najmehsedighimehr@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Najmeh Sedighimehr
Position
PhD candidate
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation Sciences, Abiverdi 1 Ave, Chamran Blvd, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
33669-71947
Phone
+98 71 3627 1551
Fax
Email
najmehsedighimehr@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Najmeh Sedighimehr
Position
PhD candidate
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation Sciences, Abiverdi 1 Ave, Chamran Blvd, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
33669-71947
Phone
+98 71 3627 1551
Fax
Email
najmehsedighimehr@gmail.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
The study protocol, statistical analysis map, and clinical study report will be published in full after the end of the study and in the form of a published article. Participant data file (IPD) and informed consent form will be published after the end of the study and at the request of the journal, in the form of supplementary data in the published article. The codes used in the analysis and data classification system (data dictionary) will be provided to the corresponding author of the article after the end of the study and will be provided to the journal, university center, or academics upon request.
When the data will become available and for how long
After the end of the study and publication of the article
To whom data/document is available
All applicants
Under which criteria data/document could be used
For scientific and research purposes and after the publication of the article
From where data/document is obtainable
The corresponding author of the article that will be published. His/Her contact information including email, contact number, and university address will be available in the article.
What processes are involved for a request to access data/document
The applicant must send his / her request for data/documentation by e-mail to the corresponding author of the article.
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