chronic pelvic pain.
Conditions
Interventions
Intervention 1: 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 immed
Sponsors
Shiraz University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
20 Years to 50 Years
Inclusion 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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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).;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).;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)).;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.;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
| Measure | Time frame |
|---|---|
| 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).;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).;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). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNajmeh Sedighimehr
Shiraz University of Medical Sciences
Outcome results
None listed