Clinical trial NCT05100381: Effectiveness of Dry Needling in Patients With Chronic Nonspecific Low Back Pain
Official title: Effectiveness of Dry Needling on Pain, Functional Disability, Postural Control and Pain Pressure Threshold in Patients With Chronic Nonspecific Low Back Pain: A Double-Blind Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: dry needling
Low Back Pain
functional disability
postural control
pain pressure threshold
Lead sponsor: Iran University of Medical Sciences
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Low back pain is a major health problem that affects psychosocial, economical, functional and physical aspects of the patients' life. The aim of this study will be to investigate the effectiveness of dry needling on pain, functional disability, postural control and pain pressure threshold in patients with chronic nonspecific low back pain using a randomized controlled trial design.

Patients with chronic nonspecific low back pain will be randomly divided into two groups: Experimental group (dry needling and routine physical therapy) and control group (sham dry needling and routine physical therapy). Primary outcomes will be pain intensity and functional disability. Postural control and pain pressure threshold will be considered as secondary outcomes.

Detailed description: Low back pain is a major health problem that affects psychosocial, economical, functional and physical aspects of the patients' life. Since patients with chronic low back pain have impaired postural control and this impairment can cause chronicity and recurrence of low back pain, it is important to evaluate the effectiveness of interventions on postural control in patients with low back pain. Previous studies have shown the effectiveness of dry needling on pain, functional disability and pain sensitivity in patients with low back pain. The effectiveness of dry needling on postural control is not fully known.

The aim of this study will be to investigate the effectiveness of dry needling on pain, functional disability, postural control and pain pressure threshold in patients with chronic nonspecific low back pain.

This study will be a double-blind randomized controlled trial. Forty patients with chronic nonspecific low back pain will be randomly divided into two groups: Experimental group (dry needling and routine physical therapy) and control group (sham dry needling and routine physical therapy). Primary outcomes will be pain intensity and functional disability. Postural control and pain pressure threshold will be considered as secondary outcomes. Outcomes will be assessed before and one week after the intervention.

All of the participants will be identified and recruited by posters and word-of-mouth from the university and the surrounding local communities. Eligible participants will be explained about the purpose and the examination involved in this investigation, and all eligible participants will sign a written informed consent before entering the study.

Eligibility criteria: Inclusion Criteria:

* Patients age between 18 to 45 years.
* Moderate pain at rest (between 30 and 60 in NPRS).
* Patients with trigger points in the lumbar multifidus muscle.
* Patients have the ability to speak and read Persian.

Exclusion Criteria:

* Currently taking anticoagulant medications
* Specific low back pain (Neurogenic low back pain, Spinal stenosis, cauda equina syndrome, spondylolisthesis, and Presence of any signs or symptoms of non-musculoskeletal pathology e.g. cancer, infection and fracture in low back and lower extremities based on paraclinical findings)
* Prior surgery to the lumbosacral spine
* Inability to obtain prone lying
* Severe malalignments in the cervical, thoracic, lumbar or pelvic region and the lower limbs
* History of uncorrected vision impairment, vestibular, hearing or cognitive impairments
* Leg length discrepancy which disturbs balance
* Systemic diseases, such as diabetes, fibromyalgia, rheumatoid arthritis, degenerative diseases and other rheumatoid diseases
* Needle phobia
* Sacroiliac pain as identified with six clinical tests: compression, distraction, sacral thrust, thigh thrust, Gaenslen's and FABER's

Primary outcomes:
measure: Pain level
timeFrame: before intervention (baseline) and one week after intervention
measure: Functional disability
timeFrame: before intervention (baseline) and one week after intervention
Secondary outcomes:
measure: Postural control
timeFrame: before intervention (baseline) and one week after intervention
measure: Pain Pressure Threshold
timeFrame: before intervention (baseline) and one week after intervention
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Physical therapy clinic at rehabilitation center of Iran university of medical sciences
state: Tehran Province
Study officials:
affiliation: Rehabilitation Research Center, Department of Physical Therapy, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran
name: Mohammadreza Pourahmadi, PhD
role: STUDY_DIRECTOR
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