Effectiveness of Dry Needling in Patients With Chronic Nonspecific Low Back Pain
ConditionLow Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorIran University of Medical Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
dry needling
Other interventionThe patients will be placed in a prone position with a pillow under their belly to accommodate lumbar lordosis. Two lengths of sterile, disposable, 0.30 mm x 75 mm and 0.30 mm x 50 mm solid filament needle (Tony, China) will be used in this study. The length of the needle for each participant will be selected based on the size of the participant. The needles will be inserted into the lumbar multifidus muscle, 1.5 - 2 cm lateral to the spinous process of two or three painful segments, perpendicular to lamina (after piercing the skin, needles are directed inferomedially). The needles will be inserted to obtain local twitch response, and this process will continue until no more local twitch response occurs in each session. Then the needles will be left in place for 20 minutes.
sham (placebo) dry needling
Other interventionThe sham dry needling method includes the insertion of the needles subcutaneously and no local twitch response will be obtained. The needles will be left in the place for 20 minutes.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain level
The 0-100 Numeric Pain Rating Scale (NPRS) will be used to evaluate changing in level of pain from the baseline to one week after the intervention. Zero indicates no pain and 100 indicates maximum pain that the patient experiences. The NPRS has the responsiveness to measure the level of pain in people with low back pain.
Time frame
before intervention (baseline) and one week after intervention2
Functional disability
The Persian version of The Oswestry Disability Index will be used to evaluate changing in functional disability from the baseline to one week after intervention. This questionnaire includes 10 activities of daily living and a total score of 100. A score below 25 indicates the lowest level of disability, 25 to 50 moderate disability, 50 to 75 severe disability, and 75 to 100 acute disability. The validity and the reliability of the Persian version of this questionnaire has been shown in the previous studies.
Time frame
before intervention (baseline) and one week after interventionSecondary outcomes
1
Postural control
The force platform (Germany, Kistler, 9260AA6) will be used to evaluate postural control from the baseline to one week after intervention. Postural control will be evaluated in four different trials in double-leg stance position: 1-Eyes open on a firm surface. 2-Eyes closed on a firm surface. 3-Eyes open on a foam surface. 4-Eyes closed on a foam surface. The duration of each trial will be 90 s, three times repetition, with one minute rest interval between each trial. The postural control variables in this investigation will be COP excursion in the anteroposterior and mediolateral direction, COP amplitude standard deviation (dispersion) in the anteroposterior and mediolateral direction, COP velocity standard deviation in the anteroposterior and mediolateral direction, mean velocity of COP, COP total area of excursion, COP plane phase in the anteroposterior and mediolateral direction, and COP total plane phase.
Time frame
before intervention (baseline) and one week after intervention2
Pain Pressure Threshold
The pressure algometer will be used to evaluate the Pain Pressure Threshold (PPT). The patients will be placed in a prone position with a pillow under their belly to accommodate lumbar lordosis and the algometer will be applied perpendicular to the muscle belly of the lumbar multifidus, approximately 1.5 cm lateral to the spinous process of the painful segments. The patients will be asked to signal verbally after perception of force change from pressure to pain. The PPT at each location will be taken three times and the mean of three repetitions will be used for statistical analysis. The validity and reliability of the pressure algometer has been shown in previous studies.
Time frame
before intervention (baseline) and one week after interventionSponsors and contacts
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Source ClinicalTrials.gov