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

Overview

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.

Interventions

• Other dry needling
  The 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, perpendicul
• Other sham (placebo) dry needling
  The 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.

Primary outcome measures

• Pain level [Time frame: before intervention (baseline) and one week after intervention]
• Functional disability [Time frame: before intervention (baseline) and one week after intervention]

Secondary outcome measures (2)

• Postural control [Time frame: before intervention (baseline) and one week after intervention]
• Pain Pressure Threshold [Time frame: before intervention (baseline) and one week after intervention]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Iran · 1 center

• Physical therapy clinic at rehabilitation center of Iran university of medical sciences — Tehran

Publications

• Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11. PMID 27745712
• Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9. PMID 22231424
• Mousavi SJ, Akbari ME, Mehdian H, Mobini B, Montazeri A, Akbarnia B, Parnianpour M. Low back pain in Iran: a growing need to adapt and implement evidence-based practice in developing countries. Spine (Phila Pa 1976). 2011 May 1;36(10):E638-46. doi: 10.1097/BRS.0b013e3181fa1da2. PMID 21270691
• Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G; COST B13 Working Group on Guidelines for Chronic Low Back Pain. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S192-300. doi: 10.1007/s00586-006-1072-1. No abstract available. PMID 16550448
• Chiarotto A, Boers M, Deyo RA, Buchbinder R, Corbin TP, Costa LOP, Foster NE, Grotle M, Koes BW, Kovacs FM, Lin CC, Maher CG, Pearson AM, Peul WC, Schoene ML, Turk DC, van Tulder MW, Terwee CB, Ostelo RW. Core outcome measurement instruments for clinical trials in nonspecific low back pain. Pain. 2018 Mar;159(3):481-495. doi: 10.1097/j.pain.0000000000001117. PMID 29194127
• Rabey M, Beales D, Slater H, O'Sullivan P. Multidimensional pain profiles in four cases of chronic non-specific axial low back pain: An examination of the limitations of contemporary classification systems. Man Ther. 2015 Feb;20(1):138-47. doi: 10.1016/j.math.2014.07.015. Epub 2014 Aug 12. PMID 25153893
• Morrisette DC, Cholewicki J, Logan S, Seif G, McGowan S. A randomized clinical trial comparing extensible and inextensible lumbosacral orthoses and standard care alone in the management of lower back pain. Spine (Phila Pa 1976). 2014 Oct 1;39(21):1733-42. doi: 10.1097/BRS.0000000000000521. PMID 25054648
• Luomajoki H, Moseley GL. Tactile acuity and lumbopelvic motor control in patients with back pain and healthy controls. Br J Sports Med. 2011 Apr;45(5):437-40. doi: 10.1136/bjsm.2009.060731. Epub 2009 Jun 23. PMID 19553222

Identifiers

NCT: NCT05100381 · IR.IUMS.REC.1400.476

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗