NCT05100381

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
8mo left

Started Jul 2022

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jul 2022Dec 2026

First Submitted

Initial submission to the registry

October 8, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 29, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

July 25, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

May 2, 2025

Status Verified

May 1, 2025

Enrollment Period

4 years

First QC Date

October 8, 2021

Last Update Submit

May 1, 2025

Conditions

Keywords

dry needlingLow Back Painfunctional disabilitypostural controlpain pressure threshold

Outcome Measures

Primary Outcomes (2)

  • 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.

    before intervention (baseline) and one week after intervention

  • 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.

    before intervention (baseline) and one week after intervention

Secondary Outcomes (2)

  • Postural control

    before intervention (baseline) and one week after intervention

  • Pain Pressure Threshold

    before intervention (baseline) and one week after intervention

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group will comprise 20 participants with chronic non-specific low back pain. The treatment will include dry needling of the lumbar multifidus muscle and routine physical therapy. 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. Routine physical therapy will include low level laser therapy and motor control training. The treatment will last 3 weeks, 6 sessions, twice a week.

Other: dry needling

Control group

PLACEBO COMPARATOR

The control group will comprise 20 participants with chronic non-specific low back pain. The treatment will include "sham" dry needling of the lumbar multifidus muscle and routine physical therapy. The sham dry needling method consists of 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. Routine physical therapy will include low level laser therapy and motor control training. The treatment will last 3 weeks, 6 sessions, twice a week.

Other: sham (placebo) dry needling

Interventions

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, 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.

Experimental group

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.

Control group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical therapy clinic at rehabilitation center of Iran university of medical sciences

Tehran, Tehran Province, 1545913487, Iran

RECRUITING

Related Publications (64)

  • 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: 27745712BACKGROUND
  • 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: 22231424BACKGROUND
  • 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: 21270691BACKGROUND
  • 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: 16550448BACKGROUND
  • 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: 29194127BACKGROUND
  • 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: 25153893BACKGROUND
  • 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: 25054648BACKGROUND
  • 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: 19553222BACKGROUND
  • Ruhe A, Fejer R, Walker B. Center of pressure excursion as a measure of balance performance in patients with non-specific low back pain compared to healthy controls: a systematic review of the literature. Eur Spine J. 2011 Mar;20(3):358-68. doi: 10.1007/s00586-010-1543-2. Epub 2010 Aug 19.

    PMID: 20721676BACKGROUND
  • Hodges PW, Tucker K. Moving differently in pain: a new theory to explain the adaptation to pain. Pain. 2011 Mar;152(3 Suppl):S90-S98. doi: 10.1016/j.pain.2010.10.020. Epub 2010 Nov 18. No abstract available.

    PMID: 21087823BACKGROUND
  • Schelldorfer S, Ernst MJ, Rast FM, Bauer CM, Meichtry A, Kool J. Low back pain and postural control, effects of task difficulty on centre of pressure and spinal kinematics. Gait Posture. 2015 Jan;41(1):112-8. doi: 10.1016/j.gaitpost.2014.09.004. Epub 2014 Sep 20.

    PMID: 25270326BACKGROUND
  • Koch C, Hansel F. Non-specific Low Back Pain and Postural Control During Quiet Standing-A Systematic Review. Front Psychol. 2019 Mar 22;10:586. doi: 10.3389/fpsyg.2019.00586. eCollection 2019.

    PMID: 30967811BACKGROUND
  • Berenshteyn Y, Gibson K, Hackett GC, Trem AB, Wilhelm M. Is standing balance altered in individuals with chronic low back pain? A systematic review. Disabil Rehabil. 2019 Jun;41(13):1514-1523. doi: 10.1080/09638288.2018.1433240. Epub 2018 Jan 30.

    PMID: 29382241BACKGROUND
  • Brumagne S, Cordo P, Verschueren S. Proprioceptive weighting changes in persons with low back pain and elderly persons during upright standing. Neurosci Lett. 2004 Aug 5;366(1):63-6. doi: 10.1016/j.neulet.2004.05.013.

    PMID: 15265591BACKGROUND
  • Crossman K, Mahon M, Watson PJ, Oldham JA, Cooper RG. Chronic low back pain-associated paraspinal muscle dysfunction is not the result of a constitutionally determined "adverse" fiber-type composition. Spine (Phila Pa 1976). 2004 Mar 15;29(6):628-34. doi: 10.1097/01.brs.0000115133.97216.ec.

    PMID: 15014272BACKGROUND
  • MacDonald D, Moseley LG, Hodges PW. Why do some patients keep hurting their back? Evidence of ongoing back muscle dysfunction during remission from recurrent back pain. Pain. 2009 Apr;142(3):183-188. doi: 10.1016/j.pain.2008.12.002. Epub 2009 Jan 30.

    PMID: 19186001BACKGROUND
  • Mannion AF, Weber BR, Dvorak J, Grob D, Muntener M. Fibre type characteristics of the lumbar paraspinal muscles in normal healthy subjects and in patients with low back pain. J Orthop Res. 1997 Nov;15(6):881-7. doi: 10.1002/jor.1100150614.

    PMID: 9497814BACKGROUND
  • Larson DJ, Brown SHM. The effects of trunk extensor and abdominal muscle fatigue on postural control and trunk proprioception in young, healthy individuals. Hum Mov Sci. 2018 Feb;57:13-20. doi: 10.1016/j.humov.2017.10.019. Epub 2017 Nov 7.

    PMID: 29121507BACKGROUND
  • Ghamkhar L, Kahlaee AH. The effect of trunk muscle fatigue on postural control of upright stance: A systematic review. Gait Posture. 2019 Jul;72:167-174. doi: 10.1016/j.gaitpost.2019.06.010. Epub 2019 Jun 11.

    PMID: 31207565BACKGROUND
  • Yalfani A, Raeisi Z, Koumasian Z. Effects of eight-week water versus mat pilates on female patients with chronic nonspecific low back pain: Double-blind randomized clinical trial. J Bodyw Mov Ther. 2020 Oct;24(4):70-75. doi: 10.1016/j.jbmt.2020.06.002. Epub 2020 Jun 27.

    PMID: 33218568BACKGROUND
  • Kalichman L, Vulfsons S. Dry needling in the management of musculoskeletal pain. J Am Board Fam Med. 2010 Sep-Oct;23(5):640-6. doi: 10.3122/jabfm.2010.05.090296.

    PMID: 20823359BACKGROUND
  • Funk MF, Frisina-Deyo AJ. Dry needling for spine related disorders: a scoping review. Chiropr Man Therap. 2020 May 11;28(1):23. doi: 10.1186/s12998-020-00310-z.

    PMID: 32393383BACKGROUND
  • Griswold D, Wilhelm M, Donaldson M, Learman K, Cleland J. The effectiveness of superficial versus deep dry needling or acupuncture for reducing pain and disability in individuals with spine-related painful conditions: a systematic review with meta-analysis. J Man Manip Ther. 2019 Jul;27(3):128-140. doi: 10.1080/10669817.2019.1589030. Epub 2019 Mar 19.

    PMID: 30935320BACKGROUND
  • Hu HT, Gao H, Ma RJ, Zhao XF, Tian HF, Li L. Is dry needling effective for low back pain?: A systematic review and PRISMA-compliant meta-analysis. Medicine (Baltimore). 2018 Jun;97(26):e11225. doi: 10.1097/MD.0000000000011225.

    PMID: 29952980BACKGROUND
  • Koppenhaver SL, Walker MJ, Rettig C, Davis J, Nelson C, Su J, Fernandez-de-Las-Penas C, Hebert JJ. The association between dry needling-induced twitch response and change in pain and muscle function in patients with low back pain: a quasi-experimental study. Physiotherapy. 2017 Jun;103(2):131-137. doi: 10.1016/j.physio.2016.05.002. Epub 2016 May 20.

    PMID: 27623385BACKGROUND
  • Koppenhaver SL, Walker MJ, Su J, McGowen JM, Umlauf L, Harris KD, Ross MD. Changes in lumbar multifidus muscle function and nociceptive sensitivity in low back pain patient responders versus non-responders after dry needling treatment. Man Ther. 2015 Dec;20(6):769-76. doi: 10.1016/j.math.2015.03.003. Epub 2015 Mar 13.

    PMID: 25801100BACKGROUND
  • Dar G, Hicks GE. The immediate effect of dry needling on multifidus muscles' function in healthy individuals. J Back Musculoskelet Rehabil. 2016 Apr 27;29(2):273-278. doi: 10.3233/BMR-150624.

    PMID: 26406203BACKGROUND
  • Kiesel KB, Uhl TL, Underwood FB, Rodd DW, Nitz AJ. Measurement of lumbar multifidus muscle contraction with rehabilitative ultrasound imaging. Man Ther. 2007 May;12(2):161-6. doi: 10.1016/j.math.2006.06.011. Epub 2006 Sep 14.

    PMID: 16973400BACKGROUND
  • Hodges PW. Pain and motor control: From the laboratory to rehabilitation. J Electromyogr Kinesiol. 2011 Apr;21(2):220-8. doi: 10.1016/j.jelekin.2011.01.002.

    PMID: 21306915BACKGROUND
  • Emami F, Yoosefinejad AK, Razeghi M. Correlations between core muscle geometry, pain intensity, functional disability and postural balance in patients with nonspecific mechanical low back pain. Med Eng Phys. 2018 Oct;60:39-46. doi: 10.1016/j.medengphy.2018.07.006. Epub 2018 Aug 1.

    PMID: 30077486BACKGROUND
  • Behennah J, Conway R, Fisher J, Osborne N, Steele J. The relationship between balance performance, lumbar extension strength, trunk extension endurance, and pain in participants with chronic low back pain, and those without. Clin Biomech (Bristol). 2018 Mar;53:22-30. doi: 10.1016/j.clinbiomech.2018.01.023. Epub 2018 Jan 31.

    PMID: 29407352BACKGROUND
  • Loizidis T, Nikodelis T, Bakas E, Kollias I. The effects of dry needling on pain relief and functional balance in patients with sub-chronic low back pain. J Back Musculoskelet Rehabil. 2020;33(6):953-959. doi: 10.3233/BMR-181265.

    PMID: 32310156BACKGROUND
  • Griswold D, Gargano F, Learman KE. A randomized clinical trial comparing non-thrust manipulation with segmental and distal dry needling on pain, disability, and rate of recovery for patients with non-specific low back pain. J Man Manip Ther. 2019 Jul;27(3):141-151. doi: 10.1080/10669817.2019.1574389. Epub 2019 Feb 9.

    PMID: 30935327BACKGROUND
  • Tellez-Garcia M, de-la-Llave-Rincon AI, Salom-Moreno J, Palacios-Cena M, Ortega-Santiago R, Fernandez-de-Las-Penas C. Neuroscience education in addition to trigger point dry needling for the management of patients with mechanical chronic low back pain: A preliminary clinical trial. J Bodyw Mov Ther. 2015 Jul;19(3):464-72. doi: 10.1016/j.jbmt.2014.11.012. Epub 2014 Nov 22.

    PMID: 26118519BACKGROUND
  • Nogueira JF, Carrasco AC, Pelegrinelli ARM, Guenka LC, Silva MF, Dela Bela LF, Dias JM, Moura FA, McVeigh JG, Cardoso JR. Posturography Comparison and Discriminant Analysis Between Individuals With and Without Chronic Low Back Pain. J Manipulative Physiol Ther. 2020 Jun;43(5):469-475. doi: 10.1016/j.jmpt.2019.01.002. Epub 2020 Jul 24.

    PMID: 32718710BACKGROUND
  • Karimi Ghasem Abad S, Akhbari B, Salavati M, Talebian Moghaddam S, Saeedi A, Seydi M, Ahangari M, Negahban H. Reliability of postural control during double-leg standing in subjects with nonspecific chronic low back pain: Dual-task paradigm and manipulated visual and somatosensory inputs. J Bodyw Mov Ther. 2021 Apr;26:49-56. doi: 10.1016/j.jbmt.2020.09.005. Epub 2020 Sep 17.

    PMID: 33992286BACKGROUND
  • da Silva RA, Vieira ER, Fernandes KBP, Andraus RA, Oliveira MR, Sturion LA, Calderon MG. People with chronic low back pain have poorer balance than controls in challenging tasks. Disabil Rehabil. 2018 Jun;40(11):1294-1300. doi: 10.1080/09638288.2017.1294627. Epub 2017 Mar 10.

    PMID: 28282992BACKGROUND
  • Wang-Price S, Zafereo J, Couch Z, Brizzolara K, Heins T, Smith L. Short-term effects of two deep dry needling techniques on pressure pain thresholds and electromyographic amplitude of the lumbosacral multifidus in patients with low back pain - a randomized clinical trial. J Man Manip Ther. 2020 Dec;28(5):254-265. doi: 10.1080/10669817.2020.1714165. Epub 2020 Jan 17.

    PMID: 31960773BACKGROUND
  • Liu L, Huang QM, Liu QG, Thitham N, Li LH, Ma YT, Zhao JM. Evidence for Dry Needling in the Management of Myofascial Trigger Points Associated With Low Back Pain: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2018 Jan;99(1):144-152.e2. doi: 10.1016/j.apmr.2017.06.008. Epub 2017 Jul 8.

    PMID: 28690077BACKGROUND
  • Gerwin RD, Shannon S, Hong CZ, Hubbard D, Gevirtz R. Interrater reliability in myofascial trigger point examination. Pain. 1997 Jan;69(1-2):65-73. doi: 10.1016/s0304-3959(96)03248-4.

    PMID: 9060014BACKGROUND
  • Chou LW, Kao MJ, Lin JG. Probable mechanisms of needling therapies for myofascial pain control. Evid Based Complement Alternat Med. 2012;2012:705327. doi: 10.1155/2012/705327. Epub 2012 Dec 31.

    PMID: 23346211BACKGROUND
  • Ylinen J. Pressure algometry. Aust J Physiother. 2007;53(3):207. doi: 10.1016/s0004-9514(07)70032-6. No abstract available.

    PMID: 17899675BACKGROUND
  • Richter P, Werner J, Heerlein A, Kraus A, Sauer H. On the validity of the Beck Depression Inventory. A review. Psychopathology. 1998;31(3):160-8. doi: 10.1159/000066239.

    PMID: 9636945BACKGROUND
  • Ghassemzadeh H, Mojtabai R, Karamghadiri N, Ebrahimkhani N. Psychometric properties of a Persian-language version of the Beck Depression Inventory--Second edition: BDI-II-PERSIAN. Depress Anxiety. 2005;21(4):185-92. doi: 10.1002/da.20070.

    PMID: 16075452BACKGROUND
  • Vasheghani-Farahani A, Tahmasbi M, Asheri H, Ashraf H, Nedjat S, Kordi R. The Persian, last 7-day, long form of the International Physical Activity Questionnaire: translation and validation study. Asian J Sports Med. 2011 Jun;2(2):106-16. doi: 10.5812/asjsm.34781.

    PMID: 22375226BACKGROUND
  • Pourahmadi MR, Bagheri R, Jannati E, Ebrahimi Takamjani I, Sarrafzadeh J, Mohsenifar H. Effect of Elastic Therapeutic Taping on Abdominal Muscle Endurance in Patients With Chronic Nonspecific Low Back Pain: A Randomized, Controlled, Single-Blind, Crossover Trial. J Manipulative Physiol Ther. 2018 Sep;41(7):609-620. doi: 10.1016/j.jmpt.2017.10.019. Epub 2018 Aug 8.

    PMID: 30098819BACKGROUND
  • Gholami Borujeni B, Yalfani A. Reduction of postural sway in athletes with chronic low back pain through eight weeks of inspiratory muscle training: A randomized controlled trial. Clin Biomech (Bristol). 2019 Oct;69:215-220. doi: 10.1016/j.clinbiomech.2019.09.006. Epub 2019 Sep 10.

    PMID: 31614295BACKGROUND
  • Koch C, Garcia-Augundez A, Gobel S, Hansel F. A case control study to investigate differences in motor control between individuals with and without non-specific low back pain during standing. PLoS One. 2020 Jul 6;15(7):e0234858. doi: 10.1371/journal.pone.0234858. eCollection 2020.

    PMID: 32628670BACKGROUND
  • Azadinia F, Ebrahimi-Takamjani I, Kamyab M, Asgari M, Parnianpour M. Effects of lumbosacral orthosis on dynamical structure of center of pressure fluctuations in patients with non-specific chronic low back pain: A randomized controlled trial. J Bodyw Mov Ther. 2019 Oct;23(4):930-936. doi: 10.1016/j.jbmt.2019.01.014. Epub 2019 Jan 31.

    PMID: 31733785BACKGROUND
  • Shahvarpour A, Preuss R, Lariviere C. The effect of extensible and non-extensible lumbar belts on trunk postural balance in subjects with low back pain and healthy controls. Gait Posture. 2019 Jul;72:211-216. doi: 10.1016/j.gaitpost.2019.06.013. Epub 2019 Jun 20.

    PMID: 31255888BACKGROUND
  • Laslett M. Evidence-based diagnosis and treatment of the painful sacroiliac joint. J Man Manip Ther. 2008;16(3):142-52. doi: 10.1179/jmt.2008.16.3.142.

    PMID: 19119403BACKGROUND
  • Mahmoudzadeh A, Rezaeian ZS, Karimi A, Dommerholt J. The effect of dry needling on the radiating pain in subjects with discogenic low-back pain: A randomized control trial. J Res Med Sci. 2016 Oct 18;21:86. doi: 10.4103/1735-1995.192502. eCollection 2016.

    PMID: 28163732BACKGROUND
  • Ostelo RW, Deyo RA, Stratford P, Waddell G, Croft P, Von Korff M, Bouter LM, de Vet HC. Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine (Phila Pa 1976). 2008 Jan 1;33(1):90-4. doi: 10.1097/BRS.0b013e31815e3a10.

    PMID: 18165753BACKGROUND
  • Boyce D, Wempe H, Campbell C, Fuehne S, Zylstra E, Smith G, Wingard C, Jones R. ADVERSE EVENTS ASSOCIATED WITH THERAPEUTIC DRY NEEDLING. Int J Sports Phys Ther. 2020 Feb;15(1):103-113.

    PMID: 32089962BACKGROUND
  • Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine (Phila Pa 1976). 2005 Jun 1;30(11):1331-4. doi: 10.1097/01.brs.0000164099.92112.29.

    PMID: 15928561BACKGROUND
  • Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017.

    PMID: 11074683BACKGROUND
  • Mousavi SJ, Parnianpour M, Mehdian H, Montazeri A, Mobini B. The Oswestry Disability Index, the Roland-Morris Disability Questionnaire, and the Quebec Back Pain Disability Scale: translation and validation studies of the Iranian versions. Spine (Phila Pa 1976). 2006 Jun 15;31(14):E454-9. doi: 10.1097/01.brs.0000222141.61424.f7.

    PMID: 16778675BACKGROUND
  • Ruhe A, Fejer R, Walker B. The test-retest reliability of centre of pressure measures in bipedal static task conditions--a systematic review of the literature. Gait Posture. 2010 Oct;32(4):436-45. doi: 10.1016/j.gaitpost.2010.09.012. Epub 2010 Oct 13.

    PMID: 20947353BACKGROUND
  • Kinser AM, Sands WA, Stone MH. Reliability and validity of a pressure algometer. J Strength Cond Res. 2009 Jan;23(1):312-4. doi: 10.1519/jsc.0b013e31818f051c.

    PMID: 19130648BACKGROUND
  • Gildir S, Tuzun EH, Eroglu G, Eker L. A randomized trial of trigger point dry needling versus sham needling for chronic tension-type headache. Medicine (Baltimore). 2019 Feb;98(8):e14520. doi: 10.1097/MD.0000000000014520.

    PMID: 30813155BACKGROUND
  • Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-2367. Epub 2017 Feb 14.

    PMID: 28192789BACKGROUND
  • Vallone F, Benedicenti S, Sorrenti E, Schiavetti I, Angiero F. Effect of diode laser in the treatment of patients with nonspecific chronic low back pain: a randomized controlled trial. Photomed Laser Surg. 2014 Sep;32(9):490-4. doi: 10.1089/pho.2014.3715.

    PMID: 25141218BACKGROUND
  • Abdelbasset WK, Nambi G, Alsubaie SF, Abodonya AM, Saleh AK, Ataalla NN, Ibrahim AA, Tantawy SA, Kamel DM, Verma A, Moawd SA. A Randomized Comparative Study between High-Intensity and Low-Level Laser Therapy in the Treatment of Chronic Nonspecific Low Back Pain. Evid Based Complement Alternat Med. 2020 Oct 28;2020:1350281. doi: 10.1155/2020/1350281. eCollection 2020.

    PMID: 33178306BACKGROUND
  • Narouei S, Barati AH, Akuzawa H, Talebian S, Ghiasi F, Akbari A, Alizadeh MH. Effects of core stabilization exercises on thickness and activity of trunk and hip muscles in subjects with nonspecific chronic low back pain. J Bodyw Mov Ther. 2020 Oct;24(4):138-146. doi: 10.1016/j.jbmt.2020.06.026. Epub 2020 Jul 30.

    PMID: 33218502BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Dry Needlingsalicylhydroxamic acid

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Mohammadreza Pourahmadi, PhD

    Rehabilitation Research Center, Department of Physical Therapy, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran

    STUDY DIRECTOR

Central Study Contacts

Bahareh Firouzeh, Bachelor

CONTACT

Mohammadreza Pourahmadi, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2021

First Posted

October 29, 2021

Study Start

July 25, 2022

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

May 2, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

The data sets of this study will be available on a reasonable request to the corresponding author.

Locations