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Low Back PainNCT05100381

Effectiveness of Dry Needling in Patients With Chronic Nonspecific Low Back Pain

A study testing dry needling in people with Low Back Pain, run by Iran University of Medical Sciences at 1 site in Iran.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Low Back Pain
What is being tested?
dry needling
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteIran
Study dates
25 Jul 2022to 30 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Bahareh Firouzeh, Bachelor contact

+98-9908080623

baharefirouze74@gmail.com

Mohammadreza Pourahmadi, PhD contact

+98-9122245593

pourahmadipt@gmail.com

Iran1 site, 1 recruiting
  • Physical therapy clinic at rehabilitation center of Iran university of medical sciences

    Tehran, Tehran Province, 1545913487

    Mohammadreza Pourahmadi, assistant professor, 09122245593, pourahmadipt@gmail.com

    Recruiting

Other trials in Iran

About this study

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

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.

Read the 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.

Conditions
Low Back Pain
Being tested
dry needling, sham (placebo) dry needling
Keywords
dry needling, Low Back Pain, functional disability, postural control, pain pressure threshold
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dry needlingOther

    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.

  • sham (placebo) dry needlingOther

    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.

Study groups in NCT05100381
Study groupRoleWhat they receive
Experimental groupExperimentalThe 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.
Receives: Other: dry needling
Control groupPlacebo comparatorThe 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.
Receives: Other: sham (placebo) dry needling

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: before intervention (baseline) and one week after intervention

  2. 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.

    Measured: before intervention (baseline) and one week after intervention

Secondary outcomes (2)
  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.

    Measured: before intervention (baseline) and one week after intervention

  2. 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.

    Measured: before intervention (baseline) and one week after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2021
  2. Study start25 Jul 2022
  3. Primary completion30 Jul 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05100381
Sponsor's protocol ID
IR.IUMS.REC.1400.476
Status last verified
May 2025
First submitted
8 Oct 2021
Last updated
2 May 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data sets of this study will be available on a reasonable request to the corresponding author.

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 19553222
  • 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.

    PubMed 20721676
  • 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.

    PubMed 21087823
  • 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.

    PubMed 25270326
  • 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.

    PubMed 30967811
  • 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.

    PubMed 29382241
  • 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.

    PubMed 15265591
  • 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.

    PubMed 15014272

Questions about this trial

What is this clinical trial studying?

A study testing dry needling in people with Low Back Pain, run by Iran University of Medical Sciences at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bahareh Firouzeh, Bachelor (+98-9908080623, baharefirouze74@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain level (time frame: before intervention (baseline) and one week after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05100381, which also lists 64 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.

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