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

Not Applicable

Recruiting

• Conditions: Low Back Pain
• Interventions: Other: dry needling; Other: sham (placebo) dry needling

• Registration Number: NCT05100381
• Lead Sponsor: Iran University of Medical Sciences

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.

Study Timeline

• Study First Submitted: 2021-10-08
• Study First Submitted QC: 2021-10-18
• Study First Posted: 2021-10-29
• Study Start: 2022-07-25
• Status Verified: 2024-02
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-06
• Primary Completion: 2024-12-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	dry needling	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.
Control group	sham (placebo) dry needling	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.

Primary Outcome Measures

Name	Time	Method
Pain level	before intervention (baseline) and one week after intervention	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.
Functional disability	before intervention (baseline) and one week after intervention	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.

Secondary Outcome Measures

Name	Time	Method
Pain Pressure Threshold	before intervention (baseline) and one week after intervention	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.
Postural control	before intervention (baseline) and one week after intervention	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.

Trial Locations

Locations (1)

Physical therapy clinic at rehabilitation center of Iran university of medical sciences; 🇮🇷 Tehran, Tehran Province, Iran, Islamic Republic of