The Effect of Dry Needling Compared to Lumbar Spine Mobilization in Patients With Chronic Non Specific Low Back Pain

NCT05214456 | Unknown

• 1 other identifier: IR. IUMS.REC.1400.651
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Low back pain is a major public health challenge worldwide. The aim of this study will be to compare the effect of dry needling with mobilization on pain, functional disability, quadratus lumborum and lumbar multifidus function, lumbar range of motion and pain pressure threshold using a randomized controlled trial design. pain and functional disability are primary outcomes and quadratus lumborum and lumbar multifidus function, lumbar range of motion and pain pressure threshold are considered as secondary outcomes. Patients will be randomly divided into two groups: The experimental group (dry needling, sham mobilization and routine physiotherapy) and the control group (mobilization, sham dry needling and routine physiotherapy).

Conditions

Low Back Pain

Keywords

Low Back Pain, dry needling, mobilization, pain pressure threshold, muscle function

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  Mean Change from Baseline in Pain Scores on the Numerical Pain Rating Scale (0 means no pain and 100 means the most imaginable pain). 9

  Pain intensity measurement before intervention and 7 days after intervention

• Functional disability

  Mean Change from Baseline in Functional disability Scores based on Oswestry Disability Index. 0% to 20% indicate minimal disability, 21% to 40% indicate moderate disability, 41%-60% indicates severe disability, 61%-80% means crippled and 81%-100% indicates that the patient is either bed-bound or exaggerating his/her symptoms. The validity and the reliability of the Persian version of this questionnaire has been shown in the previous studies.

  Before intervention and 7 days after intervention

Secondary Outcomes (3)

• Lumbar multifidus and quadratus lumborum muscles functional change

  Before intervention and 7 days after intervention

• Range of motion

  Before intervention and 7 days after intervention

• Pain pressure threshold

  Before intervention and 7 days after intervention

Study Arms (2)

Interventional group

EXPERIMENTAL

The interventional group will comprise 28 participants with chronic non-specific low back pain. The treatments of this group will include dry needling plus sham mobilization for the lumbar spine and routine physiotherapy. The needles will be inserted to obtain local twitch responses, 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 mobilization for the lumbar spine will be done in the same way as the real mobilization, with the difference that the mobilization will be applied only on the skin surface and less than the first degree of Maitland's mobilization. Routine physical therapy will include low-level laser therapy and motor control training. The treatment will last 4 weeks, 8 sessions, twice a week.

Other: Dry needling

Control group

ACTIVE COMPARATOR

The control group will comprise 28 participants with chronic non-specific low back pain. The treatments of this group will include anterior-posterior mobilization based on the Maitland technique for the lumbar spine plus sham dry needling and routine physiotherapy. Based on the findings of the patient evaluation, the severity, rhythm, time, the degree of mobilization and the place of force (spine or lamina) will be determined. For sham dry needling The needles will be inserted subcutaneously and there will be no local twitch response. 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 4 weeks, 8 sessions, twice a week.

Other: Mobilization

Interventions

Dry needling OTHER

The method of performing the dry needling technique will be based on the method presented by Dommerholt and Fernandez-de-las-Penas. The length of the needle (Tony, china) for each patient will be selected based on the size of the patient: 1) Multifidus: the patient will be placed in a prone position with a pillow under their belly to accommodate lumbar lordosis. The needles will be inserted into the lumbar multifidus muscles, 1.5 to 2 cm lateral to the spinous process of all lumbar vertebrates, perpendicular to the lamina (after piercing the skin, needles are directed inferomedially). 2) Quadratus lumborum: The patient will be placed in the side lying position with the side to be treated facing up. After identifying the lateral border of the quadratus lumborum muscle, the needle will be aimed straight downward in the direction of the transverse process, followed by slight anterior, posterior, and caudal needling to explore the entire muscle.

Interventional group

Mobilization OTHER

To perform Maitland's mobilization for lumbar spine, the anterior-posterior mobilization technique will be used and it is performed by pushing the heel (pisiform grip) or thumbs (thumb grip) to the vertebrae and can immediately reduce pain and restore motor function. First, the complete physical orthopedic evaluation of manual therapies will be performed using the Maitland evaluation method. Then, based on the findings of the patient evaluation, the severity, rhythm, duration and the degree of the mobilization and the place of force (spine or lamina) will be determined. To apply mobilization, the person will sleep in a prone position and the physiotherapist will use the heel of the hand or the thumbs to apply force to the first to fifth vertebrae of the lumbar spine. In segments that do not have a problem based on evaluation, first grade of the anterior-posterior Maitland's mobilization will be applied to the spinous process of the segment.

Also known as: Non-thrust manipulation

Control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants aged between 18 to 45 years.
• Moderate pain intensity (between 30 to 60) based on Numerical Pain Rating Scale (0 means no pain and 100 is the most imaginable pain).
• Participants with trigger points in the quadratus lumborum and lumbar multifidus muscles.
• The Participant's symptoms are provoked with passive accessory intervertebral movements on at least one level of the lumbar spine vertebrae.
• Patients are able to read and write Persian.

You may not qualify if:

• Complications that affect the treatment process such as systemic diseases, neurological disorders, inflammatory conditions, infectious conditions, structural and degenerative changes, metabolic bone diseases and bleeding disorders.
• History of lumbar surgery.
• 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 based on paraclinical findings)
• Inability to obtain prone lying.
• Pregnancy.
• Needle phobia.
• Long history of steroid use

Sponsors & Collaborators

• Iran University of Medical Sciences: lead

Study Sites (1)

IRANums

Tehran, Iran

RECRUITING

Related Publications (23)

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MeSH Terms

Conditions

Low Back Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Hamide Mirzaie, MSc student

  Iran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Mohammadreza Pourahmadi, PhD

  Iran University of Medical Sciences

  STUDY DIRECTOR

Central Study Contacts

Hamide Mirzaie, MSc student

CONTACT

00989335785767; hamide.mirzaie@yahoo.com

Mohammadreza Pourahmadi, PhD

CONTACT

00989122245593; pourahmadi.m@iums.ac.ir

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: January 15, 2022
• First Posted: January 28, 2022
• Study Start: October 20, 2022
• Primary Completion: September 30, 2023
• Study Completion: December 30, 2023
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: starting 6 months after the publication
• Access Criteria: The data will be available for physical therapists working in academic institutions and also clinicians working in the field of musculoskeletal disorders. The raw data and results of this study can be used in future relevant systematic reviews. Thus, the raw data and results of this study will be available for researchers working in the field of low back pain. Applicants can contact hamide mirzaie by Email. Email address: hamide.mirzaie@yahoo.com. Applicants should explain their project and how the data/documents of this study will be used in their project in detail. Then, the data/documents files will be sent by email to applicants on request. This process may takes 10-12 working days.

Locations

IR (1)