Effect of Acupuncture Dry Needle in Treatment of Chronic Mechanical Low Back Pain

February 14, 2024 updated by: Prince Sattam Bin Abdulaziz University

Short Term Effect of Acupuncture Dry Needle in Treatment of Chronic Mechanical Low Back Pain: A Randomized Controlled Clinical Trial

Low back pain affects about 60% to 90% of the working-age population in modern industrial society. Chronic mechanical low back pain (CMLBP) is the most common problem of the working-age population in modern industrial society; it causes a substantial economic burden due to the wide use of medical services and absence from work. The purpose of this trial was to evaluate the short-term effect of acupuncture dry needle in treatment of chronic mechanical low back pain.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Low back pain affects about 60% to 90% of the working-age population in modern industrial society. Chronic mechanical low back pain (CMLBP) is the most common problem of the working-age population in modern industrial society; it causes a substantial economic burden due to the wide use of medical services and absence from work. The purpose of this trial was to evaluate the short-term effect of acupuncture dry needle in treatment of chronic mechanical low back pain. Thirty patients their age ranged from 20 - 45 years participated in our study and divided randomly into two equal groups suffering from nonspecific low back pain. The first group (A) consist of 15 patients receiving acupuncture dry needle over trigger points of back muscles followed by stretching and strengthening exercises for back muscles, the second group (B) consist of 15 patients receiving only stretching and strengthening exercises for back muscles. The following parameters including pain severity, functional disability and lumbar range of motion (flexion, extension, right side bending and left side bending) were measured before and after treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • Riyadh
      • Al-Kharj, Riyadh, Saudi Arabia, 11942
        • Walid Kamal Abdelbasset

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ranges from 20 to 45 years old.
  2. Pain of at least 30 mm to 70 mm on a visual analogue scale (VAS) from 0 mm (no pain) to 100 mm (worst imaginable pain).
  3. Presence of MTrPs at least in 4 muscles on any side.
  4. Patients had lower back myofascial pain syndrome for at least 3 months ago.

Exclusion Criteria:

A history of previous back surgery, neurologic deficit, current lower extremity symptoms, cardiopulmonary disease with decreased activity tolerance, rheumatologic conditions, polyarticular osteoarthritis, rheumatoid arthritis and advanced lumbar degenerative disease, patients receiving other treatment in the form of physical therapy or medication for the duration of the study that may interfere with the results of this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Acupuncture dry needle
This group received acupuncture dry needle over trigger points of back muscles followed by stretching and strengthening exercises for back muscles, 2 sessions per week for 2 weeks.
Other: Acupuncture dry needle
The muscles that have been treated iliocostalis lumborum, quadratus lumborum, gluteus medius and piriformis muscles. The patients received 2 sessions per week for 2 weeks.
No Intervention: Stretching and strengthening exercises
This group received only stretching and strengthening exercises for back muscles.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: Four weeks
Pain was assessed by Visual Analog Scale (VAS). VAS is a scale that allows continuous data analysis and uses a 10 cm line with 0 in one end (no pain) and 10 (worst pain) on the other end. Patients were asked to place a mark along the line to denote their level of pain.
Four weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional disability
Time Frame: Four weeks
Functional disability of each patient was assessed by Oswestery disability questionnaire. It is valid and reliable tool. It is consists of 10 multiple choice questions for back pain, patient select one sentence out of six that best describe his pain, Higher scores indicated great pain. Scores (0-20%) minimal disability, Scores (20%- 40%) moderate, Scores (40% - 60%) severe, Scores (60%-80%) crippled, Scores (80% - 100%) patients are confined to bed.
Four weeks
Lumbar range of motion
Time Frame: Four weeks
Modified-modified Schober flexion technique was used based on the work of Williams et al. This method is reliable and valid in measuring range of motion of lumbar flexion. The investigator stood behind the standing patient to identify the posterior superior iliac spines with her or his thumbs, and then an ink mark was drawn along the midline of the lumbar spine horizontal to the posterior superior iliac spines. Another ink mark was made 15 cm above the original mark; the distance between superior and inferior skin marks was measured. Then the investigator instructed the patient to bend forward into full lumbar flexion and the new distance between superior and inferior skin marks was measured.
Four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prince Sattam Bin Abdulaziz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 11, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 21, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RHPT/022/035

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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