NCT06140264

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
Last Updated

February 15, 2024

Status Verified

November 1, 2023

Enrollment Period

4 months

First QC Date

July 9, 2023

Last Update Submit

February 14, 2024

Conditions

Keywords

Acupuncture dry needleChronic mechanical low back pain

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    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 Outcomes (2)

  • Functional disability

    Four weeks

  • Lumbar range of motion

    Four weeks

Study Arms (2)

Acupuncture dry needle

ACTIVE COMPARATOR

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

Stretching and strengthening exercises

NO INTERVENTION

This group received only stretching and strengthening exercises for back muscles.

Interventions

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.

Acupuncture dry needle

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age ranges from 20 to 45 years old.
  • 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).
  • Presence of MTrPs at least in 4 muscles on any side.
  • Patients had lower back myofascial pain syndrome for at least 3 months ago.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walid Kamal Abdelbasset

Al Kharj, Riyadh Region, 11942, Saudi Arabia

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

July 9, 2023

First Posted

November 18, 2023

Study Start

September 1, 2022

Primary Completion

January 11, 2023

Study Completion

February 21, 2023

Last Updated

February 15, 2024

Record last verified: 2023-11

Locations