NCT06207097

Brief Summary

Low back pain is a common musculoskeletal health condition in society. It is a leading cause of disability globally and has created a significant burden in terms of work disability and high healthcare costs. Studies on the treatment of combined therapies for non-specific low back pain are scarce, so it is not known in depth which intervention is the best for reducing pain. For this reason, the objective of this study was to evaluate and compare the effect of physical exercise plus dry needling versus physical exercise plus elastic bandage. For this, a randomized clinical trial was carried out with a total of 22 people, where pain was evaluated using the ENA scale and functionality using the Oswestry test. Participants received CORE stabilization exercises. CORE stability training has become a popular training trend and has begun to be applied in rehabilitation programs and sports medicine (1). The expected results of the study are that the group that receives the physical exercise intervention plus dry needling will have better results in reducing the pain and functionality variable, evaluated with ENA and Oswestry in 4 sessions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Aug 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2023

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 16, 2024

Completed
Last Updated

January 16, 2024

Status Verified

January 1, 2024

Enrollment Period

1 month

First QC Date

January 5, 2024

Last Update Submit

January 5, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain (pain scale (VAS) 1 to 109

    visual analog pain scale

    1 week

Secondary Outcomes (1)

  • dysfunction (percentage of disability due to low back pain (from 0 to 10%))

    1 week

Study Arms (2)

Dry needling plus exercise program.

EXPERIMENTAL
Other: physiotherapy techniques

Elastic taping plus exercise program.

EXPERIMENTAL
Other: physiotherapy techniques

Interventions

Dry neeling: invasive physiotherapy technique where an acupuncture needle is used on painful points Elastic taping: physiotherapy technique where elastic bandage is used on the skin Exercise program: physical exercise prescription

Dry needling plus exercise program.Elastic taping plus exercise program.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Workers of the University of the Americas, Santiago Centro Campus, Echaurren and República Headquarters

You may not qualify if:

  • Not having a diagnosis of cancer,
  • Hernia of the nucleus pulposus with neural symptoms,
  • Pregnant
  • History of recent surgery (\<6 months)
  • History of tumor
  • History of spinal fracture
  • People with belonephobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de las Americas

Santiago, Santiago Metropolitan, 7750495, Chile

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Ignacio Astudillo, PhD

    Universidad de las Americas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 5, 2024

First Posted

January 16, 2024

Study Start

August 1, 2023

Primary Completion

September 1, 2023

Study Completion

December 18, 2023

Last Updated

January 16, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations