NCT04090502

Brief Summary

This study evaluates the treatment of hamstrings in the management of patients with mechanical low back pain of non-specific origin. Half of the participants will received the application of a dry needle technique in the most hyperalgesic areas of the muscle, while the other half will received the same technique in areas not hyperalgesic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

September 12, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2023

Completed
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

4.1 years

First QC Date

September 12, 2019

Last Update Submit

October 24, 2023

Conditions

Low Back Pain

Keywords

painBackHamstrings

Outcome Measures

Primary Outcomes (1)

  • Low back pain

    The investigators use a Visual Analog Scale (VAS) to determine the intensity of the patient with blowback pain.The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain" and the other end representing "worst pain." Subjects will be asked to rate their current pain with a mark on the scale.

    Change from Baseline Pressure Pain Threshold at 3 months

Secondary Outcomes (3)

  • Disability with Oswestry Disability Index

    Change from Baseline disability at 3 months

  • The extensibility of the hamstring muscle

    Change from Baseline disability at 3 months

  • Pressure Pain Threshold

    Change from Baseline Pressure Pain Threshold at 3 months

Study Arms (2)

Grupo A. Dry needling in Trigger point

EXPERIMENTAL

Participants will be treated in the most hyperalgesic foci within the hamstring musculature.

Other: Dry needling in hamstring muscle trigger points

Grupo B. Dry needling in non-hyperalgesic areas

PLACEBO COMPARATOR

Participants will be treated in non-hyperalgesic areas within the hamstring muscles.

Other: Dry needling in hamstring muscle not trigger points

Interventions

Dry needling in hamstring muscle trigger pointsOTHER

Participants with nonspecific mechanical low back pain will be assessed for the hamstring muscle. Subsequently, the most sensitive areas associated with the shortening of the muscle will be located and the technique will be applied to this area.

Also known as: intramuscular stimulation of muscle
Grupo A. Dry needling in Trigger point
Dry needling in hamstring muscle not trigger pointsOTHER

Participants with nonspecific mechanical low back pain will be assessed for the hamstring muscle. Subsequently, the most sensitive areas associated with the shortening of the muscle will be located and the technique will be applied out of this area.

Grupo B. Dry needling in non-hyperalgesic areas

Eligibility Criteria

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

You may qualify if:

  • Nonspecific chronic low back pain lasting ≥ 3 months.
  • Age between 18 and 65 years.
  • History of non-specific lumbar pain not irradiated to lower extremities of at least 1 year of evolution.
  • Those subjects who have not received a physiotherapy session in the last 6 months.

You may not qualify if:

  • Specific low back pain (infection, tumor, inflammation, canal stenosis, spondylolisthesis, hernia or disc prolapse, structural deformity, rheumatic disease, radicular pain, cauda equina, previous history of spinal surgery).
  • Fibromyalgia.
  • Treatment with corticosteroids or oral medications in the last 6 months.
  • History of spinal surgery.
  • Contraindications typical of deep dry puncture (needle phobia, coagulation or psychological disorders, varicose regions, cysts, wounds, metal or latex allergy, lymphedema, hypothyroidism, diabetes).
  • Those subjects with a value of 0º in the Active Knee Extension (EAR) test.
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centro Investigación Fisioterapia y Dolor

Alcalá de Henares, Madrid, 28805, Spain

Location

Instituto Fisioterapia y Dolor

Alcalá de Henares, Madrid, 28807, Spain

Location

MeSH Terms

Conditions

Low Back PainPain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Back PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Tomas Gallego-Izquierdo, PhD

    Alcala University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

September 12, 2019

First Posted

September 16, 2019

Study Start

October 1, 2019

Primary Completion

October 24, 2023

Study Completion

October 24, 2023

Last Updated

October 25, 2023

Record last verified: 2023-10

Locations

ES(2)