NCT02537119

Brief Summary

Effectiveness of a technique of dynamic massage therapy in the hamstrings in patients with nonspecific low back pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started May 2015

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

May 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 27, 2016

Status Verified

September 1, 2015

Enrollment Period

3 months

First QC Date

June 26, 2015

Last Update Submit

January 26, 2016

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Hamstrings extensibility measured with sit-and-reach test

    Fixing a meter stick on top of a solid box so that 26 cm of the ruler extend over the front edge of the box toward the test subject. Used to check the increase in hip flexion.

    Two weeks

Secondary Outcomes (2)

  • Low back pain measured with visual analog scale

    Two weeks. Participants will be followed for four weeks after completion of the intervention

  • Low back disability measured with the Oswestry Disability Questionnaire

    Two weeks. Participants will be followed for four weeks after completion of the intervention

Study Arms (2)

Dynamic massage therapy

EXPERIMENTAL

Rubbing on hamstrings combined with articular movement

Procedure: Dynamic massage therapy

Massage therapy

ACTIVE COMPARATOR

Rubbing on hamstrings

Procedure: Massage therapy

Interventions

Dynamic massage therapyPROCEDURE

Dynamic massage therapy on hamstring combined with knee extension

Dynamic massage therapy
Massage therapyPROCEDURE

Rubbing on hamstrings

Massage therapy

Eligibility Criteria

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

You may qualify if:

  • years old.
  • Low back pain with over three months of evolution.
  • Practice sports regularly (at least three times a week).

You may not qualify if:

  • Fractures, Tumors, congenital anomalies, rheumatic diseases, infectious or inflammatory processes.
  • Pathology Nerve root
  • Presence of neurological deficit or neuromuscular diseases.
  • Surgery
  • Physiotherapy treatment for low back pain in the last 30 days.
  • Drugs in previous 24h

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CEU Cardenal Herrera University

Moncada, Valencia, 46113, Spain

Location

Related Publications (3)

  • Pecos-Martin D, Montanez-Aguilera FJ, Gallego-Izquierdo T, Urraca-Gesto A, Gomez-Conesa A, Romero-Franco N, Plaza-Manzano G. Effectiveness of dry needling on the lower trapezius in patients with mechanical neck pain: a randomized controlled trial. Arch Phys Med Rehabil. 2015 May;96(5):775-81. doi: 10.1016/j.apmr.2014.12.016. Epub 2015 Jan 9.

    PMID: 25582412BACKGROUND

  • Montanez-Aguilera FJ, Valtuena-Gimeno N, Pecos-Martin D, Arnau-Masanet R, Barrios-Pitarque C, Bosch-Morell F. Changes in a patient with neck pain after application of ischemic compression as a trigger point therapy. J Back Musculoskelet Rehabil. 2010;23(2):101-4. doi: 10.3233/BMR-2010-0255.

    PMID: 20555123BACKGROUND

  • Aguilera FJ, Martin DP, Masanet RA, Botella AC, Soler LB, Morell FB. Immediate effect of ultrasound and ischemic compression techniques for the treatment of trapezius latent myofascial trigger points in healthy subjects: a randomized controlled study. J Manipulative Physiol Ther. 2009 Sep;32(7):515-20. doi: 10.1016/j.jmpt.2009.08.001.

    PMID: 19748402BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Massage

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • FJavier Montañez-Aguilera, Doctor

    Cardenal Herrera University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 26, 2015

First Posted

September 1, 2015

Study Start

May 1, 2015

Primary Completion

August 1, 2015

Study Completion

January 1, 2016

Last Updated

January 27, 2016

Record last verified: 2015-09

Locations

ES(1)