NCT01153737

Brief Summary

This study investigated effectiveness of manual therapy (MT) with Electric Nerve Stimulation (TENS) to reduce pain intensity in patients with mechanical neck disorder (MND). A randomized multi-centered controlled clinical trial was performed in 12 Primary Care Physiotherapy Units in Madrid Region.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2005

Typical duration for not_applicable

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, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 30, 2010

Completed
Last Updated

November 7, 2017

Status Verified

November 1, 2017

Enrollment Period

2 years

First QC Date

June 29, 2010

Last Update Submit

November 5, 2017

Conditions

Neck Pain

Keywords

Neck painPrimary Health CareManual TherapyTENS

Outcome Measures

Primary Outcomes (1)

  • Pain intensity measured in millimeters (Visual Visual Analogue Scale, VAS)

Study Arms (2)

manual therapy

EXPERIMENTAL
Other: Manual therapy (MT)

TENS

ACTIVE COMPARATOR

Electric Nerve Stimulation (TENS)

Other: TENS

Interventions

Manual therapy (MT)OTHER

Ten treatment sessions of 30 minutes of MT or TENS on alternate days were provided by primary care physical therapists. MT techniques: neuromuscular technique, postisometric stretching, spray and stretching and Jones technique.

manual therapy
TENSOTHER

Ten treatment sessions of 30 minutes of MT or TENS on alternate days were provided by primary care physical therapists. TENS electrode placement were: in the painful area, in the metamere or in the nerve´s pathway. It was applied at a frequency of 80 Hz, with ≤150 µs pulse duration and adjusted amplitude.

TENS

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • diagnoses of subacute or chronic MND without neurological damage, according to the Classification of the Quebec Task Force on Spinal Disorders (Spitzer 1987);
  • full physical and psychological capacity to follow the clinical trial's requirements;
  • consent to participate

You may not qualify if:

  • Signs of neurological damage according to the Neurologic Screening Checklist (Hoving et al. 2002),
  • pregnant women,
  • previous neck rachis surgery,
  • patients who received physical therapy or an alternative treatment of the neck or shoulder 6 months prior to the beginning of the study,
  • patients who intended to receive other treatments during the study
  • patients with important psychiatric disorders or other health problems that would contraindicate the techniques to be used (i.e. pacemaker).
  • Patients with neck pain caused by an inflammatory, neurological or rheumatic disease, severe osteoporosis, fracture, luxation or vertebrobasilar insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Servicio Madrileño de Salud

Madrid, 28803, Spain

Location

Related Publications (4)

  • Escortell Mayor E, Lebrijo Perez G, Perez Martin Y, Asunsolo del Barco A, Riesgo Fuertes R, Saa Requejo C; TEMA-TENS Group. [Randomized clinical trial for primary care patients with neck pain: manual therapy versus electrical stimulation]. Aten Primaria. 2008 Jul;40(7):337-43. doi: 10.1157/13124126. Spanish.

    PMID: 18620635BACKGROUND

  • Escortell-Mayor E, Riesgo-Fuertes R, Garrido-Elustondo S, Asunsolo-Del Barco A, Diaz-Pulido B, Blanco-Diaz M, Bejerano-Alvarez E; TEMA-TENS Group. Primary care randomized clinical trial: manual therapy effectiveness in comparison with TENS in patients with neck pain. Man Ther. 2011 Feb;16(1):66-73. doi: 10.1016/j.math.2010.07.003. Epub 2010 Aug 5.

    PMID: 20691631BACKGROUND

  • Elustondo SG, Fuertes RR, Mayor EE, del Barco AA, Martin YP, Castro BM. Satisfaction of patients with mechanical neck disorders attended to by primary care physical therapists. J Eval Clin Pract. 2010 Jun;16(3):445-50. doi: 10.1111/j.1365-2753.2009.01138.x. Epub 2010 Mar 10.

    PMID: 20337831BACKGROUND

  • Escortell Mayor E, Lebrijo Perez G, Sanchez Sanchez B, Asunsolo del Barco A. [Difficulties in carrying out public projects of investigation in primary care]. Aten Primaria. 2008 Oct;40(10):536-7. doi: 10.1157/13127242. No abstract available. Spanish.

    PMID: 19054468RESULT

MeSH Terms

Conditions

Neck Pain

Interventions

Musculoskeletal ManipulationsTranscutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationElectric Stimulation TherapyAnalgesiaAnesthesia and Analgesia

Study Officials

  • Esperazna Escortell, MD

    Servicio Madrileño de Salud, Madrid, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

June 29, 2010

First Posted

June 30, 2010

Study Start

May 1, 2005

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

November 7, 2017

Record last verified: 2017-11

Locations

ES(1)