Clinical trial NCT01153737: Manual Therapy Effectiveness in Comparison With Electric Nerve Stimulation (TENS) in Patients With Neck Pain
Official title: Primary Care Randomized Clinical Trial: Manual Therapy Effectiveness in Comparison With TENS in Patients With Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Neck pain
Primary Health Care
Manual Therapy
TENS
Lead sponsor: Gerencia Atencion Primaria Area 3
Sponsor class: OTHER_GOV
Collaborators: name: University of Alcala
First posted: 2010-06-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The purpose of tis study is to evaluate the effectiveness of manual therapy (MT) with Electric Nerve Stimulation (TENS) to reduce pain intensity in patients with mechanical neck disorder (MND). Design: randomized multi-centered controlled clinical trial. Location: 12 Primary Care Physiotherapy Units in Madrid Region. Ninety patients were included with diagnoses of subacute or chronic MND without neurological damage, 47 patients received MT and 43 TENS. The primary outcome was pain intensity measured in millimeters using the Visual Analogue Scale. Also disability, quality of life, adverse effects and sociodemographic and prognosis variables were measured. Three evaluations were performed (before, when the procedure finished and six months after). Seventy one patients (79%) completed the follow-up measurement at six months. In more than half of the treated patients the procedure had a clinically relevant "short term" result after having ended the intervention, when either MT or TENS was used. The success rate decreased to one third of the patients 6 months after the intervention. No differences can be found in the reduction of pain, in the decrease of disability nor in the quality of life between both therapies. Both analyzed physiotherapy techniques produce a short term pain reduction that is clinically relevant.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pain intensity measured in millimeters (Visual Visual Analogue Scale, VAS)
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Servicio Madrileño de Salud
Study officials:
affiliation: Servicio Madrileño de Salud, Madrid, Spain
name: Esperazna Escortell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.