Manual Therapy Effectiveness in Comparison With Electric Nerve Stimulation (TENS) in Patients With Neck Pain

Not Applicable

Completed

• Conditions: Neck Pain
• Interventions: Other: Manual therapy (MT); Other: TENS

• Registration Number: NCT01153737
• Lead Sponsor: Gerencia Atencion Primaria Area 3

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.

Study Timeline

• Study Start: 2005-05
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Study First Submitted: 2010-06-29
• Study First Submitted QC: 2010-06-29
• Study First Posted: 2010-06-30
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-05
• Last Update Posted: 2017-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
manual therapy	Manual therapy (MT)	-
TENS	TENS	Electric Nerve Stimulation (TENS)

Primary Outcome Measures

Name	Time	Method
Pain intensity measured in millimeters (Visual Visual Analogue Scale, VAS)

Trial Locations

Locations (1)

Servicio Madrileño de Salud; 🇪🇸 Madrid, Spain