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

November 5, 2017 updated by: Gerencia Atencion Primaria Area 3

Primary Care Randomized Clinical Trial: Manual Therapy Effectiveness in Comparison With TENS in Patients With Neck Pain

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28803
        • Servicio Madrileño de Salud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: manual therapy
Other: Manual therapy (MT)
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.
ACTIVE_COMPARATOR: TENS
Electric Nerve Stimulation (TENS)
Other: TENS
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gerencia Atencion Primaria Area 3

Collaborators

University of Alcala

Investigators

  • Principal Investigator: Esperazna Escortell, MD, Servicio Madrileño de Salud, Madrid, Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (ACTUAL)

May 1, 2007

Study Completion (ACTUAL)

May 1, 2007

Study Registration Dates

First Submitted

June 29, 2010

First Submitted That Met QC Criteria

June 29, 2010

First Posted (ESTIMATE)

June 30, 2010

Study Record Updates

Last Update Posted (ACTUAL)

November 7, 2017

Last Update Submitted That Met QC Criteria

November 5, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04/1320

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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