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NCT Number: NCT01153737

Manual Therapy Effectiveness in Comparison With Electric Nerve Stimulation (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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Servicio Madrileño de Salud

Madrid, 28803, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

TENS

Other

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.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Gerencia Atencion Primaria Area 3

Other Gov

Collaborators

  • University of Alcala

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jun 30, 2010
Registry last updated
Nov 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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