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

This study has been completed.
Sponsor:
Collaborator:
University of Alcala
Information provided by:
Gerencia Atencion Primaria Area 3
ClinicalTrials.gov Identifier:
NCT01153737
First received: June 29, 2010
Last updated: February 15, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention
Neck Pain
Other: Manual therapy (MT)
Other: TENS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Primary Care Randomized Clinical Trial: Manual Therapy Effectiveness in Comparison With TENS in Patients With Neck Pain

Resource links provided by NLM:


Further study details as provided by Gerencia Atencion Primaria Area 3:

Primary Outcome Measures:
  • Pain intensity measured in millimeters (Visual Visual Analogue Scale, VAS) [ Designated as safety issue: Yes ]

Enrollment: 90
Study Start Date: May 2005
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01153737

Locations
Spain
Servicio Madrileño de Salud
Madrid, Spain, 28803
Sponsors and Collaborators
Gerencia Atencion Primaria Area 3
University of Alcala
Investigators
Principal Investigator: Esperazna Escortell, MD Servicio Madrileño de Salud
  More Information

Publications:
Responsible Party: Esperanza Escortell, Gerencia Atencion Primaria Area 3
ClinicalTrials.gov Identifier: NCT01153737     History of Changes
Other Study ID Numbers: 04/1320
Study First Received: June 29, 2010
Last Updated: February 15, 2011
Health Authority: Spain: Ministry of Health

Keywords provided by Gerencia Atencion Primaria Area 3:
Neck pain
Primary Health Care
Manual Therapy
TENS

Additional relevant MeSH terms:
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 25, 2014