Manual Therapy Effectiveness in Comparison With Electric Nerve Stimulation (TENS) in Patients With Neck Pain
Primary Purpose
Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual therapy (MT)
TENS
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring Neck pain, Primary Health Care, Manual Therapy, TENS
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
Sites / Locations
- Servicio Madrileño de Salud
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
manual therapy
TENS
Arm Description
Electric Nerve Stimulation (TENS)
Outcomes
Primary Outcome Measures
Pain intensity measured in millimeters (Visual Visual Analogue Scale, VAS)
Secondary Outcome Measures
Full Information
NCT ID
NCT01153737
First Posted
June 29, 2010
Last Updated
November 5, 2017
Sponsor
Gerencia Atencion Primaria Area 3
Collaborators
University of Alcala
1. Study Identification
Unique Protocol Identification Number
NCT01153737
Brief Title
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
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Gerencia Atencion Primaria Area 3
Collaborators
University of Alcala
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Neck pain, Primary Health Care, Manual Therapy, TENS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
manual therapy
Arm Type
Experimental
Arm Title
TENS
Arm Type
Active Comparator
Arm Description
Electric Nerve Stimulation (TENS)
Intervention Type
Other
Intervention Name(s)
Manual therapy (MT)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
TENS
Intervention Description
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 Outcome Measure Information:
Title
Pain intensity measured in millimeters (Visual Visual Analogue Scale, VAS)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esperazna Escortell, MD
Organizational Affiliation
Servicio Madrileño de Salud, Madrid, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Servicio Madrileño de Salud
City
Madrid
ZIP/Postal Code
28803
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
18620635
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.
Results Reference
background
PubMed Identifier
20691631
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.
Results Reference
background
PubMed Identifier
20337831
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.
Results Reference
background
PubMed Identifier
19054468
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.
Results Reference
result
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Manual Therapy Effectiveness in Comparison With Electric Nerve Stimulation (TENS) in Patients With Neck Pain
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