- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01153737
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
-
-
-
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
|
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)
|
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.
Collaborators
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
- 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.
- 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.
- 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.
- 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.
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.
Clinical Trials on Neck Pain
-
Fatih TekinPamukkale UniversityCompletedChronic Neck Pain | Persistent Neck Pain | Neuroscience ApproachTurkey
-
Jeff Elias, MDRecruitingCancer of Head and Neck | Pain, Neck | Pain, FaceUnited States
-
Hacettepe UniversityRecruitingNeck Pain | Cervical Pain | Neck Pain, Posterior | Neck Muscle Issue | Cervical Pain, PosteriorTurkey
-
Riphah International UniversityCompletedCervical Pain | Mechanical Neck PainPakistan
-
Riphah International UniversityCompleted
-
Instituto Brasileiro de OsteopatiaCompletedNeck Pain | Pain, NeckBrazil
-
Ankara UniversityCompleted
-
Josue Fernandez CarneroCentro Universitario La SalleCompleted
-
Sakarya UniversityUnknown
-
Shanghai University of Traditional Chinese MedicineBeijing Hospital; Dongzhimen Hospital, Beijing; Traditional Chinese Medicine... and other collaboratorsNot yet recruiting
Clinical Trials on Manual therapy (MT)
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingFibrosis | Dysphagia | Cancer Survivor | Head and Neck CarcinomaUnited States
-
Samueli Institute for Information BiologyWilliam Beaumont Army Medical Center; Palmer Center for Chiropractic Research... and other collaboratorsUnknown
-
Federal University of Rio Grande do SulCompletedTemporomandibular Disorder
-
Universidad Autonoma de MadridCompletedChronic Migraine | Chronic HeadacheSpain
-
Universidade Federal de PernambucoUnknownKnee OsteoarthritisBrazil
-
The Hong Kong Polytechnic UniversityCompletedMuscle Hypotonia | Behavior DisturbanceHong Kong
-
Campus Bio-Medico UniversityRecruiting
-
Chang Gung Memorial HospitalNot yet recruitingStroke | Cerebrovascular Disorders | Central Nervous System DiseasesTaiwan
-
Universidade Federal do Rio de JaneiroMaternidade Escola da UFRJ; Instituto de Puericultura e Pediatria Martagão...Completed
-
Alexander AchalandabasoCompletedChronic Pain | Neck PainSpain