Neck PainNCT01153737
Manual Therapy Effectiveness in Comparison With Electric Nerve Stimulation (TENS) in Patients With Neck Pain
A study testing Manual therapy (MT) and TENS in people with Neck Pain, run by Gerencia Atencion Primaria Area 3 at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Manual therapy (MT) and TENS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- May 2005to May 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Neck Pain
- Being tested
- Manual therapy (MT), TENS
- Keywords
- Neck pain, Primary Health Care, Manual Therapy, TENS
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
TENSOther
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.
| Study group | Role | What they receive |
|---|---|---|
| manual therapy | Experimental | Not described Receives: Other: Manual therapy (MT) |
| TENS | Active comparator | Electric Nerve Stimulation (TENS) Receives: Other: TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity measured in millimeters (Visual Visual Analogue Scale, VAS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
- Study startMay 2005
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gerencia Atencion Primaria Area 3
- Sponsor type
- Other government
- Collaborators
- University of Alcala
- Investigators
- Esperazna Escortell, MD, Principal investigator, Servicio Madrileño de Salud, Madrid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01153737
- Sponsor's protocol ID
- 04/1320
- Status last verified
- Nov 2017
- First submitted
- 29 Jun 2010
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 18620635Escortell-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.
PubMed 20691631Elustondo 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.
PubMed 20337831Escortell 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.
PubMed 19054468
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care Randomized Clinical Trial: Manual Therapy Effectiveness in Comparison With TENS in Patients With Neck Pain
- ClinicalTrials.gov ID
- NCT01153737
- Acronym / sponsor ID
- 04/1320
- Conditions
- Neck Pain
- Keywords
- Neck pain, Primary Health Care, Manual Therapy, TENS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Gerencia Atencion Primaria Area 3Other government
- Collaborators
- University of Alcala
- Study start
- May 2005
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 30 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| manual therapy | Experimental | Other: Manual therapy (MT) |
| TENS | Active comparator | Other: TENSElectric Nerve Stimulation (TENS) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | manual therapy |
| TENSTen 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. | Other | TENS |
Primary outcome
Pain intensity measured in millimeters (Visual Visual Analogue Scale, VAS)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Background: PubMed 18620635Escortell 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.
- Background: PubMed 20691631Escortell-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.
- Background: PubMed 20337831Elustondo 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 publication: PubMed 19054468Escortell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esperazna Escortell, MD principal investigator
Servicio Madrileño de Salud, Madrid, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy (MT) and TENS in people with Neck Pain, run by Gerencia Atencion Primaria Area 3 at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity measured in millimeters (Visual Visual Analogue Scale, VAS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01153737, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2017.