Condition category
Cancer
Date applied
09/10/2011
Date assigned
08/11/2011
Last edited
05/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ester Cerezo-Téllez

ORCID ID

Contact details

University of Alcalá
Faculty of Nursing and Physiotherapy
Madrid
E-28871
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

26/2010

Study information

Scientific title

Effectiveness of deep dry needling in active miofascial trigger points in the reduction of non-specific cervical pain

Acronym

Study hypothesis

Deep dry needling of miofascial active trigger points of cervical muscles in patients suffering frominespecific cervicalgya is effective in patient's pain dimminution.

The prevalence of Miofascial active trigger points and non-specific cervicalgia are related.

Ethics approval

1. Ethics Committee of Clinical Trials of Area 3 at University Hospital of Alcalá de Henares, Madrid (Spain), July 2010, ref: 26/2010
2. Research Central Comission of Ethics of "Gerencia Area 3 Atención Primaria", 13 April 2011, ref: 44/11

Study design

Simple blinded randomized controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Pain

Intervention

Patients in the group of "Invasive Physical Therapy" will be treated with deep dry needling in all miofascial active trigger points found in cervical musculature described. They were also be applied analytical passive stretching of the muscles where deep dry needling have been applied.

Patients in "control group" (minimal intervention group) will receive the same analytical passive stretching in the muscles where active MTrPs have been found than patients in the group of "Invasive Physical Therapy." In both groups, the intervention program will consist of 2 sessions a week over a period of 2 weeks, 4 sessions of physiotherapy in total. There will be a physiotherapy review pre-intervention as baseline, a second assessment physiotherapy during the intervention (after the 2nd session of treatment) and third assessment of physical therapy after finishing the intervention (at the end of the 4th session of physical therapy), and 4 ratings physiotherapeutic track 15, 30, 90 and 180 days.
In the event that the patient no longer reported pain (VAS = 0) before the end of the scheduled physical therapy sessions, physical therapy should be stopped keeping follow-up assessments provided.

Follow-up
After first baseline assessment pre-intervention assessments were scheduled during physical therapy.

Reviews post-intervention (4 days after physical therapy treatment so that post-needling pain does not influence the assessment):
1. After physical therapy treatments and before the third session of physical therapy
2. After the fourth physical therapy treatment
3. Assesments during the treatment
4. Physical therapy evalutations were conducted as follow-up at 15, 30, 90 and 180 days respectively.

Each group will be treated by a different physiotherapist. Before starting the study, consensus intervention meetings will be held to ensure that analytical passive stretching of the muscles in both groups is identical. All physical therapy participants in the study are specialists in physical therapy diagnosis and the Miofascial pain syndrome.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Subjective pain using Visual Analogue Scale (VAS)

Secondary outcome measures

1. Demographic
2. Antropometrics: weight and height
3. Antecedents: evolution time of the problem, previous traumatisms, etc.
4. Assesment of muscles (trapezius, levator scapulae, multifidus, esplenius cervicis) to find presence of Miofascial Active trigger points
5. Pain pressure threshold of active MTrP in mentioned musculature using algometry Foix (Wagner Intruments, USA) in Kg/cm2
6. Cervical articular range of movement (Flexoextension, rotation and lateral flexion (inclination)) using CROM goniometer in degrees
7. Strength (Flexion, extension, rotation and lateral flexion (inclination)) using digital dinamometer Microfet 2 (Hoogan Health Industries, USA) in Newtons
8. If patients have any analgesics (Non steroideal anti-inflamatory drugs)

Overall trial start date

01/06/2011

Overall trial end date

30/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Over 18 years old
2. Present a diagnostic of non specific cervical chronic (more than 3 months with pain sintomatology)
3. Neck pain (with non-traumatic antecedents, neurologic infection, discal problems)
4. Present Miofascial active Trigger Points in multifidus, splenius cervicis, levator scapulae and trapezius muscles
5. The pain must be on or over 3 points in Visual Analogue Scale
6. The patients must have signed the informed consent

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

148 patients will be selected

Participant exclusion criteria

1. Patients who present any contraindication for physical therapy treatment as deep dry needling (infection, fever, hypothyroidism, insuperable afraid of needles, injuries on the skin above the needling, metal allergy, cancer, systemic diseases)
2. Psycotic and depresive patients

Recruitment start date

01/06/2011

Recruitment end date

30/12/2013

Locations

Countries of recruitment

Spain

Trial participating centre

University of Alcalá
Madrid
E-28871
Spain

Sponsor information

Organisation

University of Alcalá, Madrid (Spain)

Sponsor details

c/o Prof Ester Cerezo-Téllez
Faculty of Physiotherapy
Madrid
E-28871
Spain

Sponsor type

University/education

Website

http://www.uah.es/

Funders

Funder type

Hospital/treatment centre

Funder name

Carlos III National Health Care Institute (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Mapfre Foundation (Spain)

Alternative name(s)

Mapfre Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Argentina

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes