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Dry Needling in Chronic Neck Pain.

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ClinicalTrials.gov Identifier: NCT03844802
Recruitment Status : Recruiting
First Posted : February 18, 2019
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Alberto Marcos Heredia-Rizo, University of Seville

Brief Summary:

Objectives: To evaluate the effectiveness of dry needling in perceived pain on patients with chronic unilateral neck pain with active or latent myofascial trigger points, and to evaluate the effectiveness of dry needling in mechanosensitivity, sensorimotor function, neck disability perception and quality of life. Finally, the study will aim to analyze the cost-utility of the intervention.

Design: Quantitative, experimental, longitudinal, prospective, and single blind study.

Subjects: Patients aged between 18 and 55 years, with non specific unilateral neck pain of at least 3 months of evolution. Methods: Both groups will undergo 4 sessions of treatment (2 times per week during 2 weeks). Both groups will be instructed in the performance of cervical exercises, which will be carried out on intervention days and at home between sessions. The intervention group will receive dry needling, using a rapid entry and exit technique, as described by Hong, in the evaluated muscles. Dry needling will evoke at least four local twitch responses in order to be successful.

For patients in the control group, the exercise program will be carried out following the same guidelines than the intervention group. Additionally, they will undergo deep dry needling in the affected muscles, but the needle will be inserted in a location far from the myofascial trigger point and without evoking local twitch responses.


Condition or disease Intervention/treatment Phase
Neck Pain Other: Dry needling and exercise Other: Sham dry needling and exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of Real and Placebo Dry Needling in Women With Unilateral Chronic Neck Pain
Actual Study Start Date : March 25, 2019
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dry needling and exercise
Dry needling and neck exercises. Patients will receive 2 dry needling sessions a week during 2 weeks (4 sessions in total). They will also undergo neck exercises in treatment days and in between sessions days at home.
Other: Dry needling and exercise

Dry needling in those assessed muscles (anterior scalene, sternocleidomastoid, levator scapulae, splenius of the head, inferior fibers of the trapezius muscle and postero-inferior serratus) that present active or latent myofascial trigger points, according to the diagnostic procedures described by Travell and Simons. The intervention technique chosen for dry needling will be the so-called rapid entry and exit technique described by Hong, and evoking between 4 and 6 local twitch responses.

Patients will also perform therapeutic neck exercises at home.


Sham Comparator: Sham dry needling and exercise
Sham dry needling and neck exercises. Patients will receive 2 "sham dry needling" sessions a week during 2 weeks (4 sessions in total). As formerly described, patients in this group will receive dry needling in those neck muscles with active or latent myofascial trigger points, but without evoking local twitch responses. They will also do neck exercises in treatment days and in between sessions days at home.
Other: Sham dry needling and exercise

Patients in this group will undergo sham-dry needling. For that purpose, sham dry needling will be carried out in those assessed muscles (anterior scalene, sternocleidomastoid, levator scapulae, splenius of the head, inferior fibers of the trapezius muscle and postero-inferior serratus) that present active or latent myofascial trigger points, according to the diagnostic procedures described by Travell and Simons. The intervention technique chosen for these participants will be to insert the needle in a location in the same muscle, but far away (at least 1-1.5 cm) from the location of the myofascial trigger point. Likewise, the needle will be inserted without evoking local twitch responses.

at a distance of 1,5 cm from the active or latent trigger point. Patients will also perform therapeutic neck exercises.





Primary Outcome Measures :
  1. Intensity of cervical pain in cervical rest position, assessed by the numeric pain rating scale (NPRS) [ Time Frame: From Baseline to after treatment, and with a 3-month follow up ]
    The Numeric Pain Rating Scale is a 11-point rating scale that ranges from 0, which denotes no pain at all, to 10, which denotes the maximum bearable pain


Secondary Outcome Measures :
  1. Intensity of cervical pain associated to both cervical rotation movements, assessed by the numeric pain rating scale (NPRS). [ Time Frame: From Baseline to after treatment, and with a 3-month follow up ]
    The Numeric Pain Rating Scale is a 11-point rating scale that ranges from 0, which denotes no pain at all, to 10, which denotes the maximum bearable pain

  2. Neck disability index (NDI) [ Time Frame: From Baseline to after treatment, and with a 3-month follow up ]
    The neck disability index is a condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. The NDI can be scored as a raw score or expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means no pain and 5 means worst imaginable pain. The final score can range from 0 to 50 points (raw score) or from 0% to 100%, with 0 points or 0% denoting no activity limitations, and 50 points or 100% denoting complete activity limitation.

  3. Number of active and latent myofascial trigger points in the evaluated muscles [ Time Frame: From Baseline to after treatment, and with a 3-month follow up ]
    The number of active or latent myofascial trigger points will be numerically quantified.

  4. Pressure pain threshold (PPT) in the evaluated muscles. [ Time Frame: From Baseline to after treatment, and with a 3-month follow up ]
    PPT levels, defined as the minimum necessary pressure to evoke pain will be evaluated using a handheld electronic pressure algometer (Somedic AB, Horby, Sweden) with a 1-cm2 contact rubber probe.

  5. Quality of Life, as assessed by the European Quality of Life test (EQ-5D). [ Time Frame: From Baseline to after treatment, and with a 3-month follow up ]
    EQ-5D is an instrument which evaluates the generic quality of life. The EQ-5D descriptive system is a preference-based health related quality of life measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers given to this questionnaire permit to find 243 unique health states or can be converted into EQ-5D index an utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).

  6. Sensitivity and discrimination response, as assessed by the two-point discrimination test [ Time Frame: From Baseline to after treatment, and with a 3-month follow up ]
    The two-point discrimination test is used to assess if the patient is able to identify two close points on a small area of skin, and how fine the ability to discriminate this area is. It is a measure of tactile agnosia, or the inability to recognize these two points despite intact cutaneous sensation and proprioception.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only female participants will be included
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Suffering unilateral non specific mechanic chronic neck pain.
  • Pain of more than 3 months of duration.
  • Self-reported pain higher than 2 in the Numeric Pain Rating Scale.

Exclusion Criteria:

  • Bilateral pain.
  • Isolated headache without neck pain.
  • Diagnosis of specific pathology.
  • Previous cervical surgery.
  • Radiculopathy.
  • Inflammatory rheumatologic disease.
  • Fibromyalgia.
  • Cognitive disorder
  • Previous history of tumoral diseases
  • Having received physiotherapy treatment in the last 3 months.
  • Having received anti-inflammatory treatment, or muscle relaxants in the last 72 hours.
  • A score equal or less than 5 in the Neck Disability Index
  • Any contraindication to the use of dry needling

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03844802


Contacts
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Contact: Fernando Piña-Pozo, PT 954486507 ferppozo@hotmail.com
Contact: Alberto M Heredia-Rizo, PhD 954486507 amheredia@us.es

Locations
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Spain
University of Sevilla Recruiting
Sevilla, Spain, 41009
Contact: Alberto M Heredia-Rizo, PhD    +34 954486507    amheredia@us.es   
Sponsors and Collaborators
University of Seville
Investigators
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Study Director: Alberto M Heredia-Rizo, PhD Physiotherapy Department, University of Sevilla, Spain

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Responsible Party: Alberto Marcos Heredia-Rizo, Assistant Professor, University of Seville
ClinicalTrials.gov Identifier: NCT03844802     History of Changes
Other Study ID Numbers: Dry Needling
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alberto Marcos Heredia-Rizo, University of Seville:
neck pain
randomized control trial
trigger points
dry needling
physical therapy
Additional relevant MeSH terms:
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Neck Pain
Pain
Neurologic Manifestations
Signs and Symptoms