Effectiveness of Dry Needling Adding to Physical Therapy in Patients With Chronic Non-Specific Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The purpose of this randomized clinical trial is to verify the effectiveness of the addition
      of the dry needling in individuals with non-specific neck pain who receive a multimodal
      physical therapy rehabilitation program.
    

Detailed description: 
      Background: Neck pain is a costly and high prevalent problem. Current evidences show that
      pain education, exercises and manual therapy are recommended to treat patients with chronic
      non-specific neck pain, but the use of dry needling has not been studied adequately when in
      combination with these therapies.

      Previous trials have shown that dry needling have effectiveness in reducing neck pain in the
      short and medium term. However, these studies have some limitations as a small sample size
      and follow-up time reduced. A clinical trial with multimodal treatment method and consistent
      with clinical practice is needed to determine the effects of dry needling on individuals with
      non-specific neck pain.

      Purpose: The purpose of this randomized clinical trial is to verify the effectiveness of the
      addition of the dry needling in individuals with non-specific neck pain who receive a
      multimodal physical therapy rehabilitation program and compare to individuals who received
      the multimodal physical therapy rehabilitation program without the use of the dry needling.

      Design: a randomized single blind placebo controlled trial will be conducted trial in
      accordance with the CONSORT guidelines. Patients (n=116) with non-specific neck pain will be
      randomized to receive 1) pain education, manual therapy, and exercise (n=58) or 2) pain
      education, manual therapy, exercise and dry needling (n=58). Participants will receive 4-6
      treatments during 4 weeks. Clinical outcomes (pain intensity, disability,global perceived
      effect, self-efficacy, quality of sleep and catastrophizing) will be obtained at follow-up
      appointments at four, twelve and twenty-four weeks after randomisation.

      Methods: The primary outcome will be pain (measured by 11-point numerical pain rating scale)
      and disability (measured by the Neck Disability Index) measure four weeks after
      randomization. Secondary outcome will be pain and disability in twelve and twenty-four weeks
      after randomization and global perceived effect (measured by global perceived rating scale),
      self-efficacy (measured by pain self-efficacy questionnaire), quality of sleep (measure by
      Pittsburgh quality index), catastrophizing (measure by pain catastrophizing scale) measured
      four weeks, twelve weeks and twenty-four weeks after randomization and and registration of
      adverse events (24h, 27h and four weeks after randomization).

      Data Analysis: All outcomes will be assessed following intention-to-treat principles. For
      each outcome, linear mixed models will be employed containing terms for participant,
      treatment center, group, time and group by time interaction. Known prognostic factors for
      increased disability in chronic neck pain will be treated as potential confounders and, in
      the presence of group imbalance despite random allocation, they will be treated as covariates
      for all outcomes. For the primary outcomes, a p < 0.05 will be considered statistically
      significant. For all secondary outcomes, a p < 0.01 will be considered statistically
      significant.

      Significance: the results of this study will provide new information about the clinical
      application of dry needling in additional component for the management of non-specific neck
      pain.
    

Intervention name(s): control; dry needling
Intervention type(s): Other; Other
Intervention description(s): Individuals with neck pain will receive a multimodal rehabilitation program composed by pain education, exercises and manual therapy. Participants will receive 4-6 treatments during 4 weeks.; Individuals with neck pain will receive a multimodal rehabilitation program composed by pain education, exercises, manual therapy and dry needling in neck muscles. Participants will receive 4-6 treatments during 4 weeks.
Other intervention name(s): active control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: dry needling; exercise; manual therapy