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Effectiveness of Dry Needling Adding to Physical Therapy in Patients With Chronic Non-Specific Neck Pain

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ClinicalTrials.gov Identifier: NCT02927977
Recruitment Status : Not yet recruiting
First Posted : October 7, 2016
Last Update Posted : October 11, 2016
Sponsor:
Information provided by (Responsible Party):
Fábio Franciscatto Stieven, Federal University of Health Science of Porto Alegre

Brief 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.

Condition or disease Intervention/treatment Phase
Neck Pain Other: control Other: dry needling Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dry-needling Added to Physical Therapy for Treating Patients With Chronic Non-specific Neck Pain: a Randomized Controlled Trial
Study Start Date : December 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control
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.
Other: control
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.
Other Name: active control

Experimental: dry needling
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. Participants will receive 4-6 treatments during 4 weeks.
Other: dry needling
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.




Primary Outcome Measures :
  1. pain intensity [ Time Frame: 4 weeks after randomisation ]
    measured by 11-point numeric rating scale

  2. disability [ Time Frame: 4 weeks after randomisation ]
    measured by neck disability index


Secondary Outcome Measures :
  1. pain intensity [ Time Frame: 12, 24 weeks after randomisation ]
    measured by 11-point numeric rating scale

  2. disability [ Time Frame: 12, 24 weeks after randomisation ]
    measured by neck disability index

  3. global perceived effect [ Time Frame: 4,12, 24 weeks after randomisation ]
    measured by global perceived rating scale

  4. quality of sleep [ Time Frame: 4,12, 24 weeks after randomisation ]
    measure by Pittsburgh quality index

  5. catastrophizing [ Time Frame: 4,12, 24 weeks after randomisation ]
    measure by pain catastrophizing scale

  6. self-efficacy [ Time Frame: 4,12, 24 weeks after randomisation ]
    measured by The Pain Self-Efficacy Questionnaire

  7. adverse events [ Time Frame: 24h, 72h and four weeks after randomisation ]
    record of the adverse events



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • able to speaking and reading in Portuguese, severity of the symptoms at least 3 points on 0-10 numeric pain rating and at least 14% disability on Neck Disability Index.

Exclusion Criteria:

  • history of whiplash associated injuries, fibromyalgia, cervical spine symptoms of radiculopathy or myelopathy, use of anticoagulant medication, pregnancy, history of spinal surgeries and "red flags" (spinal fracture, inflammatory diseases, tumor, fracture, rheumatoid arthritis, osteoporosis).

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): NCT02927977


Contacts
Contact: Marcelo F Silva, PhD +55 51 81102571 marcelofs@ufcspa.edu.br
Contact: Fábio F Stieven, master +55 51 81102571 fabio.stieven@gmail.com

Sponsors and Collaborators
Federal University of Health Science of Porto Alegre
Investigators
Principal Investigator: Fábio F Stieven, Master Federal University of Health Science of Porto Alegre

Responsible Party: Fábio Franciscatto Stieven, MsC, Federal University of Health Science of Porto Alegre
ClinicalTrials.gov Identifier: NCT02927977     History of Changes
Other Study ID Numbers: DRY01
First Posted: October 7, 2016    Key Record Dates
Last Update Posted: October 11, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Fábio Franciscatto Stieven, Federal University of Health Science of Porto Alegre:
dry needling
exercise
manual therapy

Additional relevant MeSH terms:
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms