Dry Needling in Patients With Chronic Neck Pain

• ClinicalTrials.gov Identifier: NCT02435966
• Recruitment Status: Completed
• First Posted: May 6, 2015
• Results First Posted: September 7, 2015
• Last Update Posted: September 7, 2015
• Sponsor: European University of Madrid
• Information provided by (Responsible Party): Gracia Gallego Sendarrubias, European University of Madrid

Tracking Information

• First Submitted Date: March 27, 2015
• First Posted Date: May 6, 2015
• Results First Submitted Date: August 8, 2015
• Results First Posted Date: September 7, 2015
• Last Update Posted Date: September 7, 2015
• Study Start Date: May 2013
• Actual Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 8, 2015)

Change in Pain Scores on the Visual Analog Scale (VAS: 0-10) After 30 Days [ Time Frame: Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later) ]

The Visual Analogue Scale is a validated, self-reported instrument to assess pain, with scores ranging from 0 (no pain) to 10 (maximum pain). We assess the change in chronic neck pain after 30 days, after to interventions in days 1 and 7) as compared to the baseline VAS

• Original Primary Outcome Measures (submitted: May 1, 2015): Change in Pain Scores on the Visual Analog Scale (VAS) [ Time Frame: Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later) ]

Current Secondary Outcome Measures (submitted: August 8, 2015)

• Change in the Pressure Pain Threshold Measured by Algometer [ Time Frame: Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later) ]
  Measured by algometer, with the standard measurement procedure
• Change in the Cervical Range of Motion Measured by Goniometer [ Time Frame: Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later) ]
  Measured by goniometer, with the standard measurement procedure
• Change in the Neck Disability Index Questionnaire [ Time Frame: Pre-intervention (Day 1); after 2nd intervention (7 days) ]

Original Secondary Outcome Measures (submitted: May 1, 2015)

• Change in the Pressure Pain Threshold measured by algometer [ Time Frame: Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later) ]
  Measured by algometer, with the standard measurement procedure
• Change in the Cervical Range of Motion measured by goniometer [ Time Frame: Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later) ]
  Measured by goniometer, with the standard measurement procedure
• Change in the Neck Disability index questionnaire [ Time Frame: Pre-intervention (Day 1); after 2nd intervention (7 days) ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dry Needling in Patients With Chronic Neck Pain
• Official Title: Effectiveness of Dry Needling on the Upper Trapezius and the Levator Scapulae in Patients With Chronic Neck Pain: Randomized Clinical Trial
• Brief Summary: The investigators study the efficacy of a combination of dry needling plus manual therapy against sham dry needling plus manual therapy in the treatment of chronic neck pain. The investigators identify the most active trigger point in the upper trapezius and levator scapulae and administer two treatments, with an interval of 7 days, with a follow up 30 days after the first intervention. The primary outcome is the Visual Analogue Scale of Pain. Secondary outcomes ar pressure pain threshold, Neck Disability Index (NDI) questionnaire and range of motion.

Detailed Description

A prospective single-blind randomized controlled trial, designed to assess the efficacy of dry needling in the treatment of chronic neck pain. The treatment regimes simulate the standard physiotherapy administered in real clinical settings. Patients in the intervention group receive a combination of manual therapy and dry needling (40mmx0,32 guided needles). There are two control groups. In the first one, patients receive a combination of manual therapy and sham dry needling. In the second control group, patients receive no treatment in order to assess the natural history of the disease.

Patients receive two treatment sessions with an interval of 7 days and are followed up after 30 days. The primary outcome is subjective pain assessed with a Visual Analogue Scale (VAS). Secondary outcomes are pressure pain threshold (assessed with a manual algometer), neck range of motion (assessed with a goniometer) and the Neck Disability Index (a standardized questionnaire). Measurements are taken pre and post-test after the first and the second treatment sessions, plus once more at the follow-up, except for the Neck Disability Index (only at the beginning and after the second treatment). In the non-treated group, patients were measured at the same time intervals.

The sample size was calculated to detect a VAS difference of 2 points, the minimally clinically important difference established in the literature. Then it was doubled in order to avoid possible dropouts. The trial takes place in a private practice in Madrid (Physios, c/Valverde 26). Patients are randomized by a computer program.

Patients are explored for active trigger points in the upper trapezius and the levator scapulae. They should meet the criteria of identification established by Travell & Simons in their Trigger point manual. The investigators also seek for trigger points following Travell & Simons' pain maps for these two muscles, where they identify five trigger point areas. The investigators select the most active, taking pressure pain threshold measurements of all the active trigger point, normalizing the values according to normal thresholds for each of the five areas in the two muscles. The normal thresholds were assessed in a pilot study with healthy patients. The investigators administer either dry or sham dry needling to the most active (the one with the lowest pain threshold) throughout the trial.

Dry needling is applied following Hong's technique with 40mmx0,32 guided needles, by a physiotherapist with 4 years of experience in the technique.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Neck Pain

Intervention

• Device: Dry needling
  Dry needling of the most active trigger point either in the upper trapezius or the levator scapulae with 40mm x 0,32mm ener-qi guided needles (EQ1132)
• Device: Sham Dry needling
  Sham Dry needling with a retractile needle (Park Sham Placebo Acupuncture Device) of the most active trigger point either in the upper trapezius or the levator scapulae
• Other: Manual therapy
  Standard manual therapy in the upper trapezius or the levator scapulae

Study Arms

• Experimental: Manual therapy + Dry needling
  Manual therapy + Dry needling: 2 sessions, after a 7 days interval
  Interventions:

  • Device: Dry needling
  • Other: Manual therapy
• Manual therapy + Sham Dry needling
  Manual therapy + Sham Dry needling: after a 7 days interval
  Interventions:

  • Device: Sham Dry needling
  • Other: Manual therapy
• No Intervention: Untreated control
  Natural history of the condition

• Publications *: Gallego-Sendarrubias GM, Rodriguez-Sanz D, Calvo-Lobo C, Martin JL. Efficacy of dry needling as an adjunct to manual therapy for patients with chronic mechanical neck pain: a randomised clinical trial. Acupunct Med. 2020 Aug;38(4):244-254. doi: 10.1136/acupmed-2018-011682. Epub 2020 Mar 23.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 1, 2015): 131
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: March 2015
• Actual Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion criteria

• Neck pain for at least three months (or more)
• An active trigger point in either the upper trapezius or the levator scapulae

Exclusion criteria

• Treatment for neck pain within the previous six months
• Neck Whiplash
• Fibromyalgia
• Infection in the area under treatment
• Pharmacological treatment with anti-coagulants
• Fear to needles
• Degenerative conditions
• Pregnancy

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02435966
• Other Study ID Numbers: University European of Madrid
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Gracia Gallego Sendarrubias, European University of Madrid
• Original Responsible Party: Same as current
• Current Study Sponsor: European University of Madrid
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: European University of Madrid
• Verification Date: August 2015