Comparing Dry Needling to Manual Therapy for Patients With Mechanical Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This is a comparative study to determine if there is a difference in pain reduction and
      disability between dry needling and manual therapy for patients with low back pain. Subjects
      will be seen two times per week for 3 weeks (6 visits) and will receive either dry needling
      or manual mobilizations along with patient education and a home exercise program.
    

Detailed description: 
      Procedures:

      Subjects will sign the informed consent prior to any examination procedures. Eligibility
      assessment will be performed by the treating physical therapist and will include the subject
      filling out the demographic / health history questionnaire, outcome measures, and a clinical
      examination. The treating physical therapist will use 2 components of the examination for
      eligibility criteria into the study. The treating therapist will press on the subject's
      joints in their back to try to elicit their chief complaint. The treating physical therapist
      will also press on the soft tissue of the subject's back to check for any symptomatic points.
      A symptomatic point would include recreation of their chief complaint, tenderness,
      hypersensitivity, or referred pain. The treating physical therapist will then draw an X on
      the patient's back where the most symptomatic tissue exists. This point will be used by the
      data collecting physical therapist in order to collect pain pressure threshold of the area.

      The data collecting physical therapist will have the subject complete an Oswestry Disability
      Index(ODI), gather a measure of the pain from the patient ,and the pain pressure threshold.
      Each subject will then be allocated to either the manual therapy group or the dry needling
      group.

      Once a subject is assigned to a group, they will receive either dry needling or manual
      therapy mobilizations by the treating therapist. Each subject will remain in the assigned
      group as long as they are continuing in the study up to 3 weeks. In addition to the
      treatments under investigation, a standardized home exercise program will be assigned to each
      of the subjects by the treating physical therapist. This program will be given to and
      reviewed with each subject to ensure they understand the exercises and will perform the
      exercise program 1x/day for the duration they are under the care of the physical therapist
      for the study. Subjects will be treated on day 1 of their plan of care and subsequent
      treatments will occur 2x/week for a total of 3 weeks, unless discharge occurs earlier than
      the 3 week data point. Early discharge will occur if the subject achieves resolution of
      symptoms or if they decide they no longer wish to be a research participant.

      Subsequent sessions will involve the collection of outcome data by the data-collecting
      therapist followed by treatment performed by the treating physical therapist. No adjustments
      will be made to the treatment protocol in any of the sessions. Subjects will only be
      scheduled with and treated by the same treating physical therapist each session. In the event
      that a treating physical therapist is unable to see a subject participating in the study, the
      subject will be rescheduled for a different time to receive care.
    

Intervention name(s): Manual therapy; Dry needling; Home Exercise Program
Intervention type(s): Other; Other; Other
Intervention description(s): The therapist will locate the involved segment using passive accessory intervertebral movements. The segment will be localized to the level, which provokes the patient's symptoms most easily, and this segment will be determined to be the involved level. Once this level has been identified, the therapist will compare central glides over the spinous process or a unilateral glide over the facet joint to determine which is more provocative. Whichever is most provocative will be the location of the treatment. The therapist will provide 3 bouts lasting 45 seconds just easing into the patient's symptoms at the most provocative level with approximately 45 seconds rest between each bout.; Dry needling involves inserting a dry, mono-filament needle through the skin and into an area of symptomatic soft tissue. The two-inch needles will be placed segmentally and into the lower extremities following peripheral nerve patterning by the treating physical therapist. Following initial penetration into the skin over the tender area, the therapist carefully advances the needle into the tissue below the skin. After the needle has reached the desired depth, the therapist will insert the subsequent needles. Needles will be placed along the segmental levels of the lumbar spine above and below the tender area identified and into the lower extremity in areas that correlate with a peripheral nerve map. Needles will remain in the tissue for up to 5 minutes, removed, and appropriately disposed of.; A home exercise program will be given to each subject to be completed in the clinic and at home 1x/day. The exercises will consist of active range of motion exercises and core stabilization exercises. The program is standardized for all subjects.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment