Dry Needling for Patients With Back Pain

Background: Back pain is a very common and costly disorder. The financial burden is one of
the highest of all health issues. Current treatments are not adequately effective for a large
proportion of patients who continue to experience recurrent pain and ongoing disability.
Therefore, new treatment strategies should be investigated in an attempt to reduce the
disability and high costs associated with back pain.

Dry needling is a technique in which a fine needle is used to penetrate the skin,
subcutaneous tissues, and muscle with the intent to mechanically disrupt tissue without the
use of an anesthetic. Dry needling is emerging as a treatment modality that is widely used
clinically to address a variety of musculoskeletal conditions. Recent studies of dry needling
have shown decreased pain, increased pain pressure threshold, improved range of motion, and
decreased disability in the short term. The majority of these studies examined dry needling
using methods atypical to clinical practice (dry needling as a sole treatment, or fewer
visits than is common practice). No studies have included long-term follow up. A clinical
trial with realistic treatment time frames and methods consistent with clinical practice is
needed to examine the effectiveness of dry needling on reducing pain and enhancing function
in patients presenting with back pain. Both short and long term treatment outcomes need to be
collected as there is emerging evidence that dry needling may be more effective in
maintaining treatment effects in the long term. Therefore, the aim of this trial will be to
examine the short and long term effectiveness of dry needling on pain, disability, and
patient perceived improvements in patients with low back pain.

Purpose: The aim of this trial will be to examine the short and long term effectiveness of
dry needling on pain, disability, and patient perceived improvements in patients with back
pain.

Design: The investigators will conduct a randomized controlled trial in accordance with the
CONSORT guidelines. All patients with back pain referred to physical therapy will be screened
for eligibility criteria. Participants will be randomized to receive 1) dry needling, manual
therapy, and exercise or 2) manual therapy and exercise. Participants will receive 8
treatments over a maximum of 6 weeks.

Methods: The primary outcome will be disability as measured by the Modified Oswestry
Disability Index. Pain and patient perceived improvement will also be recorded. STarT Back
clinical measurement tool will be used to monitor patient's risk dto develop chronic back
pain. Outcome measures will be assessed at 6 weeks, 6 months, and 24-months by an assessor
who is blind to the group allocation of the participants to determine the short and long-term
treatment effects.

Data Analysis: The investigators will examine the primary aim with 2-way repeated-measures
analysis of variance (ANOVA) with treatment group (MTEX vs. MTEX-DN) as the between subjects
independent variables and time (baseline, 6 weeks, 6 months, 24 months) as the
within-subjects independent variable. The hypothesis of interest is the 2-way group * time
interaction.

Significance: The successful completion of this trial will provide evidence to demonstrate
whether dry needling is effective for the management of back pain when used in a combined
treatment approach as is commonly practiced clinically.

Inclusion Criteria:

- Primary complaint of back pain

- Modified Oswestry Disability Index > 10 points=20%

Exclusion Criteria:

- Red flags noted in the patient's Low Back Medical Screening (i.e. tumor, fracture,
metabolic diseases, Rheumatoid Arthritis, prolonged history of steroid use, pregnancy,
ankylosing spondylitis, cauda equina).

- Use of high doses of blood thinners

- Evidence of central nervous system involvement, to include hyperreflexia, sensory
disturbances in the lower extremity, intrinsic muscle wasting of the hands,
unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of
the face, altered taste, the presence of pathological reflexes (i.e. positive
Hoffman's and/or Babinski reflexes), etc.

- Workers compensation or pending legal action regarding their back pain

- Insufficient English language skills to complete all questionnaires

- Inability to comply with treatment and follow-up schedule