Clinical trial NCT03586778: Dry Needling for Patients With Back Pain
Official title: Dry Needling for Patients With Back Pain: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Back Pain
Keywords: Back Pain
Dry Needling
Lead sponsor: Concord Hospital
Sponsor class: OTHER
Collaborators: name: Franklin Pierce University
First posted: 2018-07-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 attending physical therapy. The investigators hypothesize that patients who receive dry needling, manual therapy, and exercise will achieve greater reductions in pain and disability in the short (6 weeks) and long term (6 and 24 months) compared to those who receive just manual therapy, and exercise.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline of Modified Oswestry Disability Index(MODI)
timeFrame: baseline, six weeks, six months and 24 months
Secondary outcomes:
measure: Change from baseline of Visual Analog Scale (VAS)
timeFrame: baseline, six weeks, six months and 24 months
measure: Fear Avoidance Belief Questionnaire ( FABQ)
timeFrame: baseline, six weeks, six months and 24 months
measure: Global Rating of Change (GROC)
timeFrame: six weeks, six months and 24 months
measure: STarT Back
timeFrame: baseline, six weeks, six months and 24 months
Other outcomes:
Locations:
city: Concord
country: United States
facility: Concord Hospital Rehabilitation Services
state: New Hampshire
Study officials:
affiliation: Concord Hospital
name: Sebastian DG Sabadis, MS
role: PRINCIPAL_INVESTIGATOR
References: