Dry Needling for Patients With Back Pain

Dry Needling for Patients With Back Pain: A Randomized Clinical Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: Back Pain
• Intervention / Treatment: Other: dry needling; Other: manual therapy; Other: therapeutic 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Concord, New Hampshire, United States, 03301
      • Concord Hospital Rehabilitation Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MTEX-DN; dry needling, manual therapy, and therapeutic exercise	Other: dry needling; Dry Needling targeting the posterior musculature of the thoraco-lumbar spine and hips; Other: manual therapy; Manual Therapy(mobilization/ manipulation) to address joint mobility of the thoraco-lumbar spine and hips; Other: therapeutic exercise; Exercise designed to improve performance of the paraspinal and abdominal musculature as well as the hip musculature. The exercise portion will also include a stretching program targeting the trunk and hip muscles which have been placed in a shortened position as a result of poor postures.
Active Comparator: MTEX; manual therapy and therapeutic exercise	Other: manual therapy; Manual Therapy(mobilization/ manipulation) to address joint mobility of the thoraco-lumbar spine and hips; Other: therapeutic exercise; Exercise designed to improve performance of the paraspinal and abdominal musculature as well as the hip musculature. The exercise portion will also include a stretching program targeting the trunk and hip muscles which have been placed in a shortened position as a result of poor postures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of Modified Oswestry Disability Index(MODI)	Modified Oswestry Disability Index (MODI) is one of the modified versions of the Oswestry Disability Index. It consists of 10 items addressing different aspects of function. Each item is scored from 0 to 5, with higher values representing greater disability. The total score is multiplied by 2 and expressed as a percentage.	baseline, six weeks, six months and 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of Visual Analog Scale (VAS)	Visual Analog Scale (VAS) is a single item measure of pain using a 100 mm horizontal line anchored on the left side of which represents "no pain" and the right side represents "the worst pain imaginable". Patients mark a score by making a vertical line, where they feel it best represents their pain intensity.	baseline, six weeks, six months and 24 months
Fear Avoidance Belief Questionnaire ( FABQ)	Fear Avoidance Belief Questionnaire ( FABQ) focused specifically on patients' beliefs about how physical activity and work affects their low back pain.	baseline, six weeks, six months and 24 months
Global Rating of Change (GROC)	Global Rating of Change (GROC) is a 15-point scale used to quantify a patient's improvement with treatment or to record the clinical course of a condition over time. Patients are asked to describe their overall condition since the start of treatment until the present time with options ranging from -7 ("a very great deal worse") to +7 ("a very great deal better") and 0 being described as "about the same."	six weeks, six months and 24 months
STarT Back	STarT Back is a clinical measurement tool is a questionnaire used to help to categorize patients into three subgroups based on their risk for developing chronic lower back pain. The STarT Back clinical measurement tool consists of 9 items including leg pain, common pain, disability (2 items), bothersomeness, catastrophization, fear, anxiety, and depression. Each question is answered on either a 5 point Likert scale or a 10 point Likert scale.	baseline, six weeks, six months and 24 months

Collaborators and Investigators

• Sponsor: Concord Hospital
• Collaborators: Franklin Pierce University
• Investigators: Principal Investigator: Sebastian DG Sabadis, MS, Concord Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): July 28, 2020
• Study Completion (Actual): July 28, 2020

Study Registration Dates

• First Submitted: June 26, 2018
• First Submitted That Met QC Criteria: July 12, 2018
• First Posted (Actual): July 16, 2018

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Dry Needling; Back Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: CH lumbar needling

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No