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Dry Needling for Patients With Back Pain

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ClinicalTrials.gov Identifier: NCT03586778
Recruitment Status : Recruiting
First Posted : July 16, 2018
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
Franklin Pierce University
Information provided by (Responsible Party):
Eric Gattie, Concord Hospital

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.

Condition or disease Intervention/treatment Phase
Back Pain Other: dry needling Other: manual therapy Other: therapeutic exercise Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Outcome assessment will be performed by an individual blind to group assignment.
Primary Purpose: Treatment
Official Title: Dry Needling for Patients With Back Pain: A Randomized Clinical Trial
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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.




Primary Outcome Measures :
  1. Change from baseline of Modified Oswestry Disability Index(MODI) [ Time Frame: baseline, six weeks, six months and 24 months ]
    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.


Secondary Outcome Measures :
  1. Change from baseline of Visual Analog Scale (VAS) [ Time Frame: baseline, six weeks, six months and 24 months ]
    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.

  2. Fear Avoidance Belief Questionnaire ( FABQ) [ Time Frame: baseline, six weeks, six months and 24 months ]
    Fear Avoidance Belief Questionnaire ( FABQ) focused specifically on patients' beliefs about how physical activity and work affects their low back pain.

  3. Global Rating of Change (GROC) [ Time Frame: six weeks, six months and 24 months ]
    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."

  4. STarT Back [ Time Frame: baseline, six weeks, six months and 24 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03586778


Contacts
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Contact: Sebastian DG Sabadis, MS (603) 228-4610 ssabadis@crhc.org
Contact: Eric R Gattie, DPT (603) 230-5634 egattie@crhc.org

Locations
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United States, New Hampshire
Concord Hospital Rehabilitation Services Recruiting
Concord, New Hampshire, United States, 03301
Contact: Sebastian DG Sabadis, MS    603-228-4610    ssabadis@crhc.org   
Contact: Eric R Gattie, DPT    (603) 230-5634    egattie@crhc.org   
Sponsors and Collaborators
Concord Hospital
Franklin Pierce University
Investigators
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Principal Investigator: Sebastian DG Sabadis, MS Concord Hospital

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Responsible Party: Eric Gattie, Physical Therapist, Concord Hospital
ClinicalTrials.gov Identifier: NCT03586778     History of Changes
Other Study ID Numbers: CH lumbar needling
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eric Gattie, Concord Hospital:
Back Pain
Dry Needling
Additional relevant MeSH terms:
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Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms