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Dry Needling for Patients With Back Pain

Primary Purpose

Back Pain

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
dry needling
manual therapy
therapeutic exercise
Sponsored by
Concord Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain focused on measuring Back Pain, Dry Needling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Concord Hospital Rehabilitation Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MTEX-DN

MTEX

Arm Description

dry needling, manual therapy, and therapeutic exercise

manual therapy and therapeutic exercise

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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."
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.

Full Information

First Posted
June 26, 2018
Last Updated
July 28, 2020
Sponsor
Concord Hospital
Collaborators
Franklin Pierce University
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1. Study Identification

Unique Protocol Identification Number
NCT03586778
Brief Title
Dry Needling for Patients With Back Pain
Official Title
Dry Needling for Patients With Back Pain: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Withdrawn
Why Stopped
COVID-19
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
July 28, 2020 (Actual)
Study Completion Date
July 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Concord Hospital
Collaborators
Franklin Pierce University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain
Keywords
Back Pain, Dry Needling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcome assessment will be performed by an individual blind to group assignment.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MTEX-DN
Arm Type
Experimental
Arm Description
dry needling, manual therapy, and therapeutic exercise
Arm Title
MTEX
Arm Type
Active Comparator
Arm Description
manual therapy and therapeutic exercise
Intervention Type
Other
Intervention Name(s)
dry needling
Intervention Description
Dry Needling targeting the posterior musculature of the thoraco-lumbar spine and hips
Intervention Type
Other
Intervention Name(s)
manual therapy
Intervention Description
Manual Therapy(mobilization/ manipulation) to address joint mobility of the thoraco-lumbar spine and hips
Intervention Type
Other
Intervention Name(s)
therapeutic exercise
Intervention Description
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 Measure Information:
Title
Change from baseline of Modified Oswestry Disability Index(MODI)
Description
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.
Time Frame
baseline, six weeks, six months and 24 months
Secondary Outcome Measure Information:
Title
Change from baseline of Visual Analog Scale (VAS)
Description
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.
Time Frame
baseline, six weeks, six months and 24 months
Title
Fear Avoidance Belief Questionnaire ( FABQ)
Description
Fear Avoidance Belief Questionnaire ( FABQ) focused specifically on patients' beliefs about how physical activity and work affects their low back pain.
Time Frame
baseline, six weeks, six months and 24 months
Title
Global Rating of Change (GROC)
Description
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."
Time Frame
six weeks, six months and 24 months
Title
STarT Back
Description
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.
Time Frame
baseline, six weeks, six months and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian DG Sabadis, MS
Organizational Affiliation
Concord Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Concord Hospital Rehabilitation Services
City
Concord
State/Province
New Hampshire
ZIP/Postal Code
03301
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Dry Needling for Patients With Back Pain

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