Back PainNCT03586778
Dry Needling for Patients With Back Pain
A study testing dry needling, manual therapy and therapeutic exercise in people with Back Pain, run by Concord Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Back Pain
- What is being tested?
- dry needling, manual therapy and therapeutic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 28 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary complaint of back pain
- Modified Oswestry Disability Index > 10 points=20%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Concord Hospital Rehabilitation Services
Concord, New Hampshire, 03301
About this study
Official title: 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.
Read the 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.
- Conditions
- Back Pain
- Being tested
- dry needling, manual therapy, therapeutic exercise
- Keywords
- Back Pain, Dry Needling
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dry needlingOther
Dry Needling targeting the posterior musculature of the thoraco-lumbar spine and hips
manual therapyOther
Manual Therapy(mobilization/ manipulation) to address joint mobility of the thoraco-lumbar spine and hips
therapeutic exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| MTEX-DN | Experimental | dry needling, manual therapy, and therapeutic exercise Receives: Other: dry needling; Other: manual therapy; Other: therapeutic exercise |
| MTEX | Active comparator | manual therapy and therapeutic exercise Receives: Other: manual therapy; Other: therapeutic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, six weeks, six months and 24 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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."
Measured: 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.
Measured: baseline, six weeks, six months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start1 Jul 2020
- Primary completion28 Jul 2020
- Study completion28 Jul 2020
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concord Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Franklin Pierce University
- Responsible party
- Principal investigator, Eric Gattie, Concord Hospital
- Investigators
- Sebastian DG Sabadis, MS, Principal investigator, Concord Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03586778
- Sponsor's protocol ID
- CH lumbar needling
- Status last verified
- Jul 2020
- First submitted
- 26 Jun 2018
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dry Needling for Patients With Back Pain: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03586778
- Acronym / sponsor ID
- CH lumbar needling
- Conditions
- Back Pain
- Keywords
- Back Pain, Dry Needling
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Concord HospitalUniversity, hospital or other
- Collaborators
- Franklin Pierce University
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 28 Jul 2020 (actual)
- Study completion
- 28 Jul 2020 (actual)
- First posted
- 16 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MTEX-DN | Experimental | Other: dry needling, Other: manual therapy, Other: therapeutic exercisedry needling, manual therapy, and therapeutic exercise |
| MTEX | Active comparator | Other: manual therapy, Other: therapeutic exercisemanual therapy and therapeutic exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary complaint of back pain
- Modified Oswestry Disability Index > 10 points=20%
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dry needlingDry Needling targeting the posterior musculature of the thoraco-lumbar spine and hips | Other | MTEX-DN |
| manual therapyManual Therapy(mobilization/ manipulation) to address joint mobility of the thoraco-lumbar spine and hips | Other | MTEX, MTEX-DN |
| therapeutic exerciseExercise 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. | Other | MTEX, MTEX-DN |
Primary outcome
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.
4 secondary outcomes
Change from baseline of Visual Analog Scale (VAS)
Time frame: baseline, six weeks, six months and 24 months
Fear Avoidance Belief Questionnaire ( FABQ)
Time frame: baseline, six weeks, six months and 24 months
Global Rating of Change (GROC)
Time frame: six weeks, six months and 24 months
STarT Back
Time frame: baseline, six weeks, six months and 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Back Pain
Recruiting
Comparing Myofascial Exercise and Trigger Point Therapy for Non-Specific Low Back Pain
Non-specific Low Back Pain
Active, not recruiting
Integrated Feldenkrais Method With and Without DNS for Chronic Low Back Pain in Females
Chronic Low Back Pain (CLBP)
Not yet recruiting
Battlefield Acupressure for Acute Back Pain Management in the Emergency Department
Acute Back Pain
Not yet recruiting
Effects of Spinal Mobilization With and Without Clinical Pilates in Patients With Lumbar Disc Herniationc Herniation
Disc Herniation
Not yet recruitingObservational study
SERENITY Study of Chronic Pain Interference in Adults
Chronic Low Back Pain, Spinal Cord Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian DG Sabadis, MS principal investigator
Concord Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dry needling, manual therapy and therapeutic exercise in people with Back Pain, run by Concord Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of Modified Oswestry Disability Index(MODI) (time frame: baseline, six weeks, six months and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.