Neck PainNCT02731014
Dry Needling for Patients With Neck Pain
A study testing Dry Needling, Manual Therapy and Exercise in people with Neck Pain, run by Franklin Pierce University at 2 sites 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 neck pain attending physical therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neck Pain
- What is being tested?
- Dry Needling, Manual Therapy and Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2016to Sep 2019
- 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
- Age between >18 years old
- Primary complaint of neck pain
- Neck Disability Index > 10 points=20%
Who cannot join
- Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e. tumor, fracture, metabolic diseases, Rheumatoid Arthritis, osteoporosis, prolonged history of steroid use, symptoms of vertebrobasilar insufficiency, pregnancy, cervical spinal stenosis, bilateral upper extremity symptoms etc.
- Use of blood thinners
- History of whiplash injury within the past six weeks
- Evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, 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.
- Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:
- Muscle weakness involving a major muscle group of the upper extremity
Show all 13Show fewer
- Diminished upper extremity muscle stretch reflex (biceps brachii, brachioradialis, or triceps)
- Diminished or absent sensation to pinprick in any upper extremity dermatome
- Prior surgery to the neck or thoracic spine
- Chiropractic, Physical Therapy, or Acupuncture treatment for their neck pain in the last 12-months
- Workers compensation or pending legal action regarding their neck pain
- Insufficient English language skills to complete all questionnaires
- Inability to comply with treatment and follow-up schedule
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Concord Hospital Rehabilitation Services
Concord, New Hampshire, 03301
Franciscan, ST.Francis Health
Indianapolis, Indiana, 46237
About this study
Official title: Dry Needling for Patients With Neck 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 neck 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 (4 weeks) and long term (6 and 12 months) compared to those who receive sham dry needling, manual therapy, and exercise.
Read the detailed description
Background: Neck pain is a costly and common problem. Current treatments are not adequately effective for a large proportion of patients who continue to experience recurrent pain. Therefore, new treatment strategies should be investigated in an attempt to reduce the disability and high costs associated with neck 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 in mechanical neck pain 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). None 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 mechanical neck 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 neck pain.
Design: The investigators will conduct a randomized single blind placebo controlled trial in accordance with the CONSORT guidelines. All patients with mechanical neck 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) sham dry needling, manual therapy and exercise. Participants will receive 7 treatments over a maximum of 4 weeks.
Methods: The primary outcome will be disability as measured by the Neck Disability Index. Pain and patient perceived improvement will also be recorded. Outcome measures will be assessed at 4 weeks, 6 months, and 12-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 a 2-way repeated-measures analysis of variance (ANOVA) with treatment group as the between subject variable and time as the within-subjects variable. The hypothesis of interest will be the 2-way group by time interaction.
Significance: The successful completion of this trial will provide evidence to demonstrate whether dry needling is effective for the management of mechanical neck pain when used in a combined treatment approach as is commonly practiced clinically.
- Conditions
- Neck Pain
- Being tested
- Dry Needling, Sham Dry Needling, Manual Therapy, Exercise
- Keywords
- Dry Needling
- Medical subject headings
- Neck 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 cervical and thoracic spine.
Sham Dry NeedlingOther
Sham Dry Needling performed with Park sham acupuncture needles (Acuprime, UK) will be used to perform sham dry-needling. The device consists of 2 plastic tubes that slide into one another and cause a pricking sensation when pushed against the skin.
Manual TherapyOther
Manual Therapy(mobilization/ manipulation) to address joint mobility of the cervical and thoracic spine.
ExerciseOther
Exercise designed to improve performance of both the deep neck flexor musculature as well as the scapular musculature. The exercise portion will also include a stretching program targeting the cervicothoracic muscles which have been placed in a shortened position as a result of poor postures.
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling Group | Experimental | Dry Needling, Manual Therapy, and Exercise. Receives: Other: Dry Needling; Other: Manual Therapy; Other: Exercise |
| Sham Dry Needling Group | Sham comparator | Sham Dry Needling, Manual Therapy, and Exercise. Receives: Other: Sham Dry Needling; Other: Manual Therapy; Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on the Neck Disability Index (NDI)
The Neck Disability Index (NDI) was created to measure pain related disability associated with activities of daily living in people with neck pain. The NDI contains ten focused sections. The NDI is easy to complete and score. Each item is scored on a 6 point scale and can reach a maximum score of 5; therefore, the maximum score is 50. This score will calculated as a percentage, with higher scores indicating higher levels of disability.
Measured: 4 weeks, 6 months, 12 months
Secondary outcomes (3)
Change from baseline on The Global Rating Of Change Scale (GROC)
The 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: 4 weeks, 6 months, 12 months
Questionnaire used to assess blinding of patients to which needling intervention they received
Used to assess blinding of patients as to which dry needling intervention the received (real or sham).
Measured: 4 weeks
Change from baseline on the Visual Analog Scale (VAS) Pain
The 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". The VAS will be used to calculate change in pain score from baseline to 4 weeks, 6 months, and 12 months.
Measured: 4 weeks, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study startSep 2016
- Primary completionAug 2018
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Franklin Pierce University
- Sponsor type
- University, hospital or other
- Collaborators
- Newcastle University, Concord Hospital
- Responsible party
- Principal investigator, Joshua Cleland, DPT, OCS, Franklin Pierce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731014
- Sponsor's protocol ID
- HIC 15-6
- Status last verified
- Dec 2019
- First submitted
- 23 Mar 2016
- Last updated
- 18 Dec 2019
- Results posted
- No
Publications
Gattie ER, Cleland JA, Snodgrass SJ. Dry Needling for Patients With Neck Pain: Protocol of a Randomized Clinical Trial. JMIR Res Protoc. 2017 Nov 22;6(11):e227. doi: 10.2196/resprot.7980.
PubMed 29167092
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dry Needling for Patients With Neck Pain: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02731014
- Acronym / sponsor ID
- HIC 15-6
- Conditions
- Neck Pain
- Keywords
- Dry Needling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Franklin Pierce UniversityUniversity, hospital or other
- Collaborators
- Newcastle University, Concord Hospital
- Study start
- Sep 2016 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 7 Apr 2016 (estimated)
- 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 neck 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 (4 weeks) and long term (6 and 12 months) compared to those who receive sham dry needling, manual therapy, and exercise.
Detailed description
Background: Neck pain is a costly and common problem. Current treatments are not adequately effective for a large proportion of patients who continue to experience recurrent pain. Therefore, new treatment strategies should be investigated in an attempt to reduce the disability and high costs associated with neck 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 in mechanical neck pain 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). None 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 mechanical neck 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 neck pain.
Design: The investigators will conduct a randomized single blind placebo controlled trial in accordance with the CONSORT guidelines. All patients with mechanical neck 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) sham dry needling, manual therapy and exercise. Participants will receive 7 treatments over a maximum of 4 weeks.
Methods: The primary outcome will be disability as measured by the Neck Disability Index. Pain and patient perceived improvement will also be recorded. Outcome measures will be assessed at 4 weeks, 6 months, and 12-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 a 2-way repeated-measures analysis of variance (ANOVA) with treatment group as the between subject variable and time as the within-subjects variable. The hypothesis of interest will be the 2-way group by time interaction.
Significance: The successful completion of this trial will provide evidence to demonstrate whether dry needling is effective for the management of mechanical neck 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
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Needling Group | Experimental | Other: Dry Needling, Other: Manual Therapy, Other: ExerciseDry Needling, Manual Therapy, and Exercise. |
| Sham Dry Needling Group | Sham comparator | Other: Sham Dry Needling, Other: Manual Therapy, Other: ExerciseSham Dry Needling, Manual Therapy, and Exercise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between >18 years old
- Primary complaint of neck pain
- Neck Disability Index > 10 points=20%
Key exclusion criteria (13 listed)
- Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e. tumor, fracture, metabolic diseases, Rheumatoid Arthritis, osteoporosis, prolonged history of steroid use, symptoms of vertebrobasilar insufficiency, pregnancy, cervical spinal stenosis, bilateral upper extremity symptoms etc.
- Use of blood thinners
- History of whiplash injury within the past six weeks
- Evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, 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.
- Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:
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 cervical and thoracic spine. | Other | Dry Needling Group |
| Sham Dry NeedlingSham Dry Needling performed with Park sham acupuncture needles (Acuprime, UK) will be used to perform sham dry-needling. The device consists of 2 plastic tubes that slide into one another and cause a pricking sensation when pushed against the skin. | Other | Sham Dry Needling Group |
| Manual TherapyManual Therapy(mobilization/ manipulation) to address joint mobility of the cervical and thoracic spine. | Other | Dry Needling Group, Sham Dry Needling Group |
| ExerciseExercise designed to improve performance of both the deep neck flexor musculature as well as the scapular musculature. The exercise portion will also include a stretching program targeting the cervicothoracic muscles which have been placed in a shortened position as a result of poor postures. | Other | Dry Needling Group, Sham Dry Needling Group |
Primary outcome
Change from baseline on the Neck Disability Index (NDI)
Time frame: 4 weeks, 6 months, 12 months
The Neck Disability Index (NDI) was created to measure pain related disability associated with activities of daily living in people with neck pain. The NDI contains ten focused sections. The NDI is easy to complete and score. Each item is scored on a 6 point scale and can reach a maximum score of 5; therefore, the maximum score is 50. This score will calculated as a percentage, with higher scores indicating higher levels of disability.
3 secondary outcomes
Change from baseline on The Global Rating Of Change Scale (GROC)
Time frame: 4 weeks, 6 months, 12 months
Questionnaire used to assess blinding of patients to which needling intervention they received
Time frame: 4 weeks
Change from baseline on the Visual Analog Scale (VAS) Pain
Time frame: 4 weeks, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
- Derived from this study: PubMed 29167092Gattie ER, Cleland JA, Snodgrass SJ. Dry Needling for Patients With Neck Pain: Protocol of a Randomized Clinical Trial. JMIR Res Protoc. 2017 Nov 22;6(11):e227. doi: 10.2196/resprot.7980.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 Exercise in people with Neck Pain, run by Franklin Pierce University at 2 sites 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 3 inclusion and 13 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: finished, as of the sponsor's last update on 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 on the Neck Disability Index (NDI) (time frame: 4 weeks, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02731014, which also lists 1 linked publication.
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 18 Dec 2019.