Neck PainNCT02415660
Short-Term Response of Thoracic Spine Manipulation With or Without Trigger Point Dry Needling for Mechanical Neck Pain
A study testing Thoracic spinal manipulation, Trigger point dry needling and Cervical range of motion exercises in people with Neck Pain, run by Brooke Army Medical Center at 1 site in United States.
Trial summary
This study will assess the short term response of thoracic spinal manipulation with or without trigger point dry needling in 58 subjects with a primary complaint of mechanical neck pain. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Thoracic spinal manipulation, Trigger point dry needling and Cervical range of motion exercises
- Type of treatment
- Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2016to 1 Aug 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-64 years and eligible for military health care
- Primary complaint of mechanical neck pain provoked by posture, movement or palpation of neck musculature, with or without unilateral upper extremity symptoms.
- Presence of active trigger points in either the upper trapezius or deep cervical extensor muscles.
- Able to make one initial appointment at the Army Medical Department Center and School at Fort Sam Houston, one treatment visit approximately 2-3 days after the initial visit, and then a final outcome visit approximately 5-7 days after 2nd visit.
- No less than 10 points (0-50 range) on the Neck Disability Index.
Who cannot join
- Prior history of whiplash injury resulting in neck pain which required medical treatment.
- Any prior physical therapy, chiropractic, acupuncture treatment or injections for neck pain within the past 3 months.
- History of cervical spine surgery.
- History of any systemic disorder in which thoracic spine manipulation and TDN would be contraindicated (i.e. osteoporosis, bleeding disorders or anticoagulant medication use)
- Signs and symptoms consistent with nerve root compression (i.e. diminished upper extremity strength, sensation or reflexes), cervical artery insufficiency (i.e. nystagmus, gait disturbances, Horner Syndrome) or upper cervical ligament instability (i.e. Sharp-Purser, alar ligament, transverse ligament tests).
- Current primary complaint of headaches
Show all 10Show fewer
- Pending legal action regarding their neck pain
- Inability to read and understand English
- Females known or thought to be pregnant
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
AMEDD Center & School
Fort Sam Houston, Texas, 78234
About this study
Official title: Short-Term Response of Thoracic Spine Manipulation With or Without Trigger Point Dry Needling for Mechanical Neck Pain: A Randomized Clinical Trial
This study will assess the short term response of thoracic spinal manipulation with or without trigger point dry needling in 58 subjects with a primary complaint of mechanical neck pain.
Read the detailed description
Neck pain is common, and return to duty rates after medical evacuation from theater for spinal pain is low. Muscles comprise the majority of the stability for the cervical spine, yet neck muscle function can be altered in the presence of pain. Research has consistently shown the benefit of including thoracic spine manipulation (SMT) in the treatment of patients with mechanical neck pain. Emerging evidence is now also showing promising benefit of including trigger point dry needling (TDN) for the treatment of mechanical neck pain. Treatment regimens commonly address anterior cervical stabilizing musculature, but little is known regarding the response to treatment of the deep posterior stabilizing musculature.
This study will assess the short term response of thoracic SMT with or without TDN in 58 subjects with a primary complaint of mechanical neck pain. Subjects will be randomized to receive 2 treatment visits approximately 2-3 days apart of either SMT+sham TDN or SMT+TDN. TDN will be directed to the upper trapezius and deep cervical extensor muscles of the neck. Outcomes of interest will be changes in function and pain. Assessments will be made at baseline, immediately after the first treatment, at the 2nd treatment, and approximately 5-7 days after the 2nd treatment visit. A subgroup of 20 subjects (10 per group) will also have the upper trapezius and deep cervical extensor muscle activation assessed via shear wave elastography, and deep cervical flexor activation assessed via the craniocervical flexion test.
- Conditions
- Neck Pain
- Being tested
- Thoracic spinal manipulation, Trigger point dry needling, Cervical range of motion exercises, Posterior neck muscle activation exercise, Trigger point dry needling sham
- Keywords
- trigger point dry needling, thoracic spine manipulation, deep cervical extensor muscle, deep cervical flexor muscle, shear wave elastography
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic spinal manipulationProcedure or surgery
All patients will receive 3 different thrust joint manipulations to the middle and upper thoracic spine region. Each technique will be applied up to 2 times, per the discretion of the treating therapist discretion
Trigger point dry needlingProcedure or surgery
The TDN treatment will consist of a trained investigator inserting a needle through the participant's skin, into the deep cervical extensor muscles and/or the upper trapezius muscles using FDA approved (FDA regulation # 880.5580) disposable 0.2-0.3 x 40-50 mm stainless steel Seirin J-type needles (Seirin, Japan). Those subjects randomized to TDN will undergo this treatment.
Cervical range of motion exercisesBehavioural
The patient will be instructed to place 5 fingers along the manubrium, and to flex the neck down until the chin touches the fingers. The patient will then be instructed to rotate the head as far as comfortably possible to one side, and then to the other side for 10 repetitions to each side, 3-4 times per day. The patient will progress from 5 fingers, to 4, 3, 2 and eventually 1 finger as neck mobility improves.
Posterior neck muscle activation exerciseBehavioural
The patient will be instructed to sit upright in a chair, and place 1-2 fingers over the C2 spinous process. Education to localize this landmark will be provided. The patient will then perform an isometric chin tuck exercise against the resistance they will apply at C2. This position will be held x 5 seconds and repeated 10 times, 3-4 times per day.
Trigger point dry needling shamProcedure or surgery
The sham group will receive a simulated TDN. Using a toothpick in a needle guide-tube, the investigator will tap, rest, and twist the toothpick for approximately 30 seconds in the same 2 muscles, 2 sites in each muscle. The sham treatment will not penetrate the skin.
Seirin J-type stainless steel needles, 0-2-0.3 x 40-50 mmDevice
A trained investigator will insert the needle through the participants skin into the deep cervical extensors and/or the upper trapezius muscles. Needles are FDA approved (#880.5580)
| Study group | Role | What they receive |
|---|---|---|
| SMT and TDN | Experimental | Thoracic spinal manipulation and trigger point dry needling using Seirin J-type stainless steel needles, 0-2-0.3 x 40-50 mm. Exercise program consists of cervical range of motion exercises and posterior neck muscle activation exercise. Receives: Procedure: Thoracic spinal manipulation; Procedure: Trigger point dry needling; Behavioral: Cervical range of motion exercises; Behavioral: Posterior neck muscle activation exercise; Device: Seirin J-type stainless steel needles, 0-2-0.3 x 40-50 mm |
| SMT and Sham TDN | Sham comparator | Thoracic spinal manipulation and trigger point dry needling sham. Exercise program consists of cervical range of motion exercises and posterior neck muscle activation exercise. Receives: Procedure: Thoracic spinal manipulation; Behavioral: Cervical range of motion exercises; Behavioral: Posterior neck muscle activation exercise; Procedure: Trigger point dry needling sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Neck Disability Index (NDI)
The NDI is a revised form of the Oswestry Low Back Pain Index. It is designed to measure the activities of daily living in persons with neck pain.
Measured: Change in NDI from baseline to 2-3 days
Change in Neck Disability Index (NDI)
The NDI is a revised form of the Oswestry Low Back Pain Index. It is designed to measure the activities of daily living in persons with neck pain.
Measured: Change in NDI at 7-10 days
Secondary outcomes (10)
Change in Numeric Pain Rating Scale (NPRS)
An 11-point NPRS will be used to measure pain intensity. The scale is anchored on the left with the phrase "No Pain" and on the right with the phrase "Worst Imaginable Pain".
Measured: Change in pain from baseline to 2-3 days
Change in Numeric Pain Rating Scale (NPRS)
An 11-point NPRS will be used to measure pain intensity. The scale is anchored on the left with the phrase "No Pain" and on the right with the phrase "Worst Imaginable Pain".
Measured: 7-10 days
Global Rate of Change (GRC)
The GRC assesses subjective perception of overall change over time and the importance of that change. A 15-point Likert type scale ranging from -7 (very great deal worse) to +7 (a very great deal better) will be used.
Measured: 2-3 days
Global Rate of Change (GRC)
The GRC assesses subjective perception of overall change over time and the importance of that change. A 15-point Likert type scale ranging from -7 (very great deal worse) to +7 (a very great deal better) will be used.
Measured: 7-10 days
Change in Deep cervical multifidus activation using ultrasound Shear Wave Elastography (SWE)
Shear-Wave Elastography (SWE) is an evolving technology that uses advanced ultrasound imaging to quantify tissue stiffness (i.e., elasticity). This technology will be utilized to assess change in passive muscle activation response to treatment.
Measured: Day 1 pre and post intervention
Change in Deep cervical multifidus activation using ultrasound Shear Wave Elastography (SWE)
Shear-Wave Elastography (SWE) is an evolving technology that uses advanced ultrasound imaging to quantify tissue stiffness (i.e., elasticity). This technology will be utilized to assess change in passive muscle activation response to treatment.
Measured: 7-10 days
Change in Deep Neck Flexor (DNF) Activation
Change in DNF muscle activation will be assessed via the chin tuck head lift test (CTHL).
Measured: Day 1 pre and post intervention
Change in Deep Neck Flexor (DNF) Activation
Change in DNF muscle activation will be assessed via the chin tuck head lift test (CTHL).
Measured: 7-10 days
Change in Pain Pressure Threshold (PPT) as assessed using an electronic algometer.
PPT is the minimal amount of pressure that produces pain and is used to assess abnormalities in nociceptive processing or hyperalgesia.
Measured: Day 1 pre and post intervention
Change in Pain Pressure Threshold (PPT) as assessed using an electronic algometer.
PPT is the minimal amount of pressure that produces pain and is used to assess abnormalities in nociceptive processing or hyperalgesia.
Measured: 7-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study start1 Jun 2016
- Primary completion3 Mar 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Brian Young, Brooke Army Medical Center
- Investigators
- David M Boland, PT, DPT, PhD, Principal investigator, Assistant Professor, Army-Baylor Doctoral Program in PT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415660
- Sponsor's protocol ID
- 404153-1
- Status last verified
- Jan 2021
- First submitted
- 25 Mar 2015
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Walker MJ, Boyles RE, Young BA, Strunce JB, Garber MB, Whitman JM, Deyle G, Wainner RS. The effectiveness of manual physical therapy and exercise for mechanical neck pain: a randomized clinical trial. Spine (Phila Pa 1976). 2008 Oct 15;33(22):2371-8. doi: 10.1097/BRS.0b013e318183391e.
PubMed 18923311O'Leary S, Cagnie B, Reeve A, Jull G, Elliott JM. Is there altered activity of the extensor muscles in chronic mechanical neck pain? A functional magnetic resonance imaging study. Arch Phys Med Rehabil. 2011 Jun;92(6):929-34. doi: 10.1016/j.apmr.2010.12.021. Epub 2011 May 6.
PubMed 21529779Schomacher J, Falla D. Function and structure of the deep cervical extensor muscles in patients with neck pain. Man Ther. 2013 Oct;18(5):360-6. doi: 10.1016/j.math.2013.05.009. Epub 2013 Jul 12.
PubMed 23849933Cleland JA, Mintken PE, Carpenter K, Fritz JM, Glynn P, Whitman J, Childs JD. Examination of a clinical prediction rule to identify patients with neck pain likely to benefit from thoracic spine thrust manipulation and a general cervical range of motion exercise: multi-center randomized clinical trial. Phys Ther. 2010 Sep;90(9):1239-50. doi: 10.2522/ptj.20100123. Epub 2010 Jul 15.
PubMed 20634268Maher RM, Hayes DM, Shinohara M. Quantification of dry needling and posture effects on myofascial trigger points using ultrasound shear-wave elastography. Arch Phys Med Rehabil. 2013 Nov;94(11):2146-50. doi: 10.1016/j.apmr.2013.04.021. Epub 2013 May 14.
PubMed 23684553
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Response of Thoracic Spine Manipulation With or Without Trigger Point Dry Needling for Mechanical Neck Pain: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02415660
- Acronym / sponsor ID
- 404153-1
- Conditions
- Neck Pain
- Keywords
- trigger point dry needling, thoracic spine manipulation, deep cervical extensor muscle, deep cervical flexor muscle, shear wave elastography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 3 Mar 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 14 Apr 2015 (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.
This study will assess the short term response of thoracic spinal manipulation with or without trigger point dry needling in 58 subjects with a primary complaint of mechanical neck pain.
Detailed description
Neck pain is common, and return to duty rates after medical evacuation from theater for spinal pain is low. Muscles comprise the majority of the stability for the cervical spine, yet neck muscle function can be altered in the presence of pain. Research has consistently shown the benefit of including thoracic spine manipulation (SMT) in the treatment of patients with mechanical neck pain. Emerging evidence is now also showing promising benefit of including trigger point dry needling (TDN) for the treatment of mechanical neck pain. Treatment regimens commonly address anterior cervical stabilizing musculature, but little is known regarding the response to treatment of the deep posterior stabilizing musculature.
This study will assess the short term response of thoracic SMT with or without TDN in 58 subjects with a primary complaint of mechanical neck pain. Subjects will be randomized to receive 2 treatment visits approximately 2-3 days apart of either SMT+sham TDN or SMT+TDN. TDN will be directed to the upper trapezius and deep cervical extensor muscles of the neck. Outcomes of interest will be changes in function and pain. Assessments will be made at baseline, immediately after the first treatment, at the 2nd treatment, and approximately 5-7 days after the 2nd treatment visit. A subgroup of 20 subjects (10 per group) will also have the upper trapezius and deep cervical extensor muscle activation assessed via shear wave elastography, and deep cervical flexor activation assessed via the craniocervical flexion test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMT and TDN | Experimental | Procedure: Thoracic spinal manipulation, Procedure: Trigger point dry needling, Behavioral: Cervical range of motion exercises, Behavioral: Posterior neck muscle activation exercise, Device: Seirin J-type stainless steel needles, 0-2-0.3 x 40-50 mmThoracic spinal manipulation and trigger point dry needling using Seirin J-type stainless steel needles, 0-2-0.3 x 40-50 mm. Exercise program consists of cervical range of motion exercises and posterior neck muscle activation exercise. |
| SMT and Sham TDN | Sham comparator | Procedure: Thoracic spinal manipulation, Behavioral: Cervical range of motion exercises, Behavioral: Posterior neck muscle activation exercise, Procedure: Trigger point dry needling shamThoracic spinal manipulation and trigger point dry needling sham. Exercise program consists of cervical range of motion exercises and posterior neck muscle activation exercise. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-64 years and eligible for military health care
- Primary complaint of mechanical neck pain provoked by posture, movement or palpation of neck musculature, with or without unilateral upper extremity symptoms.
- Presence of active trigger points in either the upper trapezius or deep cervical extensor muscles.
- Able to make one initial appointment at the Army Medical Department Center and School at Fort Sam Houston, one treatment visit approximately 2-3 days after the initial visit, and then a final outcome visit approximately 5-7 days after 2nd visit.
- No less than 10 points (0-50 range) on the Neck Disability Index.
Key exclusion criteria (10 listed)
- Prior history of whiplash injury resulting in neck pain which required medical treatment.
- Any prior physical therapy, chiropractic, acupuncture treatment or injections for neck pain within the past 3 months.
- History of cervical spine surgery.
- History of any systemic disorder in which thoracic spine manipulation and TDN would be contraindicated (i.e. osteoporosis, bleeding disorders or anticoagulant medication use)
- Signs and symptoms consistent with nerve root compression (i.e. diminished upper extremity strength, sensation or reflexes), cervical artery insufficiency (i.e. nystagmus, gait disturbances, Horner Syndrome) or upper cervical ligament instability (i.e. Sharp-Purser, alar ligament, transverse ligament tests).
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 |
|---|---|---|
| Thoracic spinal manipulationAll patients will receive 3 different thrust joint manipulations to the middle and upper thoracic spine region. Each technique will be applied up to 2 times, per the discretion of the treating therapist discretion | Procedure or surgery | SMT and Sham TDN, SMT and TDN |
| Trigger point dry needlingThe TDN treatment will consist of a trained investigator inserting a needle through the participant's skin, into the deep cervical extensor muscles and/or the upper trapezius muscles using FDA approved (FDA regulation # 880.5580) disposable 0.2-0.3 x 40-50 mm stainless steel Seirin J-type needles (Seirin, Japan). Those subjects randomized to TDN will undergo this treatment. | Procedure or surgery | SMT and TDN |
| Cervical range of motion exercisesThe patient will be instructed to place 5 fingers along the manubrium, and to flex the neck down until the chin touches the fingers. The patient will then be instructed to rotate the head as far as comfortably possible to one side, and then to the other side for 10 repetitions to each side, 3-4 times per day. The patient will progress from 5 fingers, to 4, 3, 2 and eventually 1 finger as neck mobility improves. | Behavioural | SMT and Sham TDN, SMT and TDN |
| Posterior neck muscle activation exerciseThe patient will be instructed to sit upright in a chair, and place 1-2 fingers over the C2 spinous process. Education to localize this landmark will be provided. The patient will then perform an isometric chin tuck exercise against the resistance they will apply at C2. This position will be held x 5 seconds and repeated 10 times, 3-4 times per day. | Behavioural | SMT and Sham TDN, SMT and TDN |
| Trigger point dry needling shamThe sham group will receive a simulated TDN. Using a toothpick in a needle guide-tube, the investigator will tap, rest, and twist the toothpick for approximately 30 seconds in the same 2 muscles, 2 sites in each muscle. The sham treatment will not penetrate the skin. | Procedure or surgery | SMT and Sham TDN |
| Seirin J-type stainless steel needles, 0-2-0.3 x 40-50 mmA trained investigator will insert the needle through the participants skin into the deep cervical extensors and/or the upper trapezius muscles. Needles are FDA approved (#880.5580) | Device | SMT and TDN |
Primary outcome
Change in Neck Disability Index (NDI)
Time frame: Change in NDI from baseline to 2-3 days
The NDI is a revised form of the Oswestry Low Back Pain Index. It is designed to measure the activities of daily living in persons with neck pain.
Change in Neck Disability Index (NDI)
Time frame: Change in NDI at 7-10 days
The NDI is a revised form of the Oswestry Low Back Pain Index. It is designed to measure the activities of daily living in persons with neck pain.
10 secondary outcomes
Change in Numeric Pain Rating Scale (NPRS)
Time frame: Change in pain from baseline to 2-3 days
Change in Numeric Pain Rating Scale (NPRS)
Time frame: 7-10 days
Global Rate of Change (GRC)
Time frame: 2-3 days
Global Rate of Change (GRC)
Time frame: 7-10 days
Change in Deep cervical multifidus activation using ultrasound Shear Wave Elastography (SWE)
Time frame: Day 1 pre and post intervention
Change in Deep cervical multifidus activation using ultrasound Shear Wave Elastography (SWE)
Time frame: 7-10 days
Change in Deep Neck Flexor (DNF) Activation
Time frame: Day 1 pre and post intervention
Change in Deep Neck Flexor (DNF) Activation
Time frame: 7-10 days
Change in Pain Pressure Threshold (PPT) as assessed using an electronic algometer.
Time frame: Day 1 pre and post intervention
Change in Pain Pressure Threshold (PPT) as assessed using an electronic algometer.
Time frame: 7-10 days
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 2 Feb 2021.
- Background: PubMed 18923311Walker MJ, Boyles RE, Young BA, Strunce JB, Garber MB, Whitman JM, Deyle G, Wainner RS. The effectiveness of manual physical therapy and exercise for mechanical neck pain: a randomized clinical trial. Spine (Phila Pa 1976). 2008 Oct 15;33(22):2371-8. doi: 10.1097/BRS.0b013e318183391e.
- Background: PubMed 21529779O'Leary S, Cagnie B, Reeve A, Jull G, Elliott JM. Is there altered activity of the extensor muscles in chronic mechanical neck pain? A functional magnetic resonance imaging study. Arch Phys Med Rehabil. 2011 Jun;92(6):929-34. doi: 10.1016/j.apmr.2010.12.021. Epub 2011 May 6.
- Background: PubMed 23849933Schomacher J, Falla D. Function and structure of the deep cervical extensor muscles in patients with neck pain. Man Ther. 2013 Oct;18(5):360-6. doi: 10.1016/j.math.2013.05.009. Epub 2013 Jul 12.
- Background: PubMed 20634268Cleland JA, Mintken PE, Carpenter K, Fritz JM, Glynn P, Whitman J, Childs JD. Examination of a clinical prediction rule to identify patients with neck pain likely to benefit from thoracic spine thrust manipulation and a general cervical range of motion exercise: multi-center randomized clinical trial. Phys Ther. 2010 Sep;90(9):1239-50. doi: 10.2522/ptj.20100123. Epub 2010 Jul 15.
- Background: PubMed 23684553Maher RM, Hayes DM, Shinohara M. Quantification of dry needling and posture effects on myofascial trigger points using ultrasound shear-wave elastography. Arch Phys Med Rehabil. 2013 Nov;94(11):2146-50. doi: 10.1016/j.apmr.2013.04.021. Epub 2013 May 14.
- Individual participant dataSharing planned: No
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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.
David M Boland, PT, DPT, PhD principal investigator
Assistant Professor, Army-Baylor Doctoral Program in PT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic spinal manipulation, Trigger point dry needling and Cervical range of motion exercises in people with Neck Pain, run by Brooke Army Medical Center 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 5 inclusion and 10 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 2 Feb 2021. 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. 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 in Neck Disability Index (NDI) (time frame: Change in NDI from baseline to 2-3 days). The study lists 2 primary outcomes in all. 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 NCT02415660, which also lists 5 linked publications.
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 2 Feb 2021.