Neck PainNCT04851067
Dry Needling Versus Manual Therapy in Patients With Mechanical Neck Pain: A Randomized Control Trial
A study testing Dry Needling and Therapeutic Exercises (DNTEx) and Manual Therapy and Therapeutic Exercises (MTTEx) in people with Neck Pain, run by Hendricks Regional Health.
Trial summary
Background: The current physical therapy evidence for treating patients with the mechanical neck pain recommends both, manual therapy (MT) and dry needling (DN) along with cervical and scapulothoracic exercises.1 However, at present, investigators still don't have any evidence suggesting if one treatment approach, the… 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 and Therapeutic Exercises (DNTEx) and Manual Therapy and Therapeutic Exercises (MTTEx)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Jul 2021to Mar 2022
- 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 > 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, RA, 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 12Show 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
- 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
No sites are listed yet.
About this study
Background: The current physical therapy evidence for treating patients with the mechanical neck pain recommends both, manual therapy (MT) and dry needling (DN) along with cervical and scapulothoracic exercises.1 However, at present, investigators still don't have any evidence suggesting if one treatment approach, the manual therapy and exercises or dry needling and exercises, is superior to the other in treating patients with the mechanical neck pain. Objective: The aim of this study is to compare the effects of dry needling and manual therapy on pain, disability, range of motion, strength, and patient perceived improvements in the patients with mechanical neck pain. Methods: Investigators will conduct a randomized, single-blind, placebo-controlled trial in accordance with the CONSORT guidelines. Patients with primary complain of neck pain, with a minimum score of 2 on Numeric Pain Rating Scale (NPRS), a minimum of 10 points or 20% score of Neck Disability Index (NDI), and who are over the age of 18 will be enrolled in the study. Subjects with any red flags, history of surgery at the cervical or thoracic spine, neurological symptoms, nerve root compression, whiplash in the last 6 weeks, pending legal actions related to neck pain, on workers compensation, insufficient English language skills, and/or contraindications to dry needling or manual therapy, will be excluded from the study. A total of 75 patients will be recruited for the study, who will be randomized to two groups - (1) Dry Needling and Therapeutic Exercises (DNTEx) and (2) Manual Therapy and Therapeutic Exercises (MTTEx). All participants will be treated for seven physical therapy treatment sessions of 30 minutes each over a maximum of 6 weeks. The primary outcome measure will NDI, which will evaluate disability of patients. While secondary outcome measures would be: NPRS (score range from 0 to 10) to assess pain, Patient-Specific Functional Scale [PSFS], (score ranges from 3 to 30) will measure a patient-specific measure of function important significant to them, Range of Motion (ROM) will measure changes in the motion of flexion, extension, bilateral rotation, and bilateral side-bending at the cervical spine, The Neck Flexor Endurance Test (NFET) will measure the improvement in the endurance of neck flexor muscles, Fear Avoidance Belief Questionnaire (FABQ) will measure patients' fear of pain with movements and resulting avoidance of physical activity because of their fear, and The Patient Global Rating of Change (GROC) will measure each patient's self-perceived improvement. An assessor, who is blinded to the group allocation, will collect all outcome measures at baseline, 2weeks, discharge session/7th treatment session, and 3 months after discharge/7th treatment session. An a priori alpha level of 0.05 will be used for all analyses. Investigators will examine the primary aim with a repeated-measures analysis of covariance (ANCOVA), using pretest scores as covariates, with treatment groups (Dry needling + Exercise Vs. MT + Exercise) as the between subjects' independent variables and time (baseline, 2 weeks, Discharge [7 sessions], 12 weeks post discharge) as the within-subjects independent variable. The hypothesis of interest is the 2-way group * time interaction.
- Conditions
- Neck Pain
- Being tested
- Dry Needling and Therapeutic Exercises (DNTEx), Manual Therapy and Therapeutic Exercises (MTTEx)
- 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 Needling and Therapeutic Exercises (DNTEx)Other
Already included in arm/group descriptions.
Manual Therapy and Therapeutic Exercises (MTTEx)Other
Already included in arm/group descriptions.
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling and Therapeutic Exercises (DNTEx) | Active comparator | Dry Needling - A fine needle, of 5-10 mm, will be used to penetrate the skin, subcutaneous tissues, and muscle with the intent to stimulate Myofascial Trigger Point (MTrP) or mechanically disrupt tissue without the use of an anesthetic.
Therapeutic Exercises - Are exercises will be performed to achieve a specific physical benefit, including increasing and maintaining range of motion, strengthening weak muscles, increasing joint flexibility, or improving cardiovascular and respiratory function. Receives: Other: Dry Needling and Therapeutic Exercises (DNTEx) |
| Manual Therapy and Therapeutic Exercises (MTTEx) | Active comparator | Joint Mobilization - A manual therapy technique comprising of a continuum of skilled passive movements to the joint complex will be applied at varying speeds and amplitudes. It will include a low-grades/velocity (grades I and II), high grades (grades III and IV), and small- or large-amplitude passive movement techniques within the patient's physiological range of motion and within the patient's control with the intent to restore optimal motion, function, and/ or to reduce pain.
Joint Manipulation - A passive, high velocity, low amplitude thrust will be applied to a localized joint segment/s within its anatomical limit with the intent to restore optimal motion, function, and/ or to reduce pain. Receives: Other: Manual Therapy and Therapeutic Exercises (MTTEx) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index
The NDI is used to measure pain-related disability associated with activities of daily living in people with neck pain. The NDI contains 10 items-7 related to activities of daily living, 2 related to pain, and 1 related to concentration. Each item is scored on a 6-point scale, from 0 to 5; therefore, the maximum score is 50. The total score is expressed as a percentage (total possible score, 100%), with higher scores corresponding to greater disability.9,77 Content, construct validity, and reliability of the NDI has been previously shown in patients with neck pain. The NDI has been used by researchers to evaluate the effect of treatments on patients' perceived levels of functioning and disability. The NDI has showed good reliability and validity in patients with mechanical neck pain.
Measured: 0 Week
Neck Disability Index
The NDI is used to measure pain-related disability associated with activities of daily living in people with neck pain. The NDI contains 10 items-7 related to activities of daily living, 2 related to pain, and 1 related to concentration. Each item is scored on a 6-point scale, from 0 to 5; therefore, the maximum score is 50. The total score is expressed as a percentage (total possible score, 100%), with higher scores corresponding to greater disability.9,77 Content, construct validity, and reliability of the NDI has been previously shown in patients with neck pain. The NDI has been used by researchers to evaluate the effect of treatments on patients' perceived levels of functioning and disability. The NDI has showed good reliability and validity in patients with mechanical neck pain.
Measured: 2 Weeks
Neck Disability Index
The NDI is used to measure pain-related disability associated with activities of daily living in people with neck pain. The NDI contains 10 items-7 related to activities of daily living, 2 related to pain, and 1 related to concentration. Each item is scored on a 6-point scale, from 0 to 5; therefore, the maximum score is 50. The total score is expressed as a percentage (total possible score, 100%), with higher scores corresponding to greater disability.9,77 Content, construct validity, and reliability of the NDI has been previously shown in patients with neck pain. The NDI has been used by researchers to evaluate the effect of treatments on patients' perceived levels of functioning and disability. The NDI has showed good reliability and validity in patients with mechanical neck pain.
Measured: 4 Weeks
Neck Disability Index
The NDI is used to measure pain-related disability associated with activities of daily living in people with neck pain. The NDI contains 10 items-7 related to activities of daily living, 2 related to pain, and 1 related to concentration. Each item is scored on a 6-point scale, from 0 to 5; therefore, the maximum score is 50. The total score is expressed as a percentage (total possible score, 100%), with higher scores corresponding to greater disability.9,77 Content, construct validity, and reliability of the NDI has been previously shown in patients with neck pain. The NDI has been used by researchers to evaluate the effect of treatments on patients' perceived levels of functioning and disability. The NDI has showed good reliability and validity in patients with mechanical neck pain.
Measured: 12 Weeks post discharge
Secondary outcomes (6)
Numeric pain Rating Scale (NPRS)
The number that the respondent indicates on the scale to rate their pain intensity is recorded. Scores range from 0-10. In a 11-point numeric scale, 0 represents "NO PAIN" and 10 represents "EXTREME PAIN" (e.g., "pain as bad as you can imagine" and "worst pain imaginable"). The NPRS has been shown to be reliable and valid.
Measured: 0 week, 2 weeks, 4 weeks, and 12 weeks post discharge
Patient Specific Functional Scale (PSFS)
The PSFS focuses on the patient's opinion of their function and requires the physiotherapist to ask the patient to list three activities that are limited by the condition for which they are seeking treatment, the overall PSFS score is an average of all three activities scores. Patients select a value that best describes their current activity level on a 11-point scale. On this 11-point scale (0 represents - "unable to perform" and 10 represents - "able to perform at prior level").
Measured: 0 week, 2 weeks, 4 weeks, and 12 weeks post discharge
Global Rating of Change Scale (GROC)
It is used to measure each patient's self-perceived improvement.87 The GROC will be used, which is a 15-point global rating scale described by Jaeschke et al.87 The scale ranges from -7 (a very great deal worse) to zero (about the same) to +7 (a very great deal better). The global rating will be administered at the follow-up examinations only.
Measured: 0 week, 2 weeks, 4 weeks, and 12 weeks post discharge
Cervical Range of Motion (CROM)
Cervical Range of motion is the extent of movement of the joints in the cervical spine, which measured in degrees.88,89 Movements are measured in flexion, extension, rotation, and side bending by an inclinometer and goniometer.88 Normal CROM are - 60-80 degree of flexion, 60 degree of extension, 45 degree side bending, and 90 degree of rotation.
Measured: 0 week, 2 weeks, 4 weeks, and 12 weeks post discharge
Fear Avoidance Belief Questionnaire (FABQ)
It measure patients' fear of pain with movements and resulting avoidance of physical activity because of their fear.90, 91 The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs. There are two sub-scales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24).
Measured: 0 week, 2 weeks, 4 weeks, and 12 weeks post discharge
The Neck Flexor Endurance Test (NFET)
It assess the endurance in the endurance of neck flexor muscles.92 The test is performed with a patient in a supine, hook-lying position. Patient maximally retracts the chin and holds it isometrically. Then, patient lifts the head and neck 1-inch (2.5cm) off the table, while keeping the chin retracted to the chest. The therapist places a hand on the table just below the occipital bone of the patient's head and focuses on the skin folds along the patient's neck. Therapist can give verbal commands (such as - "Tuck your chin", "Hold your head up", "keep your chin tucked", etc.), when either the skin fold(s) begins to separate, or the patient's occiput touches the therapist's hand. The test is terminated if the skin fold(s) is separated due to loss of chin tuck or the patient's head touches the therapist's hand for more than 1 second. Normal Values are - Men: 38.9 seconds, Women: 29.4 seconds.
Measured: 0 week, 2 weeks, 4 weeks, and 12 weeks post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study startJul 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionMar 2022 (estimated)
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hendricks Regional Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeevan Pandya, Hendricks Regional Health
- Investigators
- Josh Cleland, PT, PHD, Study chair, Tuft's UniversityShane Koppenhaver, PT, PHD, Study director, Robbins College of Health and Human Sciences, Baylor UniversityLouie Puentedura, PT, PHD, Study director, Robbins College of Health and Human Sciences, Baylor University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851067
- Sponsor's protocol ID
- 13-10
- Status last verified
- Apr 2021
- First submitted
- 11 Apr 2021
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pandya J, Puentedura EJ, Koppenhaver S, Cleland J. Dry Needling Versus Manual Therapy for Patients With Mechanical Neck Pain: A Randomized Controlled Trial. J Orthop Sports Phys Ther. 2024 Apr;54(4):267-278. doi: 10.2519/jospt.2024.12091.
PubMed 38284367
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dry Needling Versus Manual Therapy in Patients With Mechanical Neck Pain: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04851067
- Acronym / sponsor ID
- 13-10
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Hendricks Regional HealthUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 20 Apr 2021 (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.
Background: The current physical therapy evidence for treating patients with the mechanical neck pain recommends both, manual therapy (MT) and dry needling (DN) along with cervical and scapulothoracic exercises.1 However, at present, investigators still don't have any evidence suggesting if one treatment approach, the manual therapy and exercises or dry needling and exercises, is superior to the other in treating patients with the mechanical neck pain. Objective: The aim of this study is to compare the effects of dry needling and manual therapy on pain, disability, range of motion, strength, and patient perceived improvements in the patients with mechanical neck pain. Methods: Investigators will conduct a randomized, single-blind, placebo-controlled trial in accordance with the CONSORT guidelines. Patients with primary complain of neck pain, with a minimum score of 2 on Numeric Pain Rating Scale (NPRS), a minimum of 10 points or 20% score of Neck Disability Index (NDI), and who are over the age of 18 will be enrolled in the study. Subjects with any red flags, history of surgery at the cervical or thoracic spine, neurological symptoms, nerve root compression, whiplash in the last 6 weeks, pending legal actions related to neck pain, on workers compensation, insufficient English language skills, and/or contraindications to dry needling or manual therapy, will be excluded from the study. A total of 75 patients will be recruited for the study, who will be randomized to two groups - (1) Dry Needling and Therapeutic Exercises (DNTEx) and (2) Manual Therapy and Therapeutic Exercises (MTTEx). All participants will be treated for seven physical therapy treatment sessions of 30 minutes each over a maximum of 6 weeks. The primary outcome measure will NDI, which will evaluate disability of patients. While secondary outcome measures would be: NPRS (score range from 0 to 10) to assess pain, Patient-Specific Functional Scale [PSFS], (score ranges from 3 to 30) will measure a patient-specific measure of function important significant to them, Range of Motion (ROM) will measure changes in the motion of flexion, extension, bilateral rotation, and bilateral side-bending at the cervical spine, The Neck Flexor Endurance Test (NFET) will measure the improvement in the endurance of neck flexor muscles, Fear Avoidance Belief Questionnaire (FABQ) will measure patients' fear of pain with movements and resulting avoidance of physical activity because of their fear, and The Patient Global Rating of Change (GROC) will measure each patient's self-perceived improvement. An assessor, who is blinded to the group allocation, will collect all outcome measures at baseline, 2weeks, discharge session/7th treatment session, and 3 months after discharge/7th treatment session. An a priori alpha level of 0.05 will be used for all analyses. Investigators will examine the primary aim with a repeated-measures analysis of covariance (ANCOVA), using pretest scores as covariates, with treatment groups (Dry needling + Exercise Vs. MT + Exercise) as the between subjects' independent variables and time (baseline, 2 weeks, Discharge [7 sessions], 12 weeks post discharge) as the within-subjects independent variable. The hypothesis of interest is the 2-way group * time interaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Needling and Therapeutic Exercises (DNTEx) | Active comparator | Other: Dry Needling and Therapeutic Exercises (DNTEx)Dry Needling - A fine needle, of 5-10 mm, will be used to penetrate the skin, subcutaneous tissues, and muscle with the intent to stimulate Myofascial Trigger Point (MTrP) or mechanically disrupt tissue without the use of an anesthetic. Therapeutic Exercises - Are exercises will be performed to achieve a specific physical benefit, including increasing and maintaining range of motion, strengthening weak muscles, increasing joint flexibility, or improving cardiovascular and respiratory function. |
| Manual Therapy and Therapeutic Exercises (MTTEx) | Active comparator | Other: Manual Therapy and Therapeutic Exercises (MTTEx)Joint Mobilization - A manual therapy technique comprising of a continuum of skilled passive movements to the joint complex will be applied at varying speeds and amplitudes. It will include a low-grades/velocity (grades I and II), high grades (grades III and IV), and small- or large-amplitude passive movement techniques within the patient's physiological range of motion and within the patient's control with the intent to restore optimal motion, function, and/ or to reduce pain. Joint Manipulation - A passive, high velocity, low amplitude thrust will be applied to a localized joint segment/s within its anatomical limit with the intent to restore optimal motion, function, and/ or to reduce pain. |
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 > 18 years old
- Primary complaint of neck pain
- Neck Disability Index > 10 points=20%
Key exclusion criteria (12 listed)
- Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e., tumor, fracture, metabolic diseases, RA, 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 Needling and Therapeutic Exercises (DNTEx)Already included in arm/group descriptions. | Other | Dry Needling and Therapeutic Exercises (DNTEx) |
| Manual Therapy and Therapeutic Exercises (MTTEx)Already included in arm/group descriptions. | Other | Manual Therapy and Therapeutic Exercises (MTTEx) |
Primary outcome
Neck Disability Index
Time frame: 0 Week
The NDI is used to measure pain-related disability associated with activities of daily living in people with neck pain. The NDI contains 10 items-7 related to activities of daily living, 2 related to pain, and 1 related to concentration. Each item is scored on a 6-point scale, from 0 to 5; therefore, the maximum score is 50. The total score is expressed as a percentage (total possible score, 100%), with higher scores corresponding to greater disability.9,77 Content, construct validity, and reliability of the NDI has been previously shown in patients with neck pain. The NDI has been used by researchers to evaluate the effect of treatments on patients' perceived levels of functioning and disability. The NDI has showed good reliability and validity in patients with mechanical neck pain.
Neck Disability Index
Time frame: 2 Weeks
The NDI is used to measure pain-related disability associated with activities of daily living in people with neck pain. The NDI contains 10 items-7 related to activities of daily living, 2 related to pain, and 1 related to concentration. Each item is scored on a 6-point scale, from 0 to 5; therefore, the maximum score is 50. The total score is expressed as a percentage (total possible score, 100%), with higher scores corresponding to greater disability.9,77 Content, construct validity, and reliability of the NDI has been previously shown in patients with neck pain. The NDI has been used by researchers to evaluate the effect of treatments on patients' perceived levels of functioning and disability. The NDI has showed good reliability and validity in patients with mechanical neck pain.
Neck Disability Index
Time frame: 4 Weeks
The NDI is used to measure pain-related disability associated with activities of daily living in people with neck pain. The NDI contains 10 items-7 related to activities of daily living, 2 related to pain, and 1 related to concentration. Each item is scored on a 6-point scale, from 0 to 5; therefore, the maximum score is 50. The total score is expressed as a percentage (total possible score, 100%), with higher scores corresponding to greater disability.9,77 Content, construct validity, and reliability of the NDI has been previously shown in patients with neck pain. The NDI has been used by researchers to evaluate the effect of treatments on patients' perceived levels of functioning and disability. The NDI has showed good reliability and validity in patients with mechanical neck pain.
Neck Disability Index
Time frame: 12 Weeks post discharge
The NDI is used to measure pain-related disability associated with activities of daily living in people with neck pain. The NDI contains 10 items-7 related to activities of daily living, 2 related to pain, and 1 related to concentration. Each item is scored on a 6-point scale, from 0 to 5; therefore, the maximum score is 50. The total score is expressed as a percentage (total possible score, 100%), with higher scores corresponding to greater disability.9,77 Content, construct validity, and reliability of the NDI has been previously shown in patients with neck pain. The NDI has been used by researchers to evaluate the effect of treatments on patients' perceived levels of functioning and disability. The NDI has showed good reliability and validity in patients with mechanical neck pain.
6 secondary outcomes
Numeric pain Rating Scale (NPRS)
Time frame: 0 week, 2 weeks, 4 weeks, and 12 weeks post discharge
Patient Specific Functional Scale (PSFS)
Time frame: 0 week, 2 weeks, 4 weeks, and 12 weeks post discharge
Global Rating of Change Scale (GROC)
Time frame: 0 week, 2 weeks, 4 weeks, and 12 weeks post discharge
Cervical Range of Motion (CROM)
Time frame: 0 week, 2 weeks, 4 weeks, and 12 weeks post discharge
Fear Avoidance Belief Questionnaire (FABQ)
Time frame: 0 week, 2 weeks, 4 weeks, and 12 weeks post discharge
The Neck Flexor Endurance Test (NFET)
Time frame: 0 week, 2 weeks, 4 weeks, and 12 weeks post discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Derived from this study: PubMed 38284367Pandya J, Puentedura EJ, Koppenhaver S, Cleland J. Dry Needling Versus Manual Therapy for Patients With Mechanical Neck Pain: A Randomized Controlled Trial. J Orthop Sports Phys Ther. 2024 Apr;54(4):267-278. doi: 10.2519/jospt.2024.12091.
- 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.
Josh Cleland, PT, PHD study chair
Tuft's University
Shane Koppenhaver, PT, PHD study director
Robbins College of Health and Human Sciences, Baylor University
Louie Puentedura, PT, PHD study director
Robbins College of Health and Human Sciences, Baylor University
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling and Therapeutic Exercises (DNTEx) and Manual Therapy and Therapeutic Exercises (MTTEx) in people with Neck Pain, run by Hendricks Regional Health.
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 12 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: status not confirmed, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeevan J Panday, PT, MHS ((317) 838-3434, Jeevan.Pandya@hendricks.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability Index (time frame: 0 Week). The study lists 4 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 NCT04851067, 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 20 Apr 2021.