- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04851067
Dry Needling Versus Manual Therapy in Patients With Mechanical Neck Pain: A Randomized Control Trial
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jeevan J Panday, PT, MHS
- Phone Number: (317) 838-3434
- Email: Jeevan.Pandya@hendricks.org
Study Contact Backup
- Name: Justin C Becker, PT,DPT
- Phone Number: (317) 838-3434
- Email: Justin.Becker@hendricks.org
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age > 18 years old
- Primary complaint of neck pain
- Neck Disability Index > 10 points=20%
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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. |
Already included in arm/group descriptions.
|
Active Comparator: 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. |
Already included in arm/group descriptions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
0 Week
|
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.
|
2 Weeks
|
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.
|
4 Weeks
|
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.
|
12 Weeks post discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric pain Rating Scale (NPRS)
Time Frame: 0 week, 2 weeks, 4 weeks, and 12 weeks post discharge
|
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.
|
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
|
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").
|
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
|
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.
|
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
|
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.
|
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
|
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).
|
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
|
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.
|
0 week, 2 weeks, 4 weeks, and 12 weeks post discharge
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Josh Cleland, PT, PHD, Tuft's University
- Study Director: Shane Koppenhaver, PT, PHD, Robbins College of Health and Human Sciences, Baylor University
- Study Director: Louie Puentedura, PT, PHD, Robbins College of Health and Human Sciences, Baylor University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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