Clinical trial NCT04851067: Dry Needling Versus Manual Therapy in Patients With Mechanical Neck Pain: A Randomized Control Trial
Official title: Dry Needling Versus Manual Therapy in Patients With Mechanical Neck Pain: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neck Pain
Lead sponsor: Hendricks Regional Health
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years old
2. Primary complaint of neck pain
3. Neck Disability Index \> 10 points=20%

Exclusion Criteria:

1. 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.
2. Use of blood thinners
3. History of whiplash injury within the past six weeks
4. 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.
5. Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:

   1. Muscle weakness involving a major muscle group of the upper extremity
   2. Diminished upper extremity muscle stretch reflex (biceps brachii, brachioradialis, or triceps)
   3. Diminished or absent sensation to pinprick in any upper extremity dermatome
6. Prior surgery to the neck or thoracic spine
7. Workers' compensation or pending legal action regarding their neck pain
8. Insufficient English language skills to complete all questionnaires
9. Inability to comply with treatment and follow-up schedule

Primary outcomes:
measure: Neck Disability Index
timeFrame: 0 Week
measure: Neck Disability Index
timeFrame: 2 Weeks
measure: Neck Disability Index
timeFrame: 4 Weeks
measure: Neck Disability Index
timeFrame: 12 Weeks post discharge
Secondary outcomes:
measure: Numeric pain Rating Scale (NPRS)
timeFrame: 0 week, 2 weeks, 4 weeks, and 12 weeks post discharge
measure: Patient Specific Functional Scale (PSFS)
timeFrame: 0 week, 2 weeks, 4 weeks, and 12 weeks post discharge
measure: Global Rating of Change Scale (GROC)
timeFrame: 0 week, 2 weeks, 4 weeks, and 12 weeks post discharge
measure: Cervical Range of Motion (CROM)
timeFrame: 0 week, 2 weeks, 4 weeks, and 12 weeks post discharge
measure: Fear Avoidance Belief Questionnaire (FABQ)
timeFrame: 0 week, 2 weeks, 4 weeks, and 12 weeks post discharge
measure: The Neck Flexor Endurance Test (NFET)
timeFrame: 0 week, 2 weeks, 4 weeks, and 12 weeks post discharge
Other outcomes:
Locations:
Study officials:
affiliation: Tuft's University
name: Josh Cleland, PT, PHD
role: STUDY_CHAIR
affiliation: Robbins College of Health and Human Sciences, Baylor University
name: Shane Koppenhaver, PT, PHD
role: STUDY_DIRECTOR
affiliation: Robbins College of Health and Human Sciences, Baylor University
name: Louie Puentedura, PT, PHD
role: STUDY_DIRECTOR
References: