Dry Needling Versus Manual Therapy in Patients With Mechanical Neck Pain: A Randomized Control Trial

NCT04851067 | Unknown DMC

• 1 other identifier: 13-10
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  12 Weeks post discharge

Secondary Outcomes (6)

• Numeric pain Rating Scale (NPRS)

  0 week, 2 weeks, 4 weeks, and 12 weeks post discharge

• Patient Specific Functional Scale (PSFS)

  0 week, 2 weeks, 4 weeks, and 12 weeks post discharge

• Global Rating of Change Scale (GROC)

  0 week, 2 weeks, 4 weeks, and 12 weeks post discharge

• Cervical Range of Motion (CROM)

  0 week, 2 weeks, 4 weeks, and 12 weeks post discharge

• Fear Avoidance Belief Questionnaire (FABQ)

  0 week, 2 weeks, 4 weeks, and 12 weeks post discharge

Study Arms (2)

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.

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.

Other: Manual Therapy and Therapeutic Exercises (MTTEx)

Interventions

Dry Needling and Therapeutic Exercises (DNTEx) OTHER

Already included in arm/group descriptions.

Dry Needling and Therapeutic Exercises (DNTEx)

Manual Therapy and Therapeutic Exercises (MTTEx) OTHER

Already included in arm/group descriptions.

Manual Therapy and Therapeutic Exercises (MTTEx)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years old
• Primary complaint of neck pain
• Neck Disability Index \> 10 points=20%

You may not qualify if:

• 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

Sponsors & Collaborators

• Hendricks Regional Health: lead

Related Publications (1)

• 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.

  PMID: 38284367 DERIVED

MeSH Terms

Conditions

Neck Pain

Interventions

Dry Needling; Exercise Therapy; Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Josh Cleland, PT, PHD

  Tuft's University

  STUDY CHAIR

• 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 DIRECTOR

Central Study Contacts

Jeevan J Panday, PT, MHS

CONTACT

(317) 838-3434; Jeevan.Pandya@hendricks.org

Justin C Becker, PT,DPT

CONTACT

(317) 838-3434; Justin.Becker@hendricks.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT,MHS, OCS, COMT, FAAOMPT

Study Record Dates

• First Submitted: April 11, 2021
• First Posted: April 20, 2021
• Study Start: July 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2022
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share