Dry Needling for Patients With Neck Pain

NCT02731014 | Completed

• 1 other identifier: HIC 15-6
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this trial will be to examine the short and long term effectiveness of dry needling on pain, disability, and patient perceived improvements in patients with neck pain attending physical therapy. The investigators hypothesize that patients who receive dry needling, manual therapy, and exercise will achieve greater reductions in pain and disability in the short (4 weeks) and long term (6 and 12 months) compared to those who receive sham dry needling, manual therapy, and exercise.

Conditions

Neck Pain

Keywords

Dry Needling

Outcome Measures

Primary Outcomes (1)

• Change from baseline on the Neck Disability Index (NDI)

  The Neck Disability Index (NDI) was created to measure pain related disability associated with activities of daily living in people with neck pain. The NDI contains ten focused sections. The NDI is easy to complete and score. Each item is scored on a 6 point scale and can reach a maximum score of 5; therefore, the maximum score is 50. This score will calculated as a percentage, with higher scores indicating higher levels of disability.

  4 weeks, 6 months, 12 months

Secondary Outcomes (3)

• Change from baseline on The Global Rating Of Change Scale (GROC)

  4 weeks, 6 months, 12 months

• Questionnaire used to assess blinding of patients to which needling intervention they received

  4 weeks

• Change from baseline on the Visual Analog Scale (VAS) Pain

  4 weeks, 6 months, 12 months

Study Arms (2)

Dry Needling Group

EXPERIMENTAL

Dry Needling, Manual Therapy, and Exercise.

Other: Dry Needling; Other: Manual Therapy; Other: Exercise

Sham Dry Needling Group

SHAM COMPARATOR

Sham Dry Needling, Manual Therapy, and Exercise.

Other: Sham Dry Needling; Other: Manual Therapy; Other: Exercise

Interventions

Dry Needling OTHER

Dry Needling targeting the posterior musculature of the cervical and thoracic spine.

Dry Needling Group

Sham Dry Needling OTHER

Sham Dry Needling performed with Park sham acupuncture needles (Acuprime, UK) will be used to perform sham dry-needling. The device consists of 2 plastic tubes that slide into one another and cause a pricking sensation when pushed against the skin.

Sham Dry Needling Group

Manual Therapy OTHER

Manual Therapy(mobilization/ manipulation) to address joint mobility of the cervical and thoracic spine.

Dry Needling Group; Sham Dry Needling Group

Exercise OTHER

Exercise designed to improve performance of both the deep neck flexor musculature as well as the scapular musculature. The exercise portion will also include a stretching program targeting the cervicothoracic muscles which have been placed in a shortened position as a result of poor postures.

Dry Needling Group; Sham Dry Needling Group

Eligibility Criteria

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

You may qualify if:

• Age between \>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, Rheumatoid Arthritis, 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
• Chiropractic, Physical Therapy, or Acupuncture treatment for their neck pain in the last 12-months
• 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

• Franklin Pierce University: lead
• Newcastle University: collaborator
• Concord Hospital: collaborator

Study Sites (2)

Franciscan, ST.Francis Health

Indianapolis, Indiana, 46237, United States

Location

Concord Hospital Rehabilitation Services

Concord, New Hampshire, 03301, United States

Location

Related Publications (1)

• Gattie ER, Cleland JA, Snodgrass SJ. Dry Needling for Patients With Neck Pain: Protocol of a Randomized Clinical Trial. JMIR Res Protoc. 2017 Nov 22;6(11):e227. doi: 10.2196/resprot.7980.

  PMID: 29167092 DERIVED

MeSH Terms

Conditions

Neck Pain

Interventions

Dry Needling; Musculoskeletal Manipulations; Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physical Therapy

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: April 7, 2016
• Study Start: September 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: September 1, 2019
• Last Updated: December 18, 2019

Record last verified: 2019-12

Locations

US (2)