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  • Dry Needling for Cervicogenic Headache

    Dry needling is a widely used intervention performed by physical therapists for a wide range of musculoskeletal and neurological conditions. Dry needling has been shown to be beneficial for cervicogenic headaches but treatment is typically applied to the neck. It is well-established that cervical pain can upregulate the trigeminal nerve and vice versa in various forms of headaches. Thus, it is plausable that reducing inflammation and irritation of the trigeminal nerve may in fact reduce neck pain and impairments. This study aims to look investigate whether dry needling the trigeminal innervation field will reduce pain and impairments known to exist in patients with cervicogenic headaches compared to a sham comparator. The study is a pilot trial for a larger RCT and will look at immediate effects only.

    Phase

    N/A

    Span

    22 weeks

    Sponsor

    Youngstown State University

    Youngstown, Ohio

    Recruiting

  • Applying Pain Adaptability to Manual Therapy Practice

    This proof-of-concept study uses an observational design to assess correlation between the below stated factors. This study design has been recommended in analgesic management in investigating novel mechanistic relationships. A convenience sample will be recruited from outpatient orthopedic clinics and University sites across a geographically diverse segment of the United States. Individuals will be educated on the purpose and risks of the study via informed consent and will determine if they would like to participate. An a priori power analysis was performed at the .05 significance level with a projected correlation of (.60) and a sample size of 28 participants was recommended to achieve 80 percent power. Given the single session design with virtual/electronic follow up a low dropout rate related to compliance is anticipated. Given the noxious application and the ability to terminate session if requested, along with aforementioned, a total drop-out rate of 10% will be anticipated. A sample size of 32 will be utilized in an attempt to obtain 28 participants. Data collection will be completed by investigators and/or clinicians whom have been trained directly by investigators on the research protocol or by the research team. Following consent, the individuals will follow the protocol below: 1. Baseline patient reported measurements will be obtained including McGill Pain Questionnaire, Fear Avoidance Belief Questionnaire, Modified Oswestry Low Back Pain Disability Questionnaire, Expectations of Treatment Scale, Hospital Anxiety and Depression Scale, Fatigue Severity Scale, Numeric Pain Rating Scale (NPRS) (current, best, and worst) 2. Baseline Demographics which have shown prognostic value 1. Age 2. Gender 3. Symptom Duration 4. Joint(s) involved 5. Presence of referred leg pain 3. Baseline Objective measures will be obtained including: 1. Active Range of Motion at lumbar spine and Coxofemoral joint 2. Neuromuscular Screening (Reflexes, light touch sensation L3-S1, neural testing) 3. Cardiopulmonary screening (Blood pressure, heart rate, pulse-oximetry, AAA) 4. Joint mobility at lumbosacral spine via Posterior -> Anterior (PA) mobilizations performed central and unilateral; Assess for comparable sign, If present progress to below 5. Pain modulation/adaptability assessment - Protocol outlined below: 6. Application of non-thrust Central or Unilateral PA mobilization application as chosen by the clinician in a pragmatic manner to address patients comparable sign. - Technique, grade, time, and location to be recorded - Pain (NPRS) to be graded continuously throughout the technique and recorded Pain Adaptability/Modulation assessment: Throughout the experiment, the participants will sit comfortably in a chair with arms rested on the arm rests and legs testing on the floor. The room temperature will be controlled at 21-23 deg C. Participants will be assured that cold stimulation will not cause any physical damage to their body, and are allowed to withdraw from the experiments at any time. Cold pressor pain - A bucket of ice and water, a temperature of 1.0C to 4.0C will be maintained by stirring regularly to prevent an increase of water temperature surrounding the hand. - Participants will submerge their left hand to 5cm above the wrist with their palm facing down. They will be encouraged to keep their hand in the water for 5 minutes. If they find the pain becoming intolerable, they can withdraw their hand immediately. - Pain intensity - During the cold stimulation, participants will be asked to rate the intensity of pain continuously using a 0 to 10 NPRS (0 = no pain at all; 10 = worst pain possible). - McGill Pain Questionnaire (MPQ) - will be completed after cold stimulation. The MPQ is designed to provide qualitative and quantitative measures of pain that can be examined statistically. The MPQ consists of 4 major classes of word descriptors (sensory, affective, evaluative, and miscellaneous) for participants to specify subjective pain experience. - Pressure pain threshold (PPT) - An electronic pressure algometer (Pain Test FPX 25) with a probe area of 1 cm squared will be used. Participants will indicate when the pressure stimulus becomes just painful. PPT's will be determined by averaging 3 assessments taken at 1-minute intervals. It will take 2 to 3 minutes to complete the PPT tests, which will lead to some participants undertaking a 6-minute cold stimulation test. - Sensory assessment - All PPT assessments will be tested at 3 sites: bilateral extensor carpi radialis, at 3 cm distal to the lateral end of the cubic crease on the elbow, and on the right soleus at 8 cm proximal to medial malleolus. - All PPT Assessments will be performed before, during (3 minutes after the initiation of cold stimulation), and 20 minutes post termination of Cold Stimulation. 4. 2-week follow up via phone call, text message, email, or virtual meeting to assess NPRS and GROC.

    Phase

    N/A

    Span

    46 weeks

    Sponsor

    Youngstown State University

    Canfield, Ohio

    Recruiting

  • Cervical-Cranial Dry Needling vs. Orthopedic Manual Therapy for Cervicogenic Headache

    The use of dry needling is becoming widely used by Physical Therapists in the United States for a number of neuromusculoskeletal conditions including cervicogenic headache (CGH). Dry needling is performed by taking a mono-filament needle and inserting it into symptomatic soft tissue. In this trial, the dry needling will be performed segmentally in the neck and along the patient's headache distribution pattern. Orthopedic manual therapy (OMT) may include both thrust and non-thrust techniques applied to a targeted spinal level and has a well-established treatment effect for patients with CGH. In this trial, the OMT will be applied pragmatically to the cervical spine at the most symptomatic level of the headache. Other interventions used in this trial will include patient education, thoracic manipulation and exercise. Patients will be randomized to receive either dry needling or OMT 2x/week for 2 weeks and then 1-2x/week for 2 weeks totaling 6-8 visits over the course of 1 month. The 1 week and 1 month outcomes collected will be reported on separately from the 3 and 12 months.

    Phase

    N/A

    Span

    388 weeks

    Sponsor

    Youngstown State University

    Youngstown, Ohio

    Recruiting

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