38 Clinical Trials for Neck Pain
Neck pain is a common issue that can lead to long-term disability and lost work time for many individuals. Despite numerous studies, finding effective treatment strategies has been challenging. One possible reason for this is that treatments may not have been tested on the specific groups of people who would benefit most. A method was developed to identify people with neck pain who are likely to see significant improvements from a manipulation technique used by physical therapists, called cervical spine thrust joint manipulation. The investigators believe that patients identified as likely responders to cervical spine manipulation will show greater improvements in disability. The investigators aim to test whether this method works with different patients and therapists across the country through a multicenter randomized clinical trial. In this study, 140 patients with primary complaints of neck pain will be enrolled from 20 clinical sites. Designed with stringent criteria for inclusion, this study is a testament to our commitment to participant safety and the effectiveness of the treatment. Participants will be randomly assigned to one of two groups: (1) one group will receive 2 sessions of cervical spine manipulation followed by 3 sessions of exercise, and (2) the other group will receive 2 sessions of gentle hands-on treatment followed by 3 sessions of exercise. The primary goal is to measure changes in disability 4 weeks after starting treatment, with follow-ups after one week, 4 weeks, 3 months, and 6 months to assess both immediate and long-term effects. By providing crucial data on the reliability of our method in identifying patients who will benefit most from cervical spine manipulation, this study has the potential to significantly enhance decision-making leading to rapid improvement. Results from this study will provide clearer guidelines on the optimal use of cervical spine manipulation, potentially revolutionizing the way patients recover from neck pain.
Assess the feasibility of recruiting, enrolling and randomizing patients with concussion symptoms and neck pain to receive manual therapy and cervical rehabilitative exercises in addition to standard concussion treatment. In the usual care workflow provided at the participating concussion clinic, cervical spine rehab is not typically introduced until after week 4. The rationale is that neck pain is often a self-limiting condition that may resolve spontaneously, without the need for specific cervical spine rehab. This study is chiefly focused on feasibility aims that revolve around developing changes to barriers in workflow issues at the participating concussion clinic, that would allow for earlier introduction of cervical spine rehab.
This study is interested in whether baseline measures of pain sensitivity i.e. the amount of pressure required to feel pain predicts pain relief following a pain inducing massage AND whether pain relief following a pain inducing massage is different than a pain free massage or placing your hand in a cold water bath. Participants with neck pain will be randomly assigned to receive a pain inducing massage, pain free massage, or to place their hand in a cold water bath.
It is expected that different physical therapy treatments influence outcomes in many different ways. Each treatment is assumed to have a "specific" treatment mechanism, which explains how that specific treatment works. Different treatments also have "shared" mechanisms, which are similar across many different types of interventions (e.g., exercise, cognitive treatments or manual therapy). In this study, the study team will investigate the several types of specific treatment mechanisms of a manual therapy-based approach and an exercise-based approach and the study team will compare these to see if they are different. The patient population will include individuals with chronic neck pain, which is a condition that leads to notable disability and pain. The study team will also evaluate several shared treatment mechanisms to see if these are similar across the two treatments (e.g., manual therapy versus exercise). The study team expects to find that there are some specific treatment mechanisms with each approach (manual therapy versus exercise) but also several "shared" mechanisms that are similar across the two seemingly different approaches. These will likely influence the outcomes and may help explain why clinicians see similar outcomes across both treatment groups for chronic neck pain. This study is important because no one has investigated whether the outcomes that occur with chronic neck pain are mostly influenced by specific or shared treatment mechanisms. Interestingly, in the psychological literature, shared treatment mechanisms demonstrate the strongest influence (more than specific treatment mechanisms).
This feasibility project aims to evaluate the effectiveness of chiropractic care combined with Tai Chi (TC) training to reduce pain and disability in adults with chronic non-specific neck pain (CNNP).
The primary aim is to test the combined effectiveness of OMT and targeted head exercise (THE) to achieve a significant decrease in headache measures of frequency, intensity, and duration in a Treatment group when compared to a Control group whose members receive only standard medical care. A parallel, 2-arm, longitudinal, randomized controlled trial (RCT) will focus upon female patients (18 to 75 years of age) who have been diagnosed with chronic cervicogenic headache (CeH) based upon a differential diagnosis that includes classification according to the International Headache Society Classification IHSD 3rd Edition, reproduction of referred headache resulting from manual pressure over the upper cervical regions, and objective MRI findings. It is estimated that a sample size of 30 will provide sufficient statistical power (79%) to detect an intervention effect that corresponds to a clinically meaningful recovery (60%). CeH is classified as a secondary headache disorder because the headache pain is a consequence of injury to, or disease of, the bony and/or soft tissues of the upper cervical spine. It has been reported that some patients diagnosed with CeH demonstrate atrophy and/or fatty infiltration (FI) of the RCPm muscles on MRI. FI and/or a reduction in the cross-sectional area (CSA) of active muscle would not be expected to be the direct cause of chronic headache, but either or both could prevent muscles from generating normal physiologic levels of force. It has been shown that there is a functional connection between the pain sensitive dura mater and RCPm muscles and it is known that mechanical stretching of the dura mater results in referred headache. While FI and/or a reduction in the CSA of active muscle would not be expected to be the direct cause of chronic headache, it is known that muscle pathology will result in functional deficits. It is proposed that pathology in RCPm muscles will compromise the normal functional relationship between the RCPm and the dura mater and result in referred head and neck pain. It is predicted that at the end of the study, the Treatment group will show a significant decrease in headache measures that will be accompanied by a significant increase in CSA and a significant decrease in FI on MRI, and restoration of a normal head posture that will not be seen in the Control group. The proposed study is unique in that we are proposing both a mechanism and a source for some instances of CeH. By testing the effectiveness of specific interventions to address a specific pathology within a specific headache population, and by restricting the study cohort to female subjects presenting with CeH, this study will increase the ability to detect a significant change in the outcomes by increasing the power of the statistical analysis.
Neck pain is a common complaint among active duty military personnel, and can have tremendous impacts on quality of life and participation in duty-related activities. Treatments for spinal pain in military personnel are typically multimodal, relying upon physical therapy, pharmacological agents, spinal manipulation, and psychotherapy. However, there does not exist a wide body of evidence to support many of these treatments in active-duty military. The Cervigard neck collar was designed to treat posture-related neck pain with minimal effort and time required for treatment by the patient. However, this has yet to be tested experimentally. The objective of this study is to evaluate the treatment effect and safety of a novel device for the treatment of neck pain using self-reported pain and function measures, as well as objective radiological measures of cervical lordosis and head posture. Participants will be randomized to be fitted with and receive the Cervigard neck collar either immediately, or 6-weeks after being screened. Participants will complete neck pain and function questionnaires, and have cervical X-Rays collected at screening, treatment, 6 weeks, and 12 weeks (for the immediate group). Participants will be instructed to wear the collar every day for the duration of the trial. Self-reported neck pain and function measures will be collected, as well as cervical X-Rays, protocol adherence measures, and adverse events. The intervention is expected to reduce neck pain/discomfort, improve function, and improve cervical lordosis.
Determine the most effective and efficient treatment protocols for treating neck pain with LLLT.
The broad long-term objective is to develop an objective biomarker for spinal health based on aberrant or abnormal movement patterns during functional activities to better target spinal manipulation therapy (SMT) and other conservative treatments. The central hypotheses are a) that aberrant spinal motions and their location (area and level) are indicative of underlying spinal dysfunction, and b) that quantified 3D cervical spine intersegmental and global motion patterns during functional tasks can be used as a biomarker for subsequent clinical studies aimed at normalizing cervical kinematics. Specific Aim: Determine the extent to which SMT can modulate, or normalize, intersegmental motion in patients with neck pain. Rationale: SMT is a force-based biomechanical event whose hypothesized mechanism of action relies on moving the segment into the para-physiological zone, resulting in normalization of spinal kinematic function. Hypothesis: Severity of abnormal or aberrant motion, identified in those with NP, will improve following SMT. Approach: Participants with chronic mechanical neck pain will be recruited and randomized into one of three groups: 1) No Treatment, 2) Light Massage (pseudo- sham), and 3) Spinal Manipulative Therapy. Using a repeated measures study design, metrics of quality of spinal motion will be compared before and after the prescribed intervention.
This study aims to assess the efficacy of Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) therapy to reduce chronic neck for military health system beneficiaries.
Cervical medial branch radiofrequency ablation (CMBRFA) is an effective treatment for cervical facet pain. The efficacy of CMBRFA was proven by studies published in the late 1990's and early 2000's. Patients were selected by a strict, labor-intensive placebo-controlled, diagnostic block protocol and were treated using a conventional monopolar cannula that was positioned parallel to the medial branch, two to three lesions per medial branch nerve and both sagittal and oblique passes. Since the original CMBRFA publications, patient selection for CMBRFA is less strict, and new RFA cannulae have been developed to improve efficiency and safety while maintaining a large ablative lesion. Current clinical patient selection criteria for CMBRFA tend to be more relaxed than described in early research studies. However, subsequent research has shown that when selection criteria are too relaxed, outcomes are poorer. A recent cross-sectional study reported that when CMBRFA is done in patients selected by \>80% pain improvement after dual medial branch blocks, outcomes are similar to patients selected with a stricter selection protocol (100% pain relief) similar to the original CMBRFA studies. Although, the cross-sectional study suggests an appropriate selection criteria, it has not been used in any prospective studies. The Trident multi-tined cannula is a recent technology that produces a large ablative lesion distal to the triple-tined tip. This design allows a perpendicular/lateral approach to CMBRFA and only requires a single lesion at each medial branch. This differs from the conventional cannula, which produces it's most extensive ablative lesion along the cannula with minimal distal projection. As a result, it requires a parallel approach with multiple burn cycles at the same medial branch. The perpendicular approach with Trident and single lesion cycle at each medial branch are appealing for safety purposes and efficiency however, it's efficacy has not been directly compared to the standard conventional cannula. Problem: There are no randomized controlled trials comparing novel technologies like Trident cannula to the previously studied conventional cannula in patients selected with a more practical selection criteria. Purpose: To compared procedural characteristics, pain, and disability outcomes of CMBRFA using either a Trident or conventional cannula in patients with confirmed facet mediated pain (defined by ≥80% symptom reduction after dual medial branch block). Central Hypothesis: Trident cannula during CMBRFA will result in noninferior improvements in pain and function compared to conventional cannula but will significantly reduce procedural discomfort, time and radiation exposure. Specific Aims: 1. Determine the proportion of patients with a successful pain response (defined as ≥50% improvement in index pain) to Trident (T-CMBRFA) versus conventional (C-CMBRFA) at 3, 6, and 12 months. 2. Determine the proportion of patients with a successful functional response (defined as ≥10% reduction on neck disability index \[NDI\]) to T-CMBRFA versus C-CMBRFA at 3, 6, and 12 months. 3. Determine the proportion of patients with a successful perception of improvement (defined as a score ≥6 on the Patient Global Impression of Change \[PGIC\]) to T-CMBRFA versus C-CMBRFA at 3, 6, and 12 months.
The study is a prospective, first-in-human, multi-center, non-randomized, single-arm study to assess the safety and efficacy of the CEM-Cage used with the CEM-Plate in patients who are appropriate candidates for a 2-level anterior cervical discectomy and fusion (ACDF). Fifty patients will be enrolled in the study and, after undergoing a 2-level ACDF, will be evaluated at 4 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months.
SpineZone is an innovative physical therapy program with its focus on treatment of cervical, thoracic, and lumbar conditions through the use of a multi-disciplinary, technology enabled platform. Standard physical therapy modalities including psychologically informed physical therapy are employed in addition to online coaching with a fundamental tenant of core strengthening. Treatments are tracked and modified in a multi-disciplinary format taking all radiographic studies into direct consideration. The goal of this study is to utilize a registry of participants undergoing either in-clinic or online rehabilitation treatment for spine pain at the SpineZone clinical in order to understand the clinical outcomes and costs of different rehabilitation modalities in this patient population.
Segmental facilitation, originally proposed by Korr in the 1950s, suggests that certain spinal segments can become hyperexcitable, leading to chronic pain development. In a facilitated segment, neurons governing sensory, motor, and autonomic functions are in a state of heightened sensitivity, making them responsive to normally weak stimuli. Clinical signs include non-fatigable muscle weakness, brisk reflexes, muscle hypertonicity, tenderness upon palpation, and trophic changes like an orange-peel appearance in the affected segment's innervated areas. It's hypothesized that increased synaptic excitability in facilitated segments could cause vasoconstriction and reduced blood flow, contributing to trophic changes and muscle hypertonicity. Manual therapies like dry needling have been shown to alleviate muscle inhibition in the extremities. Previous studies have demonstrated that mobilization of the C5-6 joint can reduce non-fatigable weakness in shoulder external rotators primarily innervated by these segments. However, the neurophysiological effects of dry needling (DN) on muscle inhibition due to a facilitated segment remain unclear. While DN has been observed to increase local tissue blood flow, its potential to mitigate the clinical signs of segmental facilitation is uncertain. While DN has been observed to increase local tissue blood flow, its potential to mitigate the clinical signs of segmental facilitation is uncertain. Therefore, this project aims to investigate whether DN applied at a facilitated segment could normalize blood flow to its associated muscles. Specifically, this study will explore whether DN at the C5-6 level improves blood flow in the infraspinatus muscle, enhances shoulder range of motion, and influences muscle strength over time. The secondary purpose is to determine whether C5-6 DN will reduce the number of tender points in the muscles supplied by C5-6.
The goal of this clinical trial is to learn how well two community-based self-management programs work in people with chronic back or neck pain from populations that have been minoritized based on race, ethnicity, or income. The main question it aims to answer is: How well does a community-based self-management program teaching mind-body skills such as mindfulness and cognitive behavioral approaches (Partners4Pain) work for reducing pain intensity and interference with general activities and enjoyment of life compared to a community-based self-management program focused on general health and wellbeing (Keys to Wellbeing)? Participants will be asked to do the following: * Attend 2 screening visits to learn about the study and see if they meet the requirements to participate. * Be randomly assigned to one of the two community-based self-management programs. * Attend 9 weekly self-management program sessions (90 minutes each) * Complete surveys about their pain and overall health at 2 months (after the programs end), 4 months, and 6 months. Funding for the project is provided through the National Center for Complementary and Integrative Health (NCCIH) and the National Institute of Neurological Disorders and Stroke (NINDS) through the NIH HEAL Initiative (https://heal.nih.gov/), R33AT012309.
The goal of this clinical trial is to measure the effects of osteopathic manipulative treatment (OMT) on tissues of the craniocervico-mandibular unit (CCMU) in individuals with neck pain and headaches. The main questions to answer are: 1. How does OMT affect CCMU muscle stiffness 2. How does OMT affect jaw motion 3. How does OMT affect autonomic function 4. Is pain pressure threshold affected by OMT of the CCMU Participants will undergo the following interventions: 1. Photos taken to measure head and neck angles 2. Ultrasound 3. Smooth Pursuit Neck Torsion Test 4. Motion Capture 5. Autonomic Protocol 6. Algometry 7. Surveys
The investigators are conducting a trial that evaluates the feasibility of telehealth group pain reprocessing therapy (PRT), with no comparison group, for the treatment of chronic back pain in a population of veterans. PRT is a psychotherapy for chronic pain that aims to help patients reconceptualize their pain as a non-dangerous signal. It has been shown to be effective in a previous RCT (n=151).
Chronic musculoskeletal pain (CP) is a major public health concern. Psychosocial treatments have been shown to be efficacious when compared to largely inert control conditions, but they are characterized by modest effects on primary outcomes. One strategy to boost efficacy is to increase our understanding of treatment mediators. Studies of mediators that directly compare different treatments with each other are needed to determine which mediators are treatment-specific, which are shared across treatments, and which contribute the most to clinical outcomes. Another strategy is to identify the patient characteristics that moderate treatment responses. Research is needed that is guided by theoretical models and that tests moderators across multiple treatments. Identifying subgroups of patients more likely to respond to one or another treatment can advance precision medicine by informing a priori patient-treatment matches that can optimize treatment effects. To accomplish these goals, the authors will conduct a randomized clinical trial to compare the mediators and moderators of the clinical effects of Cognitive-Behavioral Therapy (CBT), Acceptance and Commitment Therapy (ACT), and Emotional Awareness and Expression Therapy (EAET) on adults with chronic spinal (axial) pain. Following baseline assessment of outcome variables as well as potential mediators and moderators, 460 participants will be randomized to CBT, ACT, EAET, or treatment-as-usual control (TAU). The three treatments will be conducted as individual therapy provided weekly for 8 weeks via telehealth. The researchers will conduct weekly assessments of both potential mediators and outcomes, as well as post-treatment and 6-month follow-up assessments. The goal of the study is to identify the most powerful treatment mechanisms - specific and shared -- and reveal for whom the mediator-outcome pathways are strongest.This project can increase the effects of our psychosocial chronic pain treatments by identifying the most effective treatment mechanisms and by informing patient-treatment matches that can optimize treatment effects.
The goal of this observational trial is to compare the health history and motion capabilities of participants with low back pain disorders to participants with healthy spines. The main question\[s\] it aims to answer are to: 1. Primary outcomes of this research effort include the development of composite measures or digital biomarkers to track functional recovery over time and predict duty or work status outcomes (return-to-full duty/work, limited duty/work restrictions or medical discharge/long-term disability). 2. Secondary outcomes of this research effort include characterization of motion assessment utility to predict reinjury risk and evaluate intervention effectiveness. In addition, exploratively, the investigators will determine biopsychosocial profiles of low back pain, and neck pain military populations to identify low back and neck pain phenotypes. Participants will complete questionnaires and wear a motion monitor that will assess the participant's back and/or neck. This session will be approximately 40-70 minutes. The research team will follow up with participants at 3 month, 6 months, and 1 year to complete a short series of questionnaires and a motion assessment test.
The goal of this observational trial is to compare the health history and motion capabilities of participants with low back pain disorders to participants with healthy spines. The main question\[s\] it aims to answer are to: 1. Primary outcomes of this research effort include composite measures that differentiate between control and patient populations, predict injury or reinjury risk, identify low back and neck pain patient phenotypes, and evaluate treatment effectiveness. 2. Secondary outcomes of this research effort include an assessment of wearable motion sensor accuracy, characterization of motion assessment utility, biopsychosocial profiling of control and low back and neck pain patient populations, and differentiation of sincere and insincere motion assessment efforts. Participants will complete questionnaires and wear a motion monitor that will assess your back and/or neck. This session will be approximately 40-70 minutes. The research team will follow up with participants at 3 month, 6 months, 1 year, 2 years, 5 years to complete a short series of questionnaires and a motion assessment test.
The investigators aim to determine whether cervical paravertebral muscle twitching during motor testing as part of performing cervical RFAs is associated with a greater likelihood of treatment success, and greater magnitude or duration of analgesia. The investigators propose a straightforward grading scale based on visual and tactile information readily available during RFA procedures as part of routine practice (per radiofrequency electrode: 0 = no twitches palpated or observed; 1 = twitches palpated but not observed; 2 = twitches palpated and observed at 1-2 levels; 3= twitches palpated and observed at \>2 levels). If a higher weighted score (total score divided by number of radiofrequency lesion sites) correlates with a greater likelihood of treatment success, or magnitude or duration of analgesia following cervical RFA, cervical paraspinal muscle twitching may serve as a readily obtainable prognostic factor (marker) for effectiveness.
This proposed pilot study will investigate the safety and initial effectiveness of focused ultrasound lesioning of the contralateral mesencephalon for severe, opioid-resistant pain associated with head and neck cancer
The aim of this prospective observational study is to investigate whether the presence or absence of directional preference impacts movement coordination impairments as measured in patients with Whiplash Associated Disorders (WAD). The primary research question this study aims to answer is: 1. Is the presence of directional preference in patients with WADs associated with more favorable improvements in the specific outcome measures as compared to those patients with WADs without the presence of directional preference. Patients in this study will asked to complete the following measures at baseline, during care, discharge, and 3 month follow up. 1. Numeric Pain Rating Scale (NPRS) 2. Optimal Screening for Prediction and Referral and Outcome-Yellow Flag (OSPRO-YF) 3. Neck Disability Index (NDI) 4. Craniocervical Flexion Test (CCFT) 5. Neck Flexor Endurance Test 6. Cervical Range of Motion Patients demonstrating a directional preference will be managed utilizing a Mechanical Diagnosis and Treatment approach (MDT) while those without directional preference will be managed according to published clinical practice guidelines for patients with Neck Pain and Movement Coordination Deficits (WADs).
A multi-center, prospective, randomized, controlled comparison of the prodisc C SK and prodisc C Vivo to the control, a similar, legally marketed total disc replacement device in subjects with symptomatic cervical disc disease (SCDD).
Dry needling is a therapeutic modality used to treat a number of neuromusculoskeletal conditions. Practice trends suggest it is becoming widely used by Physical Therapists to help patients manage symptoms associated with CGH, however, there is limited scientific evidence demonstrating meaningful impact for dry needling for CGH. Manual therapy (thrust and non-thrust mobilizations) to the cervical spine are well researched and have an established treatment effect for managing symptoms related to CGH. The purpose of this study is to compare outcomes (1 week, 1 month, 3 months, 12 months) for patients with CGH treated with cervical-cranial dry needling or pragmatically applied orthopedic manual therapy to the cervical spine. In addition to either the cervical-cranial dry needling or manual therapy to the cervical spine, patients will also receive patient education, thoracic manipulation, and exercise.
This study is designed to determine if a brief educational program and a written emotional disclosure task can improve chronic back/neck pain-related outcomes and change pain beliefs and other processes in individuals with chronic back pain. Individuals will be randomly assigned to an experimental condition (pain and affect neuroscience education) or a control condition (general health activities questionnaire), and then subsequently randomized to a second experimental condition (written emotional disclosure) or a control condition (writing about healthy habits). Analyses will examine the main and interactive effects of the pain and affect neuroscience education and written emotional disclosure on improved pain-related outcomes at 1-month follow-up. Participants in both the experimental conditions are expected to show more improvement on pain severity, pain interference, psychological distress and psychological attitudes toward pain at follow-up, relative to participants in the control groups.
In this study, the research team will use low-intensity focused ultrasound (LIFU) to temporarily change brain activity in a brain region that is known to be involved in chronic pain. Through this, the research team hopes to learn about how the brain area works in response to pain. There are main questions this study aims to answer: * The effect of LIFU to inhibit the posterior region of the insula (PI) compared to sham stimulation in individuals with chronic back pain (CBP) and widespread pain symptoms. * The effect of LIFU to PI compared to sham stimulation to reduce pain intensity and magnitude of the Neurologic Pain Signature (NPS) in response to evoked thermal pain. * The effect of LIFU to PI compared to sham stimulation to reduce pain intensity and magnitude of Tonic Pain Signature in response to tonic pain.
The objective of this study is to provide pain relief to patients with facet joint disease or head and neck pain related to compression of a nerve root. The goal is to provide palliative care with superior efficacy and longer relief compared to current methods.
Participants who have a surgical procedure called Posterior Cervical (neck) Spine Surgery will normally need pain medication to relieve post operative pain. This usually includes opioid medications. In this study, the consented participant may receive a nerve block procedure, in addition to the pain relieving medication. There is a fifty-fifty chance to receive the nerve block. The goal is to see if the nerve block group needs less opioid medication, has lower pain scores and is discharged from the hospital sooner.
This phase II trial compares different pain management interventions (standard of care \[SOC\], neurofeedback \[NFB\] training, and compassionate high alert team \[CHAT\]) in patients diagnosed with head and neck cancer who are at risk of developing non-medical opioid use (NMOU). The current standard treatment includes regular clinic visits and supportive care and counseling (including topics like patient-doctor communication, cancer care goals, financial issues counseling, and other topics). NFB training is a type of therapy that uses an electroencephalograph (EEG) and a computer software program to measure brain wave activity. The goal of NFB is to help teach patients with pain how to change their own brain waves to lower their feelings of pain and help improve their quality of life. CHAT is a supportive care intervention that includes symptom and pain management, counseling (about pain, symptoms, opioid use and safety, stress, and quality of life), and support for patients and their family members. NFB and CHAT may help to manage pain and lower patient use of opioids.