Spinal Manipulative Therapy for Neck Pain
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Minnesota
Must not be taking: Chronic opioids, Botox
Disqualifiers: ASA Class III, Cervical surgery, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are using chronic opioids, you would not be eligible to participate.
What data supports the effectiveness of the treatment Spinal Manipulative Therapy for neck pain?
Research shows that spinal manipulative therapy (SMT) can be effective for managing musculoskeletal pain, which includes neck pain. It is frequently used by health professionals for spinal pain and has been established as a clinically effective treatment for several musculoskeletal disorders.
12345Is spinal manipulative therapy generally safe for humans?
Spinal manipulative therapy (SMT) is widely used, but there are concerns about its safety, especially regarding neck manipulation and the risk of stroke. Serious complications are rare but have been reported, and the reporting of adverse events in clinical trials is not always comprehensive.
24678How does Spinal Manipulative Therapy for neck pain differ from other treatments?
Spinal Manipulative Therapy (SMT) is unique because it involves hands-on techniques where practitioners use their hands to apply a controlled, sudden force to a spinal joint, which is different from drug-based treatments or surgeries. This approach is often used by chiropractors and is known for its high-velocity, low-amplitude thrusts, which aim to improve physical function and relieve pain.
910111213Eligibility Criteria
This trial is for adults aged 18 to 39 who have been experiencing nonspecific, mechanical neck pain of moderate intensity or higher (more than a 3 on a scale from 0-10) for over three months. It's not suitable for individuals outside this age range or those with different types of neck pain.Inclusion Criteria
I am between 18 and 39 years old.
My pain level is above 3 on a scale of 0 to 10.
I have had neck pain without a specific cause for more than 12 weeks.
Exclusion Criteria
I cannot be exposed to radiation due to health risks.
I am currently receiving non-drug treatments for neck pain.
Pregnancy, currently trying to get pregnant, lactation
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants are randomized into one of three groups: No Treatment, Light Massage (pseudo-sham), or Spinal Manipulative Therapy. Metrics of quality of spinal motion will be compared before and after the prescribed intervention.
4-6 weeks
Follow-up
Participants are monitored for changes in intersegmental and global range of motion, neck pain intensity, neck disability, and overall function.
4 weeks
Participant Groups
The study aims to see if Spinal Manipulative Therapy (SMT) can correct abnormal neck movements in people with chronic neck pain by comparing it against light massage and no treatment at all. Participants will be randomly assigned to one of these three groups.
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Experimental groupExperimental Treatment1 Intervention
Spinal Manipulative therapy group
Group II: No treatment groupActive Control1 Intervention
No Treatment: participants will be placed in a similar position to the other groups for the same duration, but no treatment or touch will be administered.
Group III: Pseudo sham groupPlacebo Group1 Intervention
Light massage group
Spinal Manipulative Therapy is already approved in United States, Canada, European Union, Australia for the following indications:
🇺🇸 Approved in United States as Spinal Manipulative Therapy for:
- Mechanical neck pain
- Chronic neck pain
- Headache
🇨🇦 Approved in Canada as Spinal Manipulation for:
- Mechanical neck pain
- Chronic neck pain
- Headache
- Upper limb pain
🇪🇺 Approved in European Union as Chiropractic Adjustment for:
- Mechanical neck pain
- Chronic neck pain
- Headache
- Back pain
🇦🇺 Approved in Australia as Spinal Manipulative Therapy for:
- Mechanical neck pain
- Chronic neck pain
- Headache
- Musculoskeletal pain
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MinnesotaMinneapolis, MN
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Who Is Running the Clinical Trial?
University of MinnesotaLead Sponsor
References
Immediate reduction in temporal sensory summation after thoracic spinal manipulation. [2021]Spinal manipulative techniques (SMT) have shown clinical effectiveness in some patients with musculoskeletal pain.
Complications of spinal manipulation: a comprehensive review of the literature. [2022]Spinal manipulative therapy (SMT) is a frequently applied therapy for back and neck pain. Serious complications of SMT are presented primarily in case reports. Many patients seen by physicians also seek care from therapists applying manipulative techniques. Therefore, background information on the risks of SMT is essential for physicians.
Spinal manipulation epidemiology: systematic review of cost effectiveness studies. [2022]Spinal manipulative therapy (SMT) is frequently used by health professionals to manage spinal pain. With many treatments having comparable outcomes to SMT, determining the cost-effectiveness of these treatments has been identified as a high research priority.
Internal forces sustained by the vertebral artery during spinal manipulative therapy. [2019]Spinal manipulative therapy (SMT) has been established as a clinically effective modality for the management of several musculoskeletal disorders. One major issue with the use of SMT is its safety, especially with respect to neck manipulation and the risk of stroke in the vertebrobasilar system.
Use of spinal manipulative therapy in the treatment of duodenal ulcer: a pilot study. [2006]To evaluate the effectiveness of spinal manipulative therapy (SMT) in the treatment of an internal organ disorder.
The reporting of adverse events following spinal manipulation in randomized clinical trials-a systematic review. [2022]Spinal manipulative therapy (SMT) is commonly used to treat spinal disorders. Although clinical practice guidelines recommend the use of SMT in the treatment of neck and back disorders, concerns exist about the nature and incidence of adverse events associated with the intervention. Comprehensive reporting of adverse events in clinical trials could allow for accurate incidence estimates through meta-analysis. However, it is not clear if randomized clinical trials (RCTs) that involve SMT are currently reporting adverse events adequately.
Spinal manipulative therapy has an immediate effect on thermal pain sensitivity in people with low back pain: a randomized controlled trial. [2022]Current evidence suggests that spinal manipulative therapy (SMT) is effective in the treatment of people with low back pain (LBP); however, the corresponding mechanisms are unknown. Hypoalgesia is associated with SMT and is suggestive of specific mechanisms.
The risk associated with spinal manipulation: an overview of reviews. [2022]Spinal manipulative therapy (SMT) is a widely used manual treatment, but many reviews exist with conflicting conclusions about the safety of SMT. We performed an overview of reviews to elucidate and quantify the risk of serious adverse events (SAEs) associated with SMT.
Ultrasound-guided microwave ablation for secondary hyperparathyroidism: a systematic review and meta-analysis. [2021]Microwave ablation (MWA) is used for the treatment of severe secondary hyperparathyroidism (SHPT), but its efficacy and safety still remained unclear. This study aimed to investigate the efficacy and safety of ultrasound (US)-guided MWA in patients with SHPT.
[Role of minimal invasive surgery for primary and secondary hyperparathyroidism]. [2015]The standard surgical approach to treat primary (pHPT) and secondary hyperparathyroidism (sHPT) used to be a cervicotomy with exploration of all four parathyroid glands. This access has been challenged recently by the introduction of minimally invasive techniques in order to achieve superior cosmesic results and to reduce theatre time. We analyzed the advantages and morbidities of these surgical aproaches.
[Role of minimally invasive surgery in the treatment of primary hyperparathyroidism]. [2014]The minimally invasive approach to parathyroid surgery is considered an efficient alternative to traditional cervicotomy when the pre-operative diagnostic work-up indicates a single parathyroid adenoma. Imaging techniques (ultrasound, SPECT), on the one hand, and intraoperative diagnostic techniques (radio-guided surgery, intraoperative parathyroid hormone assay), on the other, contribute to the success and development of specialized centres which prefer to use this type of surgery. The postoperative pain control and aesthetic results achieved with these techniques are today the main subjects of interest in the minimally invasive approach.
Video-assisted neck exploration for primary and secondary hyperparathyroidism: initial experience. [2017]Minimally invasive surgery (MIS) for primary hyperparathyroidism includes unilateral neck exploration, access via a totally endoscopic approach, and access via a video-assisted procedure. We report herein our initial experience with the video-assisted neck exploration procedure for primary (PHPT) and secondary hyperparathyroidism (SHPT).
Dropout associated with osteopathic manual treatment for chronic noncancerous pain in randomized controlled trials. [2021]Reviews exploring harm outcomes such as adverse effects (AE), all cause dropouts (ACD), dropouts due to inefficacy, and dropouts due to AE associated with osteopathic manipulative treatment (OMT) or osteopathic manual therapy (OMTh) are scant.