Manual Therapy for Chronic Neck Pain
(SS-MECH Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Duke University
Disqualifiers: Radicular symptoms, Neck surgery, Red flags, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?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).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What data supports the effectiveness of the treatment Manual Therapy for Chronic Neck Pain?
Research shows that a single session of spinal manipulation, a type of manual therapy, can lead to immediate and clinically important pain relief for people with chronic neck pain. However, the evidence for other manual therapy techniques like mobilization is less strong, and there is not enough evidence to support the effectiveness of ischemic compression, massage, or manual traction for this condition.
12345Is manual therapy for neck pain safe?
Manual therapy for neck pain is generally safe, with mild and short-lived side effects like dizziness affecting up to 50% of patients. Serious complications are extremely rare, occurring in about 0.0001% of cases.
678910How does manual therapy differ from other treatments for chronic neck pain?
Manual therapy, which includes techniques like spinal manipulation and mobilization, is unique because it can provide immediate pain relief in a single session, unlike other treatments that may require longer durations to show effects. It involves hands-on techniques to adjust and move the spine, which can lead to significant short-term improvements in pain levels.
1241112Eligibility Criteria
This trial is for adults 18 and older who have had neck pain rated at least a 3 out of 10 nearly every day for the past three months or more, without another diagnosis explaining the pain.Inclusion Criteria
I have had neck pain for 3 months or more without another diagnosis.
I am 18 years old or older.
I have had neck pain of 3 or more out of 10 for most days in the last 3 months.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either manual therapy or resistance exercise interventions for chronic neck pain
4 weeks
Weekly in-person sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment
6 months
Follow-up assessments at 4 weeks and 6 months
Participant Groups
The study compares specific effects of manual therapy to exercise in treating chronic neck pain. It also examines 'shared' mechanisms common to both treatments to see which influences outcomes more.
2Treatment groups
Experimental Treatment
Active Control
Group I: Manual therapy treatmentExperimental Treatment1 Intervention
Manual therapy treatments will consist of global soft tissue stretching of the upper trapezius, occipital muscles, levator scapula, and scalene muscles as the patient lies in supine. Non-thrust manipulation will consist of unilateral or central posterior-anterior accessory movements (PAIVMs) to the cervical and upper thoracic segments (in prone) at the most symptomatic levels. Passive physiological intervertebral movements of rotation will be performed in supine, as a mechanism to reduce pain and increase range of motion. Individuals with chronic neck pain randomized to the manual therapy arm, will be assigned a HEP twice daily that will consist of cervical rotations with belt or equivalent, side flexion with belt or equivalent, self-stretching exercises that are designed to target the upper thoracic musculature, and corner wall stretches.
Group II: Resisted exercise treatmentActive Control1 Intervention
In-clinic exercises will consist of chin retractions in sitting, supine clock isometric resistance, supine anterior neck flexion exercises that target the deep neck flexors, prone neck extensor exercises (with concurrent chin retraction), and lateral neck raises (bilaterally). The study team will also target the mid and upper thoracic region by performing upright rows, supine chest raises that target the mid-scapular muscles and the paraspinal muscles, prone "I, T, and Y" exercises, and proprioceptive neuromuscular facilitation exercises using a bar or a cane. Individuals randomized to the resistance exercise arm will be assigned a HEP twice daily that will consist of chin retractions in sitting, supine anterior neck flexion exercises, and elastic band rows that replicate the upright rows performed in the clinic.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
St Joseph's universityPhiladelphia, PA
The Medical University of South CarolinaCharleston, SC
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Who Is Running the Clinical Trial?
Duke UniversityLead Sponsor
The Medical University of South CarolinaCollaborator
University of Colorado - Anschutz Medical CampusCollaborator
University of Colorado, DenverCollaborator
Saint-Joseph UniversityCollaborator
References
Chronic mechanical neck pain in adults treated by manual therapy: a systematic review of change scores in randomized controlled trials of a single session. [2021]We report a systematic analysis of group change scores of subjects with chronic neck pain not due to whiplash and without headache or arm pain, in randomized clinical trials of a single session of manual therapy. A comprehensive literature search of clinical trials of chronic neck pain treated with manual therapies up to December 2006 was conducted. Trials that scored above 60% on the PEDro Scale were included. Change scores were analyzed for absolute, percentage change and effect size (ES) whenever possible. Nine trials were identified: 6 for spinal manipulation, 4 for spinal mobilization or non-manipulative manual therapy (2 overlapping trials), and 1 trial using ischemic compression. No trials were identified for massage therapy or manual traction. Four manipulation trials (five groups) reported mean immediate changes in 100-mm VAS of -18.94 (9.28) mm. ES for these changes ranged from .33 to 2.3. Two mobilization trials reported immediate VAS changes of -11.5 and -4 mm (ES of .36 and .22, respectively); one trial reported no difference in immediate pain scores versus sham mobilization. The ischemic compression study showed statistically significant immediate decreases in 100-mm pain VAS (average = -14.6 mm). There is moderate-to-high quality evidence that immediate clinically important improvements are obtained from a single session of spinal manipulation. The evidence for mobilization is less substantial, with fewer studies reporting smaller immediate changes. There is insufficient evidence for ischemic compression to draw conclusions. There is no evidence for a single session of massage or manual traction for chronic neck pain.
Validation of a novel sham cervical manipulation procedure. [2021]No clinical trial of spinal manipulation for chronic neck pain (NP), for either single or multiple intervention session(s), has used an effective manual sham-manipulation control group.
Manual therapy with or without physical medicine modalities for neck pain: a systematic review. [2018]Manual therapy interventions are often used with or without physical medicine modalities to treat neck pain. This review assessed the effect of 1) manipulation and mobilisation, 2) manipulation, mobilisation and soft tissue work, and 3) manual therapy with physical medicine modalities on pain, function, patient satisfaction, quality of life (QoL), and global perceived effect (GPE) in adults with neck pain. A computerised search for randomised trials was performed up to July 2009. Two or more authors independently selected studies, abstracted data, and assessed methodological quality. Pooled relative risk (RR) and standardised mean differences (SMD) were calculated when possible. We included 19 trials, 37% of which had a low risk of bias. Moderate quality evidence (1 trial, 221 participants) suggested mobilisation, manipulation and soft tissue techniques decrease pain and improved satisfaction when compared to short wave diathermy, and that this treatment combination paired with advice and exercise produces greater improvements in GPE and satisfaction than advice and exercise alone for acute neck pain. Low quality evidence suggests a clinically important benefit favouring mobilisation and manipulation in pain relief [1 meta-analysis, 112 participants: SMD -0.34(95% CI: -0.71, 0.03), improved function and GPE (1 trial, 94 participants) for participants with chronic cervicogenic headache when compared to a control at intermediate and long term follow-up; but no difference when used with various physical medicine modalities.
[Manual therapy in non-specific neck pain]. [2018]To investigate the effectiveness of manual therapy (MT) in patients with nonspecific neck pain (NNP).
Effect of manual soft tissue therapy on the pain in patients with chronic neck pain: A systematic review and meta-analysis. [2022]To systematically evaluate the impact of manual soft tissue therapy (MSTT) on the degree of pain in patients with chronic neck pain (CNP).
Prospective investigations into the safety of spinal manipulation. [2019]Spinal manipulation (SM) is a popular form of treatment of back and neck pain, as well as of other conditions. Uncertainty exists as to its safety. The aim of this systematic review was to summarize the data of all prospective investigations into the safety of SM. Five independent literature searches were carried out to identify all such studies. Data were extracted and validated according to pre-defined criteria. Five investigations met the inclusion criteria. The most valid studies suggest that about half of all patients will experience adverse events after chiropractic SM. These events are usually mild and transient. No reliable data exist about the incidence of serious adverse events. These data indicate that mild and transient adverse events seem to be frequent. Serious adverse events are probably rare but their incidence can only be estimated at present. Further prospective investigations are needed to define their incidence more closely.
Adverse events after manual therapy among patients seeking care for neck and/or back pain: a randomized controlled trial. [2022]The safety of the manual treatment techniques such as spinal manipulation has been discussed and there is a need for more information about potential adverse events after manual therapy. The aim of this randomized controlled trial was to investigate differences in occurrence of adverse events between three different combinations of manual treatment techniques used by manual therapists (i.e. chiropractors, naprapaths, osteopaths, physicians and physiotherapists) for patients seeking care for back and/or neck pain. In addition women and men were compared regarding the occurrence of adverse events.
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.
Do adverse events after manual therapy for back and/or neck pain have an impact on the chance to recover? A cohort study. [2020]Manual therapy is a commonly used treatment for patients with back and neck pain. Studies have shown that manual therapy-related adverse events are mainly short in duration and mild or moderate by their intensity, affecting up to 50% of the patients. If the presence of adverse events has an impact on the chance to recover from back/neck pain is poorly understood. The aim of this study was to investigate if mild or moderate adverse events after manual therapy has an impact on the chance to recover from back/neck pain in men and women.
Manual therapy in the treatment of neck pain. [2019]In general, manual therapies have been demonstrated to be effective for mechanical neck pain in the short term when used in combination with other treatments. No one treatment protocol has been shown to be optimal as specific types of manual therapies have not been investigated in detail. Safety is a prime consideration when applying these treatments. The risk of increased symptoms resulting from manual therapy is low (in the range of 1%-2%), with the most common symptom aggravation being vertigo or dizziness. The risk of serious complication or death from neck manipulation is extremely low (in the range of 0.0001%). Optimal levels of education, training, and competency are integral to the safe performance of manual therapy.
Incomplete reporting of manual therapy interventions and a lack of clinician and setting diversity in clinical trials for neck pain limits replication and real-world translation. A scoping review. [2023]Neck pain is a leading cause of disability, and manual therapy (MT) is a common intervention used across disciplines and settings to treat it. While there is consistent support for MT in managing neck pain, questions remain about the feasibility of incorporating MT from research into clinical practice. The purpose of this scoping review was to assess the adequacy of MT intervention descriptions and the variability in clinician and setting for MT delivery in trials for neck pain.
Comparative effectiveness of manipulation, mobilisation and the activator instrument in treatment of non-specific neck pain: a systematic review. [2021]Neck pain is a common problem and different forms of manual therapy are used in its treatment. The purpose of this systematic review was to critically appraise the literature that directly compared manipulation, mobilisation and the Activator instrument for non-specific neck pain.