126 Participants Needed

Manual Therapy for Chronic Neck Pain

(SS-MECH Trial)

Recruiting at 1 trial location
CE
Overseen ByChad E Cook, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Duke University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

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.12345

Is 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.678910

How 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.1241112

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).

Research Team

CE

Chad E Cook

Principal Investigator

Duke University

Eligibility 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 have had neck pain of 3 or more out of 10 for most days in the last 3 months.

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

Treatment Details

Interventions

  • Manual Therapy
Trial Overview 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.
Participant Groups
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

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

The Medical University of South Carolina

Collaborator

Trials
1
Recruited
130+

University of Colorado - Anschutz Medical Campus

Collaborator

Trials
9
Recruited
1,700+

University of Colorado, Denver

Collaborator

Trials
1,842
Recruited
3,028,000+

Saint-Joseph University

Collaborator

Trials
55
Recruited
6,200+

Findings from Research

A systematic analysis of nine clinical trials found that a single session of spinal manipulation provides moderate-to-high quality evidence for immediate pain relief in chronic neck pain, with average reductions in pain scores of about -18.94 mm on a 100-mm scale.
In contrast, the evidence for spinal mobilization and ischemic compression is less robust, showing smaller immediate changes in pain, and there is no evidence supporting the effectiveness of massage or manual traction for this condition.
Chronic mechanical neck pain in adults treated by manual therapy: a systematic review of change scores in randomized controlled trials of a single session.Vernon, H., Humphreys, BK.[2021]
A new sham cervical manipulation technique was successfully validated, effectively masking participants' awareness of their treatment group allocation, which is crucial for clinical trials.
In a study of 67 subjects with chronic neck pain, no significant differences were found in pain, tenderness, or range of motion between the real manipulation and sham groups, indicating that the sham procedure is clinically inert.
Validation of a novel sham cervical manipulation procedure.Vernon, HT., Triano, JJ., Ross, JK., et al.[2021]
Moderate quality evidence from 19 trials indicates that a combination of mobilisation, manipulation, and soft tissue techniques significantly reduces pain and improves patient satisfaction for acute neck pain compared to short wave diathermy.
Low quality evidence suggests that mobilisation and manipulation can provide clinically important pain relief and improved function for chronic cervicogenic headaches, although no significant differences were found when combined with other physical medicine modalities.
Manual therapy with or without physical medicine modalities for neck pain: a systematic review.D'Sylva, J., Miller, J., Gross, A., et al.[2018]

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]
Validation of a novel sham cervical manipulation procedure. [2021]
Manual therapy with or without physical medicine modalities for neck pain: a systematic review. [2018]
4.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Manual therapy in non-specific neck pain]. [2018]
Effect of manual soft tissue therapy on the pain in patients with chronic neck pain: A systematic review and meta-analysis. [2022]
Prospective investigations into the safety of spinal manipulation. [2019]
Adverse events after manual therapy among patients seeking care for neck and/or back pain: a randomized controlled trial. [2022]
The risk associated with spinal manipulation: an overview of reviews. [2022]
Do adverse events after manual therapy for back and/or neck pain have an impact on the chance to recover? A cohort study. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Manual therapy in the treatment of neck pain. [2019]
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]
Comparative effectiveness of manipulation, mobilisation and the activator instrument in treatment of non-specific neck pain: a systematic review. [2021]
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