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Dose Optimisation for Spinal treatment Effectiveness (The DOSE Study): A randomised controlled pilot trial investigating the effects of high and low mobilisation forces in patients with neck pain

In patients with chornic non-specific neck pain, is a high force mobilisation better than a low force mobilisation or laser for immediate improvement in pressure pain threshold scores?

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000374965
Acronym
The DOSE Study
Enrollment
66
Registered
2011-04-11
Start date
2011-04-06
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Around 30-50% of adults will experience neck pain over a 12 month period, and many are treated with manual therapy. Although evidence supports manual therapy treatment when combined with exercise, the dose is not defined. Up until now, there were few methods for objectively quantifying a manual technique to establish its optimal dose. This pilot randomised controlled trial will investigate two specific doses of posterior-to-anterior (PA) mobilisation, the most common manual technique therapists use when treating the cervical spine. Sixty patients will be randomised to receive either a high force or low force PA mobilisation, or sham treatment, with patients’ pressure pain threshold, resting pain, cervical range and stiffness measured before, immediately after and 3-5 days post-treatment. We will utilise innovative equipment we developed to standardise the manually applied forces, conducting the trial using demonstrable methods from our previous research. Determining dose-response relationships for manual therapy is essential for establishing optimal treatment strategies for patients with neck pain. The cost of neck pain is increasing, and many patients do not achieve symptom resolution. Therefore there is an urgent need for physiotherapists to provide effective treatment dosages with demonstrated patient outcomes, impacting spinal pain and advancing physiotherapy as the preferred treatment choice.

Interventions

1. High force mobilisation will consist of a single application of 3 sets of 30 seconds of oscillating pressures manually applied by thhe physiotherapist' thumbs with a mean peak force of 90N to the symptomatic spinal level. 2. Low force mobilisation will consist of a single application of 3 sets of 30 seconds of oscillating pressures manually applied by thhe physiotherapist' thumbs with a mean peak force of 30N to the symptomatic spinal level. 3. Laser will consist of a single application of 3

1. High force mobilisation will consist of a single application of 3 sets of 30 seconds of oscillating pressures manually applied by thhe physiotherapist' thumbs with a mean peak force of 90N to the symptomatic spinal level. 2. Low force mobilisation will consist of a single application of 3 sets of 30 seconds of oscillating pressures manually applied by thhe physiotherapist' thumbs with a mean peak force of 30N to the symptomatic spinal level. 3. Laser will consist of a single application of 3 sets of 30 seconds application applied using the Echolac with probe to skin contact over the symptomatic level. Laser was detuned (i.e., not active) and represented the placebo group, or an inactive treatment control.

Sponsors

Suzanne Snodgrass
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

chronic non-specific neck pain (> 90 days) aged between 18 and 55 years minimum average resting pain level over the previous 3 days of 3/10 report of neck pain that at least ‘moderately’ interferes with their normal work (work and housework)

Exclusion criteria

upper cervical pain, headache or dizziness as their primary complaint migraine history of trauma related to the neck, surgery to the neck diabetes peripheral vascular disease referred arm pain past the tip of the shoulder currently receiving other physical treatments for their neck pain (e.g., physiotherapy, chiropractic, acupuncture or similar)

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 21, 2026