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Multicenter prospective cohort study on the effect of Mechanical Diagnosis and Therapy on spine related upper and lower limb pain

Multicenter prospective cohort study on the effect of Mechanical Diagnosis and Therapy on spine related upper and lower limb pain - Multicenter prospective cohort study on the effect of Mechanical Diagnosis and Therapy on spine related upper and lower limb pain

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000007389
Enrollment
500
Registered
2012-03-01
Start date
2012-03-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Spine related upper and lower limb pain

Interventions

Each patient will be treated with routine MDT assessments and treatments for 1 month. The MDT assessments includes main outcome measures described above as well as manual muscle testing, neurological
s data into database.

Sponsors

The McKenzie Institute International Japan Branch
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Those who will be treated by credential MDT therapists who are involved in this study; Those who will have unilateral low back pain and leg pain radiating below the gluteal fold or unilateral neck pain and arm pain radiating below the shoulder for more than 6 weeks duration and a minimum pain intensity of 3 on the 11-point numerical rating scale.

Exclusion criteria

Exclusion criteria: Those with bilateral pain radiating below the gluteal fold or the shoulder; Those who will request other treatments except the MDT; Those who will be treated with other treatments except the MDT based on decision makings by the therapists; Those with history of lower quadrant surgery or trauma within the past 6 months; Those with history of upper quadrant surgery or trauma within the past 6 months; Those with history of nerve root block within the past 4 weeks; Those with history of neuropathic pathology such as diabetes or polyneuropathies; Those with history of vascular disease in the lower extremities; Those with history of vascular disease in the upper extremities; Those with systemic disease; Those with inflammatory arthropathies; Those with contraindications to manual therapy techniques such as trauma, infection or severe osteoporosis; Those who cannot communicate well for some reasons.

Design outcomes

Primary

MeasureTime frame
Pain intensity will be assessed with verbally Numerical Pain Rating Scale(0-10). The magnitude of disability will be assessed with Self-Leeds Assessment of Neuropathic Symptoms and Signs(S-LANSS) Japanese version, a questionnaire developed by a research committee for screening neuropathic pain, the Neck Pain Disability Index Japanese version, Roland-Morris Disability Questionnaire Japanese version, Hospital Anxiety and Depression Scale Japanese version, Fear Avoidance and Beliefs Questionnaire Japanese version. Overall improvement will be measured using the Global Perceived Change Scale (GPC) where patients score their perceived change after the treatment on a 7-point scale ranging from: 1 (completely recovered) to 7 (worse than ever).

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026