The Comparative effectiveness, safety and cost-effectiveness of Concomitant treatment of Chuna manual therapy strategy for Neck pain in patients with Traffic Injuries

The Comparative effectiveness, safety and cost-effectiveness of Concomitant treatment of Chuna manual therapy strategy and Usual Korean Medicine Care for Neck pain in patients with Traffic Injuries : A Multi-center Randomized Controlled Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003921

Enrollment

132

Registered

2019-05-15

Start date

2019-09-02

Completion date

Unknown

Last updated

2020-11-03

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

Conditions

None listed

Interventions

Procedure/Surgery, Others : Concomitant treatment of Chuna manual therapy strategy group Concomitant treatment of Chuna manual therapy strategy group will receive both Chuna manual therapy and usual

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. patients with more than 2 weeks and less than 13 weeks after the accident onset among neck pain patients with traffic injuries which applied to Whiplash Associated Disorders (WAD) grade I, II 2. Neck pain patients with average Numeric Rating Scale (NRS) =5 3. Patients aged 19 years or older and 70 years or younger 4. Patients who can communicate normally 5. Patients who have agreed to trial participation and provided written informed consent

Exclusion criteria

Exclusion criteria: 1. neck pain patients which were caused by other causes except for traffic accident. (e.g osteoarthritis, rheumatoid arthritis, fibromyalgia syndrome, gout etc) 2. Patients with a chronic illness that may affect clinical outcomes : cardiovascular disease, kidney disease, diabetic neuropathy, dementia, epilepsy, etc 3. Patients who have the absolute taboo of chuna manual therapy(eg, acute cauda equina syndrome, spinal dislocation, cerebral aneurysm, etc.) 4. Patients who had undergone cervical spine surgery previously. 5. Patients with congenital spinal disorder 6. Patients who have participated in other clinical studies within the past month. 7. Patients who can not communicate normally due to dementia or mild cognitive impairment. 8. Pregnant woman 9. Patients who are difficult to write a research consent form 10. Patients who can not perform clinical research normally according to judgment of researcher

Design outcomes

Primary

Measure	Time frame
Day with NRS first reduced to 50%	—

Secondary

Measure	Time frame
the areas under the curve;Numeric Rating Scale (NRS);Disability Index [Neck Disability Index (NDI)];EuroQol-5 Dimension (EQ-5D);Patient Global Impression of Change (PGIC);EuroQol-Visual Analogue Scale (EQ-VAS);12-Item Short-Form Health Survey(SF-12);Economic evaluation data;Adverse events	—

Countries

Korea, Republic of

Contacts

Public ContactByung-Cheul shin

Pusan National University Korean Medicine Hospital

Outcome results