Comparative Effectiveness and Cost-effectiveness of Chuna Manual Therapy for Chronic Neck Pain

Jaseng Medical Foundation

Status: Completed

Conditions: Chronic Neck Pain

Treatments: Procedure: Chuna manual therapy; Procedure: Physical therapy; Drug: Conventional medication

Study type: Interventional

Funder types: Other

Identifiers

NCT03294785

JS-CT-2016-14

Details and patient eligibility

About

A multi-center randomized controlled trial assessing the comparative effectiveness and cost-effectiveness of Chuna manual therapy for chronic neck pain

Full description

A multi-center randomized controlled, parallel, assessor-blinded trial will be conducted to evaluate the comparative clinical effectiveness and cost-effectiveness of Chuna manual therapy for chronic neck pain patients compared to usual care as assessed using pain, functional disability, health-related quality of life, economic evaluation, and safety measures.

Enrollment: 108 patients

Sex: All

Ages: 19 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic neck pain patients (with pain duration of 3 months or longer)
• Patients with numeric rating scale (NRS) of radicular pain ≤ neck pain in neck pain patients with or without radiculopathy
• Patients with NRS of neck pain ≥5 during the 3 days
• Patients who have agreed to trial participation and provided written informed consent

Exclusion criteria

• Patients diagnosed with serious pathology(s) which may cause neck pain (e.g. spinal metastasis of tumor(s), acute fracture, spinal dislocation)
• Patients with history of neck surgery
• Patients with other chronic disease(s) which may interfere with treatment effect, safety, or interpretation of outcomes (e.g. chronic renal failure, vertebral artery complications, rheumatoid arthritis, Down syndrome)
• Patients with progressive neurologic deficit or severe neurologic symptoms such as spinal cord injury
• Patients with severe mental illness
• Patients currently taking steroids, immunosuppressants, medicine for mental illness or other medication(s) that may interfere with study results
• Patients who have received Chuna manual therapy or physical therapy, medicine such as nonsteroidal anti-inflammatory drugs (NSAIDs), or treatment(s) that may influence pain within the past week
• Pregnant patients or patients with plans of pregnancy
• Patients participating in other clinical studies or otherwise deemed unsuitable by the researchers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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108 participants in 2 patient groups

Chuna manual therapy

Experimental group

Description:

The Chuna manual therapy group will receive Chuna manual therapy alone. Chuna manual therapy will employ a semi-standardized treatment plan of Chuna manual therapy through Chuna technique selection based on physician judgement of techniques from Chuna Medicine (Korean Society of Chuna Manual Medicine for Spine \& Nerves: Chuna Medicine: Seoul: Korean Society of Chuna Manual Medicine for Spine \& Nerves; 2017) and osteopathic manipulative medicine. The Chuna techniques employed in this study are divided into cervical, thoracic and rib cage, lumbar, pelvic, sacral, pubic, and hip joint area techniques. Chuna manual therapy sessions will be administered 2 sessions/week over a period of 5 weeks (total 10 sessions). The time duration of 1 Chuna manual therapy session will consist of approximately 10-20 minutes of diagnosis and approximately 10 minutes of treatment.

Treatment:

Procedure: Chuna manual therapy

Usual care

Active Comparator group

Description:

The usual care group will receive usual care alone. Usual care will be limited to physical therapy and conventional medication in this study. Usual care will be provided with reference to a list of most frequently used treatments in neck pain-related patients from Korean Health Insurance Review and Assessment (HIRA) 2014 statistics. Frequency and types of physical therapy used will be recorded in a separate electronic case report form for outcome assessor blinding purposes.

Treatment:

Procedure: Physical therapy

Drug: Conventional medication