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NCT Number: NCT02257723

The Effect of Integrated CAM Treatment in Hospitalized Patients

This study investigates the effect of hospital-based intensive non-surgical treatment in musculoskeletal patients admitted to an integrated hospital that offers both complementary and alternative medicine (CAM) and conventional medicine treatment.

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Key information

Conditions

Low Back Pain Arthralgia Back Pain Bone Diseases Hernia Intervertebral Disc Displacement Intervertebral Disc Herniation Joint Diseases Knee Pain Musculoskeletal Diseases Neck Pain Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Shoulder Pain Signs and Symptoms Spinal Diseases Spinal Stenosis

Sex eligibility

All sexes

Study type

Observational

Primary location

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, 06110, South Korea

Location status: Recruiting

Location contact

In-Hyuk Ha, PhD

CONTACT

[email protected]

+82-2-2222-2740

About this study

This study investigates the effect of hospital-based intensive non-surgical treatment in musculoskeletal patients admitted to an integrated hospital that offers both complementary and alternative medicine (CAM) and conventional medicine treatment.

Inpatients received treatment according to a CAM treatment protocol (herbal medicine, acupuncture, bee venom pharmacopuncture, and Chuna manipulation) and conventional medicine treatment as needed. The main outcome measures were the duration of pain, NRS of back pain, radiating leg pain, neck pain, radiating arm pain, knee pain, shoulder pain, previous surgery, previous interventions (injections), Oswestry Disability Index (ODI), Vernon-Mior Neck Disability Index, the Korean Western Ontario McMaster Index, Shoulder Pain and Disability Index, range of motion (ROM), Straight leg raise test (SLR), alcohol use, smoking at admission, 2 weeks, and discharge.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients hospitalized due to spine or joint diseases

Exclusion criteria

  • Main complaint other than back pain, radiating leg pain, neck pain, radiating arm pain, knee pain or shoulder pain
  • Cause of pain non-related to spine, joint or soft tissue; for example, spinal tumors, pregnancy, urolithiasis, etc.
  • Refusal to provide the information needed for clinical research

Treatment and study plan

Herbal medicine

Drug

Herbal medicine was taken 3 times daily in dried powder (2g) and water-base decoction form (120ml) (Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes bidentata, Psoralea corylifolia, Peucedanum japonicum, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, and Atractylodes japonica).

Other names: Traditional herbal medicine

Acupuncture

Procedure

Acupuncture treatment was administered 1-2 times daily using mainly Ah-shi points and local acupuncture points.

Pharmacopuncture

Procedure

Select ingredients similar to those included in the oral herbal medicine (Ostericum koreanum, Eucommia ulmoides, Acanthopanax Sessiliflorus, Achyranthes bidentata, Psoralea corylifolia, Peucedanum japonicum, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, and Atractylodes japonica) were freeze dried into powder form after decoction, then diluted in normal saline and adjusted for acidity and pH to be used in injections. The pharmacopuncture injections were injected once daily to the amount of 1 cc and Ah-shi points and local acupuncture points (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).

Bee venom pharmacopuncture

Procedure

Bee venom pharmacopuncture was applied after confirming a negative reaction to the hypersensitivity skin test. Diluted bee venom (saline:bee venom ratio, 10,000:1) was injected at 4-5 acupoints at the physician's discretion. Each acupuncture point was injected with approximately 0.2 cc to a total of 0.5-1 cc using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).

Chuna manipulation

Procedure

Chuna was administered 3-5 times a week. Chuna is a Korean version of spinal manipulation that incorporates conventional spinal manipulation techniques for mobilization involving high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement.

Primary outcomes

  1. NRS of low back pain (LBP)

    Time frame: Admission (baseline), 2 weeks, Discharge

    The patients were asked to quantify their current LBP, setting no pain as 0 and the most severe pain that they could possibly imagine as 10.

  2. NRS of radiating leg pain

    Time frame: Admission (baseline), 2 weeks, Discharge

    The patients were asked to quantify their current leg pain, setting no pain as 0 and the most severe pain that they could possibly imagine as 10.

  3. NRS of neck pain

    Time frame: Admission (baseline), 2 weeks, Discharge

    The patients were asked to quantify their current neck pain, setting no pain as 0 and the most severe pain that they could possibly imagine as 10.

  4. NRS of radiating arm pain

    Time frame: Admission (baseline), 2 weeks, Discharge

    The patients were asked to quantify their current radiating arm pain, setting no pain as 0 and the most severe pain that they could possibly imagine as 10.

  5. NRS of knee pain

    Time frame: Admission (baseline), 2 weeks, Discharge

    The patients were asked to quantify their current knee pain, setting no pain as 0 and the most severe pain that they could possibly imagine as 10.

  6. NRS of shoulder pain

    Time frame: Admission (baseline), 2 weeks, Discharge

    The patients were asked to quantify their current shoulder pain, setting no pain as 0 and the most severe pain that they could possibly imagine as 10.

  7. Oswestry disability index (ODI)

    Time frame: Admission (baseline), 2 weeks, Discharge

    The ODI is a survey assessing the patients' degree of functional disability in daily life consisting of 10 questions with 6 choices each corresponding to 0-5 points. The scores for each item are added, divided by 50, then multiplied by 100 to calculate the degree of disability. The Korean version of the ODI of which the reliability and validity have been verified through the research of Jeon et al. was used in this study.

  8. Vernon-Mior Neck Disability Index (NDI)

    Time frame: Admission (baseline), 2 weeks, Discharge

    NDI is a survey for evaluating disabilities that can be caused by neck pain in daily life performance. It consists of a total of 50 points by selecting a number from 0 to 5 for each item in 10 questions. The higher the score, the greater the daily disability.

  9. The Korean Western Ontario McMaster Index

    Time frame: Admission (baseline), 2 weeks, Discharge

    WOMAC is one of the most widely used indicators of the overall joint function score of the knee joint. A tool for evaluating disorders related to osteoarthritis of the lower extremities, including joints or knee joints.

    WOMAC consists of a total of 24 questions and three subscales. It consists of 5 questions about pain, 2 questions about stiffness, and 17 questions about difficulty in performing daily life related to the rest of the physical functions, so it is designed to measure the overall functional state of the joint.

  10. Shoulder Pain and Disability Index

    Time frame: Admission (baseline), 2 weeks, Discharge

    SPADI is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use.

Secondary outcomes

  1. Physical and neurological examinations

    Time frame: Admission (baseline), 2 weeks, Discharge

    The range of flexion and extension was assessed to objectively measure mobility, and straight leg raising (SLR), sensory function, muscle strength, and deep tendon reflex tests were conducted for neurological assessment.

Other outcomes

  1. Other baseline variables

    Time frame: Admission (baseline)

    The duration of pain, previous surgery, previous interventions (injections), alcohol use, smoking

Study contacts

Contact information is provided by the study sponsor or research team.

In-Hyuk Ha, PhD

CONTACT

[email protected]

+82 2 2222 2740

Me-riong Kim, Master

CONTACT

[email protected]

+82 2 2222 2746

Sponsors and collaborators

Lead sponsor

Jaseng Hospital of Korean Medicine

Other

Registry information

Official study title

The Effect of Integrated CAM Treatment in Patients Hospitalized at a Korean Medicine Hospital

Important dates

Study start
2012
Primary completion
2030
Study completion
2040
First posted
Oct 6, 2014
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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