The Effect of Integrated CAM Treatment in Hospitalized Patients

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages Any age
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

Study population: Musculoskeletal patients admitted to an integrated hospital that offers both complementary and alternative medicine (CAM) and conventional medicine treatment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

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

Conditions

Low Back Pain, Neck Pain, Knee Pain, Shoulder Pain, Intervertebral Disc Herniation, Spinal Stenosis

Being tested

Herbal medicine, Acupuncture, Pharmacopuncture, Bee venom pharmacopuncture, Chuna manipulation

Keywords

Inpatient care, Complementary and alternative medicine, Integrated medicine

Medical subject headings

Low Back Pain, Neck Pain, Shoulder Pain, Intervertebral Disc Displacement, Spinal Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Herbal medicineDrug

  Also called Traditional herbal medicine

  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).

• AcupunctureProcedure or surgery

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

• PharmacopunctureProcedure or surgery

  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 pharmacopunctureProcedure or surgery

  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 manipulationProcedure or surgery

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. NRS of low back pain (LBP)

   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.

   Measured: Admission (baseline), 2 weeks, Discharge

2. NRS of radiating leg pain

   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.

   Measured: Admission (baseline), 2 weeks, Discharge

3. NRS of neck pain

   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.

   Measured: Admission (baseline), 2 weeks, Discharge

4. NRS of radiating arm pain

   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.

   Measured: Admission (baseline), 2 weeks, Discharge

5. NRS of knee pain

   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.

   Measured: Admission (baseline), 2 weeks, Discharge

6. NRS of shoulder pain

   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.

   Measured: Admission (baseline), 2 weeks, Discharge

7. Oswestry disability index (ODI)

   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.

   Measured: Admission (baseline), 2 weeks, Discharge

8. Vernon-Mior Neck Disability Index (NDI)

   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.

   Measured: Admission (baseline), 2 weeks, Discharge

9. The Korean Western Ontario McMaster Index

   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.

   Measured: Admission (baseline), 2 weeks, Discharge

10. Shoulder Pain and Disability Index

    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.

    Measured: Admission (baseline), 2 weeks, Discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted6 Oct 2014 (estimated)
2. Study startJan 2012
3. Primary completionDec 2030 (estimated)
4. Study completionDec 2040 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (2)Papers the sponsor has linked to this study.
• Other trials for Low Back PainStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.