Health TrialsbyHealthPanel

Effectiveness and Safety of Pharmacopuncture Therapy for Chronic Lumbar Radiculopathy: A Multicenter, Pragmatic, Randomized, Comparative Clinical Trial

ConditionsLumbar RadiculopathyChronic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-70
SponsorJaseng Medical Foundation

About this trial

A pragmatic clinical study to compare the effectiveness of pharmacopuncture and physical therapy strategies in patients with chronic lumbar radiculopathy

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Persistent sciatica symptoms lasting for more than 3 months.

Presence of at least one of the following signs in one or both lower extremities: Muscle weakness / Dermatomal sensory disturbance (hypoesthesia, dysesthesia, tingling, or pain) / Decreased reflexes / Radiating pain aggravated by the Straight Leg Raising (SLR) test

Numeric Rating Scale (NRS) score of 4 or higher for leg pain.

Aged between 19 and 70 years.

Disqualifiers

Diagnosed with serious conditions that may cause lower limb radiating pain (e.g., spinal metastasis of cancer, acute vertebral fracture, or dislocation).

Presence of progressive neurological deficits or severe neurological symptoms.

Pain originating from non-spinal soft tissue disorders (e.g., tumors, fibromyalgia, rheumatoid arthritis, gout).

Presence of chronic diseases that may interfere with treatment outcomes or interpretation (e.g., stroke, myocardial infarction, renal disease, diabetic neuropathy, dementia, epilepsy).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pharmacopuncture

    Procedure/Surgery

    The physicians will decide the specific methods of pharmacopuncture based on the clinical judgment according to each participant's conditions. All applied treatment methods are documented in the case report forms.

  • Physical Therapy

    Procedure/Surgery

    The physicians will decide the specific methods of physical therapy based on the clinical judgment according to each participant's conditions. All applied treatment methods are documented in the case report forms.

Treatment groups

92 Participants
are divided into 2 treatment groups
Group A: Pharmacopuncture groupExperimental treatment 1 intervention
Group B: Physical Therapy GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Leg pain Numeric Rating Scale, NRS

Change from baseline to Week 7 on the Numeric Rating Scale of Leg pain

Time frame
Week 7

Secondary outcomes

1

Leg and low back pain Numeric Rating Scale

The pain intensity of leg and low back over the past week

Time frame
Week 1,2,3,4,5,6,7,13
2

Leg and low back pain Visual Analogue Scale

The pain intensity of leg and low back over the past week

Time frame
Week 1,2,3,4,5,6,7
3

Oswestry Disability Index

The degree of low back disability in daily life

Time frame
Week 1,7,13
4

Roland-Morris Disability Questionnaire

assesse the functional status of patients with low back pain

Time frame
Week 1,7,13

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jaseng Medical Foundation

Lead sponsor

Source ClinicalTrials.gov
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