TEAS for the Treatment of Pain in Bone Metastases of Lung Cancer
Study Details
Study Description
Brief Summary
This multicenter, prospective, randomized controlled research study aims to objectively evaluate the role of transcutaneous electrical acupoint stimulation (TEAS), which combines the theory of acupuncture with transcutaneous electrical nerve stimulation (TENS) therapy, for the treatment of pain in patients with bone metastases from lung cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: true TEAS A pair of conductive gel patch, connecting to the Huatuo SDZ-ⅡB portable electronic needle therapy instrument, are respectively affixed to the ipsilateral Jiaji acupoint group (EX-B2) or the ipsilateral limb acupoint group(Hegu (LI4) - Waiguan (TE5), or Zusanli (ST36) - Sanyinjiao (SP6)), so as contralateral side. A single TEAS treatment takes 30 min. TEAS specific parameters were dilatation wave 2/100 Hz and stimulus current intensity in degrees as tolerated by the patient. 7 days was considered as 1 session. Self-controlled treatment refers to not setting an upper limit on the number of treatment times, but must have met at least 3 days or 5 times of TEAS treatment within each session. A total of 4 sessions of treatment were administered. |
Device: Transcutaneous electrical acupoint stimulation
The patients are taken in the recumbent or sitting position, and the local skin at the acupoints is routinely disinfected. A pair of conductive gel patch, connecting to the Huatuo SDZ-ⅡB portable electronic needle therapy instrument, are respectively affixed to the ipsilateral acupoint group, so as contralateral side.
Other Names:
Drug: Routine palliative treatment
The patients in both groups received routine palliative treatment of tumors, such as chemotherapy, immunotherapy, targeted therapy, drug analgesic therapy, nutrition support, and so on.
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| Sham Comparator: sham TEAS Each step of the sham TEAS operation is the same as the TEAS group. A total of 4 sessions of treatment were administered. 10 free TEAS treatments will be given after the trial. |
Device: Sham transcutaneous electrical acupoint stimulation
The electroacupuncture instrument has a normal screen display as the Huatuo SDZ-ⅡB portable electronic needle therapy instrument, but could not output current normally.
Other Names:
Drug: Routine palliative treatment
The patients in both groups received routine palliative treatment of tumors, such as chemotherapy, immunotherapy, targeted therapy, drug analgesic therapy, nutrition support, and so on.
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Outcome Measures
Primary Outcome Measures
- The response rate of average pain in the brief pain inventory (BPI) at the end of week 4 [week 4]
According to the international consensus on palliative radiotherapy endpoints for bone metastasis clinical trials, the degree of therapeutic response for bone metastatic pain can be classified as complete response (CR: pain score of 0 and no increase in daily oral morphine equivalent dose (OMED) ), partial response (PR: ①pain score decrease of ≥ 2 and no increase in OMED; ②pain score no increase and decrease of ≥ 25% in OMED), pain progression (PP: ①≥ 2 increase in pain score with no decrease in OMED; ②≥ 1 increase in pain score with ≥ 25% increase in OMED) and indeterminate response (IR: cases not classified as CR / PR / PP). Subjects in which complete or partial relief of pain was achieved were pain responders; Subjects whose pain progressed or was indeterminate response were non responders. The response rate of average pain = ((CR+PR) / No. of subjects) *100%.
Secondary Outcome Measures
- The changes of pain and inference scores in Brief Pain Inventory [week 4, week 8, week 12]
- The changes of frequency of burst pain within 1 week [week 4, week 8, week 12]
- Daily oral morphine equivalent over the past 24h [week 4, week 8, week 12]
- Quality of life measured by EORTC QLQ-C30 score [week 4, week 8, week 12]
The European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) is an integrated system for assessing the quality of life (QoL) of cancer patients. The EORTC QLQ-C30 incorporates nine multi-item scales: five functional scales (Physical, Role, Cognitive, Emotional and Social Functioning); three symptom scales (Fatigue, Pain and Nausea/Vomiting); and a Global Health Status/QoL scale. Six single item scales are also included (Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrhoea and Financial Difficulties). Scale scores were calculated by averaging items within scales and transforming average scores linearly. All of the scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.
- The changes in mood scale scores of GAD-7 [week 4, week 8, week 12]
The Generalized Anxiety Disorder (GAD-7) questionnaire is a seven-item, self-report anxiety questionnaire designed to assess the patient's health status during the previous 2 weeks. The questionnaire scores each of the 7-item as "0" (not at all) to "3" (nearly every day), with ≥ 5 classified as mild anxiety, ≥ 10 as moderate anxiety, and ≥ 15 as severe anxiety.
- The changes in mood scale scores of PHQ-9 [week 4, week 8, week 12]
The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day)，with ≥ 5 classified as mildly depressed, ≥ 10 as moderately depressed, and ≥ 15 as severely depressed. PRIME-MD: Primary care evaluation of mental disorders; DSM-IV: The Diagnostic and Statistical Manual of Mental Disorders-IV.
- The changes of tri-lineage cell counts in blood [week 4, week 8, week 12]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Fulfilled the diagnostic criteria of non-small cell lung cancer and had a diagnosis of definite bone-metastatic-related pain.
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Potent opioid analgesics have been prescribed regularly.
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Bone protective agents (bisphosphonates or desumumab) have been used regularly.
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Expected survival ≥ 3 months with no obvious contraindication to opioid therapy.
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Stable vital signs and ECOG-PS score ≤ 2 points; able to cooperate with researchers to complete relevant study evaluations.
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Signed informed consent.
Exclusion Criteria:
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Definitively diagnosed with pain unrelated to lung cancer.
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Received local radiation therapy or surgery targeting bone metastases within 1 week before enrollment or will receive during the intervention period. The surgery including vertebroplasty, radioparticle implantation, neurological lesions, and other minimally invasive interventions.
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Venous thrombosis in the upper and lower extremities (below the elbow / knee joint), active cerebrovascular disease, severe cardiopulmonary dysfunction, or those with respiratory depression.
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Pacemaker implantation or metallic implants in vivo.
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Skin lesions at the acupoints, poor skin condition, or other situations that are not suitable for treatment with TEAS.
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Opioid hypersensitivity.
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Psychiatric disorders or severe cognitive deficits.
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Participating in other clinical trialists influencing the evaluation of the results of this study.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- The Third Affiliated hospital of Zhejiang Chinese Medical University
Investigators
- Study Chair: Yi Liang, PhD, Zhejiang Chinese Medical University, China
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021ZZ017
- 2021ZZ017
- 2014KYA162