Symptoms and General Pathology

All Conditions

Nervous System Diseases

Rare Diseases

Pain, Postoperative

Pain

Postoperative Complications

Neurologic Manifestations

Acute Graft Versus Host Disease

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Herbal and Botanical

Anesthetics

Analgesics, Opioid

Narcotics

Cola

Patients undergoing CES and general anesthesia in colon cancer surgery

Patients undergoing general anesthesia in colon cancer surgery

electrotherapy

consumption of opioids during general anesthesia

Opioid Anesthetics

colon cancer surgery

Yi-hsuan Huang, MD

Cranial electrotherapy stimulation (CES) is a non-invasive intervention to treat anxiety, depression, insomnia, and pain. But clinical studies and applications of CES in relation to acute postoperative pain are few. tThe investigators investigate a double-blind, randomized controlled trial to figure out if intraoperative CES could decrease dosage of intraoperative anesthetics and patient-controlled analgesia (PCA) consumption in patients undergoing colon cancer surgery.

Cranial electrotherapy stimulation (CES) is a non-invasive and safe intervention, transmitting microcurrents of brain stimulation and releasing various neurotransmitters such as endorphin and downstream hormones to modulate autonomic nervous system, as a result, for treating anxiety, depression, insomnia, and pain.

Acute postoperative pain annoys patients receiving surgery. Once acute postoperative pain is poorly controlled, it may result in adverse acute effects (i.e., physiologic and psychologic stress), chronic effects (i.e., delayed long-term recovery and chronic pain), and, in consequence, excess length of hospitalization and extra costs. Besides, inflammatory reactions mediated by immune system are formed after tissue injury (e.g. trauma, surgery, etc), release serial inflammatory cytokines and are related to pain signal transmission. However, clinical studies and applications of CES focus on management of chronic pain, modulation of mood and insomnia rather than acute postoperative pain in recent years.

The investigators investigate a double-blind, randomized controlled trial to figure out if intraoperative CES could decrease dosage of intraoperative anesthetics and patient-controlled analgesia (PCA) consumption in patients undergoing colon cancer surgery. The investigators also collect blood samples before and after surgery for analysis of serum cytokines. Meanwhile, Bispectral IndexTM (BISTM) monitoring and Analgesia Nociception Index (ANI) are prescribed during the surgery not only for measuring of the effects of anesthetics and sedatives on the brain, but also evaluating perioperative analgesia. Thereby, the effectiveness of CES for management of acute postoperative pain may introduce clinicians for alternative application of pain control after surgery in the future.

Cranial Electrotherapy Stimulation on Anesthetics Consumption and Postoperative Pain

Effects of Cranial Electrotherapy Stimulation on Anesthetics Consumption, Perioperative Cytokines Response, and Postoperative Pain in Patients Undergoing Colonic Surgery

The consumption of total amount of supplemental analgesics administered during colon cancer surgery

The consumption of total amount of rescue analgesics administered after colon cancer surgery

Pain assessment of NRS pain intensity scores and patient satisfaction assessed by the NRS through end of surgery to postoperative 72 hours

proinflammatory and antiinflammatory cytokines (IL-1a, IL-2, IL-6, IL-7, TNF-a, IL-4, IL-10, IL-10, IL-1, TGF-b)

Tri-Service General Hospital

Attending Physician

Neoplasms

Musculoskeletal Diseases

Behaviors and Mental Disorders

Head and Neck Neoplasms

Trismus

Muscle Cramp

Spasm

Neuromuscular Manifestations

Quality of Life

Anti-Inflammatory Agents

Antirheumatic Agents

Diclofenac

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Low-level laser therapy will be given to the PTMB group along with mandibular mobilization and stabilization exercises

Ultrasonic massage with diclofenac gel will be given to the sonophoresis group along with mandibular mobilization and stabilization exercises

Low-level laser therapy (BMI 1005 Laser 2200) Wavelength: 658 nm Power: 100 MW Energy density: 4J/cm2 Dose administered: 4J Mode: Pulsed Site of application: Over bilateral Temporomandibular joint Number of sessions: 3 sessions/week on alternating days for 12 minutes each, for 4 weeks Mandibular mobilization exercises Side to side movement of the jaw Forward jaw movement Tongue up Goldfish exercise (Partial opening) Goldfish exercise (Full opening) Exercise duration: 6 repetitions X 2 sets X 4 times a day Mandibular Stabilization exercises Exercise duration: 5 repetitions X 3 sec. Hold X 4 times a day

Photobiomodulation therapy with mandibular exercises

Ultrasound (BM1-1039) Ultrasonic massage with Diclofenac gel Frequency: 1.0 MHz Mode: Continuous Intensity: 0.8 to 1.5 W/cm2

Site of application: Over bilateral Temporomandibular joint Number of sessions: 3 sessions per week on alternating days for 8 minutes each, for 4 weeks Mandibular mobilization exercises Side to side movement Forward jaw movement Tongue up Goldfish exercise (Partial opening) Goldfish exercise (Full opening) Exercise duration: 6 repetition X 2 sets X 4 times a day Mandibular Stabilization exercises Exercise duration: 5 repetitions X 3 sec. Hold X 4 times a day

Sonophoresis with mandibular exercises

Asir J Samuel, MPT, (PhD)

Neha Sharma, MPT

Head and neck cancer originate from the several different anatomical subsites especially the squamous cell carcinoma. This involves mainly Oropharynx, Hypopharynx, and Larynx. The common treatment approaches for HNC is radiation therapy, alone or combined with chemotherapy and surgery. In the present scenario, very little literature is available improving the QOL by physiotherapeutic measures in patients with HNC. To improve QOL, a well-designed study is needed. The study will be a two-group pretest-posttest design. The study will include patients with HNC receiving radiation or chemotherapy. One group will receive photobiomodulation therapy and another group will receive Sonophoresis. Both the group will receive Mandibular mobilization and stabilization exercises after electrotherapy. The Algometer, Digital Vernier caliper and core measure Questionnaire-C30 (QLQ-C30) will be used as an outcome measure to measure the effect of interventions between baseline and post-interventions.

The trial will include two experimental groups. The study design will be two groups pretest-posttest design. The study will recruit patients with HNC receiving radiation or chemotherapy. The study will be conducted in Tertiary care teaching hospital, in the departments of Radiotherapy and physiotherapy of Maharishi Markandeshwar Hospital, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala. Total of 48 patients will be recruited in the study. Patients will be randomized by block randomization method into two groups. One group will receive Photobiomodulation therapy whereas another group will receive Sonophoresis. Mandibular mobilization and stabilization exercises will be given to both groups. The intervention will be given for 4 weeks. Three sessions of photobiomodulation therapy will be given per week on alternating days for 12 minutes, whereas three sessions of sonophoresis will also be given per week on alternating days for 8 minutes. Mandibular mobilization, as well as stabilization exercises, will be advised to perform regularly continuously for 4 weeks. There will be blinding of patients who will receive the therapy, therapist who will administer the therapy, and therapist who will assess the patients, therefore, the study will follow triple blinding.Algometer for pain measurement, Digital vernier caliper for measuring mandibular mobility and Core measure Questionnaire-C30 (QLQ-C30) for measuring the quality of life in patients with head and neck cancer will be taken as outcome measures. The outcomes will be taken before giving intervention, then again after 2 weeks of interventions and again on another 2 weeks of intervention.

Participants, outcome assessors and care provider will be blinded in the study. This will be a triple blinded randomized controlled trial

Photobiomodulation and Sonophoresis Improving Jaw Mobility and Quality of Life Among Head and Neck Cancer Survivors

Comparison of Photobiomodulation Therapy and Sonophoresis in Improving Tempomandibular Joint Mobility and Quality of Life Among Head and Neck Cancer Survivors (PBMT-S Trial): A Triple-Blind, Randomized Controlled Trial.

Algometer is a digital calibrated outcome measure, measures the pain pressure threshold.

The questionnaire are designed to measure physical, social and psychological functions of patients with cancer. The questionnaire contains physical, social, emotional and cognitive functioning multi item scales and 9 single items. These items are pain, fatigue, financial impact, appetite loss, nausea and vomiting, diarrhea, constipation, sleep disturbance and quality of life. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Time required for administration is 10 to 15 minutes.

Digital Vernier calliper measures the range of motion of mandibular mobility

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cranial Electrotherapy Stimulation on Anesthetics Consumption and Postoperative Pain	NCT03825471	Opioid Use Cytokine	electrotherapy Opioid Anesthet... colon cancer su...	20 Years - 80 Years	Tri-Service General Hospital
Photobiomodulation and Sonophoresis Improving Jaw Mobility and Quality of Life Among Head and Neck Cancer Survivors	NCT04082793	Head and Neck C... Trismus	Photobiomodulat... Sonophoresis wi...	18 Years - 70 Years	Maharishi Markendeswar University (Deemed to be University)
Cranial Electrotherapy Stimulation on Anesthetics Consumption and Postoperative Pain	NCT03825471	Opioid Use Cytokine	electrotherapy Opioid Anesthet... colon cancer su...	20 Years - 80 Years	Tri-Service General Hospital

Spots Global Cancer Trial Database for electrotherapy