An interventional study of therapeutic exercise and therapeutic exercise + transcutaneous nerve stimulation in Post-Thyroidectomy Dysphonia, sponsored by University of Lahore. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by University of Lahore · Not applicable, Interventional, and Treatment
This clinical trial evaluates rehabilitation strategies for post-thyroidectomy dysphonia. Voice impairment is a frequent complication following thyroid surgery. It often occurs even without direct laryngeal nerve transection. Surgical trauma, tissue edema, and mechanical stretching of the laryngeal nerves or surrounding musculature can cause persistent voice changes. These changes significantly lower a patient's quality of life.This study compares two distinct interventions against standard care:Therapeutic Voice and Neck Exercise AloneTherapeutic Voice and Neck Exercise Combined with Transcutaneous Electrical Nerve Stimulation (TENS)The objective is to determine if adding non-invasive nerve stimulation to standard therapeutic exercises accelerates neuromuscular recovery, improves vocal fold mobility, and enhances overall voice quality more effectively than exercise alone. Background and Rationale Thyroidectomies are common surgical procedures worldwide. Dysphonia post-surgery stems from multiple factors. These include temporary or permanent recurrent laryngeal nerve (RLN) neuropraxia, external branch of the superior laryngeal nerve (EBSLN) injury, laryngotracheal fixation, and peri laryngeal scarring. Patients frequently report hoarseness, vocal fatigue, reduced pitch range, and breathiness. Standard management typically includes watchful waiting or traditional voice therapy. Therapeutic exercises aim to stretch scarred tissues, strengthen paretic intrinsic laryngeal muscles, and optimize respiratory support. Transcutaneous Electrical Nerve Stimulation (TENS) uses low-voltage electrical currents to stimulate peripheral nerves. TENS is hypothesized to reduce local pain, increase regional blood flow, decrease muscle tension, and facilitate neural regeneration when applied to the anterior neck. By combining these therapies, this trial investigates whether sensory and motor electrical stimulation acts synergistically with active physical and vocal exercises. The goal is to provide a superior, faster recovery pathway for patients suffering from post-operative voice disorders.
Background and Clinical Problem Thyroid surgery (thyroidectomy) is a very common operation, but it often causes voice problems (dysphonia). Up to 80% of patients experience a change in their voice right after surgery, and 10% to 15% suffer from long-term hoarseness or vocal fatigue. These problems happen because the nerves that control the voice box get stretched or bruised during the operation. Furthermore, healing creates thick scar tissue that restricts the normal movement of the larynx, and the anesthesia breathing tube irritates the vocal folds. Right now, there is no standard therapy plan to help these patients recover.2. How the Combined Treatment Works This study tests a new treatment plan that combines physical voice exercises with gentle electrical nerve stimulation (TENS):Voice and Neck Exercises: These include manual throat massage to break up stiff scar tissue, neck stretches to reduce muscle guarding, and straw-blowing tasks (SOVT exercises) that use air back-pressure to protect the vocal folds from straining. TENS Therapy: Sticky electrode pads are placed on the neck. High-frequency pulses block pain signals naturally, while low-frequency pulses create tiny muscle twitches. This movement pumps away post-surgery swelling, boosts fresh blood flow, and helps bruised nerves heal.
Study Setup and Methods This is a 6-week, single-blind, randomized controlled trial tracking 90 adult patients. Participants are randomly split into three equal groups : Group A (Real TENS + Exercise): Receives 20 minutes of active electrical nerve stimulation followed by 30 minutes of voice and neck exercises. Group B (Fake TENS + Exercise): Receives the exact same exercises but uses a fake TENS machine that shuts off after 30 seconds to control for the placebo effect. 4. Tracking Progress (Measurements)Patients are tested before the study, at 3 weeks, at 6 weeks, and 3 months later using three main methods: Patient Survey (VHI-30): A form where patients rate how much their voice issues disrupt their daily life.Computer Voice Analysis: A program that measures audio recordings for pitch shaking (Jitter), volume stability (Shimmer), and air leakage (Noise-to-Harmonic Ratio).Breath and Quality Tests: Clinicians measure the maximum seconds a patient can hold a vowel sound (Maximum Phonation Time) and rate voice harshness using the GRBAS scale.
Data Analysis PlanThe study uses a statistical formula called a Two-Way Repeated Measures ANOVA. This math compares the scores across the three groups over the four different timelines. The main goal is to see if Group A (Real TENS + Exercise) demonstrates a significantly faster and more complete vocal recovery than the other two groups.
61 studies on the registry are indexed under Vocal Cord Paralysis; 16 are open to participants now.
This study's planned enrollment of 60 is above the median of 39 across 43 interventional studies indexed under Vocal Cord Paralysis.
Browse Vocal Cord Paralysis studies →University of Lahore is the lead sponsor of 232 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:1. age 18 to 60 years 2. diagnosed with dysphonia 3. able to attend 3 sessions per week for 6 weeks -
Exclusion Criteria:1. history of laryngeal surgery 2. neurological disorder affecting voice 3. pregnancy
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Behavioral: therapeutic exercise
Behavioral: therapeutic exercise + transcutaneous nerve stimulation
voice therapy exercise including vocal hygiene , resonance exercise, and breathing exercise. 3 sessions per week for 6 weeks , 45 min each session
voice therapy exercise plus transcutaneous nerve stimulation applied to laryngeal area . 3 sessions per week for 6 weeks 45 minutes each session
voice handicap index -10 score
change in VHI-10 score from baseline to 6 weeks to assess severity of dysphonia
Time frame: baseline and 6 weeks post intervention
Maximum phonation time
change in MPT in second from baseline to 6 weeks
Time frame: baseline and 6 weeks post intervention
No study locations are listed for this record.
Plan to share: Undecided — A decision regarding sharing of individual participant data has not yet been made. the data sharing plan will be determined after study completion based on institutional requirements .
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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