Post-Thyroidectomy DysphoniaNCT07811154
Effects of Therapeutic Exercise With and Without Nerve Stimulation on Dysphonia in Post Thyroidectomy Patients
A study testing therapeutic exercise and therapeutic exercise + transcutaneous nerve stimulation in people with Post-Thyroidectomy Dysphonia, run by University of Lahore.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post-Thyroidectomy Dysphonia
- What is being tested?
- therapeutic exercise and therapeutic exercise + transcutaneous nerve stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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
-
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
- Conditions
- Post-Thyroidectomy Dysphonia
- Being tested
- therapeutic exercise, therapeutic exercise + transcutaneous nerve stimulation
- Keywords
- Post-thyroidectomy dysphonia, Vocal cord paresis, Superior laryngeal nerve palsy, Vocal function exercises, Cervical physical therapy, Electrotherapy, Voice Handicap Index-30, GRBAS scale, Randomized controlled trial, Single-blind study, Thyroid surgery rehabilitation
- Medical subject headings
- Vocal Cord Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic exerciseBehavioural
voice therapy exercise including vocal hygiene , resonance exercise, and breathing exercise. 3 sessions per week for 6 weeks , 45 min each session
therapeutic exercise + transcutaneous nerve stimulationBehavioural
voice therapy exercise plus transcutaneous nerve stimulation applied to laryngeal area . 3 sessions per week for 6 weeks 45 minutes each session
| Study group | Role | What they receive |
|---|---|---|
| voice therapy only group | Experimental | Not described Receives: Behavioral: therapeutic exercise |
| voice therapy + TENS group | Experimental | Not described Receives: Behavioral: therapeutic exercise + transcutaneous nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
voice handicap index -10 score
change in VHI-10 score from baseline to 6 weeks to assess severity of dysphonia
Measured: baseline and 6 weeks post intervention
Secondary outcomes (1)
Maximum phonation time
change in MPT in second from baseline to 6 weeks
Measured: baseline and 6 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Thyroidectomy DysphoniaStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- 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.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811154
- Sponsor's protocol ID
- UOL-DYSPHONIA-2026
- Status last verified
- Aug 2026
- First submitted
- 2 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 .
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Therapeutic Exercise With and Without Nerve Stimulation on Dysphonia in Post Thyroidectomy Patients
- ClinicalTrials.gov ID
- NCT07811154
- Acronym / sponsor ID
- UOL-DYSPHONIA-2026
- Conditions
- Post-Thyroidectomy Dysphonia
- Keywords
- Post-thyroidectomy dysphonia, Vocal cord paresis, Superior laryngeal nerve palsy, Vocal function exercises, Cervical physical therapy, Electrotherapy, Voice Handicap Index-30, GRBAS scale
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| voice therapy only group | Experimental | Behavioral: therapeutic exercise |
| voice therapy + TENS group | Experimental | Behavioral: therapeutic exercise + transcutaneous nerve stimulation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| therapeutic exercisevoice therapy exercise including vocal hygiene , resonance exercise, and breathing exercise. 3 sessions per week for 6 weeks , 45 min each session | Behavioural | voice therapy only group |
| therapeutic exercise + transcutaneous nerve stimulationvoice therapy exercise plus transcutaneous nerve stimulation applied to laryngeal area . 3 sessions per week for 6 weeks 45 minutes each session | Behavioural | voice therapy + TENS group |
Primary outcome
voice handicap index -10 score
Time frame: baseline and 6 weeks post intervention
change in VHI-10 score from baseline to 6 weeks to assess severity of dysphonia
1 secondary outcome
Maximum phonation time
Time frame: baseline and 6 weeks post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: 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 .
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing therapeutic exercise and therapeutic exercise + transcutaneous nerve stimulation in people with Post-Thyroidectomy Dysphonia, run by University of Lahore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sibgha Barkat, MS speech language pathology (0314-4483182, 70186400@student.uol.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
voice handicap index -10 score (time frame: baseline and 6 weeks post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.