Post-Thyroidectomy HypoparathyroidismNCT06020820
Effectiveness Of Cervical Rehabilitation Program After Thyroidectomy
A study testing Cervical Rehabilitation program (Intervention Group) Group A in people with Post-Thyroidectomy Hypoparathyroidism, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this research is to determine the Effects of cervical rehabilitation program on neck pain, ROM and disability after thyroidectomy. Randomized controlled trials will be done at Pakistan ordinance factory (POF) Hospital. The sample size will be 52. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Post-Thyroidectomy Hypoparathyroidism
- What is being tested?
- Cervical Rehabilitation program (Intervention Group) Group A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Oct 2022to 25 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Post-thyroidectomy patients
- Indoor patients
Who cannot join
- • Any cervical fracture/dislocations
- Cervical instability
- Vertebrobasilar insufficiency
- Cervical Radiculopathy
- Disc prolapsed at cervical region
- Any neurological impairment
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan ordinance factory Hospital
Wah, Punjab Province, 47010
About this study
The aim of this research is to determine the Effects of cervical rehabilitation program on neck pain, ROM and disability after thyroidectomy. Randomized controlled trials will be done at Pakistan ordinance factory (POF) Hospital. The sample size will be 52. The subjects were divided in two groups, with 26 subjects in Group A and 26 in Group B. Study duration was of 6 months. Sampling technique applied was Non probability Convenience Sampling technique. Both males and females of aged 30-50 years with thyroidectomy were included. Tools used in the study are Numeric Pain Rating Score (NPRS), goniometer and neck disability index (NDI).
Read the detailed description
Thyroidectomy, or surgical removal of the gland, is highly recommended treatment for thyroid disorders. The most prevalent of these conditions are symptomatic benign large goiter and tumorous condition of the thyroid gland. Both younger females and postmenopausal older women are prevalent towards these disorders (nodular goiter, cancer, and hypothyroidism).
Due to hyperextended position of neck during surgery patient usually complaint about the posterior neck pain, movement difficulties of shoulder and neck, occipital headaches, shoulder stiffness, motion's cervical range of limitations and some of them experiences the discomfort symptoms such as stretching, pressing, or choking feelings in the neck, headache, shoulder stiffness, and difficulty in moving the neck or shoulders. These symptoms may persist for an extended period following surgery and may even have a negative effect on the patient's quality of life. It has been reported that hyperextension can cause bilateral hypoglossal palsy, tetraplegia and cervical artery dissection Recently, a variety of treatment modalities have been used to overcome these disturbing symptoms, such as intraoperative transcutaneous electrical nerve stimulation (TENS), preoperative bilateral greater occipital nerve (GON) block, bilateral superficial cervical plexus block combined with bilateral GON block, and postoperative neck stretching exercise. Due to surgical position of thyroidectomy patient often develops posture syndrome of thyroid surgery (PSTS), symptoms include postoperative nausea, vomiting, dizziness, headache and some discomfort associated with neck an occipital radiating pain.
Nepa Patel et al reported that both positional release technique and MET are effective for treatment of upper trapezius tightness or trigger points as the trapezius muscle works to move the neck in several directions, its degree of tightness or looseness affects neck flexibility. Om C. Wadhokar et al conducted a study on patients having neck pain with TMJ dysfunction, causes tightness of occipital muscles, difficulty in mouth opening and forward head posture. In this study suboccipital release technique was found to be more effective than conventional treatment.
In an RCT, stretching of pectoralis along with cervical mobilizations and rotation exercises were used for treatment of mechanical neck pain. And it has evaluated that it improves the active range of motion in all directions, perceived pain and disability levels. In 2019, Samah et al conducted a study to compare the effects the active neck stretching exercises and kinesio taping on patients after thyroidectomy; a significant improvement was observed in active stretching group. Another study investigated the effects of neck stretching exercises on post thyroidectomy patients with complaint of neck discomfort, and it concluded that neck stretching exercises are improving the patient disability level.
- Conditions
- Post-Thyroidectomy Hypoparathyroidism
- Being tested
- Cervical Rehabilitation program (Intervention Group) Group A, control group group B
- Keywords
- range of motion, disability, post-thyroidectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Rehabilitation program (Intervention Group) Group AOther
(Positional release technique on trapezius muscle): the therapist locate and apply pressure along the tender points in the upper fibers of the trapezius. Lateral flexion of subject's head toward the side of a tender point held for 90 seconds.
(Suboccipital muscle release): The therapist places both his palms under the sub occipital region of the subject with his curled-up fingers and places an upward pressure causing a stretch and distraction for 30 seconds,This technique was performed 3 times in one session.
Stretching of pectoralis muscle:
Pectoralis muscle stretch were performed once daily, completing three repetitions on each side with a 30-second hold. Stretching with repetition of five, three times a day for 1week neck and soulder ROMs
control group group BOther
- Relax shoulders and neck sufficiently
- look down
- turn face to the right
- turn face to the left
- incline head to the right
- incline head to the left
- turn shoulders round and round
- slowly raise hands fully then lower them. patients were asked to perform five repetitions of each stretching exercise, three times per day (morning, afternoon, and evening).
| Study group | Role | What they receive |
|---|---|---|
| Cervical Rehabilitation program (Intervention Group) Group A | Experimental | Positional release technique on trapezius muscle, Suboccipital muscle release, Stretching of pectoralis muscle Receives: Other: Cervical Rehabilitation program (Intervention Group) Group A |
| (control group) Group B | Active comparator | neck and shoulder ROMS Receives: Other: control group group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Score (NPRS):
was used to assess neck pain intensity. Patients were asked to rate how bad their neck pain was on average (NPRS; range, 0, no pain, to 10, maximum pain
Measured: 1 week
NDI
NDI is used to asses that how neck pain affects the quality of life of a person. It consists of 10 items, from 0-5 points in each item. Total score of NDI is 50 that is converted into percentage of 100.
Measured: 1 Week
cervical flexion range of motion
the person is asked to move neck forward to touch chin and the range is taken
Measured: 1 week
cervical extension range of motion
the person is asked to move neck backward as far as possible and the range is taken
Measured: 1 week
cervical Rt rotation range of motion
the person is asked to move neck sideways to Rt side like saing "no" and the range is taken
Measured: 1 week
cervical Lt rotation range of motion
the person is asked to move neck sideways to Lt side like saing "no" and the range is taken
Measured: 1 week
cervical Rt side flexion range of motion
the person is asked to move neck sideways to Rt side like touching ear to shoulder and range is taken
Measured: 1 week
cervical Lt side flexion range of motion
the person is asked to move neck sideways to Rt side like touching ear to shoulder and range is taken
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start25 Oct 2022
- Primary completion15 Jan 2023
- Study completion25 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Thyroidectomy HypoparathyroidismStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aisha Razzaq, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020820
- Sponsor's protocol ID
- Riphah IU Tayyaba sultan
- Status last verified
- Aug 2023
- First submitted
- 26 Aug 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Of Cervical Rehabilitation Program After Thyroidectomy
- ClinicalTrials.gov ID
- NCT06020820
- Acronym / sponsor ID
- Riphah IU Tayyaba sultan
- Conditions
- Post-Thyroidectomy Hypoparathyroidism
- Keywords
- range of motion, disability, post-thyroidectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 25 Feb 2023 (actual)
- First posted
- 1 Sep 2023 (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.
The aim of this research is to determine the Effects of cervical rehabilitation program on neck pain, ROM and disability after thyroidectomy. Randomized controlled trials will be done at Pakistan ordinance factory (POF) Hospital. The sample size will be 52. The subjects were divided in two groups, with 26 subjects in Group A and 26 in Group B. Study duration was of 6 months. Sampling technique applied was Non probability Convenience Sampling technique. Both males and females of aged 30-50 years with thyroidectomy were included. Tools used in the study are Numeric Pain Rating Score (NPRS), goniometer and neck disability index (NDI).
Detailed description
Thyroidectomy, or surgical removal of the gland, is highly recommended treatment for thyroid disorders. The most prevalent of these conditions are symptomatic benign large goiter and tumorous condition of the thyroid gland. Both younger females and postmenopausal older women are prevalent towards these disorders (nodular goiter, cancer, and hypothyroidism).
Due to hyperextended position of neck during surgery patient usually complaint about the posterior neck pain, movement difficulties of shoulder and neck, occipital headaches, shoulder stiffness, motion's cervical range of limitations and some of them experiences the discomfort symptoms such as stretching, pressing, or choking feelings in the neck, headache, shoulder stiffness, and difficulty in moving the neck or shoulders. These symptoms may persist for an extended period following surgery and may even have a negative effect on the patient's quality of life. It has been reported that hyperextension can cause bilateral hypoglossal palsy, tetraplegia and cervical artery dissection Recently, a variety of treatment modalities have been used to overcome these disturbing symptoms, such as intraoperative transcutaneous electrical nerve stimulation (TENS), preoperative bilateral greater occipital nerve (GON) block, bilateral superficial cervical plexus block combined with bilateral GON block, and postoperative neck stretching exercise. Due to surgical position of thyroidectomy patient often develops posture syndrome of thyroid surgery (PSTS), symptoms include postoperative nausea, vomiting, dizziness, headache and some discomfort associated with neck an occipital radiating pain.
Nepa Patel et al reported that both positional release technique and MET are effective for treatment of upper trapezius tightness or trigger points as the trapezius muscle works to move the neck in several directions, its degree of tightness or looseness affects neck flexibility. Om C. Wadhokar et al conducted a study on patients having neck pain with TMJ dysfunction, causes tightness of occipital muscles, difficulty in mouth opening and forward head posture. In this study suboccipital release technique was found to be more effective than conventional treatment.
In an RCT, stretching of pectoralis along with cervical mobilizations and rotation exercises were used for treatment of mechanical neck pain. And it has evaluated that it improves the active range of motion in all directions, perceived pain and disability levels. In 2019, Samah et al conducted a study to compare the effects the active neck stretching exercises and kinesio taping on patients after thyroidectomy; a significant improvement was observed in active stretching group. Another study investigated the effects of neck stretching exercises on post thyroidectomy patients with complaint of neck discomfort, and it concluded that neck stretching exercises are improving the patient disability level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical Rehabilitation program (Intervention Group) Group A | Experimental | Other: Cervical Rehabilitation program (Intervention Group) Group APositional release technique on trapezius muscle, Suboccipital muscle release, Stretching of pectoralis muscle |
| (control group) Group B | Active comparator | Other: control group group Bneck and shoulder ROMS |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- • Post-thyroidectomy patients
Key exclusion criteria (6 listed)
- • Any cervical fracture/dislocations
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 |
|---|---|---|
| Cervical Rehabilitation program (Intervention Group) Group A(Positional release technique on trapezius muscle): the therapist locate and apply pressure along the tender points in the upper fibers of the trapezius. Lateral flexion of subject's head toward the side of a tender point held for 90 seconds. (Suboccipital muscle release): The therapist places both his palms under the sub occipital region of the subject with his curled-up fingers and places an upward pressure causing a stretch and distraction for 30 seconds,This technique was performed 3 times in one session. Stretching of pectoralis muscle: Pectoralis muscle stretch were performed once daily, completing three repetitions on each side with a 30-second hold. Stretching with repetition of five, three times a day for 1week neck and soulder ROMs | Other | Cervical Rehabilitation program (Intervention Group) Group A |
| control group group B1. Relax shoulders and neck sufficiently 2. look down 3. turn face to the right 4. turn face to the left 5. incline head to the right 6. incline head to the left 7. turn shoulders round and round 8. slowly raise hands fully then lower them. patients were asked to perform five repetitions of each stretching exercise, three times per day (morning, afternoon, and evening). | Other | (control group) Group B |
Primary outcome
Numeric Pain Rating Score (NPRS):
Time frame: 1 week
was used to assess neck pain intensity. Patients were asked to rate how bad their neck pain was on average (NPRS; range, 0, no pain, to 10, maximum pain
NDI
Time frame: 1 Week
NDI is used to asses that how neck pain affects the quality of life of a person. It consists of 10 items, from 0-5 points in each item. Total score of NDI is 50 that is converted into percentage of 100.
cervical flexion range of motion
Time frame: 1 week
the person is asked to move neck forward to touch chin and the range is taken
cervical extension range of motion
Time frame: 1 week
the person is asked to move neck backward as far as possible and the range is taken
cervical Rt rotation range of motion
Time frame: 1 week
the person is asked to move neck sideways to Rt side like saing "no" and the range is taken
cervical Lt rotation range of motion
Time frame: 1 week
the person is asked to move neck sideways to Lt side like saing "no" and the range is taken
cervical Rt side flexion range of motion
Time frame: 1 week
the person is asked to move neck sideways to Rt side like touching ear to shoulder and range is taken
cervical Lt side flexion range of motion
Time frame: 1 week
the person is asked to move neck sideways to Rt side like touching ear to shoulder and range is taken
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Post-Thyroidectomy Hypoparathyroidism
Recruiting
Calcium Replacement Therapy in Postoperative Hypoparathyroidism
Post-Thyroidectomy Hypoparathyroidism Treatment
Recruiting
Comparing PTeye-assisted Versus Conventional Total Thyroidectomy
Hypocalcemia, Parathyroid
Not yet recruitingObservational study
Psychological Problems in Post Thyroidectomy Patients
Post-Thyroidectomy Hypoparathyroidism
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. This study is not recruiting at the moment.
Aisha Razzaq principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical Rehabilitation program (Intervention Group) Group A in people with Post-Thyroidectomy Hypoparathyroidism, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. 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: finished, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Score (NPRS): (time frame: 1 week). The study lists 8 primary outcomes in all. 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 1 Sep 2023; AzTrials last refreshed its copy on 30 Oct 2026.