Thyroiditis, PostpartumNCT05497752
Effectiveness of Cervical Rehabilitation Program on Neck Pain, ROM and Disability After Thyroidectomy.
A study testing cervical rehabilitation program in people with Thyroiditis, Postpartum, 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
- Thyroiditis, Postpartum
- What is being tested?
- cervical rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Aug 2022to 10 Jan 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
- • Both genders (male \& female)
- 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
Heavy Industrial Taxila Hospital
Rawalpindi, Punjab Province, 46000
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 will be of 6 months. Sampling technique applied will be Non probability Convenience Sampling technique. Both males and females of aged 30-50 years with thyroidectomy will be 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.
Position of neck during surgery and static posture of patient after thyroidectomy causes tightness of surrounding muscles which leads to posterior neck pain, limited ROM and functional disability. Everyone is focused on the incisional pain but not on this disability, there is some literature on neck stretching exercises to treat posterior neck pain but no other technique is used for treatment of posterior neck pain. The purpose of this study is to check the effectiveness of cervical rehabilitation program on neck pain, ROM and disability following thyroidectomy.
- Conditions
- Thyroiditis, Postpartum
- Being tested
- cervical rehabilitation program, control group
- Keywords
- positional release, suboccipital muscle release
- Medical subject headings
- Postpartum Thyroiditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical rehabilitation programOther
(Positional release technique on trapezius muscle): The subject was supine The therapist applied Pressure by pinching the trapezius muscle between the thumb and fingers.
Suboccipital muscle release):
The patient will be in a Supine lying position therapist places both his palms at suboccipital region with upward pressure causing a stretch and distraction for 30 seconds. This technique was performed 3 times in one session with a rest interval of 1 minute after each time.
(Stretching of pectoralis muscle):. once daily Stretching with repetition of five, three times a day for 1week
control groupOther
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 group | Experimental | Positional release technique on trapezius muscle, suboccipital muscle release, pectoralis muscle stretching Receives: Other: cervical rehabilitation program |
| control group | Active comparator | shoulder and neck exercises Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPRS
It used to assess neck pain intensity. Patients were asked to rate how bad their neck pain will on average (NPRS; range, 0, no pain, to 10, maximum pain). pain will be assessed at baseline and after 1 week.
Measured: 1 Week
Neck disability index
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 latterly.
0-4 points (0-8%) no disability, 5-14 points ( 10 - 28%) mild disability, 15-24 points (30-48% ) moderate disability, 25-34 points (50- 64%) severe disability, 35-50 points (70-100%) complete disability
Measured: 1 week
Secondary outcomes (6)
neck flexion ROM
Goniometer is a tool used to assess the range of motion. The range of motion from neutral position to forward movement will be measured. reading will be taken at baseline and at 1st week.
Measured: 1 week
neck Extension ROM
Goniometer is a tool used to assess the range of motion. The range of motion from neutral position to backward movement will be measured. reading will be taken at baseline and at 1st week.
Measured: 1 week
neck Rt side flexion ROM
Goniometer is a tool used to assess the range of motion. The range of motion from neutral position to Rt side, ear towards the shoulder movement will be measured. reading will be taken at baseline and at 1st week.
Measured: 1 week
neck Lt side flexion ROM
Goniometer is a tool used to assess the range of motion. The range of motion from neutral position to Lt side, ear towards the shoulder movement will be measured. reading will be taken at baseline and at 1st week.
Measured: 1 week
neck Rt Rotation ROM
Goniometer is a tool used to assess the range of motion. The range of motion from neutral position to Rt side, Face towards the Rt side movement will be measured. reading will be taken at baseline and at 1st week.
Measured: 1 week
neck Lt Rotation ROM
Goniometer is a tool used to assess the range of motion. The range of motion from neutral position to Rt side, face towards the Lt side movement will be measured. reading will be taken at baseline and at 1st week.
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 posted11 Aug 2022
- Study start10 Aug 2022
- Primary completion30 Dec 2022
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroiditis, PostpartumStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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
- 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, MSPT-OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497752
- Sponsor's protocol ID
- RiphahIU Tayyaba Sultan
- Status last verified
- Jan 2023
- First submitted
- 10 Aug 2022
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Cervical Rehabilitation Program on Neck Pain, ROM and Disability After Thyroidectomy.
- ClinicalTrials.gov ID
- NCT05497752
- Acronym / sponsor ID
- RiphahIU Tayyaba Sultan
- Conditions
- Thyroiditis, Postpartum
- Keywords
- positional release, suboccipital muscle release
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 11 Aug 2022 (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 will be of 6 months. Sampling technique applied will be Non probability Convenience Sampling technique. Both males and females of aged 30-50 years with thyroidectomy will be 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.
Position of neck during surgery and static posture of patient after thyroidectomy causes tightness of surrounding muscles which leads to posterior neck pain, limited ROM and functional disability. Everyone is focused on the incisional pain but not on this disability, there is some literature on neck stretching exercises to treat posterior neck pain but no other technique is used for treatment of posterior neck pain. The purpose of this study is to check the effectiveness of cervical rehabilitation program on neck pain, ROM and disability following thyroidectomy.
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 group | Experimental | Other: cervical rehabilitation programPositional release technique on trapezius muscle, suboccipital muscle release, pectoralis muscle stretching |
| control group | Active comparator | Other: control groupshoulder and neck exercises |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- • Both genders (male \& female)
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(Positional release technique on trapezius muscle): The subject was supine The therapist applied Pressure by pinching the trapezius muscle between the thumb and fingers. Suboccipital muscle release): The patient will be in a Supine lying position therapist places both his palms at suboccipital region with upward pressure causing a stretch and distraction for 30 seconds. This technique was performed 3 times in one session with a rest interval of 1 minute after each time. (Stretching of pectoralis muscle):. once daily Stretching with repetition of five, three times a day for 1week | Other | cervical rehabilitation group |
| control groupRelax 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). | Other | control group |
Primary outcome
NPRS
Time frame: 1 Week
It used to assess neck pain intensity. Patients were asked to rate how bad their neck pain will on average (NPRS; range, 0, no pain, to 10, maximum pain). pain will be assessed at baseline and after 1 week.
Neck disability index
Time frame: 1 week
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 latterly. 0-4 points (0-8%) no disability, 5-14 points ( 10 - 28%) mild disability, 15-24 points (30-48% ) moderate disability, 25-34 points (50- 64%) severe disability, 35-50 points (70-100%) complete disability
6 secondary outcomes
neck flexion ROM
Time frame: 1 week
neck Extension ROM
Time frame: 1 week
neck Rt side flexion ROM
Time frame: 1 week
neck Lt side flexion ROM
Time frame: 1 week
neck Rt Rotation ROM
Time frame: 1 week
neck Lt Rotation ROM
Time frame: 1 week
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 25 Jan 2023.
- Individual participant dataSharing planned: No
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, MSPT-OMPT 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 in people with Thyroiditis, Postpartum, 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 3 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 25 Jan 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?
NPRS (time frame: 1 Week). The study lists 2 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 25 Jan 2023.