- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06020820
Effectiveness Of Cervical Rehabilitation Program After Thyroidectomy
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Punjab
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Wah, Punjab, Pakistan, 47010
- Pakistan ordinance factory Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Post-thyroidectomy patients
- Indoor patients
Exclusion Criteria:
• Any cervical fracture/dislocations
- Cervical instability
- Vertebrobasilar insufficiency
- Cervical Radiculopathy
- Disc prolapsed at cervical region
- Any neurological impairment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cervical Rehabilitation program (Intervention Group) Group A
Positional release technique on trapezius muscle, Suboccipital muscle release, Stretching of pectoralis muscle
|
(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 |
|
Active Comparator: (control group) Group B
neck and shoulder ROMS
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
1 week
|
|
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.
|
1 Week
|
|
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
|
1 week
|
|
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
|
1 week
|
|
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
|
1 week
|
|
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
|
1 week
|
|
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
|
1 week
|
|
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
|
1 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aisha Razzaq, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Riphah IU Tayyaba sultan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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