Effectiveness Of Cervical Rehabilitation Program After Thyroidectomy
Primary Purpose
Post-Thyroidectomy Hypoparathyroidism
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Cervical Rehabilitation program (Intervention Group) Group A
control group group B
Sponsored by
About this trial
This is an interventional treatment trial for Post-Thyroidectomy Hypoparathyroidism focused on measuring range of motion, disability, post-thyroidectomy
Eligibility Criteria
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
Sites / Locations
- Pakistan ordinance factory Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cervical Rehabilitation program (Intervention Group) Group A
(control group) Group B
Arm Description
Positional release technique on trapezius muscle, Suboccipital muscle release, Stretching of pectoralis muscle
neck and shoulder ROMS
Outcomes
Primary Outcome Measures
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
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.
cervical flexion range of motion
the person is asked to move neck forward to touch chin and the range is taken
cervical extension range of motion
the person is asked to move neck backward as far as possible and the range is taken
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
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
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT06020820
First Posted
August 26, 2023
Last Updated
August 26, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT06020820
Brief Title
Effectiveness Of Cervical Rehabilitation Program After Thyroidectomy
Official Title
Effectiveness Of Cervical Rehabilitation Program After Thyroidectomy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 25, 2022 (Actual)
Primary Completion Date
January 15, 2023 (Actual)
Study Completion Date
February 25, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Thyroidectomy Hypoparathyroidism
Keywords
range of motion, disability, post-thyroidectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cervical Rehabilitation program (Intervention Group) Group A
Arm Type
Experimental
Arm Description
Positional release technique on trapezius muscle, Suboccipital muscle release, Stretching of pectoralis muscle
Arm Title
(control group) Group B
Arm Type
Active Comparator
Arm Description
neck and shoulder ROMS
Intervention Type
Other
Intervention Name(s)
Cervical Rehabilitation program (Intervention Group) Group A
Intervention Description
(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
Intervention Type
Other
Intervention Name(s)
control group group B
Intervention Description
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).
Primary Outcome Measure Information:
Title
Numeric Pain Rating Score (NPRS):
Description
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
Time Frame
1 week
Title
NDI
Description
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.
Time Frame
1 Week
Title
cervical flexion range of motion
Description
the person is asked to move neck forward to touch chin and the range is taken
Time Frame
1 week
Title
cervical extension range of motion
Description
the person is asked to move neck backward as far as possible and the range is taken
Time Frame
1 week
Title
cervical Rt rotation range of motion
Description
the person is asked to move neck sideways to Rt side like saing "no" and the range is taken
Time Frame
1 week
Title
cervical Lt rotation range of motion
Description
the person is asked to move neck sideways to Lt side like saing "no" and the range is taken
Time Frame
1 week
Title
cervical Rt side flexion range of motion
Description
the person is asked to move neck sideways to Rt side like touching ear to shoulder and range is taken
Time Frame
1 week
Title
cervical Lt side flexion range of motion
Description
the person is asked to move neck sideways to Rt side like touching ear to shoulder and range is taken
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aisha Razzaq
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pakistan ordinance factory Hospital
City
Wah
State/Province
Punjab
ZIP/Postal Code
47010
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness Of Cervical Rehabilitation Program After Thyroidectomy
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