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Effectiveness of Cervical Rehabilitation Program on Neck Pain, ROM and Disability After Thyroidectomy.

Primary Purpose

Thyroiditis, Postpartum

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
cervical rehabilitation program
control group
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroiditis, Postpartum focused on measuring positional release, suboccipital muscle release

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • Both genders (male & female)

    • 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

  • Heavy Industrial Taxila Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

cervical rehabilitation group

control group

Arm Description

Positional release technique on trapezius muscle, suboccipital muscle release, pectoralis muscle stretching

shoulder and neck exercises

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 10, 2022
Last Updated
January 22, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05497752
Brief Title
Effectiveness of Cervical Rehabilitation Program on Neck Pain, ROM and Disability After Thyroidectomy.
Official Title
Effectiveness of Cervical Rehabilitation Program on Neck Pain, ROM and Disability After Thyroidectomy.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 10, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
January 10, 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
Yes

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroiditis, Postpartum
Keywords
positional release, suboccipital muscle release

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 group
Arm Type
Experimental
Arm Description
Positional release technique on trapezius muscle, suboccipital muscle release, pectoralis muscle stretching
Arm Title
control group
Arm Type
Active Comparator
Arm Description
shoulder and neck exercises
Intervention Type
Other
Intervention Name(s)
cervical rehabilitation program
Intervention Description
(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
Intervention Type
Other
Intervention Name(s)
control group
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
NPRS
Description
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.
Time Frame
1 Week
Title
Neck disability index
Description
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
Time Frame
1 week
Secondary Outcome Measure Information:
Title
neck flexion ROM
Description
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.
Time Frame
1 week
Title
neck Extension ROM
Description
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.
Time Frame
1 week
Title
neck Rt side flexion ROM
Description
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.
Time Frame
1 week
Title
neck Lt side flexion ROM
Description
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.
Time Frame
1 week
Title
neck Rt Rotation ROM
Description
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.
Time Frame
1 week
Title
neck Lt Rotation ROM
Description
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.
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: • Both genders (male & female) 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, MSPT-OMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heavy Industrial Taxila Hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of Cervical Rehabilitation Program on Neck Pain, ROM and Disability After Thyroidectomy.

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