- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05624021
Effect of Functional Training and Isometric Exercises on Pain, ROM, and Functional Status in Patients With Neck Pain
November 20, 2022 updated by: AMIR IQBAL, King Saud University
Efficacy of Scapular Functional Training Combined With Isometric Exercises on Pain, Range of Motion, and Functions Among Individual With Mechanical Neck Pian
Work-related musculoskeletal disorders have been rising fast around the globe leading to neck pain and scapular muscle dysfunction, contributing to a decrease in neck movements and functional limitations.
This study aimed to determine the efficacy of scapular functional exercise (SFE) in combination with cervical isometric exercises (CIE) on neck pain, cervical range of motion, and functional limitations among participants with chronic mechanical neck pain.The study was based on a two-arm parallel group pretest-posttest randomized control trial design.
Thirty participants (females 21 and males 9; average age 28.94±3.77
years) were randomly allocated to groups A and B (n=15/group).
The group's A and B participants received a common intervention, such as CIE and hot packs.
However, group A received the SFE in addition to common interventions.
The outcomes, such as neck pain, cervical ROM, and functional limitations, were evaluated using a numeric pain rating scale (NPRS), standard universal goniometer, and neck disability index questionnaire at baseline and 4-week post-intervention.
The paired and unpaired t-test was used to analyze the intervention effects on the outcomes within-group and between-group, keeping the significance level alpha set at p<0.05.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study hypothesised that adding the scapular functional training to the cervical isometric exercises will be equally effective than cervical isometric exercises alone on managing neck pain, cervical ROM, and functional limitations among participants with chronic mechanical neck pain.
The present study is helpful for chronic mechanical neck pain patients and physiotherapist to better understand the effect of incorporation of the scapular functional training in the treatment of neck pain.
Therefore, this protocol may be used as a treatment in chronic mechanical neck pain because it alleviates pain, neck disability, improving cervical range of motion in chronic mechanical neck pain.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Riyadh, Saudi Arabia, 11433
- Rehabilitation Research Chair
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 31 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Both male and female with aged range 22-35 years
- Neck pain of more than 3 months in duration
- Having neck pain without symptoms distal to shoulder
- Participant had not received any clinical treatment for their neck pain within 1-months, and
- Willingness to participate in the study.
Exclusion Criteria:
- Having a diagnosis of cervical spinal stenosis
- Patients with serious pathology (e.g., neoplasm, fractures and inflammatory diseases, unilateral and bilateral upper extremity radicular symptoms (cervical radiculopathy)
- Prior surgery of cervical spine
- Evidence of nerve root compression
- Pregnant women, and
- Showed poor cooperation in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SFT group
Received Scapular functional training and cervical isometric exercises
|
The scapular functional training consists of press up and push up plus.
Press up was done in sitting position on the training bench, feet on the floor with straight arm and the palms on the edge of the bench fingers pointing forward and then lift off and dip down just in front of the seat by moving the shoulder girdle.
Progression is done by placing weight on the thigh.
Push-up plus exercise started from a push up position on the hand, feet or knees and keeping the torso rigid by bracing the abdominals followed by protracting the scapula as high as possible.
Progression is done moving from knees to the feet or adding resistance on the upper back.
The training continued for three sessions per week for four weeks.
The isometric neck exercises taught to all the participants to perform in neutral sitting positions at home thrice a day for 15-days continuously.
The sequences of exercises were shoulder circling in clockwise and anticlockwise direction, scapular retraction with cervical retraction, neck flexion, extension, either side of lateral bending/flexion, left and right rotation.
Each exercise follows a set of 10 repetition of maximum voluntary contraction with a progressive hold time of 3, 5, 7, and 10 seconds depending on the severity of pain and tolerance of the participants.
A hydrocollator moist heat packs was applied over back of the neck in supine position to receive optimal heating.
It was given for 20 minutes/day, five-day a week for four-week.
|
|
Active Comparator: Conventional group
Received only isometric cervical exercises and heating
|
The isometric neck exercises taught to all the participants to perform in neutral sitting positions at home thrice a day for 15-days continuously.
The sequences of exercises were shoulder circling in clockwise and anticlockwise direction, scapular retraction with cervical retraction, neck flexion, extension, either side of lateral bending/flexion, left and right rotation.
Each exercise follows a set of 10 repetition of maximum voluntary contraction with a progressive hold time of 3, 5, 7, and 10 seconds depending on the severity of pain and tolerance of the participants.
A hydrocollator moist heat packs was applied over back of the neck in supine position to receive optimal heating.
It was given for 20 minutes/day, five-day a week for four-week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neumeric pain rating scale (NPRS)
Time Frame: 4 weeks
|
Neck pain was assessed by a nuemeric pain rating scale.
It is an 11-points numeric scale marked with 0 to 10 between either end.
Zero at one end and ten at the opposite end indicate no pain and unbearable/worst imaginable pain, respectively.
The participants were asked to rate their current level of pain, as well as their worst and least amounts of pain in the past 24 hours.
|
4 weeks
|
|
Range of Motion (ROM)
Time Frame: 4 weeks
|
Cervical range of motion was measured by a standard universal goniometer.
|
4 weeks
|
|
Functional limitations
Time Frame: 4 weeks
|
The functional limitation due to mechanical neck pain was evaluated by a neck disability index questionnaire (NDI).
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: AMIR IQBAL, MPT, King Saud University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 23, 2019
Primary Completion (Actual)
December 11, 2019
Study Completion (Actual)
March 29, 2020
Study Registration Dates
First Submitted
November 7, 2022
First Submitted That Met QC Criteria
November 13, 2022
First Posted (Actual)
November 21, 2022
Study Record Updates
Last Update Posted (Actual)
November 23, 2022
Last Update Submitted That Met QC Criteria
November 20, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RRC-2019-17
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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