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Effect of Functional Training and Isometric Exercises on Pain, ROM, and Functional Status in Patients With Neck Pain

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Scapular functional training
Cervical isometric exercises
Moist heating
Sponsored by
King Saud University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Chronic pain, Range of motion, Functional limitations, Isometric exercises, Functional training

Eligibility Criteria

22 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rehabilitation Research Chair

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SFT group

Conventional group

Arm Description

Received Scapular functional training and cervical isometric exercises

Received only isometric cervical exercises and heating

Outcomes

Primary Outcome Measures

Neumeric pain rating scale (NPRS)
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.
Range of Motion (ROM)
Cervical range of motion was measured by a standard universal goniometer.
Functional limitations
The functional limitation due to mechanical neck pain was evaluated by a neck disability index questionnaire (NDI).

Secondary Outcome Measures

Full Information

First Posted
November 7, 2022
Last Updated
November 20, 2022
Sponsor
King Saud University
Collaborators
Majmaah University
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1. Study Identification

Unique Protocol Identification Number
NCT05624021
Brief Title
Effect of Functional Training and Isometric Exercises on Pain, ROM, and Functional Status in Patients With Neck Pain
Official Title
Efficacy of Scapular Functional Training Combined With Isometric Exercises on Pain, Range of Motion, and Functions Among Individual With Mechanical Neck Pian
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
August 23, 2019 (Actual)
Primary Completion Date
December 11, 2019 (Actual)
Study Completion Date
March 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Saud University
Collaborators
Majmaah University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Chronic pain, Range of motion, Functional limitations, Isometric exercises, Functional training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled Trial
Masking
ParticipantOutcomes Assessor
Masking Description
Double-blinded study
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SFT group
Arm Type
Experimental
Arm Description
Received Scapular functional training and cervical isometric exercises
Arm Title
Conventional group
Arm Type
Active Comparator
Arm Description
Received only isometric cervical exercises and heating
Intervention Type
Other
Intervention Name(s)
Scapular functional training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Cervical isometric exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Moist heating
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neumeric pain rating scale (NPRS)
Description
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.
Time Frame
4 weeks
Title
Range of Motion (ROM)
Description
Cervical range of motion was measured by a standard universal goniometer.
Time Frame
4 weeks
Title
Functional limitations
Description
The functional limitation due to mechanical neck pain was evaluated by a neck disability index questionnaire (NDI).
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir Iqbal, MPT
Organizational Affiliation
King Saud University
Official's Role
Study Chair
Facility Information:
Facility Name
Rehabilitation Research Chair
City
Riyadh
ZIP/Postal Code
11433
Country
Saudi Arabia

12. IPD Sharing Statement

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Effect of Functional Training and Isometric Exercises on Pain, ROM, and Functional Status in Patients With Neck Pain

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