NCT06494553

Brief Summary

The purpose of the study is to evaluate the effect of cervical stabilization exercises on pain intensity level, cervical range of motion, proprioception, and handgrip strength in sedentary office workers.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 10, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

July 10, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

June 25, 2024

Last Update Submit

July 2, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • handgrip strength

    Handgrip strength is a crucial measure of overall muscle strength and function to assess the functionality of the hand and forearm muscles. This measure is typically obtained using a handgrip dynamometer, a device that quantifies the maximum isometric strength of the hand and forearm muscles.

    2 months

  • cervical range of motion

    Cervical Range of Motion (CROM) refers to the degree of movement in the neck and cervical spine across different planes of motion. It is an important measure of neck flexibility and function, encompassing movements such as flexion, extension, lateral flexion, and rotation. Assessing CROM is crucial in diagnosing and managing various musculoskeletal and neurological conditions affecting the neck. This measure is typically obtained using CROM devices that play a pivotal role in accurately quantifying the range of motion in various planes, including flexion, extension, lateral flexion, and rotation.

    2 months

  • cervical pain

    Cervical pain, commonly known as neck pain, is a prevalent condition characterized by discomfort, stiffness, or aching in the cervical spine-the region of the spine that comprises the neck. This condition can arise from various causes, ranging from muscle strain to more complex structural issues, and it can significantly impact a person's quality of life, daily activities, and functional capabilities. This measure is typically obtained using Alternate Visual Analog Scale in Hausa (VAS-H). The VAS-H was used to measure the level of pain experienced by the patients. Patients were asked to rate their pain on a scale of 0-10, with 0 indicating no pain/no interference and 10 indicating the worst possible pain/extreme interference. The alternate VAS-H has been shown to have high validity, increased patient compliance, greater sensitivity, and reduced bias.

    2 months

  • cervical proprioception

    Cervical proprioception refers to the sensory ability of the neck muscles and joints to perceive their position and movement in space. This sensory feedback is critical for maintaining balance, coordinating head and eye movements, and performing complex motor tasks. Impaired proprioception in the cervical region can contribute to dizziness, balance disorders, and increased risk of injury. This measure is typically obtained using CROM devices that play a pivotal role in accurately quantifying the range of motion and proprioception in various planes, including flexion, extension, lateral flexion, and rotation.

    2 months

Study Arms (2)

control group

ACTIVE COMPARATOR

Received traditional treatment program in the form of US, IR and therapeutic exercise program that consisted of Stretching exercises included the following: 1) stretching pectoralis muscle, placing both hands on the occipital area and pulling the elbows back up, and performing arm abduction and external rotation. 2) Stretching the cervical extensors, placing both hands on the occipital area in a sitting position followed by a flexed neck posture with the head down to stretch the cervical extensors .

Device: Ultrasound therapyOther: traditional treatment programDevice: Infrared therapy

cervical stabilization exercises group

EXPERIMENTAL

Received cervical stabilization exercises (included the following: Chin tuck, cervical extension, Shoulder shrugs, Shoulder rolls, Scapular retraction) was given in 3 sets with 10 repetitions for 24 sessions (3 sessions per week for 8 weeks) plus traditional treatment program in the form of US, IR and therapeutic exercise program that consisted of Stretching exercises included the following: 1) stretching pectoralis muscle, placing both hands on the occipital area and pulling the elbows back up, and performing arm abduction and external rotation. 2) Stretching the cervical extensors, placing both hands on the occipital area in a sitting position followed by a flexed neck posture with the head down to stretch the cervical extensors.

Other: cervical stabilization exercisesDevice: Ultrasound therapyOther: traditional treatment programDevice: Infrared therapy

Interventions

Neck stabilization exercises included the following: Chin tuck, cervical extension, Shoulder shrugs, Shoulder rolls, Scapular retraction

cervical stabilization exercises group

The Chattanooga Intelect ultrasound made in America. Year of production: 2013. It was clinically proven to provide the best possible treatment outcomes by utilizing a high-quality transducer to ensure maximum ultrasound delivery to the treatment area. The output is a clean, culminated beam with the lowest available beam non-uniformity ratio

cervical stabilization exercises groupcontrol group

US, IR and therapeutic exercise program that consisted of Stretching exercises included the following: 1) stretching pectoralis muscle, placing both hands on the occipital area and pulling the elbows back up, and performing arm abduction and external rotation. 2) Stretching the cervical extensors, placing both hands on the occipital area in a sitting position followed by a flexed neck posture with the head down to stretch the cervical extensors.

cervical stabilization exercises groupcontrol group

Infrared therapy is a non-invasive treatment modality that uses infrared light to promote healing, reduce pain, and improve circulation. It involves the application of infrared light, which penetrates deep into the tissues, providing therapeutic benefits.

cervical stabilization exercises groupcontrol group

Eligibility Criteria

Age25 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age range between 25 and 35 years.
  • Both male and female patients were included.
  • Informed consent was obtained from all participants.
  • Subjects with cervical pain lasting for more than 3 months (chronic pain).
  • Cooperative patients who were able to follow instructions for assessment procedures.
  • body mass index (18.5 - 29.99 Kg/m2).

You may not qualify if:

  • Unwillingness to participate in the treatment.
  • Pre-existing heart or respiratory diseases.
  • Acute cervical pain.
  • Cervical disc or spondylosis.
  • History of any major cervical spine surgery.
  • Subjects taking analgesics.
  • Any fracture of cervical region.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Bernal-Utrera C, Gonzalez-Gerez JJ, Anarte-Lazo E, Rodriguez-Blanco C. Manual therapy versus therapeutic exercise in non-specific chronic neck pain: a randomized controlled trial. Trials. 2020 Jul 28;21(1):682. doi: 10.1186/s13063-020-04610-w.

    PMID: 32723399BACKGROUND
  • Reddy RS, Tedla JS, Dixit S, Abohashrh M. Cervical proprioception and its relationship with neck pain intensity in subjects with cervical spondylosis. BMC Musculoskelet Disord. 2019 Oct 15;20(1):447. doi: 10.1186/s12891-019-2846-z.

    PMID: 31615495BACKGROUND

MeSH Terms

Conditions

Neck Pain

Interventions

Ultrasonic Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DiathermyHyperthermia, InducedTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Simple randomization was done as the following the name of each subject was written on a paper folding it and putting it in a box; finally papers were picked and assigned to two groups
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Pre and post randomized control trial design will be used in this study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Physical therapy

Study Record Dates

First Submitted

June 25, 2024

First Posted

July 10, 2024

Study Start

July 1, 2024

Primary Completion

September 1, 2024

Study Completion

October 1, 2024

Last Updated

July 10, 2024

Record last verified: 2024-07