Comparison of Gongs and Kaltenborn Mobilization on Neck Pain

August 13, 2024 updated by: Riphah International University

Comparison of Gongs Mobilization and Kaltenborn Mobilization on Mechanical Neck Pain

The aim of this randomized controlled trial is to find the effect of Gongs mobilization in comparison with Kaltenborn mobilization on mechanical neck pain , range of motion and proprioception.A randomized control trial that will include total 44 participants. The first group will receive Gongs mobilization along with conventional therapy and 2nd group will receive Kaltenborn mobilization along with conventional therapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

: Neck pain is most common problem with point prevalence of almost 13% and lifetime prevalence of approximately 50%. Mechanical neck pain is defined as nonspecific neck pain arising from anywhere in area bounded above by superior nuchal line and below to first thoracic vertebrae tip and laterally to lateral borders of neck and pain increased by neck movement.

Impairment of cervical proprioception is significant issue in individuals with mechanical neck pain leading to disruption in sensorimotor control in neck. These disruptions can effect posture control and balance. Cervical sensorimotor control involves the central processing of sensory inputs, including visual, vestibular, and cervical proprioceptive information. This process leads to the execution of motor programs by cervical muscles, which plays a crucial role in maintaining head posture, balance, and the stability of cervical joints. Disturbances in cervical sensorimotor control, resulting from neck pain, may potentially lead to additional tissue damage, worsen pain through sensitization in both the peripheral and central nervous systems, and promote dysfunctional motion patterns.

According to literature Gongs mobilization which is an end range mobilization technique introduced by Wontae Gong at all. It has significance that movement of the joint facets other than the fixed one are maximally restricted and mobilization is induced using acceleration and gravity. For mechanical neck pain Kaltenborn mobilization also improved symptoms.

Previous studies worked on effectiveness of Kaltenborn mobilization and Gongs mobilization on neck pain. Aim of this study will be to determine which technique is more in improving pain, ROM and proprioception in mechanical neck pain patients. Our study is related to the fact that it will be helpful for future healthcare provider and will have a significant role in health promotion and spread a healthy lifestyle to public.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • Punjab
      • Attock City, Punjab, Pakistan, 43350
        • Recruiting
        • Alam Hospital Attock
        • Contact:
        • Principal Investigator:
          • Komal Shahzad, MS OMPT

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Participants falling in this category would be recruited into the study.

  • • Age 18 -65 years

    • Both male and female
    • Primary complaint of neck pain with or without radiating to Upper extremity
    • Pain confined to posterior aspect of neck with mechanical characteristics such as symptoms provoked by neck movement, by palpation of cervical muscles and by sustained posture.
    • Subjects who are willing to participate in study.
    • Patients with Mechanical neck pain

Exclusion Criteria:

  • Participants falling in this category would be excluded from the study.

    • Bilateral upper extremity symptoms
    • Whiplash injury
    • Trauma or tumor around neck
    • Previous neck surgery
    • Spinal infection
    • Cervical radiculopathy and myelopathy
    • Vascular syndromes

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: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A

Gongs mobilization and conventional therapy , sessions 3 per week , mobilization for 5 minutes and 30 minutes session for total 4 weeks. exercise 3 sets for 10 repetitions.

Modality (Hydrocollator pack, TENS for 15 minutes with pulse frequency of 10-200 Hz, pulse width 100 - 250 micro seconds.
Other: Gongs mobilization + conventional physical therapy
3 per week , mobilization for 5 minutes , exercise 3 sets for 10 repetitions for 4 consecutive weeks
Experimental: Group B

Kaltenborn mobilization along with cervical traction and conventional therapy:

Intervention will be given 3 times/week 5 minutes mobilization Exercise 3 sets for 10 repetitions and 30 minutes session for 4 consecutive weeks.

Modality including (Hydrocollator pack, TENS for 15 minutes with pulse frequency of 10-200 Hz, pulse width 100 - 250 micro seconds. Intensity tolerated by patients.
Other: Kaltenborn mobilization along with traction + conventional therapy
3 per week , mobilization for 5 minutes , exercise 3 sets for 10 repetitions for 4 consecutive weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale NPRS
Time Frame: 4 weeks
The NPRS is a segmented numeric version of the visual analog scale which is used to assess pain. It scores ranges from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score.
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cervical Joint Position Error
Time Frame: 4 weeks
The patient is sitting 90 cm from the wall, and the starting point (center of target or reference point) of the laser projection is marked. The patient (blindfolded or closed) performs active neck movement and then returns to the starting position as accurately as possible. The final laser position is measured relative to the starting position (distance or angle). The errors are measured after cervical extension and flexion.
4 weeks
: Goniometer
Time Frame: 4 weeks
: It is an instrument that measures the available range of motion at a joint.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Madiha Ali, MS OMPT, Riphah International 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 9, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Komal Shahzad

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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