The Effects of Yoga and Motor Control Exercises in Patients With Chronic Neck Pain

August 22, 2024 updated by: Ozlem Ulger, Hacettepe University

The Effects of Yoga and Motor Control Exercises on Pain Perception, Function, and Pain Cognition in Patients With Chronic Neck Pain

Identification of the effects of yoga and motor control exercises on pain intensity, pain sensitivity, function, and pain cognition in individuals with neck pain.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet 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

Patients participating in the study were divided into two parallel groups. The patients in the motor control exercise group were instructed to perform motor control exercises, which consist of strengthening of the deep cervical flexors, deep cervical extensors, and axioscapular muscles; stretching exercises; postural correction exercises, and patients in the yoga group were instructed to perform a yoga program, which consists of breathing, relaxation, and flexibility exercises.

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.
39

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 Contact Backup

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:

  • Non-specific neck pain
  • Must be pain at least 3 months

Exclusion Criteria:

  • History of any cervical spine surgery
  • Presence of neurological deficit
  • Having been diagnosed with cardiovascular or systemic diseases that would prevent him/her from taking exercise training.
  • Inflammatory, infectious, or tumoral disease of the vertebra
  • Severe/progressive scoliosis, spinal stenosis, spondylolisthesis
  • had been diagnosed with a neurological disease
  • were currently pregnant.

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.
Active Comparator: Yoga Group
A yoga exercise program will be applied in two sessions per week, a total of eight weeks.
Other: Yoga
The yoga program was applied to all patients in this group, accompanied by a physiotherapist. Sessions included selected breathing, warm-up, and relaxation exercises.
Active Comparator: Motor Control Exercise Group
Motor control exercise program will be applied two sessions per week, totally eight week.
Other: Motor control exercises
Motor control exercises with three different progressive phases were applied to all patients in this group accompanied by a physiotherapist.

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
Changes in Functional Disability
Time Frame: Change from baseline in functional status at 8 weeks
The Neck Disability Index, modified from the Oswestry Low Back Pain Questionnaire and adapted to the cervical region by Vernon et al. in 1991, will be used to assess disability due to neck pain. In the neck disability index, a score of 0-4 is defined as no disability, a score of 5-14 is defined as mild disability, a score of 15-24 is defined as moderate disability, a score of 25-43 is defined as severe disability and a score above 35 is defined as total disability.
Change from baseline in functional status at 8 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
Changes in Pain Intensity
Time Frame: Change from baseline in pain intensity at 8 weeks
It will be evaluated with the Numeric Pain Scale. Individuals will be told that '0' means the absence of pain and '10' means the presence of unbearable pain, they will be asked to indicate the average and maximum pain intensity they have experienced in the last 48 hours and the average pain intensity in the last week between 0-10 and their responses will be recorded.
Change from baseline in pain intensity at 8 weeks
Changes in Pain Sensitivity
Time Frame: Change from baseline in pain sensitivity at 8 weeks
Pressure pain threshold (PPT) assessment will be performed with a device called algometer to evaluate the individuals' pain sensitivity. Initially, 2 trials are performed on the extensor muscles of the forearm to familiarize the participant with the procedure. Afterwards, the person is positioned according to the area to be measured and the measurement points are marked with a pencil. The algometer is placed perpendicular to the skin and a constant pressure is applied. The participant is asked to say "stop" when the feeling of pressure or discomfort turns into a clear sensation of pain. Three measurements are taken at 30 s intervals at each site. The values are averaged and recorded. In this study, right/left C1-C2 and C5-6 articular region, upper part of the Trapezius muscle, Deltoid muscle insertion, lateral epicondyle will be used as measurement points. Measurements will also be made on the Tibialis anterior muscle to assess overall pain sensitivity.
Change from baseline in pain sensitivity at 8 weeks
Changes in Alexithymia
Time Frame: Change from baseline in alexithymia at 8 weeks
The alexithymia will be assessed by the Toronto Alexithymia Scale (TAS). The scale is a Likert-type self-assessment scale consisting of 20 items and scored between 1-5. Difficulties in recognizing emotions (TAS-1), difficulty in speaking emotions (TAS-2), extroverted thinking (TAS-3) subscales. The individual is asked to select the best option for each item from "Never", "Rarely", "Sometimes", "Often" and "Always". The higher the score, the higher the level of alexithymia.
Change from baseline in alexithymia at 8 weeks
Changes in Cognitive Function
Time Frame: Change from baseline in cognitive function at 8 weeks
The Montreal Cognitive Assessment Questionnaire (MoCA) will be used to assess the cognitive function of individuals. MoCA was developed as a rapid screening test for mild cognitive impairment. MoCA assesses various cognitive functions such as attention and concentration, creative functions, memory, language, visual structuring skills, abstract thinking, computation, and orientation. The application of MoCA takes about 10 minutes. The maximum total score of the test is 30. A score of 21 or above is considered normal.
Change from baseline in cognitive function at 8 weeks
Changes in Pain Catastrophizing
Time Frame: Change from baseline in pain catastrophizing at 8 weeks]
The Pain Catastrophizing Scale will be used to evaluate the individual's pain-related catastrophizing thoughts. In the scale consisting of thirteen questions, each question is scored between 0-4. It is graded as "0" never, "1" mildly, "2" moderately, "3 severely, "4" always. The answers to the thirteen questions are summed to obtain a score.
Change from baseline in pain catastrophizing at 8 weeks]
Changes in Kinesiophobia
Time Frame: Change from baseline in kinesiophobia at 8 weeks
The Tampa Kinesiophobia Scale (TKS) will be used to assess the kinesiophobia levels of individuals. The TKS is a 17-question Likert scale that examines activity-related injury/reinjury and fear-avoidance parameters. The score on the scale ranges from 17-68, and the higher the score, the higher the level of kinesiophobia.
Change from baseline in kinesiophobia at 8 weeks
Changes in Neck Awareness
Time Frame: Change from baseline in neck awareness at 8 weeks]
The Fremantle Neck Awareness Questionnaire will be used to assess how individuals perceive the neck area relative to their body. In the questionnaire, there are 9 questions measuring how individuals perceive their neck relative to their body and how they perceive their body position, and the questions are answered in Likert type as "0" I never feel like this, "4" always or often feel like this.
Change from baseline in neck awareness at 8 weeks]
Changes in Body Awareness
Time Frame: Change from baseline in body awareness at 8 weeks
The Body Awareness Rating Questionnaire will be used to assess the body awareness of individuals. This self-reported questionnaire consists of 4 different factors indicating different aspects of body awareness. The factors assess body awareness in terms of function, feeling/emotion, mood and awareness. Each item is scored on a 7-point Likert-type scale. Scores for each factor range from 6 to 42, with higher scores indicating greater body awareness
Change from baseline in body awareness at 8 weeks
Changes in Central Sensitization
Time Frame: Change from baseline in central sensitization at 8 weeks
The Central Sensitization Scale will be used to assess central sensitization. The Central Sensitization Scale is a valid and reliable scale that identifies whether patients' existing symptoms are associated with central sensitization. It consists of two parts. Part A consists of 25 items, including somatic and emotional symptoms related to central sensitization, while part B inquires about previous diagnoses of central sensitization syndromes or related diseases. The frequency of symptoms is assessed on a four-point Likert scale from 0 (never) to 4 (always). The total score ranges from 0 to 100, with higher scores indicating a high degree of central sensitization.
Change from baseline in central sensitization at 8 weeks
Changes in Hand Grip Strength
Time Frame: Change from baseline in hand grip strength at 8 weeks
A Hydraulic Hand Dynamometer will be used to measure hand grip strength. The assessment will be performed using the standard measurement method of the American Association of Hand Therapists. For the assessment, the participant is held in an upright sitting position, feet in contact with the floor, arm next to the body, elbow in 90◦ flexion, forearm and wrist in a neutral position. To assess hand grip strength, the evaluated participant's hand is placed so that it grasps the second measurement range of the dynamometer. Grip strength will be assessed by changing hands between measurements and three measurements will be taken for each hand. An interval of 15 seconds will be used between each measurement. The average of the three measurements will be recorded.
Change from baseline in hand grip strength at 8 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.
Hacettepe 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: Ozlem Ulger, Prof, Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

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.
September 1, 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 31, 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.
February 28, 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 16, 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 22, 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 23, 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 23, 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 22, 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.
  • FTREK24/24

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings