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

Not yet recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

39

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 Contact

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

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
Intervention / Treatment
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

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

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

Hacettepe University

Investigators

  • 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)

September 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

August 16, 2024

First Submitted That Met QC Criteria

August 22, 2024

First Posted (Actual)

August 23, 2024

Study Record Updates

Last Update Posted (Actual)

August 23, 2024

Last Update Submitted That Met QC Criteria

August 22, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

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