Chronic Neck PainNCT06568354
The Effects of Yoga and Motor Control Exercises in Patients With Chronic Neck Pain
A study testing Yoga in people with Chronic Neck Pain, run by Hacettepe University.
Trial summary
Identification of the effects of yoga and motor control exercises on pain intensity, pain sensitivity, function, and pain cognition in individuals with neck pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-specific neck pain
- Must be pain at least 3 months
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Neck Pain
- Being tested
- Yoga, Motor control exercises
- Keywords
- neck pain, exercise, cognition, yoga, motor control, function
- Medical subject headings
- Neck Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaOther
The yoga program was applied to all patients in this group, accompanied by a physiotherapist. Sessions included selected breathing, warm-up, and relaxation exercises.
Motor control exercisesOther
Motor control exercises with three different progressive phases were applied to all patients in this group accompanied by a physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Yoga Group | Active comparator | A yoga exercise program will be applied in two sessions per week, a total of eight weeks. Receives: Other: Yoga |
| Motor Control Exercise Group | Active comparator | Motor control exercise program will be applied two sessions per week, totally eight week. Receives: Other: Motor control exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Functional Disability
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.
Measured: Change from baseline in functional status at 8 weeks
Secondary outcomes (10)
Changes in Pain Intensity
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.
Measured: Change from baseline in pain intensity at 8 weeks
Changes in Pain Sensitivity
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.
Measured: Change from baseline in pain sensitivity at 8 weeks
Changes in Alexithymia
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.
Measured: Change from baseline in alexithymia at 8 weeks
Changes in Cognitive Function
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.
Measured: Change from baseline in cognitive function at 8 weeks
Changes in Pain Catastrophizing
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.
Measured: Change from baseline in pain catastrophizing at 8 weeks]
Changes in Kinesiophobia
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.
Measured: Change from baseline in kinesiophobia at 8 weeks
Changes in Neck Awareness
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.
Measured: Change from baseline in neck awareness at 8 weeks]
Changes in Body Awareness
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
Measured: Change from baseline in body awareness at 8 weeks
Changes in Central Sensitization
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.
Measured: Change from baseline in central sensitization at 8 weeks
Changes in Hand Grip Strength
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.
Measured: Change from baseline in hand grip strength at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Neck PainStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Ulger, Hacettepe University
- Investigators
- Ozlem Ulger, Prof, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568354
- Sponsor's protocol ID
- FTREK24/24
- Status last verified
- Aug 2024
- First submitted
- 16 Aug 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cho WS, Park CB, Kim BG. Effects of exercise therapy on pain and disability in patients with non-specific neck pain: A systematic review and meta-analysis. J Bodyw Mov Ther. 2023 Oct;36:213-220. doi: 10.1016/j.jbmt.2023.07.010. Epub 2023 Jul 13.
PubMed 37949563Cramer H, Klose P, Brinkhaus B, Michalsen A, Dobos G. Effects of yoga on chronic neck pain: a systematic review and meta-analysis. Clin Rehabil. 2017 Nov;31(11):1457-1465. doi: 10.1177/0269215517698735. Epub 2017 Mar 9.
PubMed 29050510Akodu AK, Nwanne CA, Fapojuwo OA. Efficacy of neck stabilization and Pilates exercises on pain, sleep disturbance and kinesiophobia in patients with non-specific chronic neck pain: A randomized controlled trial. J Bodyw Mov Ther. 2021 Apr;26:411-419. doi: 10.1016/j.jbmt.2020.09.008. Epub 2020 Oct 3.
PubMed 33992276Rasmussen-Barr E, Halvorsen M, Bohman T, Bostrom C, Dedering A, Kuster RP, Olsson CB, Rovner G, Tseli E, Nilsson-Wikmar L, Grooten WJA. Summarizing the effects of different exercise types in chronic neck pain - a systematic review and meta-analysis of systematic reviews. BMC Musculoskelet Disord. 2023 Oct 12;24(1):806. doi: 10.1186/s12891-023-06930-9.
PubMed 37828488
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Yoga and Motor Control Exercises on Pain Perception, Function, and Pain Cognition in Patients With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT06568354
- Acronym / sponsor ID
- FTREK24/24
- Conditions
- Chronic Neck Pain
- Keywords
- neck pain, exercise, cognition, yoga, motor control, function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 23 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Identification of the effects of yoga and motor control exercises on pain intensity, pain sensitivity, function, and pain cognition in individuals with neck pain.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga Group | Active comparator | Other: YogaA yoga exercise program will be applied in two sessions per week, a total of eight weeks. |
| Motor Control Exercise Group | Active comparator | Other: Motor control exercisesMotor control exercise program will be applied two sessions per week, totally eight week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Non-specific neck pain
- Must be pain at least 3 months
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YogaThe yoga program was applied to all patients in this group, accompanied by a physiotherapist. Sessions included selected breathing, warm-up, and relaxation exercises. | Other | Yoga Group |
| Motor control exercisesMotor control exercises with three different progressive phases were applied to all patients in this group accompanied by a physiotherapist. | Other | Motor Control Exercise Group |
Primary outcome
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.
10 secondary outcomes
Changes in Pain Intensity
Time frame: Change from baseline in pain intensity at 8 weeks
Changes in Pain Sensitivity
Time frame: Change from baseline in pain sensitivity at 8 weeks
Changes in Alexithymia
Time frame: Change from baseline in alexithymia at 8 weeks
Changes in Cognitive Function
Time frame: Change from baseline in cognitive function at 8 weeks
Changes in Pain Catastrophizing
Time frame: Change from baseline in pain catastrophizing at 8 weeks]
Changes in Kinesiophobia
Time frame: Change from baseline in kinesiophobia at 8 weeks
Changes in Neck Awareness
Time frame: Change from baseline in neck awareness at 8 weeks]
Changes in Body Awareness
Time frame: Change from baseline in body awareness at 8 weeks
Changes in Central Sensitization
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Background: PubMed 37949563Cho WS, Park CB, Kim BG. Effects of exercise therapy on pain and disability in patients with non-specific neck pain: A systematic review and meta-analysis. J Bodyw Mov Ther. 2023 Oct;36:213-220. doi: 10.1016/j.jbmt.2023.07.010. Epub 2023 Jul 13.
- Background: PubMed 29050510Cramer H, Klose P, Brinkhaus B, Michalsen A, Dobos G. Effects of yoga on chronic neck pain: a systematic review and meta-analysis. Clin Rehabil. 2017 Nov;31(11):1457-1465. doi: 10.1177/0269215517698735. Epub 2017 Mar 9.
- Background: PubMed 33992276Akodu AK, Nwanne CA, Fapojuwo OA. Efficacy of neck stabilization and Pilates exercises on pain, sleep disturbance and kinesiophobia in patients with non-specific chronic neck pain: A randomized controlled trial. J Bodyw Mov Ther. 2021 Apr;26:411-419. doi: 10.1016/j.jbmt.2020.09.008. Epub 2020 Oct 3.
- Background: PubMed 37828488Rasmussen-Barr E, Halvorsen M, Bohman T, Bostrom C, Dedering A, Kuster RP, Olsson CB, Rovner G, Tseli E, Nilsson-Wikmar L, Grooten WJA. Summarizing the effects of different exercise types in chronic neck pain - a systematic review and meta-analysis of systematic reviews. BMC Musculoskelet Disord. 2023 Oct 12;24(1):806. doi: 10.1186/s12891-023-06930-9.
- Individual participant dataSharing planned: No
Related trials for Chronic Neck Pain
Recruiting
Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
Chronic Neck Pain
RecruitingPhase 2
Phenotype-based Model for Managing Chronic Post-treatment Pain Among Head and Neck Cancer Survivors: a Pilot Study
Chronic Postsurgical Pain, Chronic Post Cancer Surgery Pain
Active, not recruiting
Multimodal Manual Therapy vs. Maitland Mobilization for Chronic Non-Specific Neck Pain
Chronic Neck Pain
Not yet recruiting
Comparison of the Effectiveness of Motor Imagery Exercises and Suboccipital Myofascial Release Techniques in Nonspecific Chronic Neck Pain
Non-specific Chronic Neck Pain
Not yet recruiting
Digital Use, 24-Hour Movement Behaviors, and Myofascial Release in University Students With Neck Pain
Forward Head Posture, Chronic Nonspecific Neck Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ozlem Ulger, Prof principal investigator
Hacettepe University
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Chronic Neck Pain, run by Hacettepe University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ozlem Ulger, Prof (+903123051577 ext. 168, ozlemulger@hacettepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Functional Disability (time frame: Change from baseline in functional status at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06568354, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.