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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

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 groups in NCT06568354
Study groupRoleWhat they receive
Yoga GroupActive comparatorA yoga exercise program will be applied in two sessions per week, a total of eight weeks.
Receives: Other: Yoga
Motor Control Exercise GroupActive comparatorMotor 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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]

  6. 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

  7. 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]

  8. 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

  9. 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

  10. 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.

  1. First posted23 Aug 2024
  2. Study start1 Sep 2024 (estimated)
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion28 Feb 2025 (estimated)

Resources

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)
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 37949563
  • Cramer 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 29050510
  • Akodu 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 33992276
  • Rasmussen-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

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.

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