NCT06568354

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 23, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

August 23, 2024

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

August 16, 2024

Last Update Submit

August 22, 2024

Conditions

Keywords

neck painexercisecognitionyogamotor controlfunction

Outcome Measures

Primary Outcomes (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.

    Change from baseline in functional status at 8 weeks

Secondary Outcomes (10)

  • Changes in Pain Intensity

    Change from baseline in pain intensity at 8 weeks

  • Changes in Pain Sensitivity

    Change from baseline in pain sensitivity at 8 weeks

  • Changes in Alexithymia

    Change from baseline in alexithymia at 8 weeks

  • Changes in Cognitive Function

    Change from baseline in cognitive function at 8 weeks

  • Changes in Pain Catastrophizing

    Change from baseline in pain catastrophizing at 8 weeks]

  • +5 more secondary outcomes

Study Arms (2)

Yoga Group

ACTIVE COMPARATOR

A yoga exercise program will be applied in two sessions per week, a total of eight weeks.

Other: Yoga

Motor Control Exercise Group

ACTIVE COMPARATOR

Motor control exercise program will be applied two sessions per week, totally eight week.

Other: Motor control exercises

Interventions

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.

Yoga Group

Motor control exercises with three different progressive phases were applied to all patients in this group accompanied by a physiotherapist.

Motor Control Exercise Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 37949563BACKGROUND
  • 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.

    PMID: 29050510BACKGROUND
  • 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.

    PMID: 33992276BACKGROUND
  • 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.

    PMID: 37828488BACKGROUND

MeSH Terms

Conditions

Neck PainMotor Activity

Interventions

Yoga

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Ozlem Ulger, Prof

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof, Spine Health Unit, Principal Investigator, PhD

Study Record Dates

First Submitted

August 16, 2024

First Posted

August 23, 2024

Study Start

September 1, 2024

Primary Completion

December 31, 2024

Study Completion

February 28, 2025

Last Updated

August 23, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share