NCT05226845

Brief Summary

Nonspecific chronic neck pain is the third most frequent problem in Spain. It has an annual presence between 15% and 50% where women are the most affected. This pain influences the psychosocial state of the person. Physical exercise has been shown to be effective in a wide variety of chronic pain conditions, including improving quality of life and emotional problems. Design: Single-blind, controlled, randomized clinical trial. Methods: The study will be approached in the Faculty of Nursing and Physiotherapy of the University of Alcalá. 52 subjects with nonspecific chronic neck pain will be selected and randomly divided into two groups. The first group should perform 5 exercises that have been shown to be effective in the management of neck pain selected by the physiotherapist focused on neck pain. The second group must choose, from a list of exercises that have been shown to be effective in the management of neck pain, 5 exercises. Both groups should record the pain, the number of repetitions and the series performed. The duration of the intervention will be a total of 8 weeks with evaluations pre-intervention, post-intervention and 4 weeks after the end of the intervention. The objective of this study is to evaluate if the exercise chosen by the patient is better than the exercises selected by the physiotherapist for the variables chronic neck pain, strength of the affected muscles, kinesiophobia and adherence to treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

July 1, 2021

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 4, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 7, 2022

Completed
Last Updated

February 25, 2022

Status Verified

February 1, 2022

Enrollment Period

29 days

First QC Date

December 4, 2021

Last Update Submit

February 8, 2022

Conditions

Keywords

Chronic neck painPhysical ExerciseKinesiophobiaCervical strengthAdherence to treatment

Outcome Measures

Primary Outcomes (1)

  • Changes in Disability

    using the Neck Disability Index Questionnaire. It is a scale whose values range from 0 to 50. The higher the score, the greater the disability.

    Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.

Secondary Outcomes (4)

  • Changes in kinesiophobia

    Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.

  • Changes in muscular endurance

    Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.

  • Adherence to treatment

    Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.

  • changes in pain

    Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.

Study Arms (2)

exercise to improve the neck strength in neck pain chosen by the therapist

EXPERIMENTAL
Other: prescribed exercise

exercise to improve the neck strength in neck pain chosen by the patient

EXPERIMENTAL
Other: chosen exercise

Interventions

the therapist chooses the five exercises to do

exercise to improve the neck strength in neck pain chosen by the therapist

the patient chooses the five exercises to perform among fifteen possibilities

exercise to improve the neck strength in neck pain chosen by the patient

Eligibility Criteria

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

You may qualify if:

  • chronic neck pain

You may not qualify if:

  • Spine surgery, shoulder girdle or cervical area surgery, whether traumatic or not.
  • Rheumatic pathology.
  • Impaired cognitive function.
  • Vascular pathology that prevents exercise.
  • Cardiopulmonary pathology that prevents exercise.
  • Fear of any of the tests or measurements to be carried out.
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Alexander achalandabaso

Alcalá de Henares, Madrid, 28805, Spain

Location

Universidad de Alcalá

Madrid, 28805, Spain

Location

Related Publications (4)

  • Geneen LJ, Moore RA, Clarke C, Martin D, Colvin LA, Smith BH. Physical activity and exercise for chronic pain in adults: an overview of Cochrane Reviews. Cochrane Database Syst Rev. 2017 Apr 24;4(4):CD011279. doi: 10.1002/14651858.CD011279.pub3.

    PMID: 28436583BACKGROUND
  • Ambrose KR, Golightly YM. Physical exercise as non-pharmacological treatment of chronic pain: Why and when. Best Pract Res Clin Rheumatol. 2015 Feb;29(1):120-30. doi: 10.1016/j.berh.2015.04.022. Epub 2015 May 23.

    PMID: 26267006BACKGROUND
  • Polaski AM, Phelps AL, Kostek MC, Szucs KA, Kolber BJ. Exercise-induced hypoalgesia: A meta-analysis of exercise dosing for the treatment of chronic pain. PLoS One. 2019 Jan 9;14(1):e0210418. doi: 10.1371/journal.pone.0210418. eCollection 2019.

    PMID: 30625201BACKGROUND
  • Sluka KA, Frey-Law L, Hoeger Bement M. Exercise-induced pain and analgesia? Underlying mechanisms and clinical translation. Pain. 2018 Sep;159 Suppl 1(Suppl 1):S91-S97. doi: 10.1097/j.pain.0000000000001235.

    PMID: 30113953BACKGROUND

MeSH Terms

Conditions

Motor ActivityKinesiophobiaTreatment Adherence and Compliance

Condition Hierarchy (Ancestors)

BehaviorPhobic DisordersAnxiety DisordersMental DisordersHealth Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 4, 2021

First Posted

February 7, 2022

Study Start

July 1, 2021

Primary Completion

July 30, 2021

Study Completion

October 30, 2021

Last Updated

February 25, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations