Is Patient Choice of Exercise Preference Important in Chronic Neck Pain?
Primary Purpose
Chronic Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
prescribed exercise
chosen exercise
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Neck Pain focused on measuring Chronic neck pain, Physical Exercise, Kinesiophobia, Cervical strength, Adherence to treatment
Eligibility Criteria
Inclusion Criteria:
- chronic neck pain
Exclusion Criteria:
- 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
Sites / Locations
- Alexander achalandabaso
- Universidad de Alcalá
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
exercise to improve the neck strength in neck pain chosen by the therapist
exercise to improve the neck strength in neck pain chosen by the patient
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Changes in kinesiophobia
using Tampa scale of kinesiophobia (TSK-11). It is a scale whose values range from11 to 44. The higher the score, the greater the kinesiophobia.
Changes in muscular endurance
using Grimmer test
Adherence to treatment
using a journal entry
changes in pain
Using the visual analog scale. It is a 100-mm long horizontal line. Zero means no pain, 100-mm means the worst pain imaginable.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05226845
Brief Title
Is Patient Choice of Exercise Preference Important in Chronic Neck Pain?
Official Title
Is Patient Choice of Exercise Preference Important in Chronic Neck Pain? A Randomized Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jaén
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Neck Pain
Keywords
Chronic neck pain, Physical Exercise, Kinesiophobia, Cervical strength, Adherence to treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
exercise to improve the neck strength in neck pain chosen by the therapist
Arm Type
Experimental
Arm Title
exercise to improve the neck strength in neck pain chosen by the patient
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
prescribed exercise
Intervention Description
the therapist chooses the five exercises to do
Intervention Type
Other
Intervention Name(s)
chosen exercise
Intervention Description
the patient chooses the five exercises to perform among fifteen possibilities
Primary Outcome Measure Information:
Title
Changes in Disability
Description
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.
Time Frame
Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.
Secondary Outcome Measure Information:
Title
Changes in kinesiophobia
Description
using Tampa scale of kinesiophobia (TSK-11). It is a scale whose values range from11 to 44. The higher the score, the greater the kinesiophobia.
Time Frame
Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.
Title
Changes in muscular endurance
Description
using Grimmer test
Time Frame
Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.
Title
Adherence to treatment
Description
using a journal entry
Time Frame
Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.
Title
changes in pain
Description
Using the visual analog scale. It is a 100-mm long horizontal line. Zero means no pain, 100-mm means the worst pain imaginable.
Time Frame
Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
chronic neck pain
Exclusion Criteria:
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
Facility Information:
Facility Name
Alexander achalandabaso
City
Alcalá De Henares
State/Province
Madrid
ZIP/Postal Code
28805
Country
Spain
Facility Name
Universidad de Alcalá
City
Madrid
ZIP/Postal Code
28805
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28436583
Citation
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.
Results Reference
background
PubMed Identifier
26267006
Citation
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.
Results Reference
background
PubMed Identifier
30625201
Citation
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.
Results Reference
background
PubMed Identifier
30113953
Citation
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.
Results Reference
background
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