Chronic Neck PainNCT05226845
Is Patient Choice of Exercise Preference Important in Chronic Neck Pain?
A study testing prescribed exercise and chosen exercise in people with Chronic Neck Pain, run by University of Jaén at 2 sites in Spain.
Trial 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. 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?
- prescribed exercise and chosen exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jul 2021to 30 Oct 2021
- 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
- chronic neck pain
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Alexander achalandabaso
Alcalá de Henares, Madrid, 28805
Universidad de Alcalá
Madrid, 28805
About this study
Official title: Is Patient Choice of Exercise Preference Important in Chronic Neck Pain? A Randomized Clinical Study
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.
- Conditions
- Chronic Neck Pain
- Being tested
- prescribed exercise, chosen exercise
- Keywords
- Chronic neck pain, Physical Exercise, Kinesiophobia, Cervical strength, Adherence to treatment
- Medical subject headings
- Motor Activity, Kinesiophobia, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prescribed exerciseOther
the therapist chooses the five exercises to do
chosen exerciseOther
the patient chooses the five exercises to perform among fifteen possibilities
| Study group | Role | What they receive |
|---|---|---|
| exercise to improve the neck strength in neck pain chosen by the therapist | Experimental | Not described Receives: Other: prescribed exercise |
| exercise to improve the neck strength in neck pain chosen by the patient | Experimental | Not described Receives: Other: chosen exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.
Secondary outcomes (4)
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.
Measured: Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.
Changes in muscular endurance
using Grimmer test
Measured: Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.
Adherence to treatment
using a journal entry
Measured: Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.
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.
Measured: Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start1 Jul 2021
- Primary completion30 Jul 2021
- Study completion30 Oct 2021
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.
- 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
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Achalandabaso, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226845
- Sponsor's protocol ID
- Alcalá University
- Status last verified
- Feb 2022
- First submitted
- 4 Dec 2021
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28436583Ambrose 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.
PubMed 26267006Polaski 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.
PubMed 30625201Sluka 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.
PubMed 30113953
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Patient Choice of Exercise Preference Important in Chronic Neck Pain? A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT05226845
- Acronym / sponsor ID
- Alcalá University
- Conditions
- Chronic Neck Pain
- Keywords
- Chronic neck pain, Physical Exercise, Kinesiophobia, Cervical strength, Adherence to treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 7 Feb 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- chronic neck pain
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| prescribed exercisethe therapist chooses the five exercises to do | Other | exercise to improve the neck strength in neck pain chosen by the therapist |
| chosen exercisethe patient chooses the five exercises to perform among fifteen possibilities | Other | exercise to improve the neck strength in neck pain chosen by the patient |
Primary outcome
Changes in Disability
Time frame: Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.
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.
4 secondary outcomes
Changes in kinesiophobia
Time frame: Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.
Changes in muscular endurance
Time frame: Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.
Adherence to treatment
Time frame: Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.
changes in pain
Time frame: Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Background: PubMed 28436583Geneen 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.
- Background: PubMed 26267006Ambrose 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.
- Background: PubMed 30625201Polaski 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.
- Background: PubMed 30113953Sluka 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prescribed exercise and chosen exercise in people with Chronic Neck Pain, run by University of Jaén at 2 sites in Spain.
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 1 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: finished, as of the sponsor's last update on 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Disability (time frame: Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.). 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 NCT05226845, 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 25 Feb 2022.