Is Patient Choice of Exercise Preference Important in Chronic Neck Pain?

Chronic Neck Pain Clinical Trial

Official title:

Is Patient Choice of Exercise Preference Important in Chronic Neck Pain? A Randomized Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05226845
• Other study ID #: Alcalá University
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: October 30, 2021

Study information

• Verified date: February 2022
• Source: University of Jaén
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Neck Pain
• Neck Pain

Intervention

Other:
• prescribed exercise
the therapist chooses the five exercises to do
• chosen exercise
the patient chooses the five exercises to perform among fifteen possibilities

Locations

Country	Name	City	State
Spain	Alexander achalandabaso	Alcalá De Henares	Madrid
Spain	Universidad de Alcalá	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
University of Jaén

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. Review. — View 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:CD011279. doi: 10.1002/14651858.CD011279.pub3. Review. — View 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. — View 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:S91-S97. doi: 10.1097/j.pain.0000000000001235. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.
Secondary	Changes in muscular endurance	using Grimmer test	Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.
Secondary	Adherence to treatment	using a journal entry	Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.
Secondary	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.	Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.