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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Neck Pain
• Intervention / Treatment: Other: prescribed exercise; Other: chosen exercise

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28805
    • Universidad de Alcalá
  • Madrid
    • Alcalá De Henares, Madrid, Spain, 28805
      • Alexander achalandabaso

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: exercise to improve the neck strength in neck pain chosen by the therapist	Other: prescribed exercise; the therapist chooses the five exercises to do
Experimental: exercise to improve the neck strength in neck pain chosen by the patient	Other: chosen exercise; the patient chooses the five exercises to perform among fifteen possibilities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
Changes in muscular endurance	using Grimmer test	Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.
Adherence to treatment	using a journal entry	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.	Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.

Collaborators and Investigators

• Sponsor: University of Jaen

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): July 30, 2021
• Study Completion (Actual): October 30, 2021

Study Registration Dates

• First Submitted: December 4, 2021
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): February 25, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Kinesiophobia; Physical Exercise; Adherence to treatment; Chronic neck pain; Cervical strength
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: Alcalá University

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No