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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05433649
Other study ID # 0004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2022
Est. completion date October 1, 2022

Study information

Verified date October 2022
Source University of Vigo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study consists of an intervention of 16 therapeutic exercise sessions during 8 weeks with a frequency of two sessions per week. All sessions had a practical focus (strength and stretching exercises) with the help of elastic bands. In addition, they had an initial session and another at the end of the intervention in which measurements of the different variables (cervical pain, cervical flexor strength, cervical extensor strength and strength of the scapular stabilising musculature) were taken on two occasions, at the beginning of the study and at the end of the intervention, an average of 2 months. Nonspecific neck pain has a higher incidence in women than in men. Female sex is a risk factor for this pathology. Clinical practice guidelines highlight the importance of preventing neck pain through exercise. There are previous studies on the effects of strength programmes on patients with non-specific neck pain, but none have used elastic bands as an implement, despite the fact that it is one of the most commonly used implements in physiotherapy clinics. Therefore, the aim of this study is to investigate the effects of an elastic band therapeutic exercise intervention in women with non-specific neck pain. It was previously hypothesised that this intervention would have positive effects on pain and strength in the cervical and scapular region.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date October 1, 2022
Est. primary completion date September 1, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Women. - 18-65 years of age. - With non-specific neck pain for at least three months, with pain intensity (30-70 on a VAS). Exclusion Criteria: - Any previous neck or shoulder surgery, fibromyalgia, cervical radiculopathy/myelopathy, history of the whiplash injury, cognitive disorder. - Missing more than sessions. - Not being able to attend the measurement sessions.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Therapeutic exercise
The therapeutic exercise intervention with the help of elastic bands was carried out for 8 weeks with a frequency of two sessions per week, for a total of 16 sessions of 45 minutes duration.

Locations

Country Name City State
Spain Pablo Hernández Lucas Pontevedra

Sponsors (1)

Lead Sponsor Collaborator
University of Vigo

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analogue Scale The visual analogue scale is a widely used tool for measuring pain. The patient is asked to indicate their perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge. With 0 mm being no pain perception and 100 mm being the maximum perceived pain. So the higher the value the worse the patient's pain sensation. Through study completion, an average of 2 months
Primary Neck flexor muscle endurance. This was measured using the deep neck flexor endurance test. When in supine position, participants were asked to flex the upper cervical spine, move their heads away from the couch approximately 2.5 cm and hold this position for as long as possible. The test ended when students dropped their heads or lost craniocervical flexion. Through study completion, an average of 2 months
Primary Neck extensor muscle endurance. Students were in prone position, head neutral, arms by their sides and a 10-cm stabilising strip of Velcro was placed at the sixth dorsal vertebra level. An inclinometer and 5-cm strap were placed around the participants head with a 2-kg weight hanging from it. Participants were asked to support this weight for as long as possible while maintaining a neutral head position. Through study completion, an average of 2 months
Primary Scapular stabiliser endurance. Participants stood with their shoulders and elbows flexed at 90°. Students' elbows were kept approximately shoulder-distance apart with a ruler and they were asked to pull both extremities of the dynamometer by externally rotating their shoulders until the dynamometer reached 1 kg. They were asked to hold this position for as long as possible. Through study completion, an average of 2 months
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