- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05433649
Effects of Therapeutic Exercise With Elastic Bands on Strength and Pain in Women With Non-specific Neck Pain.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Pontevedra, Spain, 36004
- Pablo Hernández Lucas
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
Participants performing 16 sessions of therapeutic exercise for 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.
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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.
|
|
No Intervention: Control group
They do not change their lifestyle and do not receive the therapeutic exercise sessions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale
Time Frame: Through study completion, an average of 2 months
|
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
|
|
Neck flexor muscle endurance.
Time Frame: Through study completion, an average of 2 months
|
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.
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Through study completion, an average of 2 months
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Neck extensor muscle endurance.
Time Frame: Through study completion, an average of 2 months
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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
|
|
Scapular stabiliser endurance.
Time Frame: Through study completion, an average of 2 months
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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