Effects of Therapeutic Exercise With Elastic Bands on Strength and Pain in Women With Non-specific Neck Pain.
Primary Purpose
Neck Pain, Exercise Therapy, Women
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Therapeutic exercise
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain
Eligibility Criteria
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.
Sites / Locations
- Pablo Hernández Lucas
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental group
Control group
Arm Description
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.
They do not change their lifestyle and do not receive the therapeutic exercise sessions.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05433649
Brief Title
Effects of Therapeutic Exercise With Elastic Bands on Strength and Pain in Women With Non-specific Neck Pain.
Official Title
Effects of Therapeutic Exercise With Elastic Bands on Strength and Pain in Women With Non-specific Neck Pain.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vigo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Exercise Therapy, Women
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
They do not change their lifestyle and do not receive the therapeutic exercise sessions.
Intervention Type
Behavioral
Intervention Name(s)
Therapeutic exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
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.
Time Frame
Through study completion, an average of 2 months
Title
Neck flexor muscle endurance.
Description
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.
Time Frame
Through study completion, an average of 2 months
Title
Neck extensor muscle endurance.
Description
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.
Time Frame
Through study completion, an average of 2 months
Title
Scapular stabiliser endurance.
Description
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.
Time Frame
Through study completion, an average of 2 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Pablo Hernández Lucas
City
Pontevedra
ZIP/Postal Code
36004
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Effects of Therapeutic Exercise With Elastic Bands on Strength and Pain in Women With Non-specific Neck Pain.
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