Neck PainNCT05433649
Effects of Therapeutic Exercise With Elastic Bands on Strength and Pain in Women With Non-specific Neck Pain.
A study testing Therapeutic exercise in people with Neck Pain and Exercise Therapy, run by University of Vigo at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Neck Pain, Exercise Therapy, Women
- What is being tested?
- Therapeutic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2022to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women.
- 18-65 years of age.
- With non-specific neck pain for at least three months, with pain intensity (30-70 on a VAS).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Neck Pain, Exercise Therapy, Women
- Being tested
- Therapeutic exercise
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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. Receives: Behavioral: Therapeutic exercise |
| Control group | No intervention | They do not change their lifestyle and do not receive the therapeutic exercise sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 2 months
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.
Measured: Through study completion, an average of 2 months
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.
Measured: Through study completion, an average of 2 months
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.
Measured: Through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start1 Jul 2022
- Primary completion1 Sep 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vigo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pablo Hernandez-Lucas, University of Vigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433649
- Sponsor's protocol ID
- 0004
- Status last verified
- Oct 2022
- First submitted
- 21 Jun 2022
- Last updated
- 26 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hernandez-Lucas P, Leiros-Rodriguez R, Lopez-Barreiro J, Garcia-Soidan JL. Effects of exercise therapy using elastic bands on strength and pain in women with non-specific neck pain: A randomised controlled trial. Heliyon. 2023 Nov 14;9(11):e22237. doi: 10.1016/j.heliyon.2023.e22237. eCollection 2023 Nov.
PubMed 38058646
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Therapeutic Exercise With Elastic Bands on Strength and Pain in Women With Non-specific Neck Pain.
- ClinicalTrials.gov ID
- NCT05433649
- Acronym / sponsor ID
- 0004
- Conditions
- Neck Pain, Exercise Therapy, Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of VigoUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 27 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Therapeutic exerciseParticipants 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. |
| Control group | No intervention | –They do not change their lifestyle and do not receive the therapeutic exercise sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women.
- 18-65 years of age.
- With non-specific neck pain for at least three months, with pain intensity (30-70 on a VAS).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic exerciseThe 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. | Behavioural | Experimental group |
Primary outcome
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.
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.
Neck extensor muscle endurance.
Time frame: Through study completion, an average of 2 months
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Derived from this study: PubMed 38058646Hernandez-Lucas P, Leiros-Rodriguez R, Lopez-Barreiro J, Garcia-Soidan JL. Effects of exercise therapy using elastic bands on strength and pain in women with non-specific neck pain: A randomised controlled trial. Heliyon. 2023 Nov 14;9(11):e22237. doi: 10.1016/j.heliyon.2023.e22237. eCollection 2023 Nov.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic exercise in people with Neck Pain and Exercise Therapy, run by University of Vigo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: Through study completion, an average of 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05433649, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.