NCT05433649

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 27, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

2 months

First QC Date

June 21, 2022

Last Update Submit

October 24, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

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.

Behavioral: Therapeutic exercise

Control group

NO INTERVENTION

They do not change their lifestyle and do not receive the therapeutic exercise sessions.

Interventions

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.

Experimental group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women.
  • years of age.
  • With non-specific neck pain for at least three months, with pain intensity (30-70 on a VAS).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pablo Hernández Lucas

Pontevedra, 36004, Spain

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Neck Pain

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor in health sciences

Study Record Dates

First Submitted

June 21, 2022

First Posted

June 27, 2022

Study Start

July 1, 2022

Primary Completion

September 1, 2022

Study Completion

October 1, 2022

Last Updated

October 26, 2022

Record last verified: 2022-10

Locations