Comparison of Somatosensory Versus Endurance-strength Exercise in Patients With Chronic Neck Pain

Sponsor
Alexander Achalandabaso (Other)
Overall Status
Recruiting
CT.gov ID
NCT05321537
Collaborator
(none)
60
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Study Details

Study Description

Brief Summary

Aim: To compare the effects of somatosensory exercise vs endurance-strength exercise on the deep cervical flexor muscles on pain and perceived disability in patients with chronic neck pain.

Study design: Protocol of a clinical trial, controlled, parallel and a blinded assessor.

Population: Subjects aged 18 to 65 years with neck pain of 3 or more months of evolution.

Condition or Disease Intervention/Treatment Phase
  • Other: Therapeutic exercises
N/A

Detailed Description

The study will be carried out at the Faculty of Nursing and Physiotherapy of the University of Alcalá. A total of 60 subjects with nonspecific chronic neck pain will be selected and randomly assigned into two intervention groups. The first group will perform a somatosensory exercise program and a second group will perform activation and endurance-strength exercises of the deep cervical flexors. The duration of the intervention will be 8 weeks, with 6 sessions of physical therapy and daily home exercise. The variables pain, pressure pain threshold, disability, endurance-strength, proprioception, quality of life, kinesiophobia, quality of sleep and depression will be analyzed. Measurements will be taken pre-treatment, post-treatment and a follow-up at 3 months.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A single center, parallel, randomized, blinded rater, controlled clinical trial will be conducted. The 25 requirements proposed by the CONSORT declaration will be followed.A single center, parallel, randomized, blinded rater, controlled clinical trial will be conducted. The 25 requirements proposed by the CONSORT declaration will be followed.
Masking:
Single (Outcomes Assessor)
Masking Description:
The evaluator will not know to which treatment group each belongs.
Primary Purpose:
Treatment
Official Title:
Comparison of Somatosensory Exercise Versus Endurance-strength Exercise in Patients With Chronic Neck Pain: a Randomized Clinical Trial
Actual Study Start Date :
Mar 19, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Somatosensory training

It consists of head relocation exercises, eye tracking, gaze stability and eye-head coordination. It requires the use of special material, the pupillary glasses allow the gaze to be fixed by restricting peripheral vision and the laser pointer provides visual feedback on the positioning of the head.

Other: Therapeutic exercises
A somatosensory training and an endurance-strength training protocol

Experimental: Endurance-strength training

It consists of low-load training of the craniocervical flexor muscles. This exercise is specific for the deep cervical flexor muscles, while seeking minimal activation of the superficial flexor muscles. This training consists of 5 phases, starting with a pressure of 20 mmHg, progressively increasing 2 mmHg in each phase.

Other: Therapeutic exercises
A somatosensory training and an endurance-strength training protocol

Outcome Measures

Primary Outcome Measures

  1. Pain change [Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.]

    To assess pain, the Visual Analogue Scale will be used, which consists of a 10-centimeter horizontal line, at whose ends is the maximum expression of a symptom.

  2. Disability change [Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.]

    Disability will be assessed using the validated Spanish version of the Cervical Disability Index. Its range score is 0-50, higher values mean greater disability.

Secondary Outcome Measures

  1. Pressure Pain Threshold change [Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.]

    To assess the Pressure Pain Threshold, a analog pressure algometer will be used. The pressure will be performed bilaterally on the levator scapulae, upper trapezius, splenius capitis and sternocleidomastoid.

  2. Endurance of craniocervical flexion change [Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.]

    The isometric endurance of the deep flexor muscles of the neck will be measured with the Craniocervical Flexion Test, using a pressure biofeedback.

  3. Proprioception change [Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.]

    The proprioception of the head and neck in space will be evaluated using the Cervical Joint Positioning Error Test.

  4. Kinesiophobia change [Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.]

    The patients' level of fear of movement will be evaluated using the Tampa Scale for Kinesiophobia. Range score is 11-44, higher values mean greater fear of injury.

  5. Sleep quality change [Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.]

    To assess sleep quality we will use the Pittsburgh Sleep Quality Index, using the Spanish version. Range score is 0-21, higher values mean worse outcome.

  6. Quality of life change [Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.]

    Quality of life will be assessed with the 12-Item Short Form Survey, second version (SF-12v2), using its Spanish version. This questionnaire is made up of 12 items which measure both physical and mental items. Range score is 0-47, higher values mean lower quality of life.

  7. Depression change [Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.]

    To assess depression, the Beck Depression Inventory in its second edition (BDI-II), in its Spanish version, will be used. Range score is 0-63, higher values mean worse outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Subjects of age between 18 and 65 years

  • Neck pain of 3 or more months of evolution

Exclusion Criteria:
  • Cervical Disability Index less than 15/50

  • Infection

  • Oncological processes

  • Neck or arm surgery

  • Neck or arm trauma

  • Positive neurological signs

  • Rheumatic diseases

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alcalá Alcalá De Henares Madrid Spain 28801

Sponsors and Collaborators

  • Alexander Achalandabaso

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alexander Achalandabaso, Clinical professor, University of Jaén
ClinicalTrials.gov Identifier:
NCT05321537
Other Study ID Numbers:
  • CEIM/2022/1/001
First Posted:
Apr 11, 2022
Last Update Posted:
Apr 22, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Alexander Achalandabaso, Clinical professor, University of Jaén
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 22, 2022