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Supervised versus Minimally Supervised Exercises in the Treatment of Chronic Neck Pain

Supervised versus Minimally Supervised Exercises in the Treatment of Non-Specific Chronic Neck Pain: Randomized and Blinded Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8bbz36g
Enrollment
Unknown
Registered
2023-09-14
Start date
2023-11-10
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neck Pain

Interventions

This is a two-arm, blind, randomized controlled clinical trial. Experimental group: 33 subjects of both sexes, who will receive treatment through an exercise program (motor control + joint mobility) a
while control group: supervised, this will perform all 16 interventions under the supervision of the therapist.
N04.452

Sponsors

Departamento de Fisioterapia da UFRN
Lead Sponsor
Departamento de Fisioterapia da UFRN
Collaborator

Eligibility

Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Individuals of both sexes; age between 18-50 years; present a primary complaint of non-specific neck pain (equivalent to classification grades I and II according to the Neck Pain Task Force)(5), present pain for 12 weeks or more; presenting pain equal to or greater than 3 on the END (numerical pain scale 0-10); understand, tolerate and monitor assessment and intervention procedures; not having performed previous surgery of the cervical spine.

Exclusion criteria

Exclusion criteria: Subjects who have blood clotting disorders, diffuse idiopathic skeletal hyperostosis (DISH), significant infectious disease, or other serious disabling health conditions; Pregnant or breastfeeding women; or having received treatment in the past 2 months for neck pain.

Design outcomes

Primary

MeasureTime frame
Neck disability or cervical functional capacity will be assessed using the Neck Disability Index (NDI) questionnaire. This tool was translated and adapted for the Brazilian population in 2006 and consists of 10 items with options ranging from "0" to "5" points, referring to general activities and pain. It has good construct validity and low to moderate reliability (ICC: 0.25 – 0.67) for individuals with mechanical neck pain. Each item refers to a type of activity (pain intensity, personal care, lifting objects, reading, headaches, paying attention, work, driving cars, sleeping and fun) and, within it, the evaluated individual must choose among the six achieved. Each statement corresponds to a score (between 0 and 5) and the final score (which can vary from 0 to 50) is determined by transforming an overall score into a percentage of pain and disability. If in section 8, the individual does not drive a car or does not prefer to drive, the item will be disregarded in the final score and the maximum score may reach 45 points. Thus, the higher the score, the greater the level of disability. For interpretation purposes, consider yourself without disability when the values are below 4 points; from 5 to 14 years, minimal disability; from 15 to 24, moderate disability; from 25 to 34, severe disability; and above 35 points as complete disability. Participants will be included in the study who will obtain a score of at least 5 points, subject to minimal disability. The minimal detectable difference for subjects with neck pain was reported 6.9 and the minimal clinically important difference 5.5 points. Thus, it is expected to find a decrease in cervical disability in the period of 8 weeks, verified using the NDI method/instrument, based on the verification of a variation of at least 5.16 points in the specific pre and post intervention.

Secondary

MeasureTime frame
Pain intensity will be assessed using the Brazilian version of the 11-point Numerical Pain Scale (NDS). This scale ranges from 0 to 10 points, where 0 means “no pain” and 10 “worst pain imaginable”, referring to the cervical region. In addition to the moment of the evaluation, they will also be asked about the minimum and maximum pain in the cervical region in the last week, as well as the average pain in relation to the last seven days. The EDN has good reliability and a 1.5 point reduction in pain was considered clinically important for individuals with chronic non-specific neck pain. Thus, it is expected to find a decrease in pain in the period of 8 weeks, verified through the NDE, from the verification of a variation of at least 1.5 points in the measurements pre and post intervention.;Algometry will be performed in the cervical muscles and joints to assess the pressure pain threshold (PPT) using an algometer instrument. With the subject in dorsal decubitus, three points will be evaluated bilaterally: upper trapezius fibers, scapula elevator and C5-6 zygapophyseal joint. The intensity of pain in the levator scapulae muscle will be measured anterior to the upper trapezius fiber fibers, at the location of the levator scapulae belly and zygapophyseal joint of C5-6 lateral to the spinous process of C5, through the belly of the splenius muscle of the neck . For this purpose, a digital algometer (Force TenTM – Model FDX, Wagner, Greenwich, USA) with a round tip surface area of 1 cm2 will be used and the pressure pain threshold defined as the moment when the applied pressure causes “pain” . Pressure algometry is a valid and reliable method for measuring pressure pain threshold, with studies showing good repeatability of measurements in cervical muscles (ICC: 0.78 – 0.93). The minimum detectable difference for PPT of cervical muscles of subjects with neck pain was 0.45-1.13 kg/cm2. Therefore, it is expected to find an increase in the pressure pain threshold over a per

Countries

Brazil

Contacts

Public ContactPedro Castro

Departamento de Fisioterapia da UFRN

fisiopedrocastro@gmail.com+55 (84) 99973-2011

Outcome results

None listed

Source: REBEC (via WHO ICTRP)