Feasibility and Impact of a Tele-rehabilitation Program in Patients With Chronic and Non-specific Neck Pain

Chronic neck pain has a high prevalence in developed countries, being one of the main causes of years lived with disability and deterioration of the quality of life. Telerehabilitation is presented as a resource capable of favoring, with its development and implementation, the transition to a universal and quality health service. The main objective of the study is to assess the change in disability produced by a telerehabilitation program (applied in the intervention group) in patients with chronic and nonspecific neck pain compared to the recommendation of home exercises (control group).

The study that will be carried out will be a controlled and randomized clinical trial (ECCA), single-blind, longitudinal and prospective with two groups (intervention group and control group). The main study variables that are intended to be analyzed pre and post intervention are disability, quality of life, pain, adherence, and depression and anxiety.

The study will take place between June 2020 and May 2021 in specialized physiotherapy clinics.

Study Overview

• Status: Completed
• Conditions: Chronic Non-specific Neck Pain
• Intervention / Treatment: Other: MANUAL THERAPY; Other: THERAPEUTIC EXERCISE

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Las Palmas
    • Santa Brígida, Las Palmas, Spain, 35308
      • Cristina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• People between 18 and 65 years of age
• Neck pain of more than 3 months of evolution
• Access and knowledge in the use of the internet
• Complete the informed consent

Exclusion Criteria:

• Previous trauma to the cervical region (such as whiplash)
• Neck surgery
• Osteoporosis
• Arthritis
• Cervical radiculopathy associated with externalized cervical hernia
• Vertigo or vertebrobasilar insufficiency
• Cancer
• Vertebral fracture
• Fibromyalgia
• Cognitive impairment
• Psychiatric disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Manual therapy and a telerehabilitation program; In the experimental group, an intervention based on manual therapy and a telerehabilitation program based on exercises will be carried out. The investigators will apply manual therapy for ten minutes a week based on cervical mobilizations and suboccipital inhibitions. The access to telerehabilitation will be through a web page, through which patients could see explanatory videos of the exercises as many times as they need.	Other: MANUAL THERAPY; The investigators will apply manual therapy for ten minutes a week, for 8 weeks, based on cervical mobilizations and suboccipital inhibitions.; Other: THERAPEUTIC EXERCISE; The exercises recommendations will be based on a simulation of the exercises in the same session of the manual therapy of each week, helped by the physiotherapist. The access to telerehabilitation will be through a web page, through which patients could see explanatory videos of the exercises as many times as they need.
ACTIVE_COMPARATOR: Manual therapy and recommendations for home exercises; In the control group, the same manual therapy intervention and recommendations for home exercises will be applied. This exercises recommendations will be based on a simulation of the exercise in the same session of the manual therapy of each week.	Other: MANUAL THERAPY; The investigators will apply manual therapy for ten minutes a week, for 8 weeks, based on cervical mobilizations and suboccipital inhibitions.; Other: THERAPEUTIC EXERCISE; The exercises recommendations will be based on a simulation of the exercises in the same session of the manual therapy of each week, helped by the physiotherapist. The access to telerehabilitation will be through a web page, through which patients could see explanatory videos of the exercises as many times as they need.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in disability	Using the Neck Disability Index (NDI). It is made up of 10 items and each item is scored on a 6-point Likert scale (0 to 5), leading to a total score ranging from 0 to 50 (0 to 4 = no disability; 5 to 14 = mild disability; 15 to 24 = moderate disability; 25 to 34 = severe disability; and 35 to 50 = complete disability).	Baseline, 8 weeks and 2 month after intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the health-related quality of life	Using the Short Form 12 Health Survey (SF-12). It is made up of a subset of 12 items from the SF-36 (physical function, social function, physical role, emotional role, mental health, vitality, bodily pain and general health), including 1-2 items from each of the 8 scales of the SF-36.	Baseline, 8 weeks and 2 month after intervention.
Changes in depression and anxiety	Using the Hospital Anxiety and Depression Scale (HADS). It consists of two series of seven questions (a total of 14 items), one represents the anxiety subscale and the other the depression. Each item is valued according to a four-point frequency scale that ranges from 0 to 3 (0 = I always do it; 1 = not so much; 2 = definitely not that much; 3 = not at all).	Baseline, 8 weeks and 2 month after intervention.
Changes in Kinesiophobia	Using the Tampa Scale for Kinesiophobia-11 (TSK-11), self-report of 17 items that address fear of movement and injury relapse. Four of the items are negatively written and scored inverse (4, 8, 12 and 16). The scores are added together to obtain a total score, with higher values reflecting greater kinesiophobia.	Baseline, 8 weeks and 2 month after intervention.
Changes in the pain: Visual Analog Scale (VAS)	Using the Visual Analog Scale (VAS). Each item is scored 0-10 (0= no pain; 10= the major pain that the patient can imagine) yielding a total between 0 and 10.	Baseline, 8 weeks and 2 month after intervention.
Adherence to treatment	Using a record book of the completion of the treatment program, where the activity carried out will be reflected.	At 4 and 8 weeks of treatment
Pressure pain threshold	Using a digital pressure algometer at a speed of 1 kg / cm2 / s perpendicular to the skin surface. The patient will be required to immediately indicate when the sensation of pressure (kg / cm2) becomes a sensation of pain, and thus terminate the compression.	Baseline, 8 weeks and 2 month after intervention.

Collaborators and Investigators

• Sponsor: University of Jaén

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2021
• Primary Completion (ACTUAL): February 28, 2022
• Study Completion (ACTUAL): August 31, 2022

Study Registration Dates

• First Submitted: April 7, 2021
• First Submitted That Met QC Criteria: April 7, 2021
• First Posted (ACTUAL): April 12, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 2, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: CEIM/HU/2020/50

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No