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

NCT04841642 | Completed

• 1 other identifier: CEIM/HU/2020/50
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Non-specific Neck Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Changes in the health-related quality of life

  Baseline, 8 weeks and 2 month after intervention.

• Changes in depression and anxiety

  Baseline, 8 weeks and 2 month after intervention.

• Changes in Kinesiophobia

  Baseline, 8 weeks and 2 month after intervention.

• Changes in the pain: Visual Analog Scale (VAS)

  Baseline, 8 weeks and 2 month after intervention.

• Adherence to treatment

  At 4 and 8 weeks of treatment

Study Arms (2)

Manual therapy and a telerehabilitation program

EXPERIMENTAL

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; Other: THERAPEUTIC EXERCISE

Manual therapy and recommendations for home exercises

ACTIVE COMPARATOR

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; Other: THERAPEUTIC EXERCISE

Interventions

MANUAL THERAPY OTHER

The investigators will apply manual therapy for ten minutes a week, for 8 weeks, based on cervical mobilizations and suboccipital inhibitions.

Manual therapy and a telerehabilitation program; Manual therapy and recommendations for home exercises

THERAPEUTIC EXERCISE OTHER

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.

Manual therapy and a telerehabilitation program; Manual therapy and recommendations for home exercises

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jaén: lead

Study Sites (1)

Cristina

Santa Brígida, Las Palmas, 35308, Spain

Location

MeSH Terms

Interventions

Musculoskeletal Manipulations; Exercise Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Alexander Achalandabaso, PhD

  University of Jaen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Health Sciences

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 12, 2021
• Study Start: November 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: August 31, 2022
• Last Updated: November 2, 2022

Record last verified: 2022-11

Locations

ES (1)