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

NCT ID: NCT04841642

Last Updated: 2022-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2022-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

MANUAL THERAPY

Intervention Type: OTHER

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

THERAPEUTIC EXERCISE

Intervention Type: 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 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.

Group Type: ACTIVE_COMPARATOR

MANUAL THERAPY

Intervention Type: OTHER

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

THERAPEUTIC EXERCISE

Intervention Type: 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.

Interventions

MANUAL THERAPY

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

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Jaén

OTHER

Sponsor Role: lead

Responsible Party

Alexander Achalandabaso

Doctor of Health Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexander Achalandabaso, PhD

Role: STUDY_DIRECTOR

University of Jaen

Locations

Cristina

Santa Brígida, Las Palmas, Spain

Countries

Spain

Other Identifiers

CEIM/HU/2020/50

Identifier Type: -

Identifier Source: org_study_id