Effects of Multimodal Exercises Integrated With Cognitive-behavioral Therapy in Subjects With Chronic Neck Pain

Neck Pain Clinical Trial

Official title: Effects of Multimodal Exercises Integrated With Cognitive-behavioral Therapy in Subjects With Chronic Neck Pain: a Randomized Controlled Study With One Year Follow-up

Status Suspended

Clinical Trial Summary

The etiology of cervical pain is multifactorial and studies based on the bio-psychosocial model also link chronic neck pain to psychological factors. Among them, kinesiophobia has been reported as an important determinant. Over time, the use of multidisciplinary interventions for chronic vertebral pain (instead of segmental treatments) has grown in order to improve disability, pain and proactive behaviors towards the problem manifested. To date, the evidence relating to the effects of multidisciplinary approaches is inconclusive and lacking. In light of these premises, it appears necessary to deepen the conduct of studies aimed at evaluating the efficacy of a multidisciplinary rehabilitation program that integrates cognitive-behavioral therapy based on kinesiophobia with specific exercises, in the treatment of chronic neck pain of working subjects.

Clinical Trial Description

Background The etiology of cervical pain is multifactorial and includes age, gender, incongruous postures, repeated efforts. Studies based on the bio-psychosocial model also link chronic neck pain to psychological factors. Among them, kinesiophobia has been reported as an important determinant. It is debatable whether interventions targeting cognitive processes and pain-associated behaviors can lead to clinically significant changes in terms of disability, pain and quality of life of these individuals.

Furthermore, there is uncertainty about the effectiveness of the types of exercises to be proposed. This makes it difficult to choose between general exercises (aimed at improving cervical muscle and joint skills) and motor-oriented (or task-oriented) exercises (aimed at cervical functional recovery in an ecological context). Over time, the use of multidisciplinary interventions for chronic vertebral pain (instead of segmental treatments) has grown in order to improve disability, pain and proactive behaviors towards the problem manifested. To date, the evidence relating to the effects of multidisciplinary approaches is inconclusive and lacking. In light of these premises, it appears necessary to deepen the conduct of studies aimed at evaluating the efficacy of a multidisciplinary rehabilitation program that integrates cognitive-behavioral therapy based on kinesiophobia with specific exercises, in the treatment of chronic neck pain of working subjects.

Hypothesis The hypothesis is that a multidisciplinary rehabilitation program induces clinically significant and long-term improvements in the disability, pain and quality of life of working subjects with chronic neck pain.

Objectives of the study Verify the effectiveness of a multidisciplinary program in inducing clinically significant and long-term improvements in the disability, pain and quality of life of working subjects suffering from chronic neck pain. Evaluate the work discomfort linked to the condition of chronic neck pain.

Study procedure The subjects eligible for the study will be assigned to one of two treatment programs (multidisciplinary or general) using a permuted block randomization procedure.

The interventions will be offered by a psychologist and two physiotherapists of equal experience, responsible separately for the multidisciplinary and general groups. Each participant will be assessed individually by postural observation, cervical and muscle mobility examination. Based on this evaluation, the exercises will be planned and performed on a single patient. Patients assigned to the multidisciplinary team will meet with a psychologist once a week.

Description of the interventions of the multidisciplinary program: multimodal exercises to improve, through gradual exposure, cervical mobility, postural control and strengthening of the cervical muscles; stabilization techniques for the deep neck muscles; task-oriented exercises maintaining the activation of the deep spinal muscle. Under the supervision of a psychologist, the subjects will also be involved in cognitive-behavioral therapy aimed at modifying the fear of movement (kinesiophobia) and the maladaptive behavior of the disease.

Description of the interventions of the general program: exercises for muscle strengthening, regional stretching and spinal mobilization.

Description of the interventions that will be carried out on both groups: ergonomic consultancy. At the end of the treatment, patients will be asked to continue with the exercises at home. At the end of each session a control of the program performed will be conducted based on a manual that includes the complete list of exercises to be performed. Patients' GPs will be asked to avoid referrals for other visits / other treatments while the programs are running.

Type of data collected:

• Personal and anthropometric data; lifestyle habits; work, pharmacological and pathological history; levels of neck disability, kinesiophobia, catastrophism, intensity of pain, quality of life, work discomfort.

Questionnaires will be administered before treatment, ten weeks after (post-treatment) and 12 months after the end of treatment (follow-up).

At the end of the treatment, subjects will be asked to rate the effectiveness of the treatment using a Likert Global Perceived Effect scale. Using a specific form, patients will be asked to report any symptoms they experience during the study that may require further treatment.

The end date of the follow up will be considered that of December 31, 2021.

The effects of the treatment between the two groups over time will be analyzed through the use of linear models with mixed effects for repeated measurements. The differences between the two groups relating to measures with non-normal distribution will be analyzed by Mann-Whitney U test. The null hypothesis will be rejected for p values> 0.05 (two-tailed test). ;

Related Conditions & MeSH terms

• Neck Pain

• NCT number: NCT04768790
• Study type: Interventional
• Source: University of Cagliari
• Status: Suspended
• Phase: N/A
• Start date: November 1, 2020
• Completion date: December 31, 2024