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

NCT04768790 | Suspended

• 1 other identifier: PG/2020/16818
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (6)

• Change from Baseline Neck Disability Index at 10 weeks and 12 months

  Neck Disability Index, a self-administered 10-item questionnaire concerning neck pain disability, rates the intensity of pain and its disabling effects on typical daily activities. The score, expressed as a percentage, ranges from 0 (no disability) to 100 (maximum disability). Investigators used the Italian version which proved to be reliable and valid

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

• Change from Baseline Tampa Scale of Kinesiophobia at 10 weeks and 12 months

  Tampa Scale of Kinesiophobia is a self-report questionnaire that assesses pain beliefs and pain-related fear of movement/reinjury in subjects with musculoskeletal complaints. the 13-item Italian version ranges from 13 (best health status) to 52 (worst health status).

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

• Change from Baseline Pain Catastrophizing Scale at 10 weeks and 12 months

  Pain Catastrophizing Scale assesses catastrophizing in subjects with musculoskeletal complaints, and consists of a 13-item self-report questionnaire. The total score ranges from 0 to 52 with 52 indicating the worst health status. Investigators used the Italian version which proved to be reliable and valid.

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

• Change from Baseline Numerical Rating Scale at 10 weeks and 12 months

  Numerical Rating Scale assesses pain intensity using an 11-pointnumerical rating scale ranging from 0 (no pain) to10 (the worst imaginable pain).

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

• Change from Baseline Short-Form Health Survey Questionnaire at 10 weeks and 12 months

  Quality of life is assessed using the Italian version of the self-report Short-Form Health Survey with its eight domain scores ranging from 0 (the worst perceived quality of life) to 100 (the best perceived quality of life).

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

• Change from Baseline Global Perceived Effect at 10 weeks and 12 months

  Global Perceived Effect is a self-administered measure of treatment satisfaction consisting of a five-level Likert scale (1=helped a lot, 2=helped, 3=helped only a little, 4=did not help, 5=made things worse).

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

Secondary Outcomes (2)

• Change from Baseline Work Ability Index at 10 weeks and 12 months

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

• Change from Baseline of Anamnestic survey of the upper limbs and spine's pathologies at 10 weeks and 12 months

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

Study Arms (2)

Multidisciplinary Group

EXPERIMENTAL

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. Ergonomic consultancy.

Other: multidisciplinary program

General Group

ACTIVE COMPARATOR

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

Other: General program

Interventions

multidisciplinary program OTHER

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. Ergonomic consultancy.

Multidisciplinary Group

General program OTHER

exercises for muscle strengthening, regional stretching and spinal mobilization. Ergonomic consultancy.

General Group

Eligibility Criteria

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

You may qualify if:

• diagnosis of chronic non-specific neck pain
• documented history of pain lasting more than 3 months
• good knowledge of the Italian language
• age over 18.

You may not qualify if:

• acute and subacute neck pain
• cognitive impairment
• presence of specific causes of neck pain (history of spinal surgery, spinal deformity, herniated disc, infection, fracture, myelopathy or malignancy, whiplash injury, systemic or neuromuscular disease, cognitive impairment) evaluated by medical history and diagnostics for images
• have previously undergone cognitive-behavioral therapy.

Sponsors & Collaborators

• University of Cagliari: lead

Study Sites (1)

University of Cagliari

Cagliari, 09100, Italy

Location

Related Publications (1)

• Monticone M, Simone Vullo S, Lecca LI, Meloni F, Portoghese I, Campagna M. Effectiveness of multimodal exercises integrated with cognitive-behavioral therapy in working patients with chronic neck pain: protocol of a randomized controlled trial with 1-year follow-up. Trials. 2022 May 21;23(1):425. doi: 10.1186/s13063-022-06340-7.

  PMID: 35597965 DERIVED

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marco Monticone, MD, PhD

  Dept. Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: December 13, 2020
• First Posted: February 24, 2021
• Study Start: November 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 4, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)