Convergence Dialogue Meeting With or Without Neck-specific Exercise Promoting Work Ability

NCT04928989 | Withdrawn

• 1 other identifier: 2021-00373
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

The study will be conducted at workplaces, where the work environment and tasks increase employee risk of developing neck problems. A total of 320 participants will be recruited consecutively and after informed consent randomized to convergenge dialogue meeting with or without neck-specific exercise. The main outcome measure is work ability, measured via the Work Ability Score.

Conditions

Workplace

Keywords

Neck pain; Workplace; Counceling; Exercise; Internet-based intervention

Outcome Measures

Primary Outcomes (1)

• Work Ability Score

  Current work ability compared to when it was at its best

  Change in work Ability Score from baseline, to every month until the 15 month follow-up

Secondary Outcomes (36)

• Intensity of pain and bothersomeness

  change from baseline to 3 month and 15 month follow-up

• Frequency of pain, symtoms and medications

  change from baseline to 3 month and 15 month follow-up

• Neck specific function

  change from baseline to 3 month and 15 month follow-up

• Symptom satisfaction

  change from baseline to 3 month and 15 month follow-up

• Exercise/physical activity level

  change from baseline to 3 month and 15 month follow-up

Other Outcomes (7)

• profession

  baseline

• Background data

  baseline

• ICD 10 code

  baseline

Study Arms (2)

Convergence dialogue meeting

ACTIVE COMPARATOR

Digital counceling with convergence dialogue tripartite meeting. will be conducted in accordance with work dialogue for return to work. Workplace dialogue among employee with neck problems, an expert in the work environment, and the immediate manager. The purpose of the conversations is, in open dialogue, to reach a common understanding of the situation and identify possible interventions to maintain or improve the employee´s work ability.

Other: convergence dialogue meeting

Neck-specific exercise in addition to convergence dialogue meeting

EXPERIMENTAL

Neck-specific exercise with digital web-based support and four visits to a physiotherapist. Neck-specific exercise will be performed based on a well-structured framework of neck-specific exercise for facilitation of deep neck muscles, increased muscle coordination, improved neck posture and increased neck muscle endurance. Plus additional convergence dialogue meeting as treatment arm no 1.

Other: convergence dialogue meeting

Interventions

convergence dialogue meeting OTHER

Digital counceling with convergence dialogue tripartite meeting. will be conducted in accordance with work dialogue for return to work. Workplace dialogue among employee with neck problems, an expert in the work environment, and the immediate manager. The purpose of the conversations is, in open dialogue, to reach a common understanding of the situation and identify possible interventions to maintain or improve the employee´s work ability.

Convergence dialogue meeting; Neck-specific exercise in addition to convergence dialogue meeting

Eligibility Criteria

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

You may qualify if:

• Self-reported neck problems that the person experiences as troublesome, affecting ability to perform work, and lasting at least 4 weeks.
• Neck problems as being predominant.
• Current neck pain ≥ 3 on the numeric rating scale (0-10) \[53, 55\].
• Persons of working age, 18-65 years, who have a permanent job.
• Neck problems clinically verified through a clinical examination to ensure study criteria are met.
• Answers the baseline questionnaire and attends the first intervention visit.
• Confirms being motivated to participate and completes and signs informed consent, including approval, to contact their immediate supervisor regarding a CDM.

You may not qualify if:

• Red flags and illness/injury that are contraindicated for or hinder exercise or may be confounding factors for the results, such as severe cardiovascular/lung disease, malignancy, severe rheumatic disease, severe neurological disease, spinal cord injury, diagnosed severe mental illness, drug or alcohol abuse, neck surgery, neck fracture or dislocation, severe cervical radiculopathy, myelopathy, general body pain (e.g., fibromyalgia, Ehlers-Danlos syndrome, generalized osteoarthritis).
• Known pregnancy.
• Cannot understand/communicate in Swedish and thus would be unable to understand information in the study.
• Patients who cannot imagine refraining from non-steroid anti-inflammatory drugsduring 2 days before microdialysis may not participate in the microdialysis part of the study.
• Hypersensitivity to anesthetic and antibiotics.
• Increased tendency to bleed and use of blood-thinning drugs.

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (2)

Anneli Peolsson

Linköping, Östergötland County, 58183, Sweden

Location

Dep. Medical and Health Sciences, Physiotherapy

Linköping, Östergötland County, 58183, Sweden

Location

MeSH Terms

Conditions

Neck Pain; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomization will take place from a computer-based generated randomization list developed by a statistician. Randomization will be handled by a person not involved in intervention or evaluation. Investigators/ asessors will be blinded for randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD, MSc PT, MSc HRMD

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 18, 2021
• Study Start: May 1, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)